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Published in: BMC Primary Care 1/2018

Open Access 01-12-2018 | Study protocol

A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices

Authors: W. Perry Dickinson, L. Miriam Dickinson, Bonnie T. Jortberg, Danielle M. Hessler, Douglas H. Fernald, Lawrence Fisher

Published in: BMC Primary Care | Issue 1/2018

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Abstract

Background

Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention.

Methods

A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS.

Discussion

This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation.

Trial registration

Registered with ClinicalTrials.gov – ClinicalTrials.gov ID: NCT01945918, date 08/27/2013. Modifications have been updated.
Literature
1.
go back to reference IOM Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001. IOM Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001.
2.
go back to reference Wagner EH, Austin BT, Von Korff M. Improving outcomes in chronic illness. Manag Care Q. 1996;4:12–25.PubMed Wagner EH, Austin BT, Von Korff M. Improving outcomes in chronic illness. Manag Care Q. 1996;4:12–25.PubMed
3.
go back to reference Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Millbank Q. 1996;74:511–44.CrossRef Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Millbank Q. 1996;74:511–44.CrossRef
4.
go back to reference Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002;288:1775–9.CrossRefPubMed Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002;288:1775–9.CrossRefPubMed
5.
go back to reference Bodenheimer T, Wagner EH, Grumback K. Improving primary care for patients with chronic illness: the chronic care model, part 2. JAMA. 2002;288:1909–14.CrossRefPubMed Bodenheimer T, Wagner EH, Grumback K. Improving primary care for patients with chronic illness: the chronic care model, part 2. JAMA. 2002;288:1909–14.CrossRefPubMed
6.
go back to reference Berenson RA, Hammons T, Gans DN, Zuckerman S, Merrell K, Underwood WS, Williams AF. A house is not a home: keeping patients at the center of practice redesign. Health Aff (Millwood). 2008;27:1219–30.CrossRef Berenson RA, Hammons T, Gans DN, Zuckerman S, Merrell K, Underwood WS, Williams AF. A house is not a home: keeping patients at the center of practice redesign. Health Aff (Millwood). 2008;27:1219–30.CrossRef
7.
go back to reference Grumbach K, Bodenheimer T. A primary care home for Americans: putting the house in order. JAMA. 2002;288:889–93.CrossRefPubMed Grumbach K, Bodenheimer T. A primary care home for Americans: putting the house in order. JAMA. 2002;288:889–93.CrossRefPubMed
8.
go back to reference Riley KM, Glasgow RE, Eakin EG. Resources for health: a social-ecological intervention for supporting self-management of chronic conditions. J Health Psychol. 2001;6:693–705.CrossRefPubMed Riley KM, Glasgow RE, Eakin EG. Resources for health: a social-ecological intervention for supporting self-management of chronic conditions. J Health Psychol. 2001;6:693–705.CrossRefPubMed
9.
go back to reference Glasgow RE, Toobert DJ, Hampson SE. Effects of a brief office-based intervention to facilitate diabetes dietary self-management. Diabetes Care. 1996;19:835–42.CrossRefPubMed Glasgow RE, Toobert DJ, Hampson SE. Effects of a brief office-based intervention to facilitate diabetes dietary self-management. Diabetes Care. 1996;19:835–42.CrossRefPubMed
10.
go back to reference Barrera M, Toobert DJ, Angell KL, Glasgow RE, MacKinnon DP. Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes. J Health Psychol. 2006;11:483–95.CrossRefPubMed Barrera M, Toobert DJ, Angell KL, Glasgow RE, MacKinnon DP. Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes. J Health Psychol. 2006;11:483–95.CrossRefPubMed
11.
go back to reference Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009;32:559–66.CrossRefPubMedPubMedCentral Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009;32:559–66.CrossRefPubMedPubMedCentral
12.
go back to reference Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes. A systematic review of randomized control trials. Diabetes Care. 2001;24:561–87.CrossRefPubMed Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes. A systematic review of randomized control trials. Diabetes Care. 2001;24:561–87.CrossRefPubMed
13.
go back to reference Tallia AF, Stange KC, McDaniel RR Jr, Aita VA, Miller WL, Crabtree BF. Understanding organizational designs of primary care practices. J Healthc Manag. 2003;48:45–59. discussion 60-41CrossRefPubMed Tallia AF, Stange KC, McDaniel RR Jr, Aita VA, Miller WL, Crabtree BF. Understanding organizational designs of primary care practices. J Healthc Manag. 2003;48:45–59. discussion 60-41CrossRefPubMed
14.
go back to reference Solberg LI, Brekke ML, Fazio CJ, Fowles J, Jacobsen DN, Kottke TE, Mosser G, O'Connor PJ, Ohnsorg KA, Rolnick SJ. Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv. 2000;26:171–88.PubMed Solberg LI, Brekke ML, Fazio CJ, Fowles J, Jacobsen DN, Kottke TE, Mosser G, O'Connor PJ, Ohnsorg KA, Rolnick SJ. Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv. 2000;26:171–88.PubMed
15.
go back to reference Jaen CR. Successful health information technology implementation requires practice and health care system transformation. Ann Fam Med. 2011;9:388–9. Jaen CR. Successful health information technology implementation requires practice and health care system transformation. Ann Fam Med. 2011;9:388–9.
16.
go back to reference Sittig DF, Ash JS. On the importance of using a multidimensional sociotechnical model to study health information technology. Ann Fam Med. 2011;9:390–1. Sittig DF, Ash JS. On the importance of using a multidimensional sociotechnical model to study health information technology. Ann Fam Med. 2011;9:390–1.
17.
go back to reference Glasgow RE, Bull SS, Piette JD, Steiner JF. Interactive behavior change technology. A partial solution to the competing demands of primary care. Am J Prev Med. 2004;27:80–7.CrossRefPubMed Glasgow RE, Bull SS, Piette JD, Steiner JF. Interactive behavior change technology. A partial solution to the competing demands of primary care. Am J Prev Med. 2004;27:80–7.CrossRefPubMed
18.
go back to reference Glasgow RE. Interactive media for diabetes self-management: issues in maximizing public health impact. Med Decis Mak. 2010;30:745–58. Glasgow RE. Interactive media for diabetes self-management: issues in maximizing public health impact. Med Decis Mak. 2010;30:745–58.
19.
go back to reference Oenema A, Brug J, Dijkstra A, de Weerdt I, de Vries H. Efficacy and use of an internet-delivered computer-tailored lifestyle intervention, targeting saturated fat intake, physical activity and smoking cessation: a randomized controlled trial. Ann Behav Med. 2008;35:125–35.CrossRefPubMed Oenema A, Brug J, Dijkstra A, de Weerdt I, de Vries H. Efficacy and use of an internet-delivered computer-tailored lifestyle intervention, targeting saturated fat intake, physical activity and smoking cessation: a randomized controlled trial. Ann Behav Med. 2008;35:125–35.CrossRefPubMed
20.
go back to reference Prochaska JO, Velicer WF, Redding C, Rossi JS, Goldstein M, DePue J, Greene GW, Rossi SR, Sun X, Fava JL, et al. Stage-based expert systems to guide a population of primary care patients to quit smoking, eat healthier, prevent skin cancer, and receive regular mammograms. Prev Med. 2005;41:406–16.CrossRefPubMed Prochaska JO, Velicer WF, Redding C, Rossi JS, Goldstein M, DePue J, Greene GW, Rossi SR, Sun X, Fava JL, et al. Stage-based expert systems to guide a population of primary care patients to quit smoking, eat healthier, prevent skin cancer, and receive regular mammograms. Prev Med. 2005;41:406–16.CrossRefPubMed
21.
go back to reference Vandelanotte C, De Bourdeaudhuij I, Brug J. Two-year follow-up of sequential and simultaneous interactive computer-tailored interventions for increasing physical activity and decreasing fat intake. Ann Behav Med. 2007;33:213–9.CrossRefPubMed Vandelanotte C, De Bourdeaudhuij I, Brug J. Two-year follow-up of sequential and simultaneous interactive computer-tailored interventions for increasing physical activity and decreasing fat intake. Ann Behav Med. 2007;33:213–9.CrossRefPubMed
22.
go back to reference Glasgow RE, Edwards LL, Whitesides H, Carroll N, Sanders TJ, McCray BL. Reach and effectiveness of DVD and in-person diabetes self-management education. Chronic Illn. 2009;5:243–9.CrossRefPubMed Glasgow RE, Edwards LL, Whitesides H, Carroll N, Sanders TJ, McCray BL. Reach and effectiveness of DVD and in-person diabetes self-management education. Chronic Illn. 2009;5:243–9.CrossRefPubMed
23.
go back to reference Rabin BA, Glasgow RE. Dissemination and implementation of interactive health communication applications. In: Noar SM, Harrington NG, editors. eHealth applications : promising strategies for health behavior change. New York: Routledge; 2011. Rabin BA, Glasgow RE. Dissemination and implementation of interactive health communication applications. In: Noar SM, Harrington NG, editors. eHealth applications : promising strategies for health behavior change. New York: Routledge; 2011.
24.
go back to reference Brug J, Oenema A, Campbell M. Past, present, and future of computer-tailored nutrition education. Am J Clin Nutr. 2003;77:1028S–34S.CrossRefPubMed Brug J, Oenema A, Campbell M. Past, present, and future of computer-tailored nutrition education. Am J Clin Nutr. 2003;77:1028S–34S.CrossRefPubMed
25.
go back to reference Tate DF, Jackvony EH, Wing RR. Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003;289:1833–6.CrossRefPubMed Tate DF, Jackvony EH, Wing RR. Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003;289:1833–6.CrossRefPubMed
26.
go back to reference Oenema A, Brug J, Lechner L. Web-based tailored nutrition education: results of a randomized controlled trial. Health Educ Res. 2001;16:647–60.CrossRefPubMed Oenema A, Brug J, Lechner L. Web-based tailored nutrition education: results of a randomized controlled trial. Health Educ Res. 2001;16:647–60.CrossRefPubMed
27.
go back to reference Vandelanotte C, De Bourdeaudhuij I, Brug J. Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium. Health Promot Int. 2004;19:463–70.CrossRefPubMed Vandelanotte C, De Bourdeaudhuij I, Brug J. Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium. Health Promot Int. 2004;19:463–70.CrossRefPubMed
28.
go back to reference Wanner M, Martin-Diener E, Braun-Fahrlander C, Bauer G, Martin BW. Effectiveness of active-online, an individually tailored physical activity intervention, in a real-life setting: randomized controlled trial. J Med Internet Res. 2009;11:e23.CrossRefPubMedPubMedCentral Wanner M, Martin-Diener E, Braun-Fahrlander C, Bauer G, Martin BW. Effectiveness of active-online, an individually tailored physical activity intervention, in a real-life setting: randomized controlled trial. J Med Internet Res. 2009;11:e23.CrossRefPubMedPubMedCentral
29.
go back to reference Spittaels H, De Bourdeaudhuij I, Brug J, Vandelanotte C. Effectiveness of an online computer-tailored physical activity intervention in a real-life setting. Health Educ Res. 2007;22:385–96.CrossRefPubMed Spittaels H, De Bourdeaudhuij I, Brug J, Vandelanotte C. Effectiveness of an online computer-tailored physical activity intervention in a real-life setting. Health Educ Res. 2007;22:385–96.CrossRefPubMed
30.
go back to reference Steele R, Mummery WK, Dwyer T. Using the internet to promote physical activity: a randomized trial of intervention delivery modes. J Phys Act Health. 2007;4:245–60.CrossRefPubMed Steele R, Mummery WK, Dwyer T. Using the internet to promote physical activity: a randomized trial of intervention delivery modes. J Phys Act Health. 2007;4:245–60.CrossRefPubMed
31.
go back to reference Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, Greene S, Couper M, Carlier C, Wiese C, et al. The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial. J Med Internet Res. 2008;10:e36.CrossRefPubMedPubMedCentral Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, Greene S, Couper M, Carlier C, Wiese C, et al. The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial. J Med Internet Res. 2008;10:e36.CrossRefPubMedPubMedCentral
32.
go back to reference Strecher VJ, McClure JB, Alexander GL, Chakraborty B, Nair VN, Konkel JM, Greene SM, Collins LM, Carlier CC, Wiese CJ, et al. Web-based smoking-cessation programs: results of a randomized trial. Am J Prev Med. 2008;34:373–81.CrossRefPubMedPubMedCentral Strecher VJ, McClure JB, Alexander GL, Chakraborty B, Nair VN, Konkel JM, Greene SM, Collins LM, Carlier CC, Wiese CJ, et al. Web-based smoking-cessation programs: results of a randomized trial. Am J Prev Med. 2008;34:373–81.CrossRefPubMedPubMedCentral
33.
go back to reference Austin, Boren S, Gunlock TL, Krishna S, Kramer TC. Computer-aided diabetes education: a synthesis of randomized controlled trials. AMIA Annu Symp Proc. 2006:51–5. Austin, Boren S, Gunlock TL, Krishna S, Kramer TC. Computer-aided diabetes education: a synthesis of randomized controlled trials. AMIA Annu Symp Proc. 2006:51–5.
34.
go back to reference Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the problem areas in diabetes (PAID) questionnaire. Diabet Med. 2003;20:69–72.CrossRefPubMed Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the problem areas in diabetes (PAID) questionnaire. Diabet Med. 2003;20:69–72.CrossRefPubMed
35.
go back to reference Bennett GG, Glasgow RE. The delivery of public health interventions via the internet: actualizing their potential. Annu Rev Public Health. 2009;30:273–92.CrossRefPubMed Bennett GG, Glasgow RE. The delivery of public health interventions via the internet: actualizing their potential. Annu Rev Public Health. 2009;30:273–92.CrossRefPubMed
36.
go back to reference Strecher V. Internet methods for delivering behavioral and health-related interventions (eHealth). Annu Rev Clin Psychol. 2007;3:53–76.CrossRefPubMed Strecher V. Internet methods for delivering behavioral and health-related interventions (eHealth). Annu Rev Clin Psychol. 2007;3:53–76.CrossRefPubMed
37.
go back to reference Bandura A, editor. Self-efficacy: the exercise of control. New York: W.H. Freeman; 1997. Bandura A, editor. Self-efficacy: the exercise of control. New York: W.H. Freeman; 1997.
38.
go back to reference Glasgow RE. A practical model of diabetes management and education. Diabetes Care. 1995;18:117–26.CrossRefPubMed Glasgow RE. A practical model of diabetes management and education. Diabetes Care. 1995;18:117–26.CrossRefPubMed
39.
go back to reference Glasgow RE, Eakin EG. Issues in diabetes self-management. In: Shumaker SA, Schron EB, Ockene JK, McBee WL, editors. The handbook of health behavior change 2nd edition. New York: Springer Publishing Company; 1998. p. 435–61. Glasgow RE, Eakin EG. Issues in diabetes self-management. In: Shumaker SA, Schron EB, Ockene JK, McBee WL, editors. The handbook of health behavior change 2nd edition. New York: Springer Publishing Company; 1998. p. 435–61.
40.
go back to reference Glasgow RE, Strycker LA, Toobert DJ, Eakin E. A social-ecologic approach to assessing support for disease self-management: the chronic illness resources survey. J Behav Med. 2000;23:559–83.CrossRefPubMed Glasgow RE, Strycker LA, Toobert DJ, Eakin E. A social-ecologic approach to assessing support for disease self-management: the chronic illness resources survey. J Behav Med. 2000;23:559–83.CrossRefPubMed
41.
go back to reference McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988;15:351–77.CrossRefPubMed McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988;15:351–77.CrossRefPubMed
42.
go back to reference Stokols D, Allen J, Bellingham RL. The social ecology of health promotion: implications for research and practice. Am J Health Promot. 1996;10:247–51.CrossRefPubMed Stokols D, Allen J, Bellingham RL. The social ecology of health promotion: implications for research and practice. Am J Health Promot. 1996;10:247–51.CrossRefPubMed
43.
go back to reference Battersby M, Von Korff M, Schaefer J, Davis C, Ludman E, Greene SM, Parkerton M, Wagner EH. Twelve evidence-based principles for implementing self-management support in primary care. Jt Comm J Qual Patient Saf. 2010;36:561–70.CrossRefPubMed Battersby M, Von Korff M, Schaefer J, Davis C, Ludman E, Greene SM, Parkerton M, Wagner EH. Twelve evidence-based principles for implementing self-management support in primary care. Jt Comm J Qual Patient Saf. 2010;36:561–70.CrossRefPubMed
44.
go back to reference Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007;33:57–68.CrossRefPubMed Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007;33:57–68.CrossRefPubMed
45.
go back to reference Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001;345:892–902.CrossRefPubMed Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001;345:892–902.CrossRefPubMed
46.
go back to reference Brochu M, Poehlman ET, Ades PA. Obesity, body fat distribution, and coronary artery disease. J Cardpulm Rehabil. 2000;20:96–108.CrossRef Brochu M, Poehlman ET, Ades PA. Obesity, body fat distribution, and coronary artery disease. J Cardpulm Rehabil. 2000;20:96–108.CrossRef
47.
48.
go back to reference Baron RJ. Quality improvement with an electronic health record: achievable, but not automatic. Ann Intern Med. 2007;147:549–52.CrossRefPubMed Baron RJ. Quality improvement with an electronic health record: achievable, but not automatic. Ann Intern Med. 2007;147:549–52.CrossRefPubMed
49.
go back to reference Crosson JC, Etz RS, Wu S, Straus SG, Eisenman D, Bell DS. Meaningful use of electronic prescribing in 5 exemplar primary care practices. Ann Fam Med. 2011;9:392–7. Crosson JC, Etz RS, Wu S, Straus SG, Eisenman D, Bell DS. Meaningful use of electronic prescribing in 5 exemplar primary care practices. Ann Fam Med. 2011;9:392–7.
50.
go back to reference Crosson J, Isaacson N, Lancaster D, McDonald E, Schueth A, DiCicco-Bloom B, Newman J, Wang C, Bell D. Variation in electronic prescribing implementation among twelve ambulatory practices. J Gen Intern Med. 2008;23:364–71.CrossRefPubMedPubMedCentral Crosson J, Isaacson N, Lancaster D, McDonald E, Schueth A, DiCicco-Bloom B, Newman J, Wang C, Bell D. Variation in electronic prescribing implementation among twelve ambulatory practices. J Gen Intern Med. 2008;23:364–71.CrossRefPubMedPubMedCentral
51.
go back to reference Baron RJ, Desnouee E. Practice profile. The struggle to support patients' efforts to change their unhealthy behavior. Health Aff (Millwood). 2010;29:953–5. Baron RJ, Desnouee E. Practice profile. The struggle to support patients' efforts to change their unhealthy behavior. Health Aff (Millwood). 2010;29:953–5.
52.
go back to reference Harvey G, Loftus-Hills A, Rycroft-Malone J, Titchen A, Kitson A, McCormack B, Seers K. Getting evidence into practice: the role and function of facilitation. J Adv Nurs. 2002;37:577–88.CrossRefPubMed Harvey G, Loftus-Hills A, Rycroft-Malone J, Titchen A, Kitson A, McCormack B, Seers K. Getting evidence into practice: the role and function of facilitation. J Adv Nurs. 2002;37:577–88.CrossRefPubMed
53.
go back to reference Nagykaldi Z, Mold JW, Aspy CB. Practice facilitators: a review of the literature. Fam Med. 2005;37:581–8.PubMed Nagykaldi Z, Mold JW, Aspy CB. Practice facilitators: a review of the literature. Fam Med. 2005;37:581–8.PubMed
54.
go back to reference Goodwin MA, Zyzanski SJ, Zronek S, Ruhe M, Weyer SM, Konrad N, Esola D, Stange KC. A clinical trial of tailored office systems for preventive service delivery. The study to enhance prevention by understanding practice (STEP-UP). [see comments]. Am J Prev Med. 2001;21:20–8.CrossRefPubMed Goodwin MA, Zyzanski SJ, Zronek S, Ruhe M, Weyer SM, Konrad N, Esola D, Stange KC. A clinical trial of tailored office systems for preventive service delivery. The study to enhance prevention by understanding practice (STEP-UP). [see comments]. Am J Prev Med. 2001;21:20–8.CrossRefPubMed
55.
go back to reference Margolis PA, Lannon CM, Stuart JM, Fried BJ, Keyes-Elstein L, Moore DE Jr. Practice based education to improve delivery systems for prevention in primary care: randomised trial. BMJ. 2004;328:388.CrossRefPubMedPubMedCentral Margolis PA, Lannon CM, Stuart JM, Fried BJ, Keyes-Elstein L, Moore DE Jr. Practice based education to improve delivery systems for prevention in primary care: randomised trial. BMJ. 2004;328:388.CrossRefPubMedPubMedCentral
56.
go back to reference Stange KC, Goodwin MA, Zyzanski SJ, Dietrich AJ. Sustainability of a practice-individualized preventive service delivery intervention. Am J Prev Med. 2003;25:296–300.CrossRefPubMed Stange KC, Goodwin MA, Zyzanski SJ, Dietrich AJ. Sustainability of a practice-individualized preventive service delivery intervention. Am J Prev Med. 2003;25:296–300.CrossRefPubMed
57.
go back to reference Hogg W, Baskerville N, Nykiforuk C, Mallen D. Improved preventive care in family practices with outreach facilitation: understanding success and failure. J Health Serv Res Policy. 2002;7:195–201.CrossRefPubMed Hogg W, Baskerville N, Nykiforuk C, Mallen D. Improved preventive care in family practices with outreach facilitation: understanding success and failure. J Health Serv Res Policy. 2002;7:195–201.CrossRefPubMed
58.
go back to reference Buscaj E, Hall T, Montgomery L, Fernald DH, King J, Deaner N, Dickinson WP. Practice facilitation for PCMH implementation in residency practices. Fam Med. 2016;48:795–800.PubMed Buscaj E, Hall T, Montgomery L, Fernald DH, King J, Deaner N, Dickinson WP. Practice facilitation for PCMH implementation in residency practices. Fam Med. 2016;48:795–800.PubMed
59.
go back to reference White DE, Straus SE, Stelfox HT, Holroyd-Leduc JM, Bell CM, Jackson K, Norris JM, Flemons WW, Moffatt ME, Forster AJ. What is the value and impact of quality and safety teams? A scoping review. Implement Sci. 2011;6:97. White DE, Straus SE, Stelfox HT, Holroyd-Leduc JM, Bell CM, Jackson K, Norris JM, Flemons WW, Moffatt ME, Forster AJ. What is the value and impact of quality and safety teams? A scoping review. Implement Sci. 2011;6:97.
60.
go back to reference Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012;13:120.CrossRefPubMedPubMedCentral Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012;13:120.CrossRefPubMedPubMedCentral
61.
go back to reference Alexander F, Roberts MM, Lutz W, Hepburn W. Randomisation by cluster and the problem of social class bias. J Epidemiol Community Health. 1989;43:29–36.CrossRefPubMedPubMedCentral Alexander F, Roberts MM, Lutz W, Hepburn W. Randomisation by cluster and the problem of social class bias. J Epidemiol Community Health. 1989;43:29–36.CrossRefPubMedPubMedCentral
62.
go back to reference Shah S, Peat JK, Mazurski EJ, Wang H, Sindhusake D, Bruce C, Henry RL, Gibson PG. Effect of peer led programme for asthma education in adolescents: cluster randomised controlled trial. BMJ. 2001;322:583–5.CrossRefPubMedPubMedCentral Shah S, Peat JK, Mazurski EJ, Wang H, Sindhusake D, Bruce C, Henry RL, Gibson PG. Effect of peer led programme for asthma education in adolescents: cluster randomised controlled trial. BMJ. 2001;322:583–5.CrossRefPubMedPubMedCentral
63.
go back to reference Carman WF, Elder AG, Wallace LA, McAulay K, Walker A, Murray GD, Stott DJ. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000;355:93–7.CrossRefPubMed Carman WF, Elder AG, Wallace LA, McAulay K, Walker A, Murray GD, Stott DJ. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000;355:93–7.CrossRefPubMed
64.
go back to reference Dickinson LM, Beaty B, Fox C, Pace W, Dickinson WP, Emsermann C, Kempe A. Pragmatic cluster randomized trials using covariate constrained randomization: a method for practice-based research networks (PBRNs). J Am Board Fam Med. 2015;28:663–72.CrossRefPubMed Dickinson LM, Beaty B, Fox C, Pace W, Dickinson WP, Emsermann C, Kempe A. Pragmatic cluster randomized trials using covariate constrained randomization: a method for practice-based research networks (PBRNs). J Am Board Fam Med. 2015;28:663–72.CrossRefPubMed
65.
go back to reference Li F, Lokhnygina Y, Murray DM, Heagerty PJ, DeLong ER. An evaluation of constrained randomization for the design and analysis of group-randomized trials. Stat Med. 2016;35:1565–79.CrossRefPubMed Li F, Lokhnygina Y, Murray DM, Heagerty PJ, DeLong ER. An evaluation of constrained randomization for the design and analysis of group-randomized trials. Stat Med. 2016;35:1565–79.CrossRefPubMed
67.
go back to reference Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ. 2003;327:785–9.CrossRefPubMedPubMedCentral Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ. 2003;327:785–9.CrossRefPubMedPubMedCentral
69.
go back to reference Murray D, editor. Design and analysis of group-randomized trials. New York: Oxford University Press; 1998. Murray D, editor. Design and analysis of group-randomized trials. New York: Oxford University Press; 1998.
70.
go back to reference Liddy C, wiens M, Hogg W. Methods to achieve high interrater reliability in data collection from primary care medical records. Ann Fam Med. 2011;9:57–62.CrossRefPubMedPubMedCentral Liddy C, wiens M, Hogg W. Methods to achieve high interrater reliability in data collection from primary care medical records. Ann Fam Med. 2011;9:57–62.CrossRefPubMedPubMedCentral
71.
go back to reference Glasgow RE, Dickinson WP, Fisher L, Christiansen S, Toobert DJ, Bender BG, Dickinson LM, Jortberg B, Estabrooks PA: Patient-Centered Assessment, communication, and Outcomes in the Primary Care Medical Home: Use of RE-AIM to Develop a Multi-Media Facilitation Tool. Implementation Science. In Press. Glasgow RE, Dickinson WP, Fisher L, Christiansen S, Toobert DJ, Bender BG, Dickinson LM, Jortberg B, Estabrooks PA: Patient-Centered Assessment, communication, and Outcomes in the Primary Care Medical Home: Use of RE-AIM to Develop a Multi-Media Facilitation Tool. Implementation Science. In Press.
72.
go back to reference Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001;44:119–27.CrossRefPubMed Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001;44:119–27.CrossRefPubMed
73.
go back to reference Glasgow RE, Linnan LA. Evaluation of theory-based interventions. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research, and Practice 4th ed. San Francisco: Jossey-Bass; 2008. p. 487–508. Glasgow RE, Linnan LA. Evaluation of theory-based interventions. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research, and Practice 4th ed. San Francisco: Jossey-Bass; 2008. p. 487–508.
74.
go back to reference Gaglio B, Glasgow RE. Evaluation Approaches for Dissemination and Implementation Research. In: Brownson RC, Colditz GA, Proctor EK, editors. Dissemination and implementation research in health : translating science to practice. Oxford: Oxford University Press; 2010. Gaglio B, Glasgow RE. Evaluation Approaches for Dissemination and Implementation Research. In: Brownson RC, Colditz GA, Proctor EK, editors. Dissemination and implementation research in health : translating science to practice. Oxford: Oxford University Press; 2010.
75.
go back to reference Belza B, Toobert DJ, Glasgow RE. RE-AIM for program planning: overview and applications: Center for Healthy Aging Issue Brief. VA: National Council on Aging in Arlington; 2007. Belza B, Toobert DJ, Glasgow RE. RE-AIM for program planning: overview and applications: Center for Healthy Aging Issue Brief. VA: National Council on Aging in Arlington; 2007.
76.
go back to reference Toobert DJ. RE-AIM: application to AoA evidence-based demonstration projects. In: 3rd annual Agency on Aging grantees conference. Washington, D.C. p. 2006. Toobert DJ. RE-AIM: application to AoA evidence-based demonstration projects. In: 3rd annual Agency on Aging grantees conference. Washington, D.C. p. 2006.
78.
go back to reference Glasgow R, Emmons KM. The public health need for patient-reported measures and health behaviors in electronic health records: a policy statement of the Society of Behavioral Medicine. Translational Behav Med. 2011;1:108–9. Glasgow R, Emmons KM. The public health need for patient-reported measures and health behaviors in electronic health records: a policy statement of the Society of Behavioral Medicine. Translational Behav Med. 2011;1:108–9.
79.
go back to reference Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011;40:67–71. Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011;40:67–71.
80.
go back to reference Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23:943–50.CrossRefPubMed Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23:943–50.CrossRefPubMed
81.
go back to reference Jilcott SB, Keyserling TC, Samuel-Hodge CD, Johnston LF, Gross MD, Ammerman AS. Validation of a brief dietary assessment to guide counseling for cardiovascular disease risk reduction in an underserved population. J Am Diet Assoc. 2007;107:246–55.CrossRefPubMed Jilcott SB, Keyserling TC, Samuel-Hodge CD, Johnston LF, Gross MD, Ammerman AS. Validation of a brief dietary assessment to guide counseling for cardiovascular disease risk reduction in an underserved population. J Am Diet Assoc. 2007;107:246–55.CrossRefPubMed
82.
go back to reference Moshfegh A, Goldman J, Ahuja J, Rhodes D, LaComb R: What We Eat in America, NHANES 2005–2006: Usual nutrient intakes from food and water compared to 1997 Dietary Reference Intakes for Vitamin D, Calcium, Phosphorous, and Magnesium. Beltsville: U.S. Department of Agriculture, Agricultural Research Service; 2009. Moshfegh A, Goldman J, Ahuja J, Rhodes D, LaComb R: What We Eat in America, NHANES 2005–2006: Usual nutrient intakes from food and water compared to 1997 Dietary Reference Intakes for Vitamin D, Calcium, Phosphorous, and Magnesium. Beltsville: U.S. Department of Agriculture, Agricultural Research Service; 2009.
83.
go back to reference Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35:1381–95.CrossRefPubMed
84.
go back to reference Bender BG, Bartlett SJ, Rand CS, Turner C, Wamboldt FS, Zhang L. Impact of interview mode on accuracy of child and parent report of adherence with asthma-controller medication. Pediatrics. 2007;120:e471–7.CrossRefPubMed Bender BG, Bartlett SJ, Rand CS, Turner C, Wamboldt FS, Zhang L. Impact of interview mode on accuracy of child and parent report of adherence with asthma-controller medication. Pediatrics. 2007;120:e471–7.CrossRefPubMed
85.
go back to reference Bender BG, Rankin A, Tran ZV, Wamboldt FS. Brief-interval telephone surveys of medication adherence and asthma symptoms in the childhood asthma management program continuation study. Ann Allergy Asthma Immunol. 2008;101:382–6.CrossRefPubMedPubMedCentral Bender BG, Rankin A, Tran ZV, Wamboldt FS. Brief-interval telephone surveys of medication adherence and asthma symptoms in the childhood asthma management program continuation study. Ann Allergy Asthma Immunol. 2008;101:382–6.CrossRefPubMedPubMedCentral
86.
go back to reference Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999;47:555–67.CrossRefPubMed Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999;47:555–67.CrossRefPubMed
87.
go back to reference Dawson DA, Grant BF, Li TK. Quantifying the risks associated with exceeding recommended drinking limits. Alcohol Clin Exp Res. 2005;29:902–8.CrossRefPubMed Dawson DA, Grant BF, Li TK. Quantifying the risks associated with exceeding recommended drinking limits. Alcohol Clin Exp Res. 2005;29:902–8.CrossRefPubMed
89.
go back to reference Ory MG, Jordan PJ, Bazzarre T. The behavior change consortium: setting the stage for a new century of health behavior-change research. Health Educ Res. 2002;17:500–11.CrossRefPubMed Ory MG, Jordan PJ, Bazzarre T. The behavior change consortium: setting the stage for a new century of health behavior-change research. Health Educ Res. 2002;17:500–11.CrossRefPubMed
91.
go back to reference Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50:613–21.PubMed Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50:613–21.PubMed
92.
go back to reference Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
93.
go back to reference Fisher L, Skaff MM, Mullan JT, Arean P, Glasgow R, Masharani U. A longitudinal study of affective and anxiety disorders, depressive affect and diabetes distress in adults with type 2 diabetes. Diabet Med. 2008;25:1096–101.CrossRefPubMedPubMedCentral Fisher L, Skaff MM, Mullan JT, Arean P, Glasgow R, Masharani U. A longitudinal study of affective and anxiety disorders, depressive affect and diabetes distress in adults with type 2 diabetes. Diabet Med. 2008;25:1096–101.CrossRefPubMedPubMedCentral
94.
go back to reference Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005;28:626–31.CrossRefPubMed Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005;28:626–31.CrossRefPubMed
95.
go back to reference Raudenbush SW, Liu X. Statistical power and optimal design for multisite randomized trials. Psychol Methods. 2000;5:199–213.CrossRefPubMed Raudenbush SW, Liu X. Statistical power and optimal design for multisite randomized trials. Psychol Methods. 2000;5:199–213.CrossRefPubMed
96.
go back to reference Hedeker D, Gibbons RD, Waternaux C. Sample size estimation for longitudinal designs with attrition. J Educ Behav Stat. 1999;24:70–93.CrossRef Hedeker D, Gibbons RD, Waternaux C. Sample size estimation for longitudinal designs with attrition. J Educ Behav Stat. 1999;24:70–93.CrossRef
97.
go back to reference Dempster AP, Laird NM, Rubin DB: Maximum likelihood estimation from incomplete data via the EM algorithm. J R Stat Soc 1977;Series B:1–38. Dempster AP, Laird NM, Rubin DB: Maximum likelihood estimation from incomplete data via the EM algorithm. J R Stat Soc 1977;Series B:1–38.
98.
go back to reference Little RJA, Rubin DB. Statistical analysis with missing data. New York: Wiley; 1987. Little RJA, Rubin DB. Statistical analysis with missing data. New York: Wiley; 1987.
99.
go back to reference Fairclough D, editor. Design and analysis of quality of life studies in clinical trials. Boca Raton: Chapman & Hall/CRC; 2002. Fairclough D, editor. Design and analysis of quality of life studies in clinical trials. Boca Raton: Chapman & Hall/CRC; 2002.
100.
go back to reference Diggle P, Kenward MG. Informative drop-out in longitudinal data-analysis. J R Stat Soc Ser C Appl Stat. 1994;43:49–93. Diggle P, Kenward MG. Informative drop-out in longitudinal data-analysis. J R Stat Soc Ser C Appl Stat. 1994;43:49–93.
101.
go back to reference Littell R, Milliken GA, Stroup WW, Wolfinger RD, editors. SAS System for Mixed Models. Cary: SAS Institute Inc; 1996. Littell R, Milliken GA, Stroup WW, Wolfinger RD, editors. SAS System for Mixed Models. Cary: SAS Institute Inc; 1996.
102.
go back to reference Hedeker D, Gibbons RD. Longitudinal Data Analysis. Hoboken, New Jersey: Wiley; 2006. Hedeker D, Gibbons RD. Longitudinal Data Analysis. Hoboken, New Jersey: Wiley; 2006.
103.
go back to reference Raman R, Hedeker D. A mixed-effects regression model for three-level ordinal response data. Stat Med. 2005;24:3331–45.CrossRefPubMed Raman R, Hedeker D. A mixed-effects regression model for three-level ordinal response data. Stat Med. 2005;24:3331–45.CrossRefPubMed
104.
go back to reference Bryk AS, Raudenbush SW, editors. Hierarchical Linear Models: Applications and Data Analysis Methods., Second edition. Newbury Park: Sage Publications; 2000. Bryk AS, Raudenbush SW, editors. Hierarchical Linear Models: Applications and Data Analysis Methods., Second edition. Newbury Park: Sage Publications; 2000.
105.
go back to reference Miller WL, Crabtree BF. The dance of interpretation. In: Crabtree BF, Miller WL, editors. 2nd edition. Thousand Oaks: Sage Publications, Inc; 1999. p. 127–43. Miller WL, Crabtree BF. The dance of interpretation. In: Crabtree BF, Miller WL, editors. 2nd edition. Thousand Oaks: Sage Publications, Inc; 1999. p. 127–43.
106.
go back to reference Vale MJ, Jelinek MV, Best JD, Dart AM, Grigg LE, Hare DL, Ho BP, Newman RW, JJ MN, Group CS. Coaching patients On Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med. 2003;163:2775–83.CrossRefPubMed Vale MJ, Jelinek MV, Best JD, Dart AM, Grigg LE, Hare DL, Ho BP, Newman RW, JJ MN, Group CS. Coaching patients On Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med. 2003;163:2775–83.CrossRefPubMed
107.
go back to reference Holmes-Rovner M, Stommel M, Corser WD, Olomu A, Holtrop JS, Siddiqi A, Dunn SL. Does outpatient telephone coaching add to hospital quality improvement following hospitalization for acute coronary syndrome? J Gen Intern Med. 2008;23:1464–70.CrossRefPubMedPubMedCentral Holmes-Rovner M, Stommel M, Corser WD, Olomu A, Holtrop JS, Siddiqi A, Dunn SL. Does outpatient telephone coaching add to hospital quality improvement following hospitalization for acute coronary syndrome? J Gen Intern Med. 2008;23:1464–70.CrossRefPubMedPubMedCentral
108.
go back to reference Whittemore R, Melkus GD, Sullivan A, Grey M. A nurse-coaching intervention for women with type 2 diabetes. Diabetes Educ. 2004;30:795–804.CrossRefPubMed Whittemore R, Melkus GD, Sullivan A, Grey M. A nurse-coaching intervention for women with type 2 diabetes. Diabetes Educ. 2004;30:795–804.CrossRefPubMed
Metadata
Title
A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices
Authors
W. Perry Dickinson
L. Miriam Dickinson
Bonnie T. Jortberg
Danielle M. Hessler
Douglas H. Fernald
Lawrence Fisher
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2018
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/s12875-018-0810-x

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