May 2005

Grant Results

SUMMARY

From 2001 to 2003, researchers at the Kaiser Permanente Center for Health Research conducted a comprehensive review of published trials to identify common core elements of counseling in primary care settings that are effective across behaviors for physical activity, diet and risky drinking.

The effort was part of the Evidence-Based Practice Program, sponsored by the federal Agency for Healthcare Research and Quality, to provide recommendations for clinical preventive services in the primary care setting.

Key Findings

  • The principal investigator concluded that "current evidence does not support a clear role for primary prevention [i.e., reducing the risk of developing disease] in primary care clinical settings.

    Rather, a role in secondary prevention [i.e., helping high-risk individuals — those with established disease — to avoid further deterioration] seems clearly appropriate from our results, particularly for diet."

Funding
The Robert Wood Johnson Foundation (RWJF) supported the project with a grant of $320,111 to Kaiser Foundation Hospitals, Kaiser Foundation Research Institute, the fiscal intermediary for the project.

 See Grant Detail & Contact Information
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THE PROBLEM

Five of the 10 leading factors undermining the health of the population — tobacco use, sedentary lifestyle, poor dietary habits, alcohol misuse, illicit drug use and risky sexual practices — are lifestyle-related behaviors, according to Healthy People 2010. (Healthy People 2010 is a project of the U.S. Department of Health and Human Services designed to identify the most significant preventable threats to health and to establish national goals to reduce these threats.)

The evidence suggests that brief primary care interventions (such as counseling people to change) can effectively modify these behaviors. For example, research shows that even brief counseling improves smoking abstinence rates, and longer, more intense counseling can increase cessation outcomes, especially among highly motivated patients. But the field lacks clear, and clearly communicated, evidence for the effectiveness of behavioral counseling for non-tobacco risk behaviors or a combination of risk behaviors.

This gap contributes to clinicians' perception that behavioral interventions are complicated and difficult to learn, implement and deliver.

Background

The Agency for Healthcare Research and Quality (AHRQ) is the federal agency charged with improving the quality, safety, efficiency and effectiveness of health care. Through its Evidence-Based Practice Program, the agency sponsors Systematic Evidence Reviews — comprehensive reviews of the scientific evidence on the effectiveness of particular clinical preventive services.

Two Evidence-Based Practice Centers — one located at the Oregon Health & Science University and the other at Research Triangle Institute-University of North Carolina (operated by RTI International in collaboration with the five health professions schools and the Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill) — conduct these reviews.

The U.S. Preventive Services Task Force at AHRQ uses them to provide age- and risk-factor-specific recommendations for the delivery of the preventive services in the primary care setting. In its Guide to Clinical Preventive Services, the task force had given primary care counseling services for tobacco cessation its only "A" recommendation. However, the task force did not have enough good research to formally recommend behavior change interventions for other risky behaviors.

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RWJF STRATEGY

RWJF's prior investments in this area include a grant in 2000 to the Center for the Advancement of Health to compile information — through roundtable sessions and interviews with national and academic leaders, directors of successful prevention programs and community-based practitioners — on the state of practice in implementing proven behavioral health strategies (see Grant Results on ID# 038136).

The current project sought to influence the U.S. Preventive Services Task Force's recommendations, as presented in the Guide to Clinical Preventive Services. The project directly addressed RWJF's Health & Behavior Team's objective to promote the wider use of systems for evidence-based primary care interventions for multiple health risk behaviors.

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THE PROJECT

This project had three main objectives:

  • To develop and refine methods for evaluating the research evidence on interventions used to address patients' unhealthy behaviors in each of the following areas: physical activity, diet and risky drinking.
  • To evaluate the current literature about risky drinking to demonstrate how the U.S. Preventive Services Task Force might better use the research literature to develop clinical guidelines in this area.
  • To determine whether similar types of interventions were being used for each of the behaviors being studied-physical activity, diet and risky drinking.

With guidance and oversight from an advisory panel of four national experts (see Appendix 1 for a list of panel members), the research team conducted a literature review, coded different elements of the interventions and performed statistical analysis of the articles. (The elements of counseling interventions included such strategies as giving advice, giving feedback, helping patients set goals and arrange for social support, providing referrals and support materials and changing total contact time and/or the number of counseling sessions. For a list of the elements of interventions, see Appendix 2).

In addition, researchers compared the findings from this project to a previous systematic evidence review and clinical practice guideline on various smoking cessation interventions — in particular, clinician counseling.

Dealing with the methodological problems in the published trials required more work than anticipated. Therefore, the research team was unable to complete the second objective of the project — coordinating the risky/harmful drinking portion of their review with the corresponding U.S. Preventive Services Task Force process.

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FINDINGS

The principal investigator reported the following findings to RWJF in 2004.

  • The 44 studies examined were divided roughly equally between "good" and "fair" quality ratings (51.1 percent and 48.9 percent, respectively). The research team was able to include only 34 of the studies in a qualitative analysis — 13 relating to healthy diet, 11 to risky/harmful drinking, 10 to physical activity. The researchers noted these gaps and deficiencies in the studies:
    • Many lacked information on study participants' race/ethnicity, educational level and readiness to change.
    • Few (eight) studies used intervention control groups; most of those that used controls were studying physical activity interventions.
    • One-third (14) of all the studies addressed high-risk patients. Higher disease risk status of participants differed across behaviors, being more common among the healthy diet studies.
  • The intervention elements studied produced a small effect after one year in helping people adopt healthier behaviors — with greater effects in the high-risk population. But after controlling for high-risk status, none of the intervention elements studied made a statistically significant difference in the effectiveness of the overall intervention. This finding suggests that behavioral change interventions may be less effective for low-risk patients than for higher-risk patients (see Conclusions).
  • None of the other measures of counseling intensity that correlate positively with increased effectiveness in tobacco studies — such as total contact time and the number of intervention sessions — were significantly related to differences in the effectiveness of the interventions studied. This may be due to differences in analytic approaches, to the smaller set of non-tobacco studies or to differences between effective behavioral counseling interventions for non-tobacco topics compared with tobacco. According to the principal investigator, these differences deserve further research.

Limitations

The principal investigator noted the following limitations to the findings.

  • Researchers examined only 44 trials, smaller than the numbers that have been analyzed for tobacco alone. The small number of applicable trials could reduce the study's ability to detect significant differences among the interventions.
  • Due to inconsistent and incomplete reporting in the studies reviewed, researchers may not have coded the intervention elements accurately. The researchers' use of new, untested methods to review the trials also may have contributed to inaccurately coded intervention elements. Even a little misclassification can hamper detection of significant differences among the interventions, particularly in a small study.
  • This study addresses only primary care-based behavioral interventions. Findings may not apply to other kinds of health care settings.

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CONCLUSIONS

  • The principal investigator notes that "current evidence does not support a clear role for primary prevention [i.e., reducing the risk of developing disease] in primary care clinical settings. Rather, a role in secondary prevention [i.e., helping high-risk individuals — those with established disease — to avoid further deterioration] seems clearly appropriate from our results, particularly for diet."

Communications

The research team published two articles on the project, including one in the American Journal of Preventive Medicine. In addition, the principal investigator explored the challenges confronted during this project in a broader article for the field, "Evidence-Based Behavioral Medicine: What Is It, and How Do We Achieve It?"

The article, published in the Annals of Behavioral Medicine, explains how the Consolidated Standards for Reporting Trials (CONSORT) criteria can be applied to the design, reporting and review of research testing behavioral medicine interventions.

The CONSORT approach, developed by an international group of clinical interventionists, statisticians, epidemiologists and medical editors in the late 1990s, is designed to facilitate uniform reporting of clinical intervention results and to allow readers to determine efficiently whether sources of bias threaten the validity of findings.

The Jacobs Institute of Women's Health provided an additional $10,000 in 2002 to use research from this project to produce a commissioned manuscript on the primary prevention of heart disease in women through health behavior change counseling in primary care. See the Bibliography for more details.

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LESSONS LEARNED

  1. Researchers need to be more consistent in the design and reporting of behavioral counseling intervention studies. In particular, studies should consistently define the intervention approaches used and the outcomes measured. Studies aimed at establishing an intervention's effectiveness should use an untreated control group. Researchers should also categorize high-risk status in a way that more efficiently facilitates comparisons across behaviors. (Principal Investigator)

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AFTER THE GRANT

The research team aims to publish additional articles. Once articles are accepted for publication, the research team will inform the Agency for Healthcare Research and Quality (and the U.S. Prevention Services Task Force, as appropriate) of the results of this project.

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GRANT DETAILS & CONTACT INFORMATION

Project

Defining Common Core Elements of Effective Primary Care Health Behavior Change Counseling

Grantee

Kaiser Foundation Hospitals, Kaiser Foundation Research Institute (Oakland,  CA)

  • Amount: $ 320,111
    Dates: August 2001 to December 2003
    ID#:  041378

Contact

Evelyn P. Whitlock, M.D., M.P.H.
(503) 335-2400
evelyn.whitlock@kpchr.org

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APPENDICES


Appendix 1

(Current as of the time of the grant; provided by the grantee organization; not verified by RWJF.)

Advisory Panel Members

Kathy Lohr, Ph.D.
Director
Research Triangle Institute
Research Triangle Park, N.C.

Mark Helfand, M.D., M.S.
Evidence-Based Practice
Oregon Health & Science University
Portland, Ore.

Peter Briss, M.D.
Senior Scientist and Development Coordinator
Centers for Disease Control and Prevention's Community Task Force
Centers for Disease Control and Prevention
Atlanta, Ga.

Pat Mullen, Dr.P.H.
Centers for Disease Control and Prevention's Community Task Force
Centers for Disease Control and Prevention
Atlanta, Ga.


Appendix 2

Coded Intervention Elements

  1. Assess: Any post-randomization assessment completed
  2. Advise: Any advice given related to the behavior being studied
  3. Feedback: (type: Biological, Normative, Other)
  4. Partnership building: patient-centered approach, motivational interviewing, other
  5. Motivational enhancement: method: pros/cons, balance sheets, decisional balance (benefits vs. barriers), eliciting self-motivational statements, other.
  6. Behavioral goal setting: (content: actual goal(s); method: oral agreement, written plan, prescription, behavioral contract, other)
  7. Behavioral counseling techniques: suggested or reported as used by the clinician
    1. Cognitive-behavioral problem solving and skills training (e.g. address barriers, coping with negative affect related to behavior change, "cognitive behavioral therapy," skill building (e.g., supervised exercise), guided practice, cognitive restructuring, self-monitoring, cue awareness and modification, reinforcement management, other reinforcers/rewards)
    2. Enhancement of self-efficacy
    3. Other behavioral/counseling approaches (biofeedback, relaxation, aversive conditioning, environmental change, stimulus control and contingency contracting, other)
  8. Social support
    1. Intra-treatment social support: provider encouragement, caring/empathy
    2. Extra-treatment social support: encouraging or teaching social support solicitation skills; targeting of social support, network, or norms.
  9. Information sharing/patient education
  10. Other:
    Adjuncts:
    1. Media (print, audio, video, computer, other)
    2. Materials/Supplies (prescribing, dispensing, supplying) (what: pamphlets, workbooks, audiotapes, videotapes, decision aids, diaries, memory aids; palm-pilots (specify source, purpose, content, length, literacy); for medical supplies/pharmacotherapeutics, specify purpose/category, e.g., antidepressants, dietary supplements, appetite suppressants, antabuse-type agents, contraceptives, pulse monitors, etc.)
    3. Referrals (specify to whom & for what and location: within office, within health system, within community, other)
    4. Other approaches (specify, e.g., environmental approaches/engineering; acupuncture, hypnosis, interactive voice recording [IVR], etc.)

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BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Articles

Davidson K, Goldstein M, Kaplan R, et al. "Evidence-Based Behavioral Medicine: What Is It, and How Do We Achieve It?" Annals of Behavioral Medicine, 26(3): 161–171, 2003. Abstract available online.

Goldstein MG, Whitlock EP and DePue J. "Multiple Behavioral Risk Factor Interventions in Primary Care: Summary of Research Evidence." American Journal of Preventive Medicine, 27(2 Suppl.): 61–79, 2004. Abstract available online.

Whitlock EP and Williams SE. "The Primary Prevention of Heart Disease in Women through Health Behavior Change Promotion in Primary Care." Women's Health Issues, 13(4): 122–141, 2003. Abstract available online.

Tools

"Cross-Topical Systematic Evidence Review Data Abstraction Form with Coding Instructions." Oakland, Calif.: Kaiser Permanente Center for Health Research, updated 2002.

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Report prepared by: Robert Crum
Reviewed by: Kelsey Menehan
Reviewed by: Marian Bass
Program Officer: Susan B. Hassmiller