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Effectiveness of Agency for Health Care Policy and Research clinical practice guideline and patient education methods for pregnant smokers in Medicaid maternity care
Effectiveness of Agency for Health Care Policy and Research clinical practice guideline and patient education methods for pregnant smokers in Medicaid maternity care Richard A. Windsor, PhD,a Lesa L. Woodby, PhD,a Thomas M. Miller, MD,b J. Michael Hardin, PhD,a Myra A. Crawford, PhD,a and Carlo C. DiClemente, PhDc Birmingham and Montgomery, Alabama, and Baltimore, Maryland OBJECTIVE: The purposes of this study were (1) to determine the extent to which tobacco exposure assessment and new patient education methods, derived from a meta-analysis and the Agency for Health Care Policy and Research guideline recommendations, could be provided routinely by trained Medicaid maternity care staff members and (2) to document the behavioral impact of these interventions among pregnant smokers. STUDY DESIGN: After 265 pregnant smokers were assigned at their first visit to an experimental group (n = 139) or a control group (n = 126), they received standardized risk information and were advised to quit smoking. The experimental group also received evidence-based patient education methods, including the videocassette Commit to Quit During and After Pregnancy, the publication A Pregnant Woman’s Guide to Quit Smoking, and a brief counseling session. Self-report and saliva cotinine assessments of tobacco exposure were performed at baseline and at the end of pregnancy. RESULTS: A significantly higher percentage of patients quit smoking in the experimental group (17.3%) than in the control group (8.8%). CONCLUSIONS: The application of principles of organizational development and quality improvement at the management and clinical practice levels and the delivery of evidence-based health education methods by trained prenatal care providers significantly increased smoking cessation rates among pregnant Medicaid recipients. (Am J Obstet Gynecol 2000;182:68-75.)
Key words: Agency for Health Care Policy and Research guideline, effectiveness, Medicaid maternity care, patient education methods, pregnant smokers
Tobacco exposure during and after pregnancy causes maternal, fetal, and infant morbidity and mortality.1, 2 Although the self-reported smoking rate among pregnant women declined from about 20% in 19902 to 14% in 1996,3 ≥530,000 pregnant patients annually (13.6% × 3.9 million births)3 continue to smoke after entry into obstetric care. Of the 1.52 million patients receiving
From the University of Alabama at Birmingham,a the Bureau of Family Health Services, Alabama Department of Public Health,b and the University of Maryland at Baltimore County.c Funded by grant HL RO1 56010 02, National Heart, Lung, and Blood Institute (1997-2001). Presented at the Sixteenth World Conference on Health Promotion and Health Education, San Juan, Puerto Rico, June 1998; at the Annual Meeting of the American Public Health Association, Washington, D.C., November 1998; and at the Tobacco Control in Managed Care Symposium, San Diego, California, February 1999. Received for publication January 28, 1999; revised and accepted August 3, 1999. Reprint requests: Richard A. Windsor, PhD, Research Professor and SCRIPT Principal Investigator, The University of Alabama at Birmingham, Education BLDG, Room 232R, 901 13th St S, Birmingham, AL 35294-1250. Copyright © 2000 by Mosby, Inc. 0002-9378/2000 $12.00 + 0 6/1/100135
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Medicaid obstetric care (39%4 × 3.9 million births3), 435,000 (28.6%)5 were self-reported smokers. The actual smoking prevalence rate is higher, however, because bias from patient nonresponse to surveys5 and deception6, 7 were not considered in estimating the prevalence rate during pregnancy. When nonresponse and deception are considered, the prevalence rate after entry into care is ≥20% (780,000) for the US maternity cohort and 35%5 (530,000) among patients receiving Medicaid care. Thus about two thirds of the pregnant smokers in the United States are Medicaid recipients. The size8 and demographic characteristics4, 5 of the Medicaid population, the multiple risks associated with smoking,1, 2 and the associated health care costs9 have significant implications for managed care organizations, public health agencies, and health care providers. The most recent national tobacco control initiative with significant implications for managed care organization and public health agency maternity care program providers was the dissemination in 1996 of the Smoking Cessation Clinical Practice Guideline by the Agency for Health Care Policy and Research.10 The guideline reported that patient education methods, if provided rou-
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tinely to smokers by trained health care providers, can significantly change behavior. Health Plan Employer Data and Information Set performance measures for tobacco (3.0), although problematic because of concerns about data reliability and validity, were also disseminated in 1996 by the National Commission on Quality Assurance. Because of the recent date of dissemination of the guideline and the Health Plan Employer Data and Information Set and National Commission on Quality Assurance performance measures, no empiric data have been published about their impact on provider clinical practices and patient smoking behaviors. Smoking Cessation or Reduction in Pregnancy Trial (SCRIPT) This is the first evaluation report of the 5-year (19972001) SCRIPT supported by the National Institutes of Health. SCRIPT was designed to confirm the effectiveness11 of patient education methods (derived from a meta-analysis and from the Agency for Health Care Policy and Research guideline recommendations) delivered by trained regular staff members to a representative sample of pregnant smokers whose care was supported by Medicaid. It was critical to conduct a rigorous formative evaluation11 before initiation of such a trial designed to change public health Medicaid policies and clinical practices for a statewide prenatal care system. This evaluation had five objectives: (1) To identify, randomly select, and recruit eligible sites and patients representative of the Alabama Medicaid maternity population; (2) to establish practice-science partnerships with state, area, and clinic Medicaid program managers and prenatal care providers; (3) to recruit and train staff members at eligible sites; (4) to document the extent to which recommended, new patient education methods could routinely be provided by regular staff members to pregnant patients who smoked; and (5) to evaluate the behavioral impact of the new patient education methods. Study design Statewide organizational and policy development methods. A critical step at the onset of planning was to involve program managers of Medicaid maternity care services in the preparation of the organizational development plan to introduce and to evaluate evidence-based educational methods at multiple service sites.12, 13 A formal contract and management-science partnership between tobacco control research specialists at the University of Alabama at Birmingham and directors of services in the Bureau of Family Health Services of the Alabama Department of Public Health were established to implement project plans. A SCRIPT management committee, which consisted of Bureau of Family Health Services medical (obstetric), nursing, social services, and nutrition and WIC (Women, Infants, and Children program) management
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personnel and University of Alabama at Birmingham health education specialists, was created to make all policy decisions. A consensus-building process was initiated in the joint preparation of the National Institutes of Health proposal and was maintained by regular communications and planning meetings. Selection of Medicaid maternity care sites and patients. The SCRIPT management committee designed a site selection process to yield a representative sample of the state’s population of pregnant smokers receiving Medicaid-supported care. Among the >60,000 infants born each year in Alabama, ≥30,000 (about 50%) were born to patients in the Medicaid system.4, 14 Self-reported smoking rates by race of patients receiving Medicaid in all 67 counties were derived from the 1996 Alabama maternal-child statistics data set.14 Because a county needed ≥50 pregnant smokers per year (≥1 per week) to be eligible for SCRIPT, 50 counties were excluded. The 17 eligible counties provided services to about 40% of the annual Medicaid maternity census. After these 17 counties were stratified by percentages of black and white population and numbers of pregnant smokers into 8 clusters, a 50% sample of 8 counties was randomly selected. The SCRIPT cohort was derived from the 10 maternity care sites in the 8 randomly selected counties. These sites annually provide services to approximately 20% of the new Medicaid maternity census. A comparison of the 1996 maternal and infant health vital statistics14 among the SCRIPT counties (n = 8), SCRIPT-eligible counties (n = 9), and noneligible counties (n = 50) confirmed that there were no significant differences in infant mortality rates; low birth weight rates; percentages of persons receiving WIC and family planning services; and percentages of black and white population. Site organizational development and training methods. Orientation discussions were held with the nursing, social services and WIC program administrators of the participating public health areas before meetings were held with county site staff members. All nurses, social workers, and WIC program staff members and nutritionists from each of the 10 sites (approximately 80) attended on-site SCRIPT orientation sessions during March and April 1997. The same consensus development procedures used to create the SCRIPT management committee were used to establish partnerships at the 10 study sites. Participation was voluntary for sites and staff members. A Practice Advisory Committee with 1 representative per site was established to ensure input from the field to the SCRIPT management committee. The practice advisory committee reviewed and approved all policies, procedures, instruments, and materials. A 1-day progress review meeting of the SCRIPT management committee and practice advisory committee was held annually to assess all aspects of SCRIPT. Although almost all staff members were interested in
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determining the validity of patient self-reports of tobacco exposure and in documenting whether the new counseling methods were more effective than existing methods, concerns were expressed about increases in time spent at each visit with each pregnant smoker. This issue was addressed by examining the number of smokers counseled on each intake day and the time spent by each type of service provider at each site. At the site with the highest census (≥800 new maternity patients per year) an average of 200 pregnant patients who smoked entered care each year. About 4 new smokers were seen per week—≤1 smoker per day. With 2 nurses to provide care this site needed to reorganize its procedures and time only enough to allow for 1 new pregnant smoker or no new pregnant smokers on a given day. Patient flow analysis of maternity care practices. Patient flow analyses, which were conducted in August and September 1997, documented for ≥2 patients per site the type of services provided and the time per provider from sign-in to exit. Because assessment of tobacco use was already part of the normal intake process by each provider, site practices were reviewed to determine the methods used to identify current smokers. With SCRIPT staff guidance and patient flow analysis data we reached a consensus about how each site would reorganize its patient education procedures and the time (3-5 minutes) spent with each new smoker. The patient flow analysis, consensus building approach, and practice advisory committee discussions assuaged staff concerns about time and other issues. Evaluation research design Phase 1. The objectives of phase 1 were to randomly select and to recruit a representative sample of Alabama Medicaid maternity care sites and to document their patients’ smoking prevalence rate, passive smoke exposure rate, and smoking behavioral change rate. A site plan for integrating the new patient assessment methods into routine care was jointly developed by the University of Alabama at Birmingham and site staff members during training meetings (2 hours at each site) in May and June 1997. Tobacco exposures of all site staff members were documented by self-report and saliva cotinine test, providing them with personal experience of the same methods used to assess patient tobacco exposure and cotinine values. During a 4-week period in July 1997 all new patients were routinely screened at their first visit by clinic staff members to confirm their smoking status. This was a natural history study. Among the 443 patients screened, only 6 smokers and 16 nonsmokers refused to participate. Approximately 95% (n = 421) consented to provide a saliva sample and complete a 2-page self-administered baseline form. Smoking status after entry into care of the 93 self-reported smokers at baseline was docu-
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mented by means of an assessment at a regular clinic visit within 30 to 90 days. Sites transmitted the patient baseline and follow-up assessment forms by fax within ≤24 hours to the SCRIPT data coordinator by means of the TELEform computer software system (Cardiff Software, Inc, Vista, Calif). Phase 1 was completed in December 1997. Phase 2. Phase 2 was designed to train prenatal care staff members, to field-test the new patient education methods and data-collection procedures, and to produce biochemically confirmed estimates of the rates of smoking cessation and significant reduction among patients. We affirmed staff expertise by having each clinic select the practitioner who would be the primary patient educator to provide the new procedures. In September 1997 site training was provided in 2-hour sessions to teach the primary patient educators how to provide the new patient education methods. Among the 1100 new patients screened by site staff members between October 1997 and January 1998, a total of 172 of the 290 self-reported smokers (60%) agreed to participate in the field test. Of these 172 smokers, 80% were randomly assigned to the experimental group (n = 139). Only 20% of the smokers (n = 34) were randomly assigned to the control group because the phase 1 natural history study confirmed valid estimates of smoking prevalence and the normal rate of change in tobacco use of patients after the onset of maternity care. Phase 1 (n = 93) and phase 2 (n = 34) smokers were combined to form a total control group of 126 for experimental and control group baseline and follow-up comparisons. The 4:1 ratio of experimental to control group patients was also selected to give staff members multiple opportunities to provide the new patient education methods. Phase 2, which included patient follow-up assessments, was completed in December 1998. Patient education methods for pregnant smokers. Patient treatment methods were organized into 4 standard practice behaviors: ask, advise, assist, and arrange.10 The health education procedures provided by staff members to experimental and control group patients are described in Fig 1. Control group patient education methods. Control group patients had their tobacco use status identified at their first visit by a self-report (ask) and a saliva sample. Each patient was informed of the serious health risks to mother, fetus, and infant and received a strong, clear, personal message to quit smoking and to eliminate passive exposure (ETS) (advise). Experimental group patient education methods. In addition to the ask and advise components, experimental group patients were provided a 3-component patient education program (assist and arrange). Component 1, a videocassette entitled Commit to Quit During and After
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Fig 1. SCRIPT model: Brief cessation counseling for pregnant smokers.
Pregnancy,15 was developed (1) to enhance the patient’s motivation to quit smoking, (2) to ensure patient exposure to recommended smoking cessation skills, and (3) to significantly reduce counseling time. After a brief overview (1 minute) about the purposes of the patient education program, each patient viewed the 14-minute videocassette in private. The videocassette presents 3 salient motivational concepts: (1) strong visual and personal verbal messages about maternal, fetal, and infant risk; (2) promotion of patient self-efficacy and outcome expectations through testimonials of pregnant smokers who had quit smoking; and (3) demonstration of behavioral skills to quit smoking. Because 80% of these smokers lived with at least another smoker, each patient was also given the videocassette to take home to help her to establish a smoke-free residence. More than 90% of phase 1 and phase 2 patients expressed their readiness to quit smoking, contemplation or preparation stage of change. Stage of change,16 however, had not been a predictor of smoking cessation in our previous trial with 814 pregnant smokers.6, 17 Accordingly, although the videocassette content was designed to increase patient motivation, the empiric evidence from >1000 patients did not support the use of
varying stage-based intervention methods for pregnant smokers under Medicaid care. Component 2, A Pregnant Woman’s Guide to Quit Smoking,18 was given to each patient to review while she watched the videocassette, especially in reference to day 1 skills. This tailored guide uses a self-directed, 7-day smoking cessation plan that teaches patients 12 problemsolving and coping skills related to smoking cessation. The social learning (cognitive) theory19 was used in Birmingham trial I20 and trial II6 as the conceptual framework to develop the guide18 and the counseling methods. Our central theme was to enhance self-efficacy and outcome expectations. All primary patient educators, the practice advisory committee, and a sample of 30 patients participated in focus group sessions during phase 2 to help define the final structure, process, and content of the guide, videocassette, and patient counseling session. Three former pregnant smokers who had successfully used the guide and videocassette to quit smoking served as SCRIPT consultants. Patient-centered counseling component. After experimental group patients viewed the videocassette and concurrently reviewed day 1 of the guide, they received
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Table I. Meta-analysis23 of effectiveness of A Pregnant Woman’s Guide to Quit Smoking18 Experimental group Principal investigator
Year
Site
Lowe Gebauer Hartmann Valbo Windsor O’Conner Hjalmarson Windsor
1998 1998 1996 1994 1993 1992 1991 1985
Australia Ohio NC Norway‡ Ala Canada§ Sweden Ala
Walsh Burlington Ershoff Sexton
1997 1991 1989 1984
Australia Md Calif Md
Control group
No.
%
No.
%
Risk ratio
95% Confidence interval*
Nurse and physician (obstetric) Nurse Physician (obstetric) Physician (obstetric) Health educator Nurse Physician and nurse (obstetric) Health educator
56 84 107 161 400 101 417 102
9 16 20 25 14 12 13 14
58 94 100 155 100 101 231 104
0 0 10 8 3 5 8 2
10.9† 21.0† 2.3 4.0 5.3 2.6 1.7 8.0
10.9-121.6 21.0-135.0 2.3 -4.4 4.0-7.3 5.3-14.2 2.6-6.4 1.7 -2.7 8.0-27.7
Nurse and physician (obstetric) Physician Health educator Nurse
127 70 126 395
12 13 22 27
125 69 116 388
0 6 17 3
15.0† 2.3 1.4 12.0
15.0-76.0 2.3-6.5 1.4-2.40 12.0-20.2
Provider
*1-tailed test. †Assumes control group ≤1%. ‡Combined data from 2 studies. §French and English.
component 3, a patient-centered counseling session of ≤5 minutes. This component (assist) was designed also to increase motivation and to help each patient prepare a personal action plan to quit smoking. By means of a structured patient interaction form the patient and provider briefly reviewed the risks associated with smoking and rewards of quitting smoking, clarified concerns, and discussed what the patient had learned from the videocassette and guide. Each patient was asked to describe her “preparation” plans (dates, times, and actions); to say when she would use the guide to begin the smoking cessation process; and to set a smoking cessation date. The patient was asked to sign a written agreement to use the guide. Chart reminder forms were placed in experimental group patients’ records to prompt staff members to assess smoking status at each visit (arrange). Measurement of tobacco exposure. At the first prenatal visit after informed consent was given, all patients completed a brief self-administered baseline form and provided a saliva sample. During a routine visit ≥60 days after the first visit, smoking status was again documented by means of the self-report form and a saliva cotinine test. Because a dose-response relationship among maternal smoking, infant birth weight, and significant reduction in cotinine values has been established, significant reduction was measured in terms of a ≥31-ng/mL cutoff. A patient was considered to have achieved a significant reduction if the follow-up cotinine value was ≥50% less than the baseline cotinine level.6, 20-22 Meta-analysis of the effectiveness of patient education methods. A review of the literature23 was performed before a final decision was made about the evidence base for SCRIPT patient education methods. Our meta-analysis applied 3 screening criteria: (1) documentation of experimental and control group baseline comparability,
(2) independent confirmation of patient self-reports of smoking status, and (3) documentation of a significantly higher smoking cessation rate in the experimental group than in the control group. Twelve of 32 evaluation studies that met these 3 criteria are presented in chronologic order in Table I.23 The first 8 studies shared 3 salient characteristics: (1) Each translated and adapted the guide18 to their language, patient population, and prenatal care setting; (2) each confirmed the feasibility of routine delivery of the guide to patients by differently trained providers; (3) all 8 documented a higher smoking cessation rate in the experimental group than in the control group. The combined risk ratio and experimental and control group smoking cessation rates for the 8 studies in Table I were as follows: relative risk, 2.9; experimental group smoking cessation rate, 15.1% (n = 1428 patients); and control group smoking cessation rate, 5.3% (n = 943 patients). On the basis of this evidence, the Agency for Health Care Policy and Research guideline, National Cancer Institute practice recommendations, and the tailored guide were used to define and standardize the SCRIPT patient education procedures. Results Process evaluation. Of the 1540 patients screened in phase 1 and phase 2, a total of 25.3% (n = 389) reported being smokers. Among the 265 self-reported pregnant smokers who participated, 84% were white. Cotinine analysis of phase 1 data confirmed a 24% deception rate among patients who reported not being smokers at their first visit. Most of the deception (50%) in this study occurred among patients who said at their first visit that they had quit smoking after conception. If the same deception rate is assumed for phase 2 patients from the same sites, the smoking prevalence rate among Alabama patients receiving Medicaid in 1997 at the onset of care
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Table II. Experimental and control group baseline comparability Baseline variables
Experimental group
Control group
Mean age (y) Black (%) Gestational age (mo) Readiness to quit smoking score* Amount smoked (cigarettes/d) ≥1 smoker in home (%) Mean cotinine level (ng/mL)
23 18 2.2 2.0 10 77 204 N = 139
23 14 3.0 2.0 10 84 201 N = 126
TOTAL SAMPLE
Table IV. Experimental and control group effectiveness rates
Behavior
Experimental Control group group
Smoking cessation rate (%) Significant reduction rate (%) No significant change (%) TOTAL SAMPLE
Odds ratio
95% Confidence interval (1-tailed)
17.3
8.8
2.2
2.2-4.1
21.7
15.8
1.5
1.5-2.6
61.0
75.4
0.51
0.51-0.80
N = 139
N = 126
*0 is negative; 3 is positive.
Table III. Experimental and control group comparison of mediating behavioral variables Process variables High perceived infant harm (%) High perceived maternal harm (%) New home ETS policy (%) Smoking cessation attempts after first visit Tried to quit smoking, 24 h (%) Tried to quit smoking, ≥1 wk (%) Amount smoked (cigarettes/d)
Experimental group
Control group
72 78 50 1.8
45 65 32 1.2
72 44 7.5
66 39 10.4
was 44%, 60% among white patients and 20% among black patients. These data, combined with published evaluation study reports6, 7 documenting deception rates of 28% and 50% by means of cotinine tests, confirm a substantial problem of nondisclosure of tobacco use by pregnant Medicaid-eligible patients. Data in Table II confirm experimental and control group baseline comparability. Baseline characteristics of phase 1 and phase 2 refusals (n = 124) versus participants (n = 265) revealed no significant differences by race, age, or estimated gestational age. About 70% of the eligible smokers agreed to participate in phase 1 and phase 2. Among the 139 experimental group patients, only 1 did not view the videocassette at the site. Our consensus development training sessions and technical assistance with specific quarterly performance feedback to each site produced a significant change in the clinical practice behaviors of 28 maternity care providers (primary patient educators) and other providers at 10 sites during an 18-month period. This is the first empiric evidence to confirm the feasibility of routine delivery by regular staff members of Agency for Health Care Policy and Research–recommended evidence-based patient education methods for pregnant smokers. Data in Table III present an experimental and control group comparison of the impact of the intervention on variables associated with patient smoking cessation. Although experimental and control group patient re-
Table V. Experimental and control group cotinine values at baseline and follow-up Experimental group
Behavior Smoking cessation Significant reduction No significant change
Baseline
Followup
97 228 218
4 77 188
Control group
Baseline 40 238 195
Followup 4 79 183
All values are in nanograms per milliliter.
sponses to each question in Table III reflect, in part, social desirability, these data suggested a consistently larger intervention effect among experimental group patients. Impact evaluation. Data in Table IV confirm that the experimental group smoking cessation rate was significantly higher than the control group rate, and data in Table V present the cotinine level changes by group. Smoking cessation rates did not vary by race. As noted, the average baseline cotinine value of those in the experimental group who quit smoking was 97 ng/mL (moderate tobacco exposure), in contrast to the corresponding control group value of 40 ng/mL (very light tobacco exposure). The SCRIPT intervention assisted a significantly higher percentage of heavier smokers to quit smoking during pregnancy. These are the first data to confirm the effectiveness of Agency for Health Care Policy and Research–recommended evidence-based educational methods for pregnant smokers. Patients who reported smoking cessation at follow-up and whose saliva cotinine value was ≤30 ng/mL were counted as quitting smoking. Only 10% who reported smoking cessation had a cotinine value ≥31 ng/mL. Patients unavailable for follow-up or with insufficient saliva samples were counted as continuing smokers. These data documented achievement of a “patient follow-up” site performance measure of ≥90%. The baseline characteristics of the 34 patients unavailable for follow-
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up (13%) and the patients who were followed up were not significantly different. The significant reduction rates for the experimental and control group were not statistically different. As noted in Table V, however, the average decrease in cotinine values was about 65% among those with significant reduction in both the experimental group and the control group, 228 ng/mL to 77 ng/mL in the experimental group and 238 ng/mL to 79 ng/mL in the control group. Thus a large percentage of very heavy smokers in both the experimental group and the control group (≥200 ng/mL) reduced their tobacco exposure. These data, combined with the results of our previous studies of significant reduction,6, 20-22 confirmed that significant reduction was an additional measure of behavioral impact and harm reduction, especially among heavier smokers. Comment These process and impact data confirmed successful achievement of the 5 SCRIPT formative evaluation objectives. We finalized all procedures with this evidencebased insight and initiated SCRIPT phase 3 in May 1998. We are currently documenting among a cohort of >1200 pregnant smokers (>600 in the experimental group and >600 in the control group) whether the new health education methods (1) can be routinely delivered during a 24-month period by regular staff members (feasibility), (2) can produce significant changes in patient smoking behavior (effectiveness), and (3) can significantly increase infant birth weight (clinical impact) among a statewide representative sample of Medicaid-supported patients. This insight is not currently available in the smoking and pregnancy evaluation research literature. These results can be contrasted with those reported by the Smoking Cessation in Pregnancy study7 conducted by the Centers for Disease Control and Prevention from 1990 through 1993 among patients receiving Medicaid at 64 prenatal clinics in Colorado (n = 1741 patients), Maryland (n = 1936 patients), and Missouri (n = 1895 patients). The Smoking Cessation in Pregnancy study—the only study in the United States comparable in scope, purposes, and sample size to SCRIPT—was designed to evaluate the effectiveness of new patient education methods delivered by public health prenatal care staff members. Substantial problems were encountered by clinic staff members in the routine performance of the new patient assessment and patient education methods at multiple sites in all 3 states. The Smoking Cessation in Pregnancy study patient education methods for pregnant smokers were not effective (3% smoking cessation rate in the experimental group and 3% smoking cessation rate in the control group)23 in part because that program was unable to conduct phase 1 and phase 2 formative evaluation studies. This evaluation demonstrated that evidence-based pa-
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tient education methods with policy and management support, specific practice guidance, and staff training were superior to the usual care (informational) methods provided to pregnant smokers. We documented the feasibility and effectiveness of these new methods among diverse care practices. The integration of new evidencebased methods into the clinical practices of multiple service providers and into a Medicaid system of care in transition, however, was a challenging and complex process. These results were especially encouraging because the Bureau of Family Health Services of the Alabama Department of Public Health and SCRIPT sites throughout phases 1, 2, and 3 have been undergoing a significant transition from the traditional public health prenatal care services system to a Medicaid-funded maternity care system as mandated by the Health Care Financing Administration. Dissemination of new evidence-based patient education methods by managed care organizations and public health agencies to providers must consider the following lessons learned by SCRIPT in their efforts to change clinical practice behaviors. The application of a consensus development–quality improvement philosophy was critical to the establishment of partnerships with the state and area level administrators of Medicaid-supported program services. Strong productive practice-science linkages must be created at the practice level by means of the same team-building methods. The philosophy of providing “best clinical practice” methods was an important theme used to persuade the 80 professional staff members and 28 primary patient educators at the 10 sites to participate in a rigorous evaluation of existing and new clinical procedures. Policy, structure, process, and content of patient assessment and patient education methods must be thoroughly and jointly reviewed by all stakeholders at each site to define appropriate modifications. Training sessions must reflect a flexible consensus building approach to make optimal use of provider knowledge. Specific performance benchmarks of practice behaviors (Health Plan Employer Data and Information Set measures) must be jointly defined and routinely monitored to document individual provider and site implementation progress. Sufficient time, personnel, technical expertise, and implementation resources must be available to conduct all of these developmental activities, so that the new methods being introduced have a real opportunity for routine delivery to patients. An increasing percentage of patients whose care is supported by Medicaid will be enrolled throughout the United States in managed health care plans within the coming years.24 An estimated two thirds of pregnant smokers in obstetric care will be Medicaid recipients. In a 1997 survey of the tobacco control activities of 550 eligible managed care organizations, almost half of the respondents indicated that pregnant women composed
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their major target member group.25 Thus multiple salient factors confirm a significant need and a commitment among managed care organizations and public health agencies to expand their organizational efforts in tobacco control. This study and related reports provide excellent evidence-based insight about how health care plans and providers can integrate Agency for Health Care Policy and Research–recommended patient education methods into clinical practices. The success of the SCRIPT phase 1, 2, and 3 activities has been achieved because of the consistent and enthusiastic support of the following colleagues: Don Williamson, MD, State Health Officer, Alabama Department of Public Health; Sherry George, Phyllis Gilchrist, Laurie Stout, Sharon Gerogiannis, Connie McMichael, Wendy Blackmon, and Martha Kreauter, SCRIPT Management Committee, Alabama Department of Public Health, Bureau of Family Health Services; Robert Azadian, Toya Russell, Stephanie Chisolm, Baoyi Zheng, and Karen Cole, University of Alabama; Vanessa Mills, Addie Hightower, Lora Harris, Jackie Strickland, Leslie Turner, Lesa Cotton, Candace Adkins, Marla Odom, Suzie Harrison, and Blyth Keith, Practice Advisory Committee; Mario Orlandi, PhD, and Johnson and Johnson Health Care System, Inc, consultants; Nancy Krivit, Florida Department of Public Health; and David Schlundt, PhD, Vanderbilt University. REFERENCES
1. Hasselmeyer E, Meyer M, Catz C. Pregnancy and infant health. In: Smoking and health: a report of the Surgeon General. Washington: Office of Smoking and Health, Dept. of Health, Education, and Welfare (US); 1979. Publication No.: 79-50066. 2. Healthy people 2000: national health promotion and disease prevention objectives. Midcourse review and 1995 revisions. Washington: Dept. of Health and Human Services (US); 1996. 3. Centers for Disease Control and Prevention, National Center for Health Statistics. Monthly Vital Statistics Report. Table 4: live births by race of mother. Vital Health Stat 21 1997;46(1 Suppl 2):12. 4. Health Policy Studies Division. State Medicaid coverage of pregnant women and children for 1997: National Governor’s Association issue brief. 1998. p. 8. 5. Office of Applied Studies, Substance Abuse and Mental Health Services Administration. Preliminary results from the 1996 national household survey on drug abuse [table 32b]. Rockville (MD): SAMHSA; 1997. p. 90. DHHS publication No.: (SMA) 997-3149. 6. Windsor RA, Lowe JB, Perkins LL, Smith-Yoder D, Artz L, Crawford M, et al. Health education for pregnant smokers: its behavioral impact and cost benefit. Am J Public Health 1993;83:201-6. 7. Kendrick JS, Zahniser SC, Miller N, Salas N, Stine J, Gargiullo PM, et al. Integrating smoking cessation into routine public prenatal care: the Smoking Cessation in Pregnancy project. Am J Public Health 1995;85:217-22.
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8. Windsor RA, Li CQ, Lowe JB, Perkins LL, Ershoff D, Glynn T. The dissemination of smoking cessation methods for pregnant women: achieving the year 2000 objectives. Am J Public Health 1993;83;173-8. 9. Li CQ, Windsor RA, Lowe JB, Goldenberg RL. Evaluation of the impact of dissemination of smoking cessation methods on the low birthweight rate and on health care costs: achieving year 2000 objectives for the nation. Am J Prev Med 1992;8;171-7. 10. Fiore MC, Bailey WC, Cohen SJ, et al. Smoking cessation. Clinical practice guideline No.: 18. Rockville(MD): Dept. of Health and Human Services (US), Public Health Service, Agency for Health Care Policy and Research; 1996 Apr. AHCPR Publication No.: 96-0692. 11. Windsor RA, Baranowski T, Clark N, Cutter G. Evaluation of health promotion, health education and disease prevention programs. 2nd ed. Mountain View (CA): Mayfield; 1994. p. 14. 12. Abrams D, Orleans C, Niaura R, Goldman M, Prochaska J, Velicer W. Integrating individual and public health perspectives for treatment of tobacco dependence under managed health care: a combined stepped-care and matching model. Ann Behav Med 1996;18:290-304. 13. Solberg LI, Kottke TE, Brekke ML, Calomeni CA, Conn SA, Davidson G. Using continuous quality improvement to increase preventive services in clinical practice: going beyond guidelines. Prev Med 1996;25:259-67. 14. Woolbright A, Henderson N. Alabama selected maternal-child statistics data set: 1996. Montgomery (AL): Alabama Department of Public Health, Center for Health Statistics; 1997. 15. Windsor R, Crawford M, Woodby L. Commit to quit during and after pregnancy [videocassette]. Birmingham (AL): University of Alabama at Birmingham Medical Television; 1998. 16. Prochaska JO, DiClemente CC. Stages and processes of selfchange of smoking: toward an integrative model of change. J Consult Clin Psychol 1983;51:390-5. 17. Woodby LL, Windsor RA, Snyder SW, Kohler CL, Diclemente CC. Predictors of smoking cessation during pregnancy. Addiction 1999;94:283-92. 18. Windsor R. A pregnant woman’s guide to quit smoking. 5th ed. Washington: Society for Public Health Education; 1998. ISBN 0935105-01-8 (1985). Available from The Society for Public Health Education, 750 First St NE, Suite 910, Washington, DC 20002-4242. Telephone (202)408-9804. Fax (202)408-9815. E-mail [email protected]. (1-20 review copies, $6 per copy; request bulk prices.) 19. Bandura A. Social learning theory. Englewood Cliffs (NJ): Prentice-Hall; 1977. 20. Windsor RA, Cutter G, Morris J, Reese Y, Manzella B, Bartlett EE, et al. The effectiveness of smoking cessation methods for smokers in public health maternity clinics: a randomized trial. Am J Public Health, 1985;75:1389-92. 21. Li CQ, Windsor RA, Perkins L, Goldenberg RL, Lowe JB. The impact on infant birth weight and gestational age of cotinine-validated smoking reduction during pregnancy. JAMA 1993;269:1519-24. 22. Windsor R, Li C, Boyd N, Hartmann K. The use of significant reduction rates to evaluate health education methods for pregnant smokers: a new harm reduction-behavioral indicator. Health Educ Behav 1999;94:283-92. 23. Windsor R, Boyd N, Orleans T. A meta-evaluation of smoking cessation intervention research among pregnant women: improving the science and art. Health Educ Res Theory Pract 1998;13:419-38. 24. Felt-Lisk S, Yang S. Changes in health plans serving Medicaid, 1993-1996. Health Aff (Millwood) 1997;16:125-33. 25. Schuessler L. Addressing tobacco in managed care organizations: report of the Prudential Center for Health Care Research. Atlanta: Prudential Center for Health Care Research; 1998.
Key words: Agency for Health Care Policy and Research guideline, effectiveness, Medicaid maternity care, patient education methods, pregnant smokers
Tobacco exposure during and after pregnancy causes maternal, fetal, and infant morbidity and mortality.1, 2 Although the self-reported smoking rate among pregnant women declined from about 20% in 19902 to 14% in 1996,3 ≥530,000 pregnant patients annually (13.6% × 3.9 million births)3 continue to smoke after entry into obstetric care. Of the 1.52 million patients receiving
From the University of Alabama at Birmingham,a the Bureau of Family Health Services, Alabama Department of Public Health,b and the University of Maryland at Baltimore County.c Funded by grant HL RO1 56010 02, National Heart, Lung, and Blood Institute (1997-2001). Presented at the Sixteenth World Conference on Health Promotion and Health Education, San Juan, Puerto Rico, June 1998; at the Annual Meeting of the American Public Health Association, Washington, D.C., November 1998; and at the Tobacco Control in Managed Care Symposium, San Diego, California, February 1999. Received for publication January 28, 1999; revised and accepted August 3, 1999. Reprint requests: Richard A. Windsor, PhD, Research Professor and SCRIPT Principal Investigator, The University of Alabama at Birmingham, Education BLDG, Room 232R, 901 13th St S, Birmingham, AL 35294-1250. Copyright © 2000 by Mosby, Inc. 0002-9378/2000 $12.00 + 0 6/1/100135
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Medicaid obstetric care (39%4 × 3.9 million births3), 435,000 (28.6%)5 were self-reported smokers. The actual smoking prevalence rate is higher, however, because bias from patient nonresponse to surveys5 and deception6, 7 were not considered in estimating the prevalence rate during pregnancy. When nonresponse and deception are considered, the prevalence rate after entry into care is ≥20% (780,000) for the US maternity cohort and 35%5 (530,000) among patients receiving Medicaid care. Thus about two thirds of the pregnant smokers in the United States are Medicaid recipients. The size8 and demographic characteristics4, 5 of the Medicaid population, the multiple risks associated with smoking,1, 2 and the associated health care costs9 have significant implications for managed care organizations, public health agencies, and health care providers. The most recent national tobacco control initiative with significant implications for managed care organization and public health agency maternity care program providers was the dissemination in 1996 of the Smoking Cessation Clinical Practice Guideline by the Agency for Health Care Policy and Research.10 The guideline reported that patient education methods, if provided rou-
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tinely to smokers by trained health care providers, can significantly change behavior. Health Plan Employer Data and Information Set performance measures for tobacco (3.0), although problematic because of concerns about data reliability and validity, were also disseminated in 1996 by the National Commission on Quality Assurance. Because of the recent date of dissemination of the guideline and the Health Plan Employer Data and Information Set and National Commission on Quality Assurance performance measures, no empiric data have been published about their impact on provider clinical practices and patient smoking behaviors. Smoking Cessation or Reduction in Pregnancy Trial (SCRIPT) This is the first evaluation report of the 5-year (19972001) SCRIPT supported by the National Institutes of Health. SCRIPT was designed to confirm the effectiveness11 of patient education methods (derived from a meta-analysis and from the Agency for Health Care Policy and Research guideline recommendations) delivered by trained regular staff members to a representative sample of pregnant smokers whose care was supported by Medicaid. It was critical to conduct a rigorous formative evaluation11 before initiation of such a trial designed to change public health Medicaid policies and clinical practices for a statewide prenatal care system. This evaluation had five objectives: (1) To identify, randomly select, and recruit eligible sites and patients representative of the Alabama Medicaid maternity population; (2) to establish practice-science partnerships with state, area, and clinic Medicaid program managers and prenatal care providers; (3) to recruit and train staff members at eligible sites; (4) to document the extent to which recommended, new patient education methods could routinely be provided by regular staff members to pregnant patients who smoked; and (5) to evaluate the behavioral impact of the new patient education methods. Study design Statewide organizational and policy development methods. A critical step at the onset of planning was to involve program managers of Medicaid maternity care services in the preparation of the organizational development plan to introduce and to evaluate evidence-based educational methods at multiple service sites.12, 13 A formal contract and management-science partnership between tobacco control research specialists at the University of Alabama at Birmingham and directors of services in the Bureau of Family Health Services of the Alabama Department of Public Health were established to implement project plans. A SCRIPT management committee, which consisted of Bureau of Family Health Services medical (obstetric), nursing, social services, and nutrition and WIC (Women, Infants, and Children program) management
Windsor et al 69
personnel and University of Alabama at Birmingham health education specialists, was created to make all policy decisions. A consensus-building process was initiated in the joint preparation of the National Institutes of Health proposal and was maintained by regular communications and planning meetings. Selection of Medicaid maternity care sites and patients. The SCRIPT management committee designed a site selection process to yield a representative sample of the state’s population of pregnant smokers receiving Medicaid-supported care. Among the >60,000 infants born each year in Alabama, ≥30,000 (about 50%) were born to patients in the Medicaid system.4, 14 Self-reported smoking rates by race of patients receiving Medicaid in all 67 counties were derived from the 1996 Alabama maternal-child statistics data set.14 Because a county needed ≥50 pregnant smokers per year (≥1 per week) to be eligible for SCRIPT, 50 counties were excluded. The 17 eligible counties provided services to about 40% of the annual Medicaid maternity census. After these 17 counties were stratified by percentages of black and white population and numbers of pregnant smokers into 8 clusters, a 50% sample of 8 counties was randomly selected. The SCRIPT cohort was derived from the 10 maternity care sites in the 8 randomly selected counties. These sites annually provide services to approximately 20% of the new Medicaid maternity census. A comparison of the 1996 maternal and infant health vital statistics14 among the SCRIPT counties (n = 8), SCRIPT-eligible counties (n = 9), and noneligible counties (n = 50) confirmed that there were no significant differences in infant mortality rates; low birth weight rates; percentages of persons receiving WIC and family planning services; and percentages of black and white population. Site organizational development and training methods. Orientation discussions were held with the nursing, social services and WIC program administrators of the participating public health areas before meetings were held with county site staff members. All nurses, social workers, and WIC program staff members and nutritionists from each of the 10 sites (approximately 80) attended on-site SCRIPT orientation sessions during March and April 1997. The same consensus development procedures used to create the SCRIPT management committee were used to establish partnerships at the 10 study sites. Participation was voluntary for sites and staff members. A Practice Advisory Committee with 1 representative per site was established to ensure input from the field to the SCRIPT management committee. The practice advisory committee reviewed and approved all policies, procedures, instruments, and materials. A 1-day progress review meeting of the SCRIPT management committee and practice advisory committee was held annually to assess all aspects of SCRIPT. Although almost all staff members were interested in
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determining the validity of patient self-reports of tobacco exposure and in documenting whether the new counseling methods were more effective than existing methods, concerns were expressed about increases in time spent at each visit with each pregnant smoker. This issue was addressed by examining the number of smokers counseled on each intake day and the time spent by each type of service provider at each site. At the site with the highest census (≥800 new maternity patients per year) an average of 200 pregnant patients who smoked entered care each year. About 4 new smokers were seen per week—≤1 smoker per day. With 2 nurses to provide care this site needed to reorganize its procedures and time only enough to allow for 1 new pregnant smoker or no new pregnant smokers on a given day. Patient flow analysis of maternity care practices. Patient flow analyses, which were conducted in August and September 1997, documented for ≥2 patients per site the type of services provided and the time per provider from sign-in to exit. Because assessment of tobacco use was already part of the normal intake process by each provider, site practices were reviewed to determine the methods used to identify current smokers. With SCRIPT staff guidance and patient flow analysis data we reached a consensus about how each site would reorganize its patient education procedures and the time (3-5 minutes) spent with each new smoker. The patient flow analysis, consensus building approach, and practice advisory committee discussions assuaged staff concerns about time and other issues. Evaluation research design Phase 1. The objectives of phase 1 were to randomly select and to recruit a representative sample of Alabama Medicaid maternity care sites and to document their patients’ smoking prevalence rate, passive smoke exposure rate, and smoking behavioral change rate. A site plan for integrating the new patient assessment methods into routine care was jointly developed by the University of Alabama at Birmingham and site staff members during training meetings (2 hours at each site) in May and June 1997. Tobacco exposures of all site staff members were documented by self-report and saliva cotinine test, providing them with personal experience of the same methods used to assess patient tobacco exposure and cotinine values. During a 4-week period in July 1997 all new patients were routinely screened at their first visit by clinic staff members to confirm their smoking status. This was a natural history study. Among the 443 patients screened, only 6 smokers and 16 nonsmokers refused to participate. Approximately 95% (n = 421) consented to provide a saliva sample and complete a 2-page self-administered baseline form. Smoking status after entry into care of the 93 self-reported smokers at baseline was docu-
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mented by means of an assessment at a regular clinic visit within 30 to 90 days. Sites transmitted the patient baseline and follow-up assessment forms by fax within ≤24 hours to the SCRIPT data coordinator by means of the TELEform computer software system (Cardiff Software, Inc, Vista, Calif). Phase 1 was completed in December 1997. Phase 2. Phase 2 was designed to train prenatal care staff members, to field-test the new patient education methods and data-collection procedures, and to produce biochemically confirmed estimates of the rates of smoking cessation and significant reduction among patients. We affirmed staff expertise by having each clinic select the practitioner who would be the primary patient educator to provide the new procedures. In September 1997 site training was provided in 2-hour sessions to teach the primary patient educators how to provide the new patient education methods. Among the 1100 new patients screened by site staff members between October 1997 and January 1998, a total of 172 of the 290 self-reported smokers (60%) agreed to participate in the field test. Of these 172 smokers, 80% were randomly assigned to the experimental group (n = 139). Only 20% of the smokers (n = 34) were randomly assigned to the control group because the phase 1 natural history study confirmed valid estimates of smoking prevalence and the normal rate of change in tobacco use of patients after the onset of maternity care. Phase 1 (n = 93) and phase 2 (n = 34) smokers were combined to form a total control group of 126 for experimental and control group baseline and follow-up comparisons. The 4:1 ratio of experimental to control group patients was also selected to give staff members multiple opportunities to provide the new patient education methods. Phase 2, which included patient follow-up assessments, was completed in December 1998. Patient education methods for pregnant smokers. Patient treatment methods were organized into 4 standard practice behaviors: ask, advise, assist, and arrange.10 The health education procedures provided by staff members to experimental and control group patients are described in Fig 1. Control group patient education methods. Control group patients had their tobacco use status identified at their first visit by a self-report (ask) and a saliva sample. Each patient was informed of the serious health risks to mother, fetus, and infant and received a strong, clear, personal message to quit smoking and to eliminate passive exposure (ETS) (advise). Experimental group patient education methods. In addition to the ask and advise components, experimental group patients were provided a 3-component patient education program (assist and arrange). Component 1, a videocassette entitled Commit to Quit During and After
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Fig 1. SCRIPT model: Brief cessation counseling for pregnant smokers.
Pregnancy,15 was developed (1) to enhance the patient’s motivation to quit smoking, (2) to ensure patient exposure to recommended smoking cessation skills, and (3) to significantly reduce counseling time. After a brief overview (1 minute) about the purposes of the patient education program, each patient viewed the 14-minute videocassette in private. The videocassette presents 3 salient motivational concepts: (1) strong visual and personal verbal messages about maternal, fetal, and infant risk; (2) promotion of patient self-efficacy and outcome expectations through testimonials of pregnant smokers who had quit smoking; and (3) demonstration of behavioral skills to quit smoking. Because 80% of these smokers lived with at least another smoker, each patient was also given the videocassette to take home to help her to establish a smoke-free residence. More than 90% of phase 1 and phase 2 patients expressed their readiness to quit smoking, contemplation or preparation stage of change. Stage of change,16 however, had not been a predictor of smoking cessation in our previous trial with 814 pregnant smokers.6, 17 Accordingly, although the videocassette content was designed to increase patient motivation, the empiric evidence from >1000 patients did not support the use of
varying stage-based intervention methods for pregnant smokers under Medicaid care. Component 2, A Pregnant Woman’s Guide to Quit Smoking,18 was given to each patient to review while she watched the videocassette, especially in reference to day 1 skills. This tailored guide uses a self-directed, 7-day smoking cessation plan that teaches patients 12 problemsolving and coping skills related to smoking cessation. The social learning (cognitive) theory19 was used in Birmingham trial I20 and trial II6 as the conceptual framework to develop the guide18 and the counseling methods. Our central theme was to enhance self-efficacy and outcome expectations. All primary patient educators, the practice advisory committee, and a sample of 30 patients participated in focus group sessions during phase 2 to help define the final structure, process, and content of the guide, videocassette, and patient counseling session. Three former pregnant smokers who had successfully used the guide and videocassette to quit smoking served as SCRIPT consultants. Patient-centered counseling component. After experimental group patients viewed the videocassette and concurrently reviewed day 1 of the guide, they received
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Table I. Meta-analysis23 of effectiveness of A Pregnant Woman’s Guide to Quit Smoking18 Experimental group Principal investigator
Year
Site
Lowe Gebauer Hartmann Valbo Windsor O’Conner Hjalmarson Windsor
1998 1998 1996 1994 1993 1992 1991 1985
Australia Ohio NC Norway‡ Ala Canada§ Sweden Ala
Walsh Burlington Ershoff Sexton
1997 1991 1989 1984
Australia Md Calif Md
Control group
No.
%
No.
%
Risk ratio
95% Confidence interval*
Nurse and physician (obstetric) Nurse Physician (obstetric) Physician (obstetric) Health educator Nurse Physician and nurse (obstetric) Health educator
56 84 107 161 400 101 417 102
9 16 20 25 14 12 13 14
58 94 100 155 100 101 231 104
0 0 10 8 3 5 8 2
10.9† 21.0† 2.3 4.0 5.3 2.6 1.7 8.0
10.9-121.6 21.0-135.0 2.3 -4.4 4.0-7.3 5.3-14.2 2.6-6.4 1.7 -2.7 8.0-27.7
Nurse and physician (obstetric) Physician Health educator Nurse
127 70 126 395
12 13 22 27
125 69 116 388
0 6 17 3
15.0† 2.3 1.4 12.0
15.0-76.0 2.3-6.5 1.4-2.40 12.0-20.2
Provider
*1-tailed test. †Assumes control group ≤1%. ‡Combined data from 2 studies. §French and English.
component 3, a patient-centered counseling session of ≤5 minutes. This component (assist) was designed also to increase motivation and to help each patient prepare a personal action plan to quit smoking. By means of a structured patient interaction form the patient and provider briefly reviewed the risks associated with smoking and rewards of quitting smoking, clarified concerns, and discussed what the patient had learned from the videocassette and guide. Each patient was asked to describe her “preparation” plans (dates, times, and actions); to say when she would use the guide to begin the smoking cessation process; and to set a smoking cessation date. The patient was asked to sign a written agreement to use the guide. Chart reminder forms were placed in experimental group patients’ records to prompt staff members to assess smoking status at each visit (arrange). Measurement of tobacco exposure. At the first prenatal visit after informed consent was given, all patients completed a brief self-administered baseline form and provided a saliva sample. During a routine visit ≥60 days after the first visit, smoking status was again documented by means of the self-report form and a saliva cotinine test. Because a dose-response relationship among maternal smoking, infant birth weight, and significant reduction in cotinine values has been established, significant reduction was measured in terms of a ≥31-ng/mL cutoff. A patient was considered to have achieved a significant reduction if the follow-up cotinine value was ≥50% less than the baseline cotinine level.6, 20-22 Meta-analysis of the effectiveness of patient education methods. A review of the literature23 was performed before a final decision was made about the evidence base for SCRIPT patient education methods. Our meta-analysis applied 3 screening criteria: (1) documentation of experimental and control group baseline comparability,
(2) independent confirmation of patient self-reports of smoking status, and (3) documentation of a significantly higher smoking cessation rate in the experimental group than in the control group. Twelve of 32 evaluation studies that met these 3 criteria are presented in chronologic order in Table I.23 The first 8 studies shared 3 salient characteristics: (1) Each translated and adapted the guide18 to their language, patient population, and prenatal care setting; (2) each confirmed the feasibility of routine delivery of the guide to patients by differently trained providers; (3) all 8 documented a higher smoking cessation rate in the experimental group than in the control group. The combined risk ratio and experimental and control group smoking cessation rates for the 8 studies in Table I were as follows: relative risk, 2.9; experimental group smoking cessation rate, 15.1% (n = 1428 patients); and control group smoking cessation rate, 5.3% (n = 943 patients). On the basis of this evidence, the Agency for Health Care Policy and Research guideline, National Cancer Institute practice recommendations, and the tailored guide were used to define and standardize the SCRIPT patient education procedures. Results Process evaluation. Of the 1540 patients screened in phase 1 and phase 2, a total of 25.3% (n = 389) reported being smokers. Among the 265 self-reported pregnant smokers who participated, 84% were white. Cotinine analysis of phase 1 data confirmed a 24% deception rate among patients who reported not being smokers at their first visit. Most of the deception (50%) in this study occurred among patients who said at their first visit that they had quit smoking after conception. If the same deception rate is assumed for phase 2 patients from the same sites, the smoking prevalence rate among Alabama patients receiving Medicaid in 1997 at the onset of care
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Table II. Experimental and control group baseline comparability Baseline variables
Experimental group
Control group
Mean age (y) Black (%) Gestational age (mo) Readiness to quit smoking score* Amount smoked (cigarettes/d) ≥1 smoker in home (%) Mean cotinine level (ng/mL)
23 18 2.2 2.0 10 77 204 N = 139
23 14 3.0 2.0 10 84 201 N = 126
TOTAL SAMPLE
Table IV. Experimental and control group effectiveness rates
Behavior
Experimental Control group group
Smoking cessation rate (%) Significant reduction rate (%) No significant change (%) TOTAL SAMPLE
Odds ratio
95% Confidence interval (1-tailed)
17.3
8.8
2.2
2.2-4.1
21.7
15.8
1.5
1.5-2.6
61.0
75.4
0.51
0.51-0.80
N = 139
N = 126
*0 is negative; 3 is positive.
Table III. Experimental and control group comparison of mediating behavioral variables Process variables High perceived infant harm (%) High perceived maternal harm (%) New home ETS policy (%) Smoking cessation attempts after first visit Tried to quit smoking, 24 h (%) Tried to quit smoking, ≥1 wk (%) Amount smoked (cigarettes/d)
Experimental group
Control group
72 78 50 1.8
45 65 32 1.2
72 44 7.5
66 39 10.4
was 44%, 60% among white patients and 20% among black patients. These data, combined with published evaluation study reports6, 7 documenting deception rates of 28% and 50% by means of cotinine tests, confirm a substantial problem of nondisclosure of tobacco use by pregnant Medicaid-eligible patients. Data in Table II confirm experimental and control group baseline comparability. Baseline characteristics of phase 1 and phase 2 refusals (n = 124) versus participants (n = 265) revealed no significant differences by race, age, or estimated gestational age. About 70% of the eligible smokers agreed to participate in phase 1 and phase 2. Among the 139 experimental group patients, only 1 did not view the videocassette at the site. Our consensus development training sessions and technical assistance with specific quarterly performance feedback to each site produced a significant change in the clinical practice behaviors of 28 maternity care providers (primary patient educators) and other providers at 10 sites during an 18-month period. This is the first empiric evidence to confirm the feasibility of routine delivery by regular staff members of Agency for Health Care Policy and Research–recommended evidence-based patient education methods for pregnant smokers. Data in Table III present an experimental and control group comparison of the impact of the intervention on variables associated with patient smoking cessation. Although experimental and control group patient re-
Table V. Experimental and control group cotinine values at baseline and follow-up Experimental group
Behavior Smoking cessation Significant reduction No significant change
Baseline
Followup
97 228 218
4 77 188
Control group
Baseline 40 238 195
Followup 4 79 183
All values are in nanograms per milliliter.
sponses to each question in Table III reflect, in part, social desirability, these data suggested a consistently larger intervention effect among experimental group patients. Impact evaluation. Data in Table IV confirm that the experimental group smoking cessation rate was significantly higher than the control group rate, and data in Table V present the cotinine level changes by group. Smoking cessation rates did not vary by race. As noted, the average baseline cotinine value of those in the experimental group who quit smoking was 97 ng/mL (moderate tobacco exposure), in contrast to the corresponding control group value of 40 ng/mL (very light tobacco exposure). The SCRIPT intervention assisted a significantly higher percentage of heavier smokers to quit smoking during pregnancy. These are the first data to confirm the effectiveness of Agency for Health Care Policy and Research–recommended evidence-based educational methods for pregnant smokers. Patients who reported smoking cessation at follow-up and whose saliva cotinine value was ≤30 ng/mL were counted as quitting smoking. Only 10% who reported smoking cessation had a cotinine value ≥31 ng/mL. Patients unavailable for follow-up or with insufficient saliva samples were counted as continuing smokers. These data documented achievement of a “patient follow-up” site performance measure of ≥90%. The baseline characteristics of the 34 patients unavailable for follow-
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up (13%) and the patients who were followed up were not significantly different. The significant reduction rates for the experimental and control group were not statistically different. As noted in Table V, however, the average decrease in cotinine values was about 65% among those with significant reduction in both the experimental group and the control group, 228 ng/mL to 77 ng/mL in the experimental group and 238 ng/mL to 79 ng/mL in the control group. Thus a large percentage of very heavy smokers in both the experimental group and the control group (≥200 ng/mL) reduced their tobacco exposure. These data, combined with the results of our previous studies of significant reduction,6, 20-22 confirmed that significant reduction was an additional measure of behavioral impact and harm reduction, especially among heavier smokers. Comment These process and impact data confirmed successful achievement of the 5 SCRIPT formative evaluation objectives. We finalized all procedures with this evidencebased insight and initiated SCRIPT phase 3 in May 1998. We are currently documenting among a cohort of >1200 pregnant smokers (>600 in the experimental group and >600 in the control group) whether the new health education methods (1) can be routinely delivered during a 24-month period by regular staff members (feasibility), (2) can produce significant changes in patient smoking behavior (effectiveness), and (3) can significantly increase infant birth weight (clinical impact) among a statewide representative sample of Medicaid-supported patients. This insight is not currently available in the smoking and pregnancy evaluation research literature. These results can be contrasted with those reported by the Smoking Cessation in Pregnancy study7 conducted by the Centers for Disease Control and Prevention from 1990 through 1993 among patients receiving Medicaid at 64 prenatal clinics in Colorado (n = 1741 patients), Maryland (n = 1936 patients), and Missouri (n = 1895 patients). The Smoking Cessation in Pregnancy study—the only study in the United States comparable in scope, purposes, and sample size to SCRIPT—was designed to evaluate the effectiveness of new patient education methods delivered by public health prenatal care staff members. Substantial problems were encountered by clinic staff members in the routine performance of the new patient assessment and patient education methods at multiple sites in all 3 states. The Smoking Cessation in Pregnancy study patient education methods for pregnant smokers were not effective (3% smoking cessation rate in the experimental group and 3% smoking cessation rate in the control group)23 in part because that program was unable to conduct phase 1 and phase 2 formative evaluation studies. This evaluation demonstrated that evidence-based pa-
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tient education methods with policy and management support, specific practice guidance, and staff training were superior to the usual care (informational) methods provided to pregnant smokers. We documented the feasibility and effectiveness of these new methods among diverse care practices. The integration of new evidencebased methods into the clinical practices of multiple service providers and into a Medicaid system of care in transition, however, was a challenging and complex process. These results were especially encouraging because the Bureau of Family Health Services of the Alabama Department of Public Health and SCRIPT sites throughout phases 1, 2, and 3 have been undergoing a significant transition from the traditional public health prenatal care services system to a Medicaid-funded maternity care system as mandated by the Health Care Financing Administration. Dissemination of new evidence-based patient education methods by managed care organizations and public health agencies to providers must consider the following lessons learned by SCRIPT in their efforts to change clinical practice behaviors. The application of a consensus development–quality improvement philosophy was critical to the establishment of partnerships with the state and area level administrators of Medicaid-supported program services. Strong productive practice-science linkages must be created at the practice level by means of the same team-building methods. The philosophy of providing “best clinical practice” methods was an important theme used to persuade the 80 professional staff members and 28 primary patient educators at the 10 sites to participate in a rigorous evaluation of existing and new clinical procedures. Policy, structure, process, and content of patient assessment and patient education methods must be thoroughly and jointly reviewed by all stakeholders at each site to define appropriate modifications. Training sessions must reflect a flexible consensus building approach to make optimal use of provider knowledge. Specific performance benchmarks of practice behaviors (Health Plan Employer Data and Information Set measures) must be jointly defined and routinely monitored to document individual provider and site implementation progress. Sufficient time, personnel, technical expertise, and implementation resources must be available to conduct all of these developmental activities, so that the new methods being introduced have a real opportunity for routine delivery to patients. An increasing percentage of patients whose care is supported by Medicaid will be enrolled throughout the United States in managed health care plans within the coming years.24 An estimated two thirds of pregnant smokers in obstetric care will be Medicaid recipients. In a 1997 survey of the tobacco control activities of 550 eligible managed care organizations, almost half of the respondents indicated that pregnant women composed
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their major target member group.25 Thus multiple salient factors confirm a significant need and a commitment among managed care organizations and public health agencies to expand their organizational efforts in tobacco control. This study and related reports provide excellent evidence-based insight about how health care plans and providers can integrate Agency for Health Care Policy and Research–recommended patient education methods into clinical practices. The success of the SCRIPT phase 1, 2, and 3 activities has been achieved because of the consistent and enthusiastic support of the following colleagues: Don Williamson, MD, State Health Officer, Alabama Department of Public Health; Sherry George, Phyllis Gilchrist, Laurie Stout, Sharon Gerogiannis, Connie McMichael, Wendy Blackmon, and Martha Kreauter, SCRIPT Management Committee, Alabama Department of Public Health, Bureau of Family Health Services; Robert Azadian, Toya Russell, Stephanie Chisolm, Baoyi Zheng, and Karen Cole, University of Alabama; Vanessa Mills, Addie Hightower, Lora Harris, Jackie Strickland, Leslie Turner, Lesa Cotton, Candace Adkins, Marla Odom, Suzie Harrison, and Blyth Keith, Practice Advisory Committee; Mario Orlandi, PhD, and Johnson and Johnson Health Care System, Inc, consultants; Nancy Krivit, Florida Department of Public Health; and David Schlundt, PhD, Vanderbilt University. REFERENCES
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