ORIGINAL RESEARCH
Do State Restrictions on Advanced Practice Registered Nurses Impact Patient Outcomes for Hypertension and Diabetes Control? Deanna E. Grimes, DrPH, RN, Eric J. Thomas, MD, MPH, Nikhil S. Padhye, PhD, Madelene J. Ottosen, PhD, RN, and Richard M. Grimes, MBA, PhD ABSTRACT
The Institute of Medicine recommends that nurses practice to the full extent of their education and training, yet, state regulations continue to limit the scope of practice for advanced practice registered nurses (APRNs). One reason is the unproven belief that patient outcomes will be inferior if APRNs practice without regulations. This study examined whether the absence of restrictions on APRNs results in inferior outcomes for patients with hypertension or diabetes. We used publicly available data for patients seen in Federally Qualified Community Health Centers during 2013 in 6 states with the most restrictions and in 10 states with the least restrictions. Keywords: advance practice registered nurses, nurse practitioners, patient outcomes, primary care, state regulations on scope of practice Ó 2018 Elsevier Inc. All rights reserved.
BACKGROUND
T
he current shortage of primary care providers in the United States has been exacerbated by aging of the population, increases in chronic diseases in the population, and increasing insurance coverage of primary care.1 Advanced practice registered nurses (APRNs), also referred to as nurse practitioners (NPs), can add to the primary care workforce. We are using the term of APRN in this report unless referring to published works that use the term NP. Since 1995, several meta-analyses, systematic reviews, and randomized trials have shown that APRNs provide primary care of equal quality as primary care physicians and are seen by patients as being better at educating and counseling them about healthrelated issues.2-8 These findings were recently confirmed in a study showing that advanced practice clinicians (NPs and physician assistants) were no more likely to order guideline-discordant medications or diagnostic procedures than physicians.9 The American Association of Nurse Practitioners10 reported 222,000 APRNs were licensed to 620
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practice in the United States in 2016, with 20,000 new APRNs entering the workforce yearly. It also reported 83.4% were certified in an area of primary care. This is occurring at a time when the Association of American Medical Colleges is estimating that there will be a shortage of 45,000 primary care physicians by 2020 in the US.11 APRNs can facilitate care during the shortage because they are more likely to locate in areas with fewer physicians per capita.12 Recognizing the importance of APRNs in primary care, the National Academy of Medicine (NAM), formerly the Institute of Medicine, recommended that nurses practice to the full extent of their education and training.13 The NAM, however, notes that regulations defining scope-of-practice limitations vary widely by state and limit the ability of APRNs to practice.14 Significant opposition exists to allowing APRNs to practice at the full scope of their education and training. The American Academy of Family Physicians has taken the position that “Granting independent practice to nurse practitioners would be creating two classes of care: one run by physician-led teams and one Volume 14, Issue 8, September 2018
run by less qualified health professionals. Americans should not be forced into this two-tier scenario. Everyone deserves to be under the care of a doctor.”15p7 The American Medical Association published an 11-part statement on Guidelines for Integrated Practice of Physician and Nurse Practitioner. Six of these statements clearly state that physicians should supervise the care provided by NPs.16 The Council of Medical Specialty Societies (CMSS) has also issued a statement opposing the NAM recommendations based on the disparity in hours of education between physicians and APRNs.17 The differences between the NAM recommendations and physician society concerns are reflected in the patchwork of state laws regulating APRN scope of practice, which range from independent practice to close supervision by a physician. The 2010 NAM report identified 4 major categories that characterize physician involvement in care provided by APRNs: (1) requirement for physician involvement for prescriptions; (2) requirement for on-site oversight by physicians; (3) quantitative requirements for review of APRN charts; and (4) maximum APRN-tophysician ratios. The same NAM report differentiated all 50 states according to their regulatory requirements. The NAM categorized 6 states (Alabama, Missouri, Nevada, South Dakota, Texas, and Virginia) as having restrictions for APRNs in 4 four categories, and 10 states (Alaska, Arizona, Idaho, Iowa, Maine, New Hampshire New Mexico, Oregon, Washington, and Wyoming) did not restrict APRNs in any of the 4 categories.14 No research could be found to support the belief that restricting or not restricting APRN practice has an effect on patient outcomes. The objective of this study was to examine whether the states with the least restrictions (LR) on the scope of practice of APRNs have patient outcomes inferior to patient outcomes in the most restrictive states (MR), as measured by rates of controlled hypertension and diabetes in Federally Qualified Community Health Centers (FQCHCs). METHODS Design
To address the objective, we needed to compare measurable patient outcomes on a large number of patients with similar socioeconomic characteristics www.npjournal.org
and common conditions in the MR states with those in the LR states. Therefore, this study was designed as a cross-sectional analysis of publicly available, national data reported in 2013. This study was approved by The University of Texas Health Science Center at Houston Institutional Review Board, The Committee for the Protection of Human Subjects. Participants and Setting
FQCHCs are primary care organizations that have received grants to operate from the US Department of Health and Human Services (DHHS), Health Resources and Services Administration (HRSA), Bureau of Primary Health Care (BPHC). These FQCHCs exist at the local level to serve large numbers of similar, vulnerable populations and must adhere to the same FQCHC policies regarding staffing, services, etc. In 2010, there were 1,124 such centers in the US.18,19 Source of Data
FQCHCs submit annual reports to HRSA, BPHC. The agencies report the number of patients served, the socioeconomic characteristics of those patients, numbers of selected diagnoses of the patients, staffing patterns in the agencies, care provided, and outcomes for patients with certain diagnoses. These reports are available on the HRSA, BPHC website for each state (DHHS, HRSA, BPHC).20 The data in these reports are aggregated to the state level. No patient-level data are available. At the time of the current study, we accessed the reports provided on the BPHC website for 2013. There were 146 FQCHCs in the 6 MR states and 154 FQCHCs in the 10 LR states.20 We verified that the NAM 2010 evaluation of states according to LRs and MRs for APRNs was still applicable in 2013. Between 2010 and mid-2013, there were no changes in the lack of regulatory restrictions in the 10 states that did not restrict APRNs in any of the 4 categories. Restrictions were maintained in 5 of the 6 states that were categorized by the NAM as having restrictions in all 4 categories.21,22 Nevada amended its statutes governing APRN practice in 2013.22 Portions of the changes went into effect July 1, 2013, with most of the changes implemented January 1, 2014.23 We believe it unlikely that the small changes in regulations from July 2013 forward would have been adequate to affect patient outcomes during that same year. The Journal for Nurse Practitioners - JNP
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outcomes are reported by HRSA as the percentage of total patients cared for by FQCHCs in each state with hypertension or diabetes mellitus and the percentage of those patients who have these conditions controlled. Frequencies of patients with controlled hypertension were calculated for each state by taking a product of the total number of patients, fraction of patients with hypertension, and the fraction of patients with controlled hypertension. The frequencies of patients with controlled and uncontrolled hypertension were aggregated for the LR and MR groups of states. The procedure was repeated for the controlled diabetes outcome. The calculation of these outcomes is provided Table 1.
To determine the accuracy of our assumption that we were comparing outcomes for similar types of patients treated in similar types of agencies, we examined the socioeconomic characteristics of the patients cared for by the FQCHC in the 10 LR states and in the 6 MR states. Second, we examined the staffing patterns in the 6 states with MR and the 10 with LR to ensure that APRNs were providing significant levels of care in the LR and in the MR states. Outcomes and Measures
HRSA uses blood pressure (BP) control, defined as BP < 140/90, and diabetes control, defined as HbA1c 9%, as indicators of quality.24 Data on these
Table 1. 2013 Outcome Data on Federally Qualified Community Health Centers in the Six Most Restrictive and Ten Least Restrictive States Patients Serveda State
Patients With Hypertensiona
Patients With Hypertension Controlleda
Patients With Diabetesa
Patients With Diabetes Controlleda
No.
%
No.
%
No.
%
No.
%
No.
Alabama
330,401
29.4
97,137
56.6
54,980
14.3
47,247
70.5
33,309
Missouri
442,058
30.9
136,595
58.7
80,181
14.2
62,772
71.0
44,568
Nevada
70,014
25.8
18,063
63.8
11,524
13.5
9,451
68.3
6,455
South Dakota
54,743
0.17
9,306
62.5
5,816
79.0
43,246
75.3
32,564
1,124,022
23.5
264,145
64.5
170,373
15.9
178,719
64.8
115,810
286,604
33.3
95,439
60.9
58,122
15.9
45,570
73.1
33,311
2,307,842
26.9
620,688
61.4
380,998.9
16.8
387,008
68.7
266,020
Alaska
100,595
22.0
22,130
62.5
13,831
08.4
8,449
68.9
5,822
Arizona
438,260
22.8
99,923
63.3
63,251
13.3
52,288
65.9
38,412
Idaho
138,434
17.6
24,364
60.9
14,837
09.9
13,704
74.1
10,155
Iowa
179,599
24.4
43.822
64.5
28,265
12.9
23,168
70.8
16,403
Maine
182,546
26.7
48,739
72.5
35,336
10.6
19,349
79.3
15,344
New Hampshire
70,884
24.2
17,153
67.8
11,630
10.1
7,159
82.9
5,935
New Mexico
290,202
21.4
62,103
65.7
40,801
12.5
36,275
68.1
24,703
Oregon
323,148
23.7
76,586
65.3
50,010
12.8
41,362
73.3
30,319
Washington
836,637
19.7
164,817
63.3
104,329
11.9
99,559
69.0
68,696
Wyoming
19,896
15.4
3,063
64.5
1,976
05.5
1,094
46.7
511
Total
2,580,201
21.8
562,705
64.7
364,271
12.0
308,413
70.1
216,302
Most restrictive
Texas Virginia Total Least restrictive
a
Data are directly from the Health Resources & Services Administration Report. Data are calculated from U.S. Department of Health and Human Services, Health Resources & Services Administration Health Center Program, 2013 Health Center Data (http://bphc.hrsa.gov/uds/datacenter.aspx?year¼2013).
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Table 2. Socioeconomic Characteristics of Patients Served by Federally Qualified Community Health Centers in 2013 in 6 Most Restrictive and 10 Least Restrictive States
FQCHC Patient Characteristics
Most Restrictive States
Least Restrictive States
Total Patients: 2,307,842
Total Patients: 2,580,201
No.
%
No.
%
Patients aged > 65 years
182,586
7.9
231,557
8.8
Women aged > 65 years
110,753
4.8
133,693
5.1
1,235,875
53.6
1,319,597
49.9
389,040
16.9
436,175
16.5
1,041,891
45.1
869,436
32.9
Medicare title XVIII
198,755
8.6
259,007
9.8
Have private insurance
329,190
14.3
464,673
17.6
Medicaid and other public insurance
738,006
32.0
987,085
37.3
Below 100% of poverty Between 100% and 200% of poverty Uninsured
FQCHC ¼ Federally Qualified Community Health Centers. Most restrictive states: Alabama, Missouri, Nevada, South Dakota, Texas, and Virginia. Least restrictive states: Alaska, Arizona, Idaho, Iowa, Maine, New Hampshire, New Mexico, Oregon, Washington, and Wyoming. Source of data: U.S. Department of Health and Human Services, Health Resources & Services Administration Health Center Program, 2013 Health Center Data (http://bphc. hrsa.gov/uds/datacenter.aspx?year¼2013).
Most Restrictive States
Least Restrictive States
Primary care physicians, No.
596.58
909.65
NP providers, No.
614.07
691.07
All medical service clinic visits, No.
6,060,495
6,955,398
Medical service clinic visits to NPs, No.
1,711,848
1,728,261
the poverty level; (4) between 100% and 200% of the poverty level; (5) uninsured, (6) eligible for title XVIII Medicare; (7) had private health insurance; or (8) were on Medicaid or other public insurance. The patient populations served by the FQCHCs in the LR states were quite similar to those in the MR states in age and poverty status. Exceptions were in the categories of percentage of patients without insurance and percentage receiving Medicaid and other public insurance. In the MR states, about 12% more patients were without insurance, and 5% fewer patients received Medicaid or other public insurance (Table 2). It must be noted, however, that all of these patients were receiving health care in the FQCHCs, which are required to provide care without regard to having insurance or the ability to pay. An examination of race and ethnicity would also have been desirable. There were, however, more than 230,000 patients with missing data on race or who reported more than 1 race in the MR states and more than 480,000 such patients in the LR states. This large amount of missing data would likely bias any analysis on race or ethnicity.
24.8
Staffing Patterns in the FQCHCs
RESULTS Characteristics of the Participants
The socioeconomic characteristics of patients in the data that we examined were the proportions of patients served by the FQCHC who were (1) aged older than 65; (2) women aged older than 65; (3) below 100% of Table 3. Primary Care Providers and Clinic Visits for Medical Services in 2013 to Federally Qualified Community Health Centers in the 6 Most Restrictive and 10 Least Restrictive States
Service Providers Full time equivalent
All medical service clinic visits to NPs, %
28.2
NP ¼ nurse practitioner. Source of data: U.S. Department of Health and Human Services, Health Resources & Services Administration Health Center Program, 2013 Health Center Data (http:// bphc.hrsa.gov/uds/datacenter.aspx?year¼2013).
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The FQCHCs reports provide data on the total numbers of full time equivalents (FTEs) for primary care physician providers, FTE for NP providers (HRSA uses the term NP instead of APRN), the The Journal for Nurse Practitioners - JNP
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Table 4. Comparison of 2013 Outcomes for Hypertension and Diabetes Control for Patients in Federally Qualified Community Health Centers in the Most Restrictive and Least Restrictive States Most Restrictive States
Least Restrictive States Hypertension Controlled %
Diabetes Controlled %
Hypertension Controlled %
Diabetes Controlled %
Alabama
56.6
70.5
Alaska
62.5
68.9
Missouri
58.7
71.0
Arizona
63.3
65.9
Nevada
63.8
68.3
Idaho
60.9
74.1
South Dakota
62.5
75.3
Iowa
64.5
70.8
Texas
64.5
64.8
Maine
72.5
79.3
Virginia
60.9
73.1
New Hampshire
67.8
82.9
New Mexico
65.7
68.1
Oregon
63.3
73.3
Washington
63.3
69.0
64.5
46.7
64.7
70.1
State
State
Wyoming a
Weighted average a
61.4
68.7
a
Weighted average
From Table 1.
total number of patient clinic visits categorized as medical service visits, and the total number of medical service visits to NPs. From that data we calculated the percentage of medical service clinic visits attributed to NPs (Table 3): 28% of these visits were to NPs in the MR states and 25% were to NPs in the LR states. The average number of annual patient visits per NP was slightly higher in the MR states (2,787) than in LR states (2,501), or about 1 more visit to an NP per day. Results on Outcomes
The 2013 FQCHC data on hypertension and diabetes by state in the 6 MR states and in the 10 LR states are described in Table 1. In the MR states, 620,688 individuals (26.9%) had hypertension (range, 17.0%-33.3%) and 387,008 (16.8%) had diabetes mellitus (range, 14.2%-79.0%). In the LR states, 562,705 individuals (21.8%) had hypertension (range, 15.4%-26.7%) and 308,413 (12.0%) had diabetes mellitus (range, 5.5%-13.3%). In the MR states, 61.4% (380,999 of 620,688) of patients with hypertension were controlled compared with 64.7% (364,271 of 562,705) of patients with hypertension who were controlled in the LR states. In the MR states, 68.7% (266,020 of 387,008) of diabetic patients were controlled compared with 624
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70.1% (216,302 of 308,413) of diabetic patients who were controlled in LR states (Table 1). Table 4 provides a summary of the percentage controlled in each LR and MR state. DISCUSSION
We investigated whether patients seen in FQCHCs in states without restrictions (LR) on APRN practice would have a level of control of hypertension and diabetes inferior to those from patients in states with the 4 restrictions (MR) on APRN practice. We did not find any evidence of inferior outcomes for control of hypertension or diabetes for FQCHC patients in LR states, suggesting that restricting APRN scope of practice may not improve the outcomes for hypertensive and diabetic patients. The differences are actual differences between the 2 groups of states; therefore, statistical inference tests are not needed. Any differences should be viewed as significant or not by the readers’ perception of what may be an important difference. From that perspective, one has to judge “real significance” vs “statistical significance.” These results cannot be considered a definitive answer to the question of the utility of APRN restrictions but do offer evidence that such restrictions may not be necessary, particularly for management of vulnerable patients with these chronic conditions. Volume 14, Issue 8, September 2018
We hope that the results will open a new line of policy discussion that will go beyond which health professional has the most years of education. Additional research that would allow examination of the utility of state-level restrictions on patient outcomes, which was not possible in our study, is necessary. Such a study would, at a minimum, be able to use patient-level data to investigate the levels of comanagement of patients by physicians and nurses and obtain accurate and complete data on patient race and ethnicity and any other confounders deemed appropriate. In addition, other clinical conditions and diagnoses should also be examined. CONCLUSIONS AND IMPLICATIONS FOR HEALTH CARE POLICY
The results of this study led us to conclude that there is no evidence that the lack of state restrictions on APRN practice leads to inferior patient outcomes for control of hypertension and diabetes in FQCHC patients. Restricting APRN scope of practice may not be necessary for optimum primary care management of patients with these common chronic health conditions. This study has important implications for health care at a time when the population is aging and at increased risk for these chronic diseases and when there is a predicted decline in the number of primary care physicians. Improving access to primary care for our vulnerable populations is a challenge given inadequate health insurance coverage and a shortage of primary care physicians in low-income communities. APRNs can be an important asset in filling the gap. References 1. Iglehart JK. Expanding the role of advanced nurse practitionerserisks and rewards. N Engl J Med. 2013;368(20):1935-1941. 2. Brown SA, Grimes DE. A meta-analysis of nurse practitioners and nurse midwives in primary care. Nurs Res. 1995;44(6):332-339. 3. Charlton CR, Dearing KS, Berry JA, Johnson MJ. Nurse practitioners’ communication styles and their impact on patient outcomes: an integrated literature review. J Am Acad Nurse Pract. 2008;20(7):382-388. 4. Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002;324:819-823. 5. Laurant M, Reeves D, Hermens R, Braspenning J, Grol R, Sibbald B. Substitution of doctors by nurses in primary care. Cochrane Database Syst Rev. 2005;(2):CD001271. https://doi.org/10.1002/14651858.CD001271.pub2. 6. Martínez-González NA, Djalali S, Tandjung R, et al. Substitution of physicians by nurses in primary care: a systematic review and meta-analysis. BMC Health Serv Res. 2014;14:214. https://doi.org/10.1186/1472-6963-14-214. 7. Mundinger MO, Kane RL, Lenz ER, et al. Primary care outcomes in patients treated by nurse practitioners or physicians: a randomized trial. JAMA. 2000;283(1):59-68.
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8. Newhouse RP, Stanik-Hutt J, White KM, et al. Advanced practice nurse outcomes 1990-2008. A systematic review. Nurs Econ. 2011;29(5):230-250. 9. Mafi JN, Wee CC, Davis RB, Landon BE. Comparing use of low-value health care services among U.S. advanced practice clinicians and physicians. Ann Intern Med. 2016;165(4):237-244. https://doi.org/10.7326/M15-2152. 10. American Association of Nurse Practitioners. NP Fact Sheet. http://www .aAPRN.org/all-about-nps/np-fact-sheet, 2016. Accessed February 28, 2018. 11. Rice University’s Baker Institute for Public Policy. Health Policy Research Newsletter. 2017;12(2). 12. Graves JA, Mishra P, Dittus RS, Parikh R, Perloff J, Buerhaus PI. Role of geography and nurse practitioner scope-of-practice in efforts to expand primary care system capacity: health reform and the primary care workforce. Med Care. 2016;54:81-89. 13. Institute of Medicine (IOM). The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2010. 14. IOM. Annex 3-1: State practice regulations for nurse practitioners. In: The Future of Nursing: Leading Change, Advancing Health. Washington, DC: The National Academies Press; 2010:157-161. 15. American Academy of Family Physicians. PCMH White Paper. Primary care for the 21st century: ensuring a quality, physician-led team for every patient. http://www.aafp.org, 2012. Accessed February 17, 2018. 16. American Medical Association Report of the Council on Medical Education and Council on Medical Services. Guidelines for the integrated practice of physicians and nurse practitioners-Policy H-160.950. https://www.amaassn .org/sites/default/files/media-browser/public/about-ama/councils/Council% 20Reports/council-on-medical-service/i12-cmecms-jointreport, 2012. Accessed February 17, 2018. 17. Council of Medical Specialty Societies. CMSS Response to The Future of Nursing Report—November 15, 2010. https://cmss.org/CMSS-Response-To-The-Future -Of-Nursing-Report-November-15-2010./, 2010. Accessed February 17, 2018. 18. U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Primary Health Care. Health Center Program. http://bphc.hrsa.gov/index.html, 2016. Accessed February 17, 2018. 19. U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Primary Health Care. Health Center Program Fact Sheet. https://www.bphc.hrsa.gov/about/healthcenterfactsheet .pdf, 2016. Accessed February 17, 2018. 20. U.S. Department of Health and Human Services, Health Resources and Services Administration. Health Center Program, Health Center Data. http:// bphc.hrsa.gov/uds/datacenter.aspx?year¼2013. 21. Phillips SJ. 23rd Annual legislative update: as healthcare reforms, NPs continue to evolve. Nurse Pract. 2011;36(1):30-52. 22. Phillips SJ. 26th Annual legislative update: progress for APRN authority to practice. Nurse Pract. 2014;39(1):29-52. 23. Statute AB 170. https://www.leg.state.nv.us/Session/77th2013/Bills/AB/AB170 .pdf. Accessed February 17, 2018. 24. U.S. Department of Health and Human Services, Health Resources and Services Administration Health Center Program, Health Outcomes and Disparities. https:// bphc.hrsa.gov/qualityimprovement/performancemeasures/healthoutcomes.html, 2016. Accessed February 17, 2018.
Deanna E. Grimes, DrPH, RN, FAAN, is a professor emerita, and can be reached at
[email protected]; Nikhil S. Padhye, PhD, is a research associate professor, Madelene J. Ottosen, PhD, RN, is an assistant professor at the Cizik School of Nursing at UTHealth, The University of Texas Health Science Center at Houston Cizik School of Nursing, Houston, Texas. Eric J. Thomas, MD, MPH, is professor and associate dean for Healthcare Quality and Griff T. Ross Professor in Humanities and Richard M.Grimes MBA PhD is an adjunct professor at the University of Texas Health Science Center at Houston McGovern Medical School, Houston, Texas. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest. 1555-4155/18/$ see front matter © 2018 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.nurpra.2018.06.005
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