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(Circulation. 1997;95:1085-1090.)
© 1997 American Heart Association, Inc.

Articles

The Multilevel Compliance Challenge: Recommendations for a Call to Action

A Statement for Healthcare Professionals

Nancy Houston Miller, RN; Martha Hill, PhD, RN; Thomas Kottke, MD; Ira S. Ockene, MD; For the Expert Panel on Compliance

Key Words: AHA Medical/Scientific Statements • lifestyle • prevention • risk factors

	The Compliance Challenge

Top The Compliance Challenge Background A Multilevel Challenge Recommended Actions to Enhance... Summary References

 
Compliance with medical recommendations, the extent to which recommendations are followed as defined, presents complex and interesting challenges. Compliance is a means to an end, an approach to maintaining or improving health as well as managing symptoms and signs of disease. Also known as adherence, compliance is a complex behavioral process strongly influenced by the environments in which patients live, healthcare providers practice, and healthcare systems deliver care.

The rationale for enhancing compliance is based on the premise that the patient will get well or stay well if the physician, other healthcare providers, and the healthcare organization make appropriate recommendations, providing that the patient has the requisite knowledge, motivation, skills, and resources to follow the recommendations. The benefits of prevention and treatment for patients with cardiovascular disease, stroke, and/or associated risk factors are abundantly clear. Yet many patients do not receive appropriate advice. Moreover, some patients follow the advice exactly but do not benefit from treatment, and others follow the advice incompletely, inconsistently, or not at all, yet improve or become well. With the recognition that noncompliance with preventive and therapeutic recommendations is far more prevalent and varied than previously thought, more effective interventions are needed to reduce risk and improve patient outcomes.

To further meet its goals for improved risk reduction, secondary prevention, and patient outcomes,¹ the American Heart Association convened an expert panel on compliance. The charge to the panel was to (1) evaluate existing models and research related to compliance, (2) determine if sufficient data exist to make specific recommendations about compliance, and (3) make recommendations for future research to enhance compliance. The panel reviewed the literature and concluded that the data are sufficient to support recommendations for improving patient outcomes by addressing issues of compliance. In this report the panel makes recommendations not only for patients but also for providers and healthcare organizations (ie, medical centers, clinics, physicians' offices) as well as for future research in the field of compliance.

	Background

Top The Compliance Challenge Background A Multilevel Challenge Recommended Actions to Enhance... Summary References

 
Almost all research on compliance focuses on a health outcome and presumes that adherence to selected recommendations mediates or facilitates achievement of the desired outcome. Although studies have examined efforts to raise individual compliance, few are randomized controlled trials with compliance as the outcome.² Still fewer have addressed efforts to remediate compliance when patients have difficulty implementing recommended behaviors or to improve long-term compliance. Randomized controlled trials using a full range of methods to enhance compliance are scarce. The most promising strategies are combinations of interventions, including patient education,³ contracts,^{4 5} self-monitoring,^{6 7} social support,⁸ telephone follow-up,⁹ and tailoring, ¹⁰ with multicomponent strategies also shown to be effective in remediating poor compliance.¹¹

Several recent studies suggest that compliance during the first month of treatment is the most powerful predictor of long-term compliance.^{12 13 14 15} Many studies show a decrease in compliance over time.¹⁶ Only one showed improvement in compliance over time.¹⁷ In this 4-year study of an ambulatory care model, compliance with taking medication was improved with regular telephone follow-up by a nurse or pharmacist.

A large body of literature documents valid and reliable methods of assessing compliance. Use of these methods is clinically important. For example, it is important to distinguish between patients not using a recommended treatment and those not responding to a given treatment. These methods, both direct and indirect, include patient interview, biological markers and outcomes, appointments made and kept, prescriptions filled and refilled, pill counts, and utilization of health care. Newer methods to assess drug use include low dose, slow turnover, chemical markers, and electronic monitors attached to packages, which give a substantially more accurate picture of drug exposure in ambulatory patients.¹⁸ Such data indicate that noncompliance is the basis for lack of response to therapy. The data also provide information on noncompliance as it occurs as well as information on the benefits and consequences of the intervention. Many more doses are delayed and omitted than were indicated by earlier methods. To summarize, one third or more of ambulatory patients take prescribed doses at intervals that frequently are longer than prescribed—often hours, sometimes days, occasionally weeks. The intervals that stretch into days or weeks are drug holidays.¹⁹ The patterns of delay and omission of doses seem to be remarkably similar across drugs, diseases, prognosis, and—surprisingly—symptoms.

The economic consequences of variations in dose-timing in taking medications are specific to the drug, the disease and its severity, and the nature and severity of any comorbidity. Focusing on dosing intervals, pharmacokinetics, and pharmacodynamics has broadened the emphasis of compliance from solely behavioral issues ("Why do patients not take their medicines as they've been told to do?") to include a pharmacological/therapeutic focus ("What are the clinical and economic consequences of various patterns of noncompliant dosing with this drug?").

Finally, a number of randomized controlled trials are being conducted in both primary and secondary prevention to control risk factors and decrease morbidity and mortality,^{20 21 22 23} supporting the multilevel approach to the compliance challenge. Multiple interventions directed at the patient, provider, and healthcare organization were used in all of these studies. In these and other studies, management of risk factors by multidisciplinary teams within systems designed to modify healthcare delivery and respond to patient and provider needs have been more successful than physicians alone providing interventions in a traditional, minimally structured environment.^{9 24 25 26 27 28}

	A Multilevel Challenge

Top The Compliance Challenge Background A Multilevel Challenge Recommended Actions to Enhance... Summary References

 
The literature on compliance is dominated by reports of patients' noncompliance with prevention and treatment recommendations, most commonly medication taking. There are fewer reports on how the behavior of healthcare professionals and the delivery of medical care contribute to patient compliance with any health behavior. The expert panel recognized the importance of a multilevel approach to the compliance challenge: patient, provider, and organization. A summary of the evidence supporting this approach follows.

Patient
Compliance with recommendations for entering and remaining in care, modifying lifestyle, and taking medications varies from patient to patient and within individual patients. Many factors affect compliance, including the behaviors recommended, the complexity of the regimen, and the ease with which a patient can incorporate those recommendations into his or her daily routine. Compliance also varies according to incentive versus therapeutic intent or goal and ability to pay for care. It is difficult to predict which patients will comply and to what extent they will comply with a given behavior at any point in time. For decades it has been known that compliance with lifestyle behaviors and drug regimens has been overestimated by both patients and providers.^{29 30}

The majority of research on patient compliance has focused on identifying and minimizing barriers to compliance encountered by patients. Such barriers include practical and logistical issues such as lack of transportation and health insurance, inability to take time off from work to keep medical appointments, and lack of a continuing provider. Sociodemographic characteristics contribute less to noncompliance than many other factors.^{31 32} The relation between compliance and gender, socioeconomic status, and marital status is weak and inconsistent.^{33 34} Personality characteristics have not been shown to affect compliance.³⁵ While behaviors differ, in general, factors that appear to significantly influence compliance include the patient's knowledge, previous levels of compliance, confidence in ability to follow recommended behaviors, perception of health and benefits of therapy or behavior, availability of social support, and complexity of the regimen.^{15 36 37 38 39} Some factors are affected by the patient's relationship and communication with the provider. However, this is only part of the problem. If patients lack the motivation and skills to undertake a recommended behavior or treatment, it is unlikely that they will do so. Moreover, if compliance is not continually reinforced over time, the behavior is not maintained.

Enhancing a patient's motivation requires careful assessment of his or her readiness to make and maintain behavioral changes. Building a patient's skills requires that he or she learn tasks such as reading food labels, selecting appropriate foods in restaurants, and incorporating taking medications into his or her daily routine. Thus, patients must learn new strategies to help them adopt and maintain a new behavior, especially when daily routines are interrupted. Although these strategies may differ for different behaviors, whether smoking cessation, dietary modification, or taking a new medication, certain skills are commonly required, such as problem solving, self-monitoring, developing prompts and reminder systems, identifying a potential relapse into an old behavior, enlisting social support, setting appropriate and realistic goals, and rewarding achievement of new behaviors.^{5 10 11 40 41 42} Moreover, multiple skills are often necessary for patients to comply with new behaviors and maintain them over time or to give up established unhealthy behaviors. Asking a patient to modify several lifestyle behaviors, especially for an asymptomatic condition, such as hypertension or hypercholesterolemia, further complicates the compliance challenge, underscoring the need for long-term motivation and multiple skills. Even with motivation and skills, patients have difficulty complying. Two aspects of compliance must be considered: errors of omission—delayed and omitted doses—are predominant in prescribed drug regimens, while errors of commission are common with dietary and other lifestyle behaviors. Patients need to incorporate self-reminders into their daily routine, and they need advice on how to adapt to changes in their schedules and environment. Business travel and vacations, for example, can lead to delays or omissions in taking medications and dietary errors such as increased intake of foods high in fat and sodium.

Healthcare Provider
In addition to the physician, other healthcare providers, including pharmacists, nurses, nutritionists, health educators, and psychologists who are involved in primary and secondary prevention of cardiovascular disease play a role in enhancing compliance by interpreting recommendations, educating and motivating patients, monitoring responses to recommended behaviors, and providing feedback. Various barriers affect their success in promoting compliance. Until recently, physicians typically worked autonomously, primarily managing acute and chronic illnesses. Although most physicians accept the importance of preventive services, they have little time to incorporate the necessary strategies to help a patient comply with a new therapy or behavior.⁴³ Furthermore, like other healthcare professionals, they receive little reinforcement when they provide such services. In addition, lack of financial reimbursement for education and counseling is a serious disincentive.

Physicians recognize that they lack the skills to provide services such as dietary advice and that this deficiency is a significant barrier to patient compliance.⁴⁴ For example, numerous studies have shown that skill training is necessary to use a reminder system for smoking intervention.^{45 46} Physicians can be trained to provide effective counseling for both smoking cessation and nutritional change, but such counseling requires an appropriate office-support system.^{47 48 49} Lack of perceived patient demand has been shown to be an important barrier to physicians giving dietary advice. Likewise, lack of demand by patients was the most frequently cited reason for physicians not to provide smoking cessation advice.⁵⁰ Tutorials to educate physicians, when combined with exit interviews, home visits, and group classes for patients, have been shown to decrease morbidity and mortality in hypertensive patients.³

Effective communication between physician and patient depends in part on the physician's confidence in his or her ability to teach and enhance patient skills as well as the amount of time available to provide preventive services.^{51 52} Physicians most often respond to patients' complaints. With few exceptions, unless the patient tells the physician about a change in lifestyle behavior or problems with carrying out recommendations, these topics are not addressed in clinical practice. For example, physicians often overlook smoking cessation or weight loss. Therefore, if preventive strategies are to be incorporated into practice, both patient and provider need a cue.

Lack of a sense that peers are providing such services can also be a significant barrier to physicians adopting compliance-enhancing strategies.^{53 54} Although physicians may receive adequate training during residency, they frequently identify with the behaviors of others in their practice. If preventive services are not an explicit priority for a practice, it is unlikely that they will be delivered.

Healthcare Organization
The policies of the healthcare organization, including hospitals, healthcare maintenance organizations (HMOs), and physicians' offices, influence the extent to which preventive services are provided. Even patients who receive care from organizations that provide preventive services do not receive optimal primary and secondary recommendations.⁵⁵ Moreover, patients who must rely on other settings and different providers, such as emergency room departments for primary care, are particularly vulnerable to reduced compliance and health outcomes.

It is well established that systems designed to deliver disease prevention interventions within a single organization can result in a higher proportion of patients achieving the goals set for them.^{28 56} It has also been demonstrated in nonrandomized trials that the organization of smoking intervention systems in multiple independent clinics increases the proportion of smokers who are identified, advised to quit, offered help, and reinforced for their attempts to quit.^{46 47} In a randomized trial of cancer prevention, encouraging healthcare organizations to adopt treatment systems improved the proportion of patients receiving appropriate services.⁵⁷ Systems by their nature, however, can also be used negatively, reducing innovation and individualization.

Despite a desire to improve care, organizations often lack knowledge about how to change in response to documented need. When providers are trained in continuous quality improvement and the organization is committed to rapid implementation of effective innovations, changes in practice behavior and positive patient outcomes have been demonstrated.^{28 49}

	Recommended Actions to Enhance Compliance

Top The Compliance Challenge Background A Multilevel Challenge Recommended Actions to Enhance... Summary References

 
To improve patient outcomes by decreasing morbidity and mortality from cardiovascular disease and stroke requires a commitment by patients, healthcare providers, and organizations delivering care. Maximum use of strategies to enhance compliance must be made. Application of these strategies is particularly important now, when there is great pressure to decrease costs and improve quality and patient outcomes. The solution to the compliance challenge is not as simple as telling patients what to do and then telling them again if the desired effect is not achieved. A multilevel approach requires educational and behavioral strategies. Careful methods of assessment and effective strategies to promote patient, provider, and organizational behaviors are needed. Moreover, while the economic burden of noncompliance must be addressed,⁵⁸ other social, cultural, and psychological factors affecting behavior at every level must be understood and respected. Particular consideration must be given to populations that are underserved.

The literature on compliance supports a multilevel approach. Patients, providers, and healthcare organizations must integrate their efforts to better manage the problem of noncompliance. Table 1 highlights actions and strategies that enhance compliance with prevention and treatment recommendations to reduce risk and improve patient outcomes. Key studies providing evidence that supports this approach are cited.

View this table: [in this window] [in a new window]   Table 1. Actions to Increase Compliance With Prevention and Treatment Recommendations

While much is known about the actions and strategies that may improve compliance, further research is needed. Important areas requiring investigation include identifying persons at highest risk for noncompliance, methods for monitoring and improving compliance, and strategies to sustain recommended health behaviors over time.

The expert panel encourages the AHA to assume a leadership role in advocating implementation of actions and strategies to improve compliance (Table 1) and recommendations for further research in Table 2. The panel recommends that

View this table: [in this window] [in a new window]   Table 2. Recommended Topics for Research in Compliance

 Consumer health information products be developed to facilitate compliance by patients and family members

 Programs for healthcare providers and organizations be implemented to enhance knowledge and skills in improving compliance

 Research be initiated to identify new and successful methods to increase patient compliance

	Summary

Top The Compliance Challenge Background A Multilevel Challenge Recommended Actions to Enhance... Summary References

 
Despite the universally accepted importance of compliance, strategies known for more than two decades to be effective are not routinely incorporated into clinical practice. For the benefits of primary and secondary prevention to be realized in diverse population groups and settings, emphasis must be placed on implementing strategies at the patient, provider, and organization levels. Current knowledge of compliance strategies, if integrated into a multilevel approach, offers enormous promise for decreasing risk and improving patient outcomes.

	Acknowledgments

 
The authors gratefully acknowledge the work of the other members of the Expert Panel on Compliance: William Applegate, MD; Jackie Dunbar-Jacob, PhD, RN; K. Lance Gould, MD; Thomas A. Pearson, PhD, MD; and John Urquhart, MD. They contributed to the review of research and the manuscript.

	Footnotes

 
"The Multilevel Compliance Challenge: Recommendations for a Call to Action" was approved by the American Heart Association Science Advisory and Coordinating Committee in December 1996.

A single reprint is available by calling 800-242-8721 (US only) or writing the American Heart Association, Public Information, 7272 Greenville Avenue, Dallas, TX 75231-4596. Ask for reprint No. 71-0107. To purchase additional reprints: up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 214-706-1466, fax 214-691-6342, or E-mail pubauth@amhrt.org. To make photocopies for personal or educational use, call the Copyright Clearance Center, 508-750-8400.

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				P. M. Ho, J. S. Rumsfeld, F. A. Masoudi, D. L. McClure, M. E. Plomondon, J. F. Steiner, and D. J. Magid Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med, September 25, 2006; 166(17): 1836 - 1841. [Abstract] [Full Text] [PDF]

				S. H Simpson, D. T Eurich, S. R Majumdar, R. S Padwal, R. T Tsuyuki, J. Varney, and J. A Johnson A meta-analysis of the association between adherence to drug therapy and mortality BMJ, July 1, 2006; 333(7557): 15. [Abstract] [Full Text] [PDF]

				R. L. Sacco, R. Adams, G. Albers, M. J. Alberts, O. Benavente, K. Furie, L. B. Goldstein, P. Gorelick, J. Halperin, R. Harbaugh, et al. Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline. Circulation, March 14, 2006; 113(10): e409 - e449. [Abstract] [Full Text] [PDF]

				E. C. Okonofua, K. N. Simpson, A. Jesri, S. U. Rehman, V. L. Durkalski, and B. M. Egan Therapeutic Inertia Is an Impediment to Achieving the Healthy People 2010 Blood Pressure Control Goals Hypertension, March 1, 2006; 47(3): 345 - 351. [Abstract] [Full Text] [PDF]

				R. L. Sacco, R. Adams, G. Albers, M. J. Alberts, O. Benavente, K. Furie, L. B. Goldstein, P. Gorelick, J. Halperin, R. Harbaugh, et al. Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic Attack: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association Council on Stroke: Co-Sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline. Stroke, February 1, 2006; 37(2): 577 - 617. [Abstract] [Full Text] [PDF]

				S. C. Smith Jr Evidence-Based Medicine: Making the Grade: Miles to Go Before We Sleep Circulation, January 17, 2006; 113(2): 178 - 179. [Full Text] [PDF]

				Response by Bennett, Lane, Welch, Perkins, Brater, and Murray West J Nurs Res, December 1, 2005; 27(8): 998 - 999. [PDF]

				B. Fletcher, K. Berra, P. Ades, L. T. Braun, L. E. Burke, J. L. Durstine, J. M. Fair, G. F. Fletcher, D. Goff, L. L. Hayman, et al. Managing Abnormal Blood Lipids: A Collaborative Approach Circulation, November 15, 2005; 112(20): 3184 - 3209. [Abstract] [Full Text] [PDF]

				S. H. Woolf and R. E. Johnson The Break-Even Point: When Medical Advances Are Less Important Than Improving the Fidelity With Which They Are Delivered Ann. Fam. Med, November 1, 2005; 3(6): 545 - 552. [Abstract] [Full Text] [PDF]

				T. J. Wang and R. S. Vasan Epidemiology of Uncontrolled Hypertension in the United States Circulation, September 13, 2005; 112(11): 1651 - 1662. [Full Text] [PDF]

				C. J. Possidente, K. K. Bucci, and W. J. McClain Motivational interviewing: A tool to improve medication adherence? Am. J. Health Syst. Pharm., June 15, 2005; 62(12): 1311 - 1314. [Full Text] [PDF]

				A. Rozanski Integrating Psychologic Approaches Into the Behavioral Management of Cardiac Patients Psychosom Med, May 1, 2005; 67(Supplement_1): S67 - S73. [Abstract] [Full Text] [PDF]

				E. J. Benjamin, M. Jessup, J. M. Flack, H. M. Krumholz, K. Liu, V. M. Nadkarni, D. A. Rhoades, B. L. Rodriguez, R. P. Scott, M. P. Taylor, et al. Discovering the Full Spectrum of Cardiovascular Disease: Minority Health Summit 2003: Report of the Outcomes Writing Group Circulation, March 15, 2005; 111(10): e124 - e133. [Full Text] [PDF]

				A. Rozanski, J. A. Blumenthal, K. W. Davidson, P. G. Saab, and L. Kubzansky The epidemiology, pathophysiology, and management of psychosocial risk factors in cardiac practice: The emerging field of behavioral cardiology J. Am. Coll. Cardiol., March 1, 2005; 45(5): 637 - 651. [Abstract] [Full Text] [PDF]

				E. S. Parris, D. B. Lawrence, L. A. Mohn, and L. B. Long Adherence to Statin Therapy and LDL Cholesterol Goal Attainment by Patients With Diabetes and Dyslipidemia Diabetes Care, March 1, 2005; 28(3): 595 - 599. [Abstract] [Full Text] [PDF]

				R. J. Zacker Exercise: A Key Component of Diabetes Management Diabetes Spectr, July 1, 2004; 17(3): 142 - 144. [Full Text] [PDF]

				D. L. McKay, J. M. Berkowitz, J. B. Blumberg, and J. P. Goldberg Communicating Cardiovascular Disease Risk Due to Elevated Homocysteine Levels: Using the EPPM to Develop Print Materials Health Educ Behav, June 1, 2004; 31(3): 355 - 371. [Abstract] [PDF]

				P. A. Tabor and D. A. Lopez Comply With Us: Improving Medication Adherence Journal of Pharmacy Practice, June 1, 2004; 17(3): 167 - 181. [Abstract] [PDF]

				B. K. Reddy, D. J. Kennedy, W. R. Colyer, M. W. Burket, W. J. Thomas, S. A. Khuder, J. I. Shapiro, R. V. Topp, and C. J. Cooper Compliance with Antihypertensive Therapy after Renal Artery Stenting Biol Res Nurs, July 1, 2003; 5(1): 37 - 46. [Abstract] [PDF]

				P. Greenland Improving Risk of Coronary Heart Disease: Can a Picture Make the Difference? JAMA, May 7, 2003; 289(17): 2270 - 2272. [Full Text] [PDF]

				A. J. Bellg Maintenance of Health Behavior Change in Preventive Cardiology: Internalization and Self-Regulation of New Behaviors Behav Modif, January 1, 2003; 27(1): 103 - 131. [Abstract] [PDF]

				H. P. McDonald, A. X. Garg, and R. B. Haynes Interventions to Enhance Patient Adherence to Medication Prescriptions: Scientific Review JAMA, December 11, 2002; 288(22): 2868 - 2879. [Abstract] [Full Text] [PDF]

P. A. Scott, A. M. Pancioli, L. A. Davis, S. M. Frederiksen, and J. Eckman Prevalence of Atrial Fibrillation and Antithrombotic Prophylaxis in Emergency Department Patients Stroke, November 1, 2002; 33(11): 2664 - 2669. [Abstract]