Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
NCT ID: NCT02299791
Last Updated: 2017-10-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
4856 participants
INTERVENTIONAL
2010-09-30
2014-05-31
Brief Summary
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Detailed Description
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The investigators adapted the ALL intervention for CHCs through an iterative, stakeholder-driven process. The investigators then conducted a cluster-randomized pragmatic trial in 11 CHCs in a staggered process with six 'early' CHCs implementing the intervention one year before five 'late' CHCs. The investigators measured monthly rates of cardioprotective prescribing rates. Through segmented regression analysis, the investigators evaluated the intervention's effects in June 2011-May 2013. Participants included 11 CHCs serving \~6,500 adult patients with diabetes mellitus (DM) who were indicated for cardioprotective medications per national guidelines. The investigators also conducted a process evaluation to identify factors important to implementation success.
Our overarching goals were to identify and resolve issues in disseminating a successful program from a large, well-organized health system into CHCs. The investigators hypothesized that cross-setting translation was feasible, and that adapting and implementing proven QI approaches could improve the care CHCs provide without requiring them to develop native initiatives. The investigators anticipated that this implementation would involve substantially adapting potentially 'translatable' practices and interventions, due to the differences between private, integrated care settings and CHCs in terms of patient needs and vulnerability, and system resources.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Early Intervention
6 study clinics received the ALL intervention starting 6/1/11
ALL
This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries
Late implementation
5 study clinics received the ALL intervention starting 6/1/12
ALL
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
Interventions
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ALL
This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries
ALL
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
OCHIN, Inc.
OTHER
Virginia Garcia Memorial Health Center
UNKNOWN
Multnomah County Health Department
OTHER_GOV
Oregon Health and Science University
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Rachel Gold, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
References
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Gold R, Muench J, Hill C, Turner A, Mital M, Milano C, Shah A, Nelson C, DeVoe JE, Nichols GA. Collaborative development of a randomized study to adapt a diabetes quality improvement initiative for federally qualified health centers. J Health Care Poor Underserved. 2012 Aug;23(3 Suppl):236-46. doi: 10.1353/hpu.2012.0132.
Gold R, Bunce A, Cowburn S, Davis JV, Hollombe C, Nelson CA, Puro J, Muench J, Hill C, Jaworski V, Mercer M, Howard C, Perrin N, DeVoe J. Cardiovascular care guideline implementation in community health centers in Oregon: a mixed-methods analysis of real-world barriers and challenges. BMC Health Serv Res. 2017 Apr 5;17(1):253. doi: 10.1186/s12913-017-2194-3.
Gold R, Bunce AE, Cohen DJ, Hollombe C, Nelson CA, Proctor EK, Pope JA, DeVoe JE. Reporting on the Strategies Needed to Implement Proven Interventions: An Example From a "Real-World" Cross-Setting Implementation Study. Mayo Clin Proc. 2016 Aug;91(8):1074-83. doi: 10.1016/j.mayocp.2016.03.014. Epub 2016 Apr 23.
Gold R, Nelson C, Cowburn S, Bunce A, Hollombe C, Davis J, Muench J, Hill C, Mital M, Puro J, Perrin N, Nichols G, Turner A, Mercer M, Jaworski V, Howard C, Abiles E, Shah A, Dudl J, Chan W, DeVoe J. Feasibility and impact of implementing a private care system's diabetes quality improvement intervention in the safety net: a cluster-randomized trial. Implement Sci. 2015 Jun 10;10:83. doi: 10.1186/s13012-015-0259-4.
Related Links
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