Skip to main content
Top
Published in: Implementation Science 1/2015

Open Access 01-12-2015 | Study protocol

Supporting Practices to Adopt Registry-Based Care (SPARC): protocol for a randomized controlled trial

Authors: Rebecca S Etz, Rosalind E Keith, Anna M Maternick, Karen L Stein, Roy T Sabo, Melissa S Hayes, Purvi Sevak, John Holland, Jesse C Crosson

Published in: Implementation Science | Issue 1/2015

Login to get access

Abstract

Background

Diabetes is predicted to increase in incidence by 42% from 1995 to 2025. Although most adults with diabetes seek care from primary care practices, adherence to treatment guidelines in these settings is not optimal. Many practices lack the infrastructure to monitor patient adherence to recommended treatment and are slow to implement changes critical for effective management of patients with chronic conditions. Supporting Practices to Adopt Registry-Based Care (SPARC) will evaluate effectiveness and sustainability of a low-cost intervention designed to support work process change in primary care practices and enhance focus on population-based care through implementation of a diabetes registry.

Methods

SPARC is a two-armed randomized controlled trial (RCT) of 30 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN). Participating practices (including control groups) will be introduced to population health concepts and tools for work process redesign and registry adoption at a meeting of practice-level implementation champions. Practices randomized to the intervention will be assigned study peer mentors, receive a list of specific milestones, and have access to a physician informaticist. Peer mentors are clinicians who successfully implemented registries in their practices and will help champions in the intervention practices throughout the implementation process. During the first year, peer mentors will contact intervention practices monthly and visit them quarterly. Control group practices will not receive support or guidance for registry implementation. We will use a mixed-methods explanatory sequential design to guide collection of medical record, participant observation, and semistructured interview data in control and intervention practices at baseline, 12 months, and 24 months. We will use grounded theory and a template-guided approach using the Consolidated Framework for Implementation Research to analyze qualitative data on contextual factors related to registry adoption. We will assess intervention effectiveness by comparing changes in patient-level hemoglobin A1c scores from baseline to year 1 between intervention and control practices.

Discussion

Findings will enhance our understanding of how to leverage existing practice resources to improve diabetes care in primary care practices by implementing and using a registry. SPARC has the potential to validate the effectiveness of low-cost implementation strategies that target practice change in primary care.

Trial registration

Appendix
Available only for authorised users
Literature
1.
go back to reference Centers for Disease Control and Prevention. National diabetes statistics report, 2014: estimates of diabetes and its burden in the United States. Atlanta, GA: U.S. Department of Health and Human Services; 2014. Centers for Disease Control and Prevention. National diabetes statistics report, 2014: estimates of diabetes and its burden in the United States. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
2.
go back to reference Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010;8(1):29.PubMedPubMedCentral Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010;8(1):29.PubMedPubMedCentral
3.
go back to reference American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033–46.PubMedCentral American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033–46.PubMedCentral
4.
go back to reference Dall TM, Zhang Y, Chen YJ, Quick WW, Yang WG, Fogli J. The economic burden of diabetes. Health Affairs (Project Hope). 2010;29(2):297–303. Dall TM, Zhang Y, Chen YJ, Quick WW, Yang WG, Fogli J. The economic burden of diabetes. Health Affairs (Project Hope). 2010;29(2):297–303.
5.
go back to reference Narayan KM, Gregg EW, Fagot-Campagna A, Engelgau MM, Vinicor F. Diabetes—a common, growing, serious, costly, and potentially preventable public health problem. Diabetes Res Clin Pract. 2000;50 Suppl 2:S77–84.PubMed Narayan KM, Gregg EW, Fagot-Campagna A, Engelgau MM, Vinicor F. Diabetes—a common, growing, serious, costly, and potentially preventable public health problem. Diabetes Res Clin Pract. 2000;50 Suppl 2:S77–84.PubMed
6.
go back to reference Sloan FA, Bethel MA, Ruiz D, Shea AM, Shea AH, Feinglos MN. The growing burden of diabetes mellitus in the US elderly population. Arch Intern Med. 2008;168(2):192–9.PubMed Sloan FA, Bethel MA, Ruiz D, Shea AM, Shea AH, Feinglos MN. The growing burden of diabetes mellitus in the US elderly population. Arch Intern Med. 2008;168(2):192–9.PubMed
7.
go back to reference Trogdon JG, Hylands T. Nationally representative medical costs of diabetes by time since diagnosis. Diabetes Care. 2008;31(12):2307–11.PubMedPubMedCentral Trogdon JG, Hylands T. Nationally representative medical costs of diabetes by time since diagnosis. Diabetes Care. 2008;31(12):2307–11.PubMedPubMedCentral
8.
go back to reference Ziemer DC, Miller CD, Rhee MK, Doyle JP, Watkins C, Cook CB, et al. Clinical inertia contributes to poor diabetes control in a primary care setting. Diabetes Educator. 2005;31(4):564–71.PubMed Ziemer DC, Miller CD, Rhee MK, Doyle JP, Watkins C, Cook CB, et al. Clinical inertia contributes to poor diabetes control in a primary care setting. Diabetes Educator. 2005;31(4):564–71.PubMed
9.
go back to reference Van Bruggen R, Gorter K, Stolk R, Klungel O, Rutten G. Clinical inertia in general practice: widespread and related to the outcome of diabetes care. Fam Pract. 2009;26(6):428–36.PubMed Van Bruggen R, Gorter K, Stolk R, Klungel O, Rutten G. Clinical inertia in general practice: widespread and related to the outcome of diabetes care. Fam Pract. 2009;26(6):428–36.PubMed
10.
go back to reference Grant RW, Lutfey KE, Gerstenberger E, Link CL, Marceau LD, McKinlay JB. The decision to intensify therapy in patients with type 2 diabetes: results from an experiment using a clinical case vignette. J Am Board Fam Med. 2009;22(5):513–20.PubMedPubMedCentral Grant RW, Lutfey KE, Gerstenberger E, Link CL, Marceau LD, McKinlay JB. The decision to intensify therapy in patients with type 2 diabetes: results from an experiment using a clinical case vignette. J Am Board Fam Med. 2009;22(5):513–20.PubMedPubMedCentral
11.
go back to reference Bolen SD, Bricker E, Samuels TA, Yeh H-C, Marinopoulos SS, McGuire M, et al. Factors associated with intensification of oral diabetes medications in primary care provider-patient dyads: a cohort study. Diabetes Care. 2009;32(1):25–31.PubMedPubMedCentral Bolen SD, Bricker E, Samuels TA, Yeh H-C, Marinopoulos SS, McGuire M, et al. Factors associated with intensification of oral diabetes medications in primary care provider-patient dyads: a cohort study. Diabetes Care. 2009;32(1):25–31.PubMedPubMedCentral
12.
go back to reference Bolen SD, Samuels TA, Yeh H-C, Marinopoulos S, McGuire M, Abuid M, et al. Failure to intensify antihypertensive treatment by primary care providers: a cohort study in adults with diabetes mellitus and hypertension. J Gen Intern Med. 2008;23(5):543–50.PubMedPubMedCentral Bolen SD, Samuels TA, Yeh H-C, Marinopoulos S, McGuire M, Abuid M, et al. Failure to intensify antihypertensive treatment by primary care providers: a cohort study in adults with diabetes mellitus and hypertension. J Gen Intern Med. 2008;23(5):543–50.PubMedPubMedCentral
13.
go back to reference Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione C, et al. Why don’t diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008;23(5):588–94.PubMedPubMedCentral Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione C, et al. Why don’t diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008;23(5):588–94.PubMedPubMedCentral
14.
go back to reference Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, et al. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007;30(4):807–12.PubMed Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, et al. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007;30(4):807–12.PubMed
15.
go back to reference McEwen LN, Bilik D, Johnson SL, Halter JB, Karter AJ, Mangione CM, et al. Predictors and impact of intensification of antihyperglycemic therapy in type 2 diabetes: Translating Research Into Action for Diabetes (TRIAD). Diabetes Care. 2009;32(6):971–6.PubMedPubMedCentral McEwen LN, Bilik D, Johnson SL, Halter JB, Karter AJ, Mangione CM, et al. Predictors and impact of intensification of antihyperglycemic therapy in type 2 diabetes: Translating Research Into Action for Diabetes (TRIAD). Diabetes Care. 2009;32(6):971–6.PubMedPubMedCentral
16.
go back to reference Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care. 2005;28(3):600–6.PubMed Shah BR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical inertia in response to inadequate glycemic control: do specialists differ from primary care physicians? Diabetes Care. 2005;28(3):600–6.PubMed
17.
go back to reference Subramanian U, Schmittdiel JA, Gavin N, Traylor A, Uratsu C, Selby J, et al. The association of patient age with cardiovascular disease risk factor treatment and control in diabetes. J Gen Intern Med. 2009;24(9):1049–52.PubMedPubMedCentral Subramanian U, Schmittdiel JA, Gavin N, Traylor A, Uratsu C, Selby J, et al. The association of patient age with cardiovascular disease risk factor treatment and control in diabetes. J Gen Intern Med. 2009;24(9):1049–52.PubMedPubMedCentral
18.
go back to reference Sharma MA, Cheng N, Moore M, Coffman M, Bazemore AW. Patients with high-cost chronic conditions rely heavily on primary care physicians. J Am Board Fam Med. 2014;27(1):11–2.PubMed Sharma MA, Cheng N, Moore M, Coffman M, Bazemore AW. Patients with high-cost chronic conditions rely heavily on primary care physicians. J Am Board Fam Med. 2014;27(1):11–2.PubMed
19.
go back to reference Spann SJ, Nutting PA, Galliher JM, Peterson KA, Pavlik VN, Dickinson LM, et al. Management of type 2 diabetes in the primary care setting: a practice-based research network study. Ann Fam Med. 2006;4(1):23–31.PubMedPubMedCentral Spann SJ, Nutting PA, Galliher JM, Peterson KA, Pavlik VN, Dickinson LM, et al. Management of type 2 diabetes in the primary care setting: a practice-based research network study. Ann Fam Med. 2006;4(1):23–31.PubMedPubMedCentral
20.
go back to reference Strickland PAO, Hudson SV, Piasecki A, Hahn K, Cohen D, Orzano AJ, et al. Features of the Chronic Care Model (CCM) associated with behavioral counseling and diabetes care in community primary care. J Am Board Fam Med. 2010;23(3):295–305.PubMedPubMedCentral Strickland PAO, Hudson SV, Piasecki A, Hahn K, Cohen D, Orzano AJ, et al. Features of the Chronic Care Model (CCM) associated with behavioral counseling and diabetes care in community primary care. J Am Board Fam Med. 2010;23(3):295–305.PubMedPubMedCentral
21.
go back to reference Sperl-Hillen JM, O’Connor PJ. Factors driving diabetes care improvement in a large medical group: ten years of progress. Am J Manag Care. 2005;11(5 Suppl):S177–85.PubMed Sperl-Hillen JM, O’Connor PJ. Factors driving diabetes care improvement in a large medical group: ten years of progress. Am J Manag Care. 2005;11(5 Suppl):S177–85.PubMed
22.
go back to reference Elliott DJ, Robinson EJ, Sanford M, Herrman JW, Riesenberg LA. Systemic barriers to diabetes management in primary care: a qualitative analysis of Delaware physicians. Am J Med Qual. 2011;26(4):284–90.PubMed Elliott DJ, Robinson EJ, Sanford M, Herrman JW, Riesenberg LA. Systemic barriers to diabetes management in primary care: a qualitative analysis of Delaware physicians. Am J Med Qual. 2011;26(4):284–90.PubMed
24.
25.
go back to reference Davis K, Abrams M, Stremikis K. How the Affordable Care Act will strengthen the nation’s primary care foundation. J Gen Intern Med. 2011;26(10):1201–3.PubMedPubMedCentral Davis K, Abrams M, Stremikis K. How the Affordable Care Act will strengthen the nation’s primary care foundation. J Gen Intern Med. 2011;26(10):1201–3.PubMedPubMedCentral
26.
go back to reference Cusak CM, Knudson AD, Kronstadt JL, Singer RF, Brown AL. Practice-based population health: information technology to support transformation to proactive primary care. AHRQ publication no. 10-0092-EF; 2010. pcmh.ahrq.gov/page/defining-pcmh. Cusak CM, Knudson AD, Kronstadt JL, Singer RF, Brown AL. Practice-based population health: information technology to support transformation to proactive primary care. AHRQ publication no. 10-0092-EF; 2010. pcmh.ahrq.gov/page/defining-pcmh.
27.
go back to reference Goldberg DG, Kuzel AJ. Elements of the patient-centered medical home in family practices in Virginia. Ann Fam Med. 2009;7(4):301–8.PubMedPubMedCentral Goldberg DG, Kuzel AJ. Elements of the patient-centered medical home in family practices in Virginia. Ann Fam Med. 2009;7(4):301–8.PubMedPubMedCentral
28.
go back to reference Crosson JC, Ohman-Strickland PA, Cohen DJ, Clark EC, Crabtree BF. Typical electronic health record use in primary care practices and the quality of diabetes care. Ann Fam Med. 2012;10(3):221–7.PubMedPubMedCentral Crosson JC, Ohman-Strickland PA, Cohen DJ, Clark EC, Crabtree BF. Typical electronic health record use in primary care practices and the quality of diabetes care. Ann Fam Med. 2012;10(3):221–7.PubMedPubMedCentral
29.
go back to reference Eggleston EM, Klompas M. Rational use of electronic health records for diabetes population management. Curr Diab Rep. 2014;14(4):1–10. Eggleston EM, Klompas M. Rational use of electronic health records for diabetes population management. Curr Diab Rep. 2014;14(4):1–10.
30.
go back to reference Centers for Medicare & Medicaid Services. Medicare program; revisions to payment policies under the physician fee schedule, clinical laboratory fee schedule, access to identifiable data for the Center for Medicare and Medicaid innovation models & other revisions to Part B for CY 2015. 2014. https://www.federalregister.gov/a/2014-26183. Centers for Medicare & Medicaid Services. Medicare program; revisions to payment policies under the physician fee schedule, clinical laboratory fee schedule, access to identifiable data for the Center for Medicare and Medicaid innovation models & other revisions to Part B for CY 2015. 2014. https://​www.​federalregister.​gov/​a/​2014-26183.
31.
go back to reference Edwards ST, Landon BE. Medicare’s chronic care management payment—payment reform for primary care. N Engl J Med. 2014;371:2049–51.PubMed Edwards ST, Landon BE. Medicare’s chronic care management payment—payment reform for primary care. N Engl J Med. 2014;371:2049–51.PubMed
32.
go back to reference Rittenhouse DR, Casalino LP, Shortell SM, McClellan SR, Gillies RR, Alexander JA, et al. Small and medium-size physician practices use few patient-centered medical home processes. Health Affairs (project Hope). 2011;30(8):1575–84. Rittenhouse DR, Casalino LP, Shortell SM, McClellan SR, Gillies RR, Alexander JA, et al. Small and medium-size physician practices use few patient-centered medical home processes. Health Affairs (project Hope). 2011;30(8):1575–84.
33.
go back to reference Crabtree BF, Nutting PA, Miller WL, McDaniel RR, Stange KC, Jaen CR, et al. Primary care practice transformation is hard work: insights from a 15-year developmental program of research. Med Care. 2011;49:S28–35.PubMedPubMedCentral Crabtree BF, Nutting PA, Miller WL, McDaniel RR, Stange KC, Jaen CR, et al. Primary care practice transformation is hard work: insights from a 15-year developmental program of research. Med Care. 2011;49:S28–35.PubMedPubMedCentral
34.
go back to reference Peterson KA, Radosevich DM, O’Connor PJ, Nyman JA, Prineas RJ, Smith SA, et al. Improving diabetes care in practice: findings from the TRANSLATE trial. Diabetes Care. 2008;31(12):2238–43.PubMedPubMedCentral Peterson KA, Radosevich DM, O’Connor PJ, Nyman JA, Prineas RJ, Smith SA, et al. Improving diabetes care in practice: findings from the TRANSLATE trial. Diabetes Care. 2008;31(12):2238–43.PubMedPubMedCentral
35.
go back to reference Crabtree BF, Nutting PA, Miller WL, Stange KC, Stewart EE, Jaén CR. Summary of the National Demonstration Project and recommendations for the patient-centered medical home. Ann Fam Med. 2010;8 Suppl 1:S80–90.PubMedPubMedCentral Crabtree BF, Nutting PA, Miller WL, Stange KC, Stewart EE, Jaén CR. Summary of the National Demonstration Project and recommendations for the patient-centered medical home. Ann Fam Med. 2010;8 Suppl 1:S80–90.PubMedPubMedCentral
36.
go back to reference Balasubramanian BA, Chase SM, Nutting PA, ULTRA. Study Team, Cohen DJ, Strickland PAO, et al. Using Learning Teams for Reflective Adaptation (ULTRA): insights from a team-based change management strategy in primary care. Ann Fam Med. 2010;8(5):425–32. Doi: 10.1370/afm.1159.PubMedPubMedCentral Balasubramanian BA, Chase SM, Nutting PA, ULTRA. Study Team, Cohen DJ, Strickland PAO, et al. Using Learning Teams for Reflective Adaptation (ULTRA): insights from a team-based change management strategy in primary care. Ann Fam Med. 2010;8(5):425–32. Doi: 10.1370/afm.1159.PubMedPubMedCentral
37.
go back to reference Selby JV. Health systems, patients factors, and quality of care for diabetes: a synthesis of findings from the TRIAD study. Diabetes Care. 2010;33(4):940–7. Selby JV. Health systems, patients factors, and quality of care for diabetes: a synthesis of findings from the TRIAD study. Diabetes Care. 2010;33(4):940–7.
38.
go back to reference Ackermann RT, Thompson TJ, Selby JV, Safford MM, Stevens M, Brown AF, et al. Is the number of documented diabetes process-of-care indicators associated with cardiovascular risk factor levels, patient satisfaction, or self-rated quality of diabetes care? The TRIAD Study. Diabetes Care. 2006;29(9):2108–13.PubMed Ackermann RT, Thompson TJ, Selby JV, Safford MM, Stevens M, Brown AF, et al. Is the number of documented diabetes process-of-care indicators associated with cardiovascular risk factor levels, patient satisfaction, or self-rated quality of diabetes care? The TRIAD Study. Diabetes Care. 2006;29(9):2108–13.PubMed
39.
go back to reference Mangione CM, Gerzoff RB, Williamson DF, Steers WN, Kerr EA, Brown AF, et al. The association between quality of care and the intensity of diabetes disease management programs. Ann Intern Med. 2006;145(2):107–16.PubMed Mangione CM, Gerzoff RB, Williamson DF, Steers WN, Kerr EA, Brown AF, et al. The association between quality of care and the intensity of diabetes disease management programs. Ann Intern Med. 2006;145(2):107–16.PubMed
42.
go back to reference Proctor EK, Powell BJ, McMillen J. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8:139.PubMedPubMedCentral Proctor EK, Powell BJ, McMillen J. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8:139.PubMedPubMedCentral
43.
go back to reference Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs principles and practices. Health Serv Res. 2003;48(6.2):1–22. Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs principles and practices. Health Serv Res. 2003;48(6.2):1–22.
44.
go back to reference Crabtree BF, Miller WL, Stange KC. Understanding practice from the ground up. J Fam Pract. 2001;50(10):881–7.PubMed Crabtree BF, Miller WL, Stange KC. Understanding practice from the ground up. J Fam Pract. 2001;50(10):881–7.PubMed
46.
go back to reference Wild H. The economic rationale for adherence in the treatment of type 2 diabetes mellitus. Am J Manag Care. 2012;18:S43–8.PubMed Wild H. The economic rationale for adherence in the treatment of type 2 diabetes mellitus. Am J Manag Care. 2012;18:S43–8.PubMed
47.
go back to reference Damschroder LJ, Aaron DC, Keith RE, Kirsch SR, Alexander JA, Lowery JC. Fostering implementation of health service research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.PubMedPubMedCentral Damschroder LJ, Aaron DC, Keith RE, Kirsch SR, Alexander JA, Lowery JC. Fostering implementation of health service research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.PubMedPubMedCentral
Metadata
Title
Supporting Practices to Adopt Registry-Based Care (SPARC): protocol for a randomized controlled trial
Authors
Rebecca S Etz
Rosalind E Keith
Anna M Maternick
Karen L Stein
Roy T Sabo
Melissa S Hayes
Purvi Sevak
John Holland
Jesse C Crosson
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-015-0232-2

Other articles of this Issue 1/2015

Implementation Science 1/2015 Go to the issue