Feedback GAP: study protocol for a cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care

Noah M Ivers, Karen Tu, Jill Francis, Jan Barnsley, Baiju Shah, Ross Upshur, Alex Kiss, Jeremy M Grimshaw, Merrick Zwarenstein, Noah M Ivers, Karen Tu, Jill Francis, Jan Barnsley, Baiju Shah, Ross Upshur, Alex Kiss, Jeremy M Grimshaw, Merrick Zwarenstein

Abstract

Background: Audit and feedback to physicians is commonly used alone or as part of multifaceted interventions. While it can play an important role in quality improvement, the optimal design of audit and feedback is unknown. This study explores how feedback can be improved to increase acceptability and usability in primary care. The trial seeks to determine whether a theory-informed worksheet appended to feedback reports can help family physicians improve quality of care for their patients with diabetes and/or ischemic heart disease.

Methods: Two-arm cluster trial was conducted with participating primary care practices allocated using minimization to simple feedback or enhanced feedback group. The simple feedback group receives performance feedback reports every six months for two years regarding the proportion of their patients with diabetes and/or ischemic heart disease who are meeting quality targets. The enhanced feedback group receives these same reports as well as a theory-informed worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Participants are family physicians from across Ontario who use electronic medical records; data for rostered patients are used to produce the feedback reports and for analysis.

Outcomes: The primary disease outcomes are the blood pressure (BP), and low-density lipoprotein cholesterol (LDL) levels. The primary process measure is a composite score indicating the number of recommended activities (e.g., tests and prescriptions) conducted by the family physicians for their patients with diabetes and/or ischemic heart disease within the appropriate timeframe. Secondary outcomes are the proportion of patients whose results meet targets for glucose, LDL, and BP as well as the percent of patients receiving relevant prescriptions. A qualitative process evaluation using semi-structured interviews will explore perceived barriers to behaviour change in response to feedback reports and preferences with regard to feedback design.

Analysis: Intention-to-treat approach will be used to analyze the trial. Analysis will be performed on patient-level variables using generalized estimating equation models to adjust for covariates and account for the clustered nature of the data. The trial is powered to show small, but clinically important differences of 7 mmHG in systolic BP and 0.32 mmol/L in LDL.

Trial registration: ClinicalTrials.gov NCT00996645.

Figures

Figure 1
Figure 1
Illustration of hypothesized role played by goal-setting and action-plan worksheet to promote increased effort to improve care.
Figure 2
Figure 2
Trial Design and Cluster-Patient Flow.

References

    1. Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;339(4):229–234. doi: 10.1056/NEJM199807233390404.
    1. Burge FI, Bower K, Putnam W, Cox JL. Quality indicators for cardiovascular primary care. Can J Cardiol. 2007;23(5):383–388.
    1. Narayan KM, Benjamin E, Gregg EW, Norris SL, Engelgau MM. Diabetes translation research: where are we and where do we want to be? Ann Intern Med. 2004;140(11):958–963.
    1. Davis D, Davis N. In: Knowledge Translation in Health Care - Moving from Evidence to Practice. Straus S, Tetroe J, Graham ID, editor. UK: Wiley-Blackwell; 2009. Educational Interventions; p. 116.
    1. Shojania KG, Ranji SR, McDonald KM, Grimshaw JM, Sundaram V, Rushakoff RJ, Owens DK. Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis. JAMA. 2006;296(4):427–440. doi: 10.1001/jama.296.4.427.
    1. Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. CMAJ. 1995;153(10):1423–1431.
    1. Davis DA, Mazmanian PE, Fordis M, Van Harrison R, Thorpe KE, Perrier L. Accuracy of physician self-assessment compared with observed measures of competence: a systematic review. JAMA. 2006;296(9):1094–1102. doi: 10.1001/jama.296.9.1094.
    1. Jamtvedt G, Young JM, Kristoffersen DT, O'Brien MA, Oxman AD. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2006;2(2):CD000259.
    1. Foy R, Eccles MP, Jamtvedt G, Young J, Grimshaw JM, Baker R. What do we know about how to do audit and feedback? Pitfalls in applying evidence from a systematic review. BMC Health Serv Res. 2005;5:50. doi: 10.1186/1472-6963-5-50.
    1. Hysong SJ. Meta-analysis: audit and feedback features impact effectiveness on care quality. Med Care. 2009;47(3):356–363. doi: 10.1097/MLR.0b013e3181893f6b.
    1. Gardner B, Whittington C, McAteer J, Eccles MP, Michie S. Using theory to synthesise evidence from behaviour change interventions: the example of audit and feedback. Soc Sci Med. 2010;70(10):1618–1625. doi: 10.1016/j.socscimed.2010.01.039.
    1. Kluger AN, DeNisi A. The Effects of Feedback Interventions on Performance: A Historical Review, a Meta-Analysis, and a Preliminary Feedback Intervention Theory. Psychol Bull. 1996;119(2):254–284. doi: 10.1037/0033-2909.119.2.254.
    1. Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982;92(1):111–135. doi: 10.1037/0033-2909.92.1.111.
    1. Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation. A 35-year odyssey. Am Psychol. 2002;57(9):705–717. doi: 10.1037/0003-066X.57.9.705.
    1. Gollwitzer PM. Implementation Intentions. Am Psychol. 1999;54(7):493–503. doi: 10.1037/0003-066X.54.7.493.
    1. Locke EA. A theory of goal setting & task performance. Englewood Cliffs, N.J.: Prentice Hall; 1990.
    1. Bandura A. In: Encyclopedia of human behavior. Ramachandran VS, editor. Toronto: Academic Press; 1994. Self-efficacy; pp. 71–81.
    1. Ajzen I, Manstead ASR. In: The scope of social psychology: Theory and applications. van den Bos K, Hewstone M, de Wit J, Schut H, Stroebe M, editor. New York: Psychology Press; 2007. Changing health-related behaviors: An approach based on the theory of planned behavior; pp. 43–63.
    1. Gollwitzer PM, Fujita K, Oettingen G. In: Handbook of self-regulation: research, theory, and applications. Baumeister RF, Vohs KD, editor. New York: Guilford Press; 2004. Planning and the Implementation of Goals; pp. 211–228.
    1. Kirschner K, Braspenning J, Maassen I, Bonte A, Burgers J, Grol R. Improving access to primary care: the impact of a quality-improvement strategy. Qual Saf Health Care. 2010;19(3):248–251. doi: 10.1136/qshc.2008.031526.
    1. O'Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen J, Kristoffersen DT, Forsetlund L, Bainbridge D, Freemantle N, Davis DA, Haynes RB, Harvey EL. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007;4(4):CD000409.
    1. Davies P, Walker AE, Grimshaw JM. A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implement Sci. 2010;5:14. doi: 10.1186/1748-5908-5-14.
    1. Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering usual medical care in clinical trial design. PLoS Med. 2009;6(9):e1000111. doi: 10.1371/journal.pmed.1000111.
    1. Stand Up To Diabetes - .
    1. Tu K, Klein-Geltink J, Mitiku TF, Mihai C, Martin J. De-identification of primary care electronic medical records free-text data in Ontario, Canada. BMC Med Inform Decis Mak. 2010;10:35. doi: 10.1186/1472-6947-10-35.
    1. Tu K, Manuel D, Lam K, Kavanagh D, Mitiku TF, Guo H. Diabetics can be identified in an electronic medical record using laboratory tests and prescriptions. J Clin Epidemiol. 2010. in press .
    1. Ivers NM, Pylypenko B, Tu K. Identifying Ischemic Heart Disease in an Electronic Medical Record. Journal of Primary Care and Community Health; in press .
    1. OntarioMD Funding Eligible EMR Offerings: EMR Advisor.
    1. Jackson GL, Weinberger M. A decade with the chronic care model: some progress and opportunity for more. Med Care. 2009;47(9):929–931. doi: 10.1097/MLR.0b013e3181b63537.
    1. Quality Improvement and Innovation Partnership: Advancing Improvement in Primary Healthcare in Ontario.
    1. Kiefe CI, Allison JJ, Williams OD, Person SD, Weaver MT, Weissman NW. Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial. JAMA. 2001;285(22):2871–2879. doi: 10.1001/jama.285.22.2871.
    1. Sniehotta FF. Towards a theory of intentional behaviour change: plans, planning, and self-regulation. Br J Health Psychol. 2009;14(Pt 2):261–273. doi: 10.1348/135910708X389042.
    1. Luszczynska A, Haynes C. Changing nutrition, physical activity and body weight among student nurses and midwives: effects of a planning intervention and self-efficacy beliefs. J Health Psychol. 2009;14(8):1075–1084. doi: 10.1177/1359105309342290.
    1. Introduction to MAINPRO CPD, The College of Family Physicians of Canada.
    1. Shershneva MB, Wang MF, Lindeman GC, Savoy JN, Olson CA. Commitment to Practice Change: An Evaluator's Perspective. Eval Health Prof. 2010;33(3):256–75. doi: 10.1177/0163278710363960.
    1. Wakefield JG. Commitment to change: exploring its role in changing physician behavior through continuing education. J Contin Educ Health Prof. 2004;24(4):197–204. doi: 10.1002/chp.1340240403.
    1. Mazmanian PE, Johnson RE, Zhang A, Boothby J, Yeatts EJ. Effects of a signature on rates of change: a randomized controlled trial involving continuing education and the commitment-to-change model. Acad Med. 2001;76(6):642–646. doi: 10.1097/00001888-200106000-00018.
    1. Overton GK, MacVicar R. Requesting a commitment to change: conditions that produce behavioral or attitudinal commitment. J Contin Educ Health Prof. 2008;28(2):60–66. doi: 10.1002/chp.158.
    1. Minim: allocation by minimisation in clinical trials by Stephen Evans, Patrick Royston and Simon Day.
    1. Hewitt CE, Torgerson DJ. Is restricted randomisation necessary? BMJ. 2006;332(7556):1506–1508. doi: 10.1136/bmj.332.7556.1506.
    1. Scott NW, McPherson GC, Ramsay CR, Campbell MK. The method of minimization for allocation to clinical trials. a review. Control Clin Trials. 2002;23(6):662–674. doi: 10.1016/S0197-2456(02)00242-8.
    1. Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005;330(7495):843. doi: 10.1136/bmj.330.7495.843.
    1. Bhattacharyya OK, Estey EA, Cheng AY. Canadian Diabetes Association 2008. Update on the Canadian Diabetes Association 2008 clinical practice guidelines. Can Fam Physician. 2009;55(1):39–43.
    1. Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009;25(10):567–579.
    1. Cooper A, Skinner J, Nherera L, Feder G, Ritchie G, Kathoria M, Turnbull N, Shaw G, MacDermott K, Minhas R, Packham C, Squires H, Thomson D, Timmis A, Walsh J, Williams H, White A. Clinical Guidelines and Evidence Review for Post Myocardial Infarction: Secondary prevention in primary and secondary care for patients following a myocardial infarction. Anonymous London: National Collaborating Centre for Primary Care and Royal College of General Practitioners. 2007. [Anonymous]
    1. NICE and Diabetes: A Summary of Relevant Guidelines, November 2009.
    1. Holbrook A, Thabane L, Keshavjee K, Dolovich L, Bernstein B, Chan D, Troyan S, Foster G, Gerstein H. COMPETE II Investigators. Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial. CMAJ. 2009;181(1-2):37–44.
    1. Canadian Hypertension Education Program. Campbell N, Kwong MM. 2010 Canadian Hypertension Education Program recommendations: An annual update. Can Fam Physician. 2010;56(7):649–653.
    1. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665. doi: 10.1136/bmj.b1665.
    1. Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. New York: Oxford University Press; 2000.
    1. Littenberg B, MacLean CD. Intra-cluster correlation coefficients in adults with diabetes in primary care practices: the Vermont Diabetes Information System field survey. BMC Med Res Methodol. 2006;6:20. doi: 10.1186/1471-2288-6-20.
    1. Kizer JR, Madias C, Wilner B, Vaughan CJ, Mushlin AI, Trushin P, Gotto AM Jr, Pasternak RC. Relation of different measures of low-density lipoprotein cholesterol to risk of coronary artery disease and death in a meta-regression analysis of large-scale trials of statin therapy. Am J Cardiol. 2010;105(9):1289–1296. doi: 10.1016/j.amjcard.2009.12.051.
    1. Hysong SJ, Best RG, Pugh JA. Audit and feedback and clinical practice guideline adherence: Making feedback actionable. Implement Sci. 2006;1:9. doi: 10.1186/1748-5908-1-9.
    1. Levy P, Williams J. The Social Context of Performance Appraisal: A Review and Framework for the Future. Journal of Management. 2004;30(6):881–905.
    1. Rowan MS, Hogg W, Martin C, Vilis E. Family physicians' reactions to performance assessment feedback. Can Fam Physician. 2006;52(12):1570–1571.
    1. McAlearney AS, Chisolm DJ, Schweikhart S, Medow MA, Kelleher K. The story behind the story: physician skepticism about relying on clinical information technologies to reduce medical errors. Int J Med Inform. 2007;76(11-12):836–842. doi: 10.1016/j.ijmedinf.2006.09.021.
    1. Stand Up To Diabetes - About Diabetes Testing Report - .
    1. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. 'Psychological Theory' Group. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005;14(1):26–33. doi: 10.1136/qshc.2004.011155.
    1. Sandelowski M. Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Res Nurs Health. 2000;23(3):246–255. doi: 10.1002/1098-240X(200006)23:3<246::AID-NUR9>;2-H.
    1. Doroodchi H, Abdolrasulnia M, Foster JA, Foster E, Turakhia MP, Skelding KA, Sagar K, Casebeer LL. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events. BMC Fam Pract. 2008;9:42. doi: 10.1186/1471-2296-9-42.
    1. Berthold HK, Gouni-Berthold I, Bestehorn KP, Bohm M, Krone W. Physician gender is associated with the quality of type 2 diabetes care. J Intern Med. 2008;264(4):340–50. doi: 10.1111/j.1365-2796.2008.01967.x.
    1. Kuzel AJ. In: Doing Qualitative Research. Research Methods for Primary Care. Crabtree B, Miller W, editor. Vol. 3. California: Sage Publications; 1992. Sampling in Qualitative Inquiry; p. 41.
    1. Ritchie J, Spencer L. In: Analyzing qualitative data. Bryman A, Burgess RG, editor. London: Routledge; 1994. Qualitative data analysis for applied policy research; pp. 173–194. full_text.
    1. Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000;320(7227):114–116. doi: 10.1136/bmj.320.7227.114.
    1. Jones NE, Suurdt J, Ouelette-Kuntz H, Heyland DK. Implementation of the Canadian Clinical Practice Guidelines for Nutrition Support: a multiple case study of barriers and enablers. Nutr Clin Pract. 2007;22(4):449–457. doi: 10.1177/0115426507022004449.
    1. Wolf ZR. Exploring the audit trail for qualitative investigations. Nurse Educ. 2003;28(4):175–178. doi: 10.1097/00006223-200307000-00008.
    1. Barbour RS. Checklists for improving rigour in qualitative research: a case of the tail wagging the dog? BMJ. 2001;322(7294):1115–1117. doi: 10.1136/bmj.322.7294.1115.
    1. Kuper A, Lingard L, Levinson W. Critically appraising qualitative research. BMJ. 2008;337:a1035. doi: 10.1136/bmj.a1035.
    1. van der Veer SN, de Keizer NF, Ravelli AC, Tenkink S, Jager KJ. Improving quality of care. A systematic review on how medical registries provide information feedback to health care providers. Int J Med Inform. 2010;79(5):305–323. doi: 10.1016/j.ijmedinf.2010.01.011.
    1. Thiru K, Hassey A, Sullivan F. Systematic review of scope and quality of electronic patient record data in primary care. BMJ. 2003;326(7398):1070. doi: 10.1136/bmj.326.7398.1070.

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