- Email: [email protected]
Chronic Illness Care in Russia
Chronic Illness Care in Russia* A Pilot Project To Improve Asthma Care in a “Closed City” Phillip A. Hertzman, MD; H. William Kelly, PharmD; and David Coultas, MD
Context: In Russia, where health status has deteriorated since the late 1960s, asthma is a growing medical and public health problem. Objective: To create a model for improving care and outcomes of patients with asthma through altering the culture of health care, physician behavior, and public policy in a Russian community. Design: A 6-month, nonrandomized, before-and-after intervention evaluation. Setting: Outpatients of Medical-Sanitary Unit No. 50, the central health authority in Sarov, Russia, a “closed” nuclear city. Participants: A consecutive sample of 85 adult patients with severe-persistent or moderatepersistent asthma. Interventions: A comprehensive asthma-care program that emphasized patient education and self-management with treatment based on internationally accepted guidelines modified for local resources. Main outcome measures: Missed work or school, patients requiring emergency department visits, number of patients hospitalized, daytime symptoms, nighttime symptoms, rescue inhaler use, patient satisfaction, and FEV1. Results: After 6 months, significant reductions were observed in the proportion of patients missing work or school (1.2% vs 11.8%), emergency department visits (4.8% vs 15.7%), hospitalizations (0% vs 9.4%), daily symptoms (47.1% vs 65.9%), and nightly symptoms (14.1% vs 37.6%). Patient satisfaction with asthma control (81.2% vs 31.8%) and average level of FEV1 (84.0% vs 72.4%) significantly increased from baseline. Conclusions: The model for changing asthma management in this Russian community was effective in improving asthma outcomes and offers a reproducible paradigm approach for improving chronic illness care. (CHEST 2005; 127:861– 865) Key words: asthma; delivery of health care; Russia Abbreviations: NAEPP ⫽ National Asthma Education and Prevention Program; NNT ⫽ number needed to treat
conditions in Russia began to deteriorate H ealth in the late 1960s and worsened further after the breakup of the Soviet Union in 1991.1–5 By 1997, health conditions in Russia had declined to the point that the death rate exceeded the birth rate, and life *From the Los Alamos Medical Center (Dr. Hertzman), Los Alamos, NM; University of New Mexico School of Medicine (Dr. Kelly), Albuquerque, NM; and University of Florida College of Medicine (Dr. Coultas), Jacksonville, FL. The work was supported by a grant from the American International Health Alliance/United States Agency for International Development, with in-kind support from Respironics, Inc. and GlaxoSmithKline. Manuscript received April 1, 2004; revision accepted October 7, 2004. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: [email protected]). Correspondence to: Phillip A. Hertzman, MD, Los Alamos Medical Center, Suite 130, West Rd, Los Alamos, NM 87544; e-mail: [email protected] www.chestjournal.org
expectancy had declined sharply.6 – 8 This collapse in public health has been characterized as the worst ever witnessed in the industrialized world during peacetime.8,9 Building on a scientific collaboration begun in 1992 between the Los Alamos National Laboratory and the All-Russian Scientific Institute of Experimental Physics in Sarov, Russia, a medical partnership to address health concerns in Sarov was established in 1997 between an independent group of New Mexico physicians and the municipal and health authorities of Sarov. Sarov, a previously “secret nuclear city” known as Arzamas-16 not found on any map during the Soviet era, remains a “closed scientific city” of 86,000 inhabitants. The primary goal of the partnership was to improve health in Sarov by focusing on specific problems identified by the community. A planning team CHEST / 127 / 3 / MARCH, 2005
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from Sarov that included representatives from the office of the mayor, the city Duma, the health-care administration, and health-care providers identified asthma as a growing medical problem and public health need. The partnership developed a pilot project to improve the care and outcomes of asthmatic patients by implementing a comprehensive intervention. The project emphasized physician and patient education, patient self-management, medical care based on published national and international guidelines, and analysis of outcomes. The purpose of this article is to describe the process for improving asthma care in a Russian city, which may serve as a model for improving care for other chronic illnesses in Russia. Materials and Methods Setting Health care for all residents of Sarov is administered by a central health authority, the Medical-Sanitary Unit No. 50. In this unit, there are 900 hospital beds, six outpatient polyclinics, and 460 physicians. Ambulatory care is provided to patients by a variety of subspecialty physicians in the polyclinics. Formulary medications are provided free of charge to qualifying patients with specific diseases. Patients with chronic illnesses may be required to visit a physician at monthly intervals in order to receive medication for the following month. Most of the visits to the polyclinics by asthma patients in the past were due to worsening asthma or to obtain free medications. In the traditional health system, patients with asthma had little input or control over the management of their illness, were apt to be hospitalized for acute asthma flares, had no access to peak flowmeters or spacers, and were not regularly monitored with spirometry. Nurses played little role in the care or education of patients. Although inhaled corticosteroids were available, patients in Russia were not generally maintained on inhaled daily corticosteroids.10 Any patient education generally consisted of occasional lectures to large groups of patients. Some of the nontraditional treatments that were common included salt room treatments, ultraviolet light treatments, and “breathing mountain air.” Project Development A coordinating team of six pulmonary and allergy physicians from Medical-Sanitary Unit No. 50 in Sarov was organized to develop a strategic plan for the project in cooperation with the US team. The US team consisted of a pulmonologist, a clinical pharmacologist, and two family physicians. A meeting of all team members was conducted in September 2000. To assess the needs and resources for patients with asthma, the Russian coordinating team leader completed a “community asthma assessment survey” that was developed by the coordinating team. This information was gathered from the departmental records of Medical-Sanitary Unit No. 50. The US team developed a physician training program for improving asthma care. The training program consisted of workshops on current concepts of asthma utilizing problem-based learning methods and training in using metered-dose inhalers, spacers, peak flowmeters, and performance of spirometry. The problem-based sessions were based on cases specifically devel862
oped to teach the principles of asthma management from the National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 2.11 The cases were translated into Russian by the Sarov team and adapted to reflect local practices. The workshops were led by the US team onsite in Sarov, and a total of 80 Russian physicians participated in the training. After completion of the physician training, the US and Russian coordinating team developed a protocol for conducting the project. A system for collecting clinical data was developed to provide the outcome measures for assessing the effectiveness of the intervention. Components of this system included a patient diary, a data input form for physician visits, and an English/ Russian database for compiling the data. Patient Intervention Patients already known to the physicians of the coordinating team who fit the category of moderate-persistent or severepersistent asthma based on the NAEPP guidelines11 (based on frequency of daytime symptoms, frequency of nighttime symptoms, and FEV1) were consecutively enrolled for the pilot project. Patients enrolled in the project and the community physicians who participated in the asthma workshop were aware that the goal of the project was to improve the control of asthma, but were not aware of specific outcome variables used for evaluation of the project. A coordinating team physician saw all patients monthly. Each patient maintained a standard diary for recording daily peak flowmeter readings and reporting medication use, number of days and nights with asthma symptoms, emergency department visits, hospitalizations, days of missed school or work, satisfaction with asthma control, use of spacers, and use of cigarettes. These diaries were brought to each monthly visit and were reviewed by the physician along with an interim clinical history. In addition, spirometry was performed and inhaler technique was observed. A physician recorded all results on a standardized data collection form. In addition to clinical care, all patients attended monthly “asthma school” sessions taught by the Russian physicians. Specific learning objectives were defined for each of six classes at the asthma school, where patients were taught basic concepts of asthma, and appropriate use of metered-dose inhalers, spacers, and peak flowmeters. Patient knowledge about asthma was assessed by completing a written test at each class and by comparing performance before and after completing the 6-month curriculum. Each patient also demonstrated competent use of inhalers, spacers, and peak flowmeters prior to completing the school. Every patient was evaluated and counseled by a physician on asthma-related aspects of lifestyle and health, including smoking, physical activity, environmental triggers, and allergic triggers. Each patient learned about symptom recognition, early control of acute asthma flares, self-adjustment of medication based on symptoms and regular peak flow measurements according to the NAEPP,11 and each received a written action plan attached to their diaries. The treatment summarized in Table 1 was based on the published NAEPP guidelines11 with certain exceptions based on local resources. Theophylline was substituted for inhaled longacting 2-agonists; however, theophylline levels were not measured. The use of high-potency inhaled corticosteroids (fluticasone, 110 g/puff) was limited due to cost and availability, and distribution of these medications was recorded and monitored. Except for fluticasone, which was donated by the pharmaceutical manufacturer, all other medications were formulary medications provided free of charge. After 6 months, the outcomes were Clinical Investigations
reported eczema, and 36.5% had a family history of asthma. Asthma severity was rated as moderate persistent in 63.5% and severe persistent in 36.5%. All 85 patients completed the program, attended six sessions of the asthma school, and passed the knowledge and skills tests. At the time of completion, all participants were taking their medications regularly, checking peak flows daily, and 83 of 85 patients reported using a spacer regularly with their corticosteroid metered-dose inhalers. After 6 months, all indicators of asthma control, including self-reported and objective outcomes (ie, emergency department visits, hospitalizations, and spirometry), were significantly improved (Tables 2, 3). Overall, the absolute proportion of patients reporting daily symptoms and nightly symptoms decreased by 18.8% (number needed to treat [NNT] ⫽ 5) and 23.5% (NNT ⫽ 4), respectively. Moreover, the absolute increase in patient satisfaction with asthma control increased 49.4%. Consistent with these subjective measures of outcome, the objective measures of asthma control including emergency department visits, hospitalizations, and level of FEV1 also improved. The absolute reductions in emergency department visits and hospitalizations were 10.9% (NNT ⫽ 9) and 9.4% (NNT ⫽ 11), respectively. On average, the level of FEV1 was mildly impaired before the intervention (72.4% predicted) and normalized after the intervention (84.0% predicted). Although all outcome measures improved, a substantial proportion of patients continued using a rescue inhaler daily (n ⫽ 46; 54.1%). These patients included 14 of 24 patients who continued to have a low FEV1. A substantial number of patients (n ⫽ 32; 38%) continued daily use despite normalization of FEV1. However, data were not collected on other potential factors (eg, improper use because of misunderstanding, or lack of confidence to discontinue treatment) that may have contributed to the overuse of rescue inhaler.
Table 1—Treatment Protocol for Patients in the Asthma Project, Sarov, Russia Moderate-persistent asthma: beclomethasone, 50 g/puff; medium dose; 8 to 16 puffs per day (divided twice daily); add sustainedrelease theophylline (10 mg/kg/d or 400 mg for adults in two divided doses) if needed. Severe-persistent asthma: medium-dose beclomethasone plus sustained-release theophylline (10 mg/kg/d or 400 mg for adults in two divided doses); or high-dose inhaled corticosteroid (fluticasone, 110 g/puff; 2 to 6 puffs bid). Step down: after 3 mo of good control, step down to lower step (see National Heart, Lung, and Blood Institute guidelines).11 If well controlled on 2 puffs bid fluticasone, switch patient down to beclomethasone 4 puffs bid. Acute exacerbation or deterioration of condition at any degree of severity: methylprednisolone, 40 mg/d po for either 5 d, or until peak flow has improved to 80% of personal best.
analyzed, shortcomings were discussed with the coordinating team, and modifications in the protocol were implemented. This article describes the results after 6 months. Data Analysis Patient data were recorded on standardized forms at each visit and later entered into the database. Proportions and means were used to describe baseline characteristics. Differences between the baseline and 6-month data were compared using 2 for proportions and paired t tests for continuous variables.
Results From the community needs survey, there were an estimated 595 adults and 190 children with asthma in Sarov. Among these were an estimated 5,000 asthma-related outpatient visits to the polyclinic, 600 emergency department calls, and 100 hospitalizations annually. Of the 85 adult patients enrolled, 67% were female (mean age, 50.2 ⫾ 12.0 [⫾ SD]; range, 19 to 75 years). A minority of the patients were current or former smokers, 9.4% and 10.6%, respectively. Furthermore, 25.9% reported allergic rhinitis, 23.5%
Table 2—Clinical Outcomes During Previous 30 Days for Categorical Variables Among Asthmatic Adults From Sarov, Russia* Outcome Measure Patients Patients Patients Patients Patients Patients Patients
who missed work or school (n ⫽ 85) requiring emergency department visits (n ⫽ 83) hospitalized (n ⫽ 85) satisfied with asthma control (n ⫽ 85) using rescue inhaler every day (n ⫽ 85) having daily symptoms (n ⫽ 85) having symptoms every night (n ⫽ 85)
Baseline,† %
6 Months, %
Odds Ratio (95% CI)
p Value
11.8 15.7 9.4 31.8 77.6 65.9 37.6
1.2 4.8 0 81.2 54.1 47.1 14.1
0.09 (0.00–0.70) 0.27 (0.07–0.96) NA 9.26 (4.31–20.17) 0.34 (0.17–0.69) 0.46 (0.24–0.89) 0.27 (0.12–0.61)
0.006 0.012 0.004 ⬍ 0.001 ⬍ 0.001 0.003 ⬍ 0.001
*CI ⫽ confidence interval; NA ⫽ not applicable. †Reference value for calculation of odds ratio. www.chestjournal.org
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Table 3—Clinical Outcomes During Previous 30 Days for Continuous Variables Among Asthmatic Adults From Sarov, Russia* Outcome Measure
Baseline
6 Months
p Value
Days with symptoms (n ⫽ 85) Nights with symptoms (n ⫽ 85) Days of rescue inhaler use (n ⫽ 85) FEV 1, % predicted (n ⫽ 75)†
23.1 ⫾ 10.5
18.3 ⫾ 12.4
0.002
14.8 ⫾ 12.8
6.6 ⫾ 10.7
⬍ 0.001
25.5 ⫾ 9.2
19.6 ⫾ 12.5
⬍ 0.001
72.4 ⫾ 26.3
84.0 ⫾ 19.1
⬍ 0.001
*Data are presented as mean ⫾ SD. †Final FEV1 measured at 6-month physician visit. Comparison limited to 75 because spirometry was performed on 75 subjects at baseline (88.2%).
Discussion As in previously published studies,12–17 our pilot project demonstrated that improving outpatient management of asthma improved health outcomes and patient satisfaction, and conserved resources by reducing hospitalizations, emergency department visits, and absence from work and school. Furthermore, this project provides an example of how structural changes in health-care delivery, advocated by international guidelines for chronic illnesses, can be successfully adapted by diverse health-care cultures. While the results of this pilot project are encouraging, opportunities for further improvement remain for outcomes, which fall short of the NAEPP guidelines (Tables 2, 3), such as the excessive use of rescue inhalers by some patients and frequency of persistent nocturnal symptoms. With any cross-cultural endeavor, unexpected difficulties occur. In this project, obstacles that were not initially apparent included a lack of convenient patient scheduling, underutilization of nurses, reluctance to use outpatient oral corticosteroids for acute asthma flares, and limited physician computer skills. In response to these issues, we persuaded administrators to allow patient visits during regular clinic hours, encouraged increased responsibilities for nurses, reviewed and stressed the importance of early and aggressive outpatient care for asthma flares with the team physicians, and provided basic computer training for team members. Changes in the culture of health-care and physician behavior in Sarov resulted from a new approach to evaluation and treatment of asthma using standardized clinical guidelines adapted to resources available in the community. With emphasis on patient education and self-management skills, a new type of partnership between physicians, nurses, and patients evolved. For example, three of the Russian 864
coordinating team physicians taught new skills to their nurses who began to function in a much more substantive role in educating and evaluating selfmanagement skills of patients. Importantly, in contrast to previous patterns in the former Soviet Union,8,18 strategic planning for the project was accomplished by a team effort of health providers, rather than being dictated by directives from higher authorities. Also, rather than concealing unfavorable results, our team reported data that included patients who did not improve. This allowed meaningful analysis of the patients with suboptimal outcomes and identified opportunities for further improvements. As a result, the protocol was modified to include additional clinical guidelines for the evaluation of patients with “difficult asthma.” In addition, a new curriculum was developed for the asthma school specifically for patients who did not improve and for those who overused their rescue inhalers. Notably, the success of this pilot project influenced public policy in a way that will augment the sustainability of the project. The Sarov Duma has since voted to provide high-potency inhaled corticosteroids as formulary items, free of charge, for all children with moderate-persistent or severe-persistent asthma, and for adult patients with severe persistent asthma. Chronic diseases are the largest cause of death in the world. While numerous countries in transition have witnessed a rapid deterioration of chronic disease risk and mortality profiles, the global response to the problem remains inadequate.19 Asthma, as in other industrialized countries, presents a growing medical problem and public health need.20 –22 Although this study was limited by the small sample size and nonrandomized design, this is the first report demonstrating the feasibility and effectiveness of changing chronic illness care in the Russian Federation. Moreover, the success of this model provided evidence that triggered interest of other physicians who wanted to improve the care of patients with hypertension and diabetes, and as previously mentioned influenced health policy decisions of the local government. The success and sustainability of this project required the commitment of motivated local physicians, aggressive education of health-care providers, restricting use of expensive or limited resources, a strong emphasis on patient education and self-management, and securing support and commitment from local government for expendable supplies and medications. Using a team approach, an effective asthma management program adapted for the limited resources in Sarov, Russia provided substantial clinical benefits and offers a model for improving chronic illness care in diverse health systems. Clinical Investigations
ACKNOWLEDGMENT: The excellent work of Larissa Kosyreva, MD, Tamara Gorbenko, MD, Tatiana Zabusova, MD, at the Medical-Sanitary Unit No. 50, Sarov, Russia, and Irina Parfenova is gratefully recognized. The authors thank Joanna Fair MD, PhD, for her thoughtful review of the manuscript.
References 1 Wines M, Zuger A. In Russia, the ill and infirm include health care itself. New York Times. December 4, 2000; sect A:1 2 Field MG. The health crisis in the former Soviet Union: a report form the “post war” zone. Soc Sci Med 1996; 41:1469 – 1478 3 Tulchinsky TH, Varavikova EA. Addressing the epidemiologic transition in the former Soviet Union: strategies for health system and public health reform in Russia. Am J Public Health 1996; 86:313–320 4 Barr DA, Field MG. The current state of health care in the former Soviet Union: implications for health care policy and reform. Am J Public Health 1996; 86:307–312 5 Barr DA, Schmid RS. Medical education in the former Soviet Union. Acad Med 1996; 71:141–145 6 Sinyavsky A. The Russian intelligentsia. New York, NY. Columbia University Press, 1997 7 Notzon FC, Komarov YM, Ermakov SP. Causes of declining life expectancy in Russia. JAMA 1998; 279:793–797 8 Garrett L. Betrayal of trust: the collapse of global public health. New York, NY: Hyperion, 2000; 123–128 9 Shkolnikov V, Mesle F. Health crisis in Russia, parts I and II. Popul 1996; 8:123–190 10 Chuchalin AG, Ovcharenko SI, Goriachkina LA, et al. Epoch Study Group. The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia. Int J Clin Pract 2002; 56:15–20 11 National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program: Expert Panel Report 2; guidelines for the diagnosis and management of asthma. Bethesda, MD: US Department of Health and Human
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Services, 1997; National Institutes of Health publication No. 97– 4051. Available at: www.nhlbi.nih.gov/guidelines/asthma/ asthgdln.htm. Accessed February 23, 2005 Weiss KB, Sullivan SD. The health economics of asthma and rhinitis: I. Assessing the economic impact. J Allergy Clin Immunol 2001; 107:3– 8 Donahue JG, Weiss ST, Livingston JM, et al. Inhaled steroids and the risk of hospitalization for asthma. JAMA 1997; 277:887– 891 Suissa S, Ernst P, Benayoun S, et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med 2000; 343:332–336 Gibson PG, Coughlan J, Abramson M, et al. The effects of self-management education and regular practitioner review in adults with asthma: In: The Cochrane Library. Oxford, UK: Update Software, 1998 Lahdensuo A, Haahtela T, Herrala J, et al. Randomised comparison of cost effectiveness of guided self management and traditional treatment of asthma in Finland. BMJ 1998; 316:1138 –1139 Kelly CS, Morrow AL, Shults J, et al. Outcomes evaluation of a comprehensive intervention program for asthmatic children enrolled in Medicaid. Pediatrics 2000; 105:1029 –1035 Mesle F, Shlolnikov VM, Hertrich V. Tendances recentes de la Mortalite par cause en Russie 1965–1994. Moscow, Russia, Institut National d“Etudes Demoraphiques, Paris and Center for Demography and Human Ecology, 1996 Yach D, Hawkes C, Gould CL, et al. The global burden of chronic diseases. JAMA 2004; 291:2616 –2622 ISAAC. The International Study of Asthma and Allergies in Childhood (Steering Committee). Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema. Lancet 1998; 351:1225–1232 Sunyer J, Anto JM, Tobias A, et al. Generational increase of self-reported first attack of asthma in fifteen industrialized countries: European Community Respiratory Health Study (ECRHS). Eur Respir J 1999; 14:885– 891 CDC. Surveillance for asthma, United States 1960 –1995. MMWR Morb Mortal Wkly Rep, 1998; 47(SS-1)
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Context: In Russia, where health status has deteriorated since the late 1960s, asthma is a growing medical and public health problem. Objective: To create a model for improving care and outcomes of patients with asthma through altering the culture of health care, physician behavior, and public policy in a Russian community. Design: A 6-month, nonrandomized, before-and-after intervention evaluation. Setting: Outpatients of Medical-Sanitary Unit No. 50, the central health authority in Sarov, Russia, a “closed” nuclear city. Participants: A consecutive sample of 85 adult patients with severe-persistent or moderatepersistent asthma. Interventions: A comprehensive asthma-care program that emphasized patient education and self-management with treatment based on internationally accepted guidelines modified for local resources. Main outcome measures: Missed work or school, patients requiring emergency department visits, number of patients hospitalized, daytime symptoms, nighttime symptoms, rescue inhaler use, patient satisfaction, and FEV1. Results: After 6 months, significant reductions were observed in the proportion of patients missing work or school (1.2% vs 11.8%), emergency department visits (4.8% vs 15.7%), hospitalizations (0% vs 9.4%), daily symptoms (47.1% vs 65.9%), and nightly symptoms (14.1% vs 37.6%). Patient satisfaction with asthma control (81.2% vs 31.8%) and average level of FEV1 (84.0% vs 72.4%) significantly increased from baseline. Conclusions: The model for changing asthma management in this Russian community was effective in improving asthma outcomes and offers a reproducible paradigm approach for improving chronic illness care. (CHEST 2005; 127:861– 865) Key words: asthma; delivery of health care; Russia Abbreviations: NAEPP ⫽ National Asthma Education and Prevention Program; NNT ⫽ number needed to treat
conditions in Russia began to deteriorate H ealth in the late 1960s and worsened further after the breakup of the Soviet Union in 1991.1–5 By 1997, health conditions in Russia had declined to the point that the death rate exceeded the birth rate, and life *From the Los Alamos Medical Center (Dr. Hertzman), Los Alamos, NM; University of New Mexico School of Medicine (Dr. Kelly), Albuquerque, NM; and University of Florida College of Medicine (Dr. Coultas), Jacksonville, FL. The work was supported by a grant from the American International Health Alliance/United States Agency for International Development, with in-kind support from Respironics, Inc. and GlaxoSmithKline. Manuscript received April 1, 2004; revision accepted October 7, 2004. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: [email protected]). Correspondence to: Phillip A. Hertzman, MD, Los Alamos Medical Center, Suite 130, West Rd, Los Alamos, NM 87544; e-mail: [email protected] www.chestjournal.org
expectancy had declined sharply.6 – 8 This collapse in public health has been characterized as the worst ever witnessed in the industrialized world during peacetime.8,9 Building on a scientific collaboration begun in 1992 between the Los Alamos National Laboratory and the All-Russian Scientific Institute of Experimental Physics in Sarov, Russia, a medical partnership to address health concerns in Sarov was established in 1997 between an independent group of New Mexico physicians and the municipal and health authorities of Sarov. Sarov, a previously “secret nuclear city” known as Arzamas-16 not found on any map during the Soviet era, remains a “closed scientific city” of 86,000 inhabitants. The primary goal of the partnership was to improve health in Sarov by focusing on specific problems identified by the community. A planning team CHEST / 127 / 3 / MARCH, 2005
861
from Sarov that included representatives from the office of the mayor, the city Duma, the health-care administration, and health-care providers identified asthma as a growing medical problem and public health need. The partnership developed a pilot project to improve the care and outcomes of asthmatic patients by implementing a comprehensive intervention. The project emphasized physician and patient education, patient self-management, medical care based on published national and international guidelines, and analysis of outcomes. The purpose of this article is to describe the process for improving asthma care in a Russian city, which may serve as a model for improving care for other chronic illnesses in Russia. Materials and Methods Setting Health care for all residents of Sarov is administered by a central health authority, the Medical-Sanitary Unit No. 50. In this unit, there are 900 hospital beds, six outpatient polyclinics, and 460 physicians. Ambulatory care is provided to patients by a variety of subspecialty physicians in the polyclinics. Formulary medications are provided free of charge to qualifying patients with specific diseases. Patients with chronic illnesses may be required to visit a physician at monthly intervals in order to receive medication for the following month. Most of the visits to the polyclinics by asthma patients in the past were due to worsening asthma or to obtain free medications. In the traditional health system, patients with asthma had little input or control over the management of their illness, were apt to be hospitalized for acute asthma flares, had no access to peak flowmeters or spacers, and were not regularly monitored with spirometry. Nurses played little role in the care or education of patients. Although inhaled corticosteroids were available, patients in Russia were not generally maintained on inhaled daily corticosteroids.10 Any patient education generally consisted of occasional lectures to large groups of patients. Some of the nontraditional treatments that were common included salt room treatments, ultraviolet light treatments, and “breathing mountain air.” Project Development A coordinating team of six pulmonary and allergy physicians from Medical-Sanitary Unit No. 50 in Sarov was organized to develop a strategic plan for the project in cooperation with the US team. The US team consisted of a pulmonologist, a clinical pharmacologist, and two family physicians. A meeting of all team members was conducted in September 2000. To assess the needs and resources for patients with asthma, the Russian coordinating team leader completed a “community asthma assessment survey” that was developed by the coordinating team. This information was gathered from the departmental records of Medical-Sanitary Unit No. 50. The US team developed a physician training program for improving asthma care. The training program consisted of workshops on current concepts of asthma utilizing problem-based learning methods and training in using metered-dose inhalers, spacers, peak flowmeters, and performance of spirometry. The problem-based sessions were based on cases specifically devel862
oped to teach the principles of asthma management from the National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 2.11 The cases were translated into Russian by the Sarov team and adapted to reflect local practices. The workshops were led by the US team onsite in Sarov, and a total of 80 Russian physicians participated in the training. After completion of the physician training, the US and Russian coordinating team developed a protocol for conducting the project. A system for collecting clinical data was developed to provide the outcome measures for assessing the effectiveness of the intervention. Components of this system included a patient diary, a data input form for physician visits, and an English/ Russian database for compiling the data. Patient Intervention Patients already known to the physicians of the coordinating team who fit the category of moderate-persistent or severepersistent asthma based on the NAEPP guidelines11 (based on frequency of daytime symptoms, frequency of nighttime symptoms, and FEV1) were consecutively enrolled for the pilot project. Patients enrolled in the project and the community physicians who participated in the asthma workshop were aware that the goal of the project was to improve the control of asthma, but were not aware of specific outcome variables used for evaluation of the project. A coordinating team physician saw all patients monthly. Each patient maintained a standard diary for recording daily peak flowmeter readings and reporting medication use, number of days and nights with asthma symptoms, emergency department visits, hospitalizations, days of missed school or work, satisfaction with asthma control, use of spacers, and use of cigarettes. These diaries were brought to each monthly visit and were reviewed by the physician along with an interim clinical history. In addition, spirometry was performed and inhaler technique was observed. A physician recorded all results on a standardized data collection form. In addition to clinical care, all patients attended monthly “asthma school” sessions taught by the Russian physicians. Specific learning objectives were defined for each of six classes at the asthma school, where patients were taught basic concepts of asthma, and appropriate use of metered-dose inhalers, spacers, and peak flowmeters. Patient knowledge about asthma was assessed by completing a written test at each class and by comparing performance before and after completing the 6-month curriculum. Each patient also demonstrated competent use of inhalers, spacers, and peak flowmeters prior to completing the school. Every patient was evaluated and counseled by a physician on asthma-related aspects of lifestyle and health, including smoking, physical activity, environmental triggers, and allergic triggers. Each patient learned about symptom recognition, early control of acute asthma flares, self-adjustment of medication based on symptoms and regular peak flow measurements according to the NAEPP,11 and each received a written action plan attached to their diaries. The treatment summarized in Table 1 was based on the published NAEPP guidelines11 with certain exceptions based on local resources. Theophylline was substituted for inhaled longacting 2-agonists; however, theophylline levels were not measured. The use of high-potency inhaled corticosteroids (fluticasone, 110 g/puff) was limited due to cost and availability, and distribution of these medications was recorded and monitored. Except for fluticasone, which was donated by the pharmaceutical manufacturer, all other medications were formulary medications provided free of charge. After 6 months, the outcomes were Clinical Investigations
reported eczema, and 36.5% had a family history of asthma. Asthma severity was rated as moderate persistent in 63.5% and severe persistent in 36.5%. All 85 patients completed the program, attended six sessions of the asthma school, and passed the knowledge and skills tests. At the time of completion, all participants were taking their medications regularly, checking peak flows daily, and 83 of 85 patients reported using a spacer regularly with their corticosteroid metered-dose inhalers. After 6 months, all indicators of asthma control, including self-reported and objective outcomes (ie, emergency department visits, hospitalizations, and spirometry), were significantly improved (Tables 2, 3). Overall, the absolute proportion of patients reporting daily symptoms and nightly symptoms decreased by 18.8% (number needed to treat [NNT] ⫽ 5) and 23.5% (NNT ⫽ 4), respectively. Moreover, the absolute increase in patient satisfaction with asthma control increased 49.4%. Consistent with these subjective measures of outcome, the objective measures of asthma control including emergency department visits, hospitalizations, and level of FEV1 also improved. The absolute reductions in emergency department visits and hospitalizations were 10.9% (NNT ⫽ 9) and 9.4% (NNT ⫽ 11), respectively. On average, the level of FEV1 was mildly impaired before the intervention (72.4% predicted) and normalized after the intervention (84.0% predicted). Although all outcome measures improved, a substantial proportion of patients continued using a rescue inhaler daily (n ⫽ 46; 54.1%). These patients included 14 of 24 patients who continued to have a low FEV1. A substantial number of patients (n ⫽ 32; 38%) continued daily use despite normalization of FEV1. However, data were not collected on other potential factors (eg, improper use because of misunderstanding, or lack of confidence to discontinue treatment) that may have contributed to the overuse of rescue inhaler.
Table 1—Treatment Protocol for Patients in the Asthma Project, Sarov, Russia Moderate-persistent asthma: beclomethasone, 50 g/puff; medium dose; 8 to 16 puffs per day (divided twice daily); add sustainedrelease theophylline (10 mg/kg/d or 400 mg for adults in two divided doses) if needed. Severe-persistent asthma: medium-dose beclomethasone plus sustained-release theophylline (10 mg/kg/d or 400 mg for adults in two divided doses); or high-dose inhaled corticosteroid (fluticasone, 110 g/puff; 2 to 6 puffs bid). Step down: after 3 mo of good control, step down to lower step (see National Heart, Lung, and Blood Institute guidelines).11 If well controlled on 2 puffs bid fluticasone, switch patient down to beclomethasone 4 puffs bid. Acute exacerbation or deterioration of condition at any degree of severity: methylprednisolone, 40 mg/d po for either 5 d, or until peak flow has improved to 80% of personal best.
analyzed, shortcomings were discussed with the coordinating team, and modifications in the protocol were implemented. This article describes the results after 6 months. Data Analysis Patient data were recorded on standardized forms at each visit and later entered into the database. Proportions and means were used to describe baseline characteristics. Differences between the baseline and 6-month data were compared using 2 for proportions and paired t tests for continuous variables.
Results From the community needs survey, there were an estimated 595 adults and 190 children with asthma in Sarov. Among these were an estimated 5,000 asthma-related outpatient visits to the polyclinic, 600 emergency department calls, and 100 hospitalizations annually. Of the 85 adult patients enrolled, 67% were female (mean age, 50.2 ⫾ 12.0 [⫾ SD]; range, 19 to 75 years). A minority of the patients were current or former smokers, 9.4% and 10.6%, respectively. Furthermore, 25.9% reported allergic rhinitis, 23.5%
Table 2—Clinical Outcomes During Previous 30 Days for Categorical Variables Among Asthmatic Adults From Sarov, Russia* Outcome Measure Patients Patients Patients Patients Patients Patients Patients
who missed work or school (n ⫽ 85) requiring emergency department visits (n ⫽ 83) hospitalized (n ⫽ 85) satisfied with asthma control (n ⫽ 85) using rescue inhaler every day (n ⫽ 85) having daily symptoms (n ⫽ 85) having symptoms every night (n ⫽ 85)
Baseline,† %
6 Months, %
Odds Ratio (95% CI)
p Value
11.8 15.7 9.4 31.8 77.6 65.9 37.6
1.2 4.8 0 81.2 54.1 47.1 14.1
0.09 (0.00–0.70) 0.27 (0.07–0.96) NA 9.26 (4.31–20.17) 0.34 (0.17–0.69) 0.46 (0.24–0.89) 0.27 (0.12–0.61)
0.006 0.012 0.004 ⬍ 0.001 ⬍ 0.001 0.003 ⬍ 0.001
*CI ⫽ confidence interval; NA ⫽ not applicable. †Reference value for calculation of odds ratio. www.chestjournal.org
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Table 3—Clinical Outcomes During Previous 30 Days for Continuous Variables Among Asthmatic Adults From Sarov, Russia* Outcome Measure
Baseline
6 Months
p Value
Days with symptoms (n ⫽ 85) Nights with symptoms (n ⫽ 85) Days of rescue inhaler use (n ⫽ 85) FEV 1, % predicted (n ⫽ 75)†
23.1 ⫾ 10.5
18.3 ⫾ 12.4
0.002
14.8 ⫾ 12.8
6.6 ⫾ 10.7
⬍ 0.001
25.5 ⫾ 9.2
19.6 ⫾ 12.5
⬍ 0.001
72.4 ⫾ 26.3
84.0 ⫾ 19.1
⬍ 0.001
*Data are presented as mean ⫾ SD. †Final FEV1 measured at 6-month physician visit. Comparison limited to 75 because spirometry was performed on 75 subjects at baseline (88.2%).
Discussion As in previously published studies,12–17 our pilot project demonstrated that improving outpatient management of asthma improved health outcomes and patient satisfaction, and conserved resources by reducing hospitalizations, emergency department visits, and absence from work and school. Furthermore, this project provides an example of how structural changes in health-care delivery, advocated by international guidelines for chronic illnesses, can be successfully adapted by diverse health-care cultures. While the results of this pilot project are encouraging, opportunities for further improvement remain for outcomes, which fall short of the NAEPP guidelines (Tables 2, 3), such as the excessive use of rescue inhalers by some patients and frequency of persistent nocturnal symptoms. With any cross-cultural endeavor, unexpected difficulties occur. In this project, obstacles that were not initially apparent included a lack of convenient patient scheduling, underutilization of nurses, reluctance to use outpatient oral corticosteroids for acute asthma flares, and limited physician computer skills. In response to these issues, we persuaded administrators to allow patient visits during regular clinic hours, encouraged increased responsibilities for nurses, reviewed and stressed the importance of early and aggressive outpatient care for asthma flares with the team physicians, and provided basic computer training for team members. Changes in the culture of health-care and physician behavior in Sarov resulted from a new approach to evaluation and treatment of asthma using standardized clinical guidelines adapted to resources available in the community. With emphasis on patient education and self-management skills, a new type of partnership between physicians, nurses, and patients evolved. For example, three of the Russian 864
coordinating team physicians taught new skills to their nurses who began to function in a much more substantive role in educating and evaluating selfmanagement skills of patients. Importantly, in contrast to previous patterns in the former Soviet Union,8,18 strategic planning for the project was accomplished by a team effort of health providers, rather than being dictated by directives from higher authorities. Also, rather than concealing unfavorable results, our team reported data that included patients who did not improve. This allowed meaningful analysis of the patients with suboptimal outcomes and identified opportunities for further improvements. As a result, the protocol was modified to include additional clinical guidelines for the evaluation of patients with “difficult asthma.” In addition, a new curriculum was developed for the asthma school specifically for patients who did not improve and for those who overused their rescue inhalers. Notably, the success of this pilot project influenced public policy in a way that will augment the sustainability of the project. The Sarov Duma has since voted to provide high-potency inhaled corticosteroids as formulary items, free of charge, for all children with moderate-persistent or severe-persistent asthma, and for adult patients with severe persistent asthma. Chronic diseases are the largest cause of death in the world. While numerous countries in transition have witnessed a rapid deterioration of chronic disease risk and mortality profiles, the global response to the problem remains inadequate.19 Asthma, as in other industrialized countries, presents a growing medical problem and public health need.20 –22 Although this study was limited by the small sample size and nonrandomized design, this is the first report demonstrating the feasibility and effectiveness of changing chronic illness care in the Russian Federation. Moreover, the success of this model provided evidence that triggered interest of other physicians who wanted to improve the care of patients with hypertension and diabetes, and as previously mentioned influenced health policy decisions of the local government. The success and sustainability of this project required the commitment of motivated local physicians, aggressive education of health-care providers, restricting use of expensive or limited resources, a strong emphasis on patient education and self-management, and securing support and commitment from local government for expendable supplies and medications. Using a team approach, an effective asthma management program adapted for the limited resources in Sarov, Russia provided substantial clinical benefits and offers a model for improving chronic illness care in diverse health systems. Clinical Investigations
ACKNOWLEDGMENT: The excellent work of Larissa Kosyreva, MD, Tamara Gorbenko, MD, Tatiana Zabusova, MD, at the Medical-Sanitary Unit No. 50, Sarov, Russia, and Irina Parfenova is gratefully recognized. The authors thank Joanna Fair MD, PhD, for her thoughtful review of the manuscript.
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