Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics

Study Overview
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Brief Summary
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The purpose of the ALL Study is to determine the effectiveness of the dissemination of the ALL intervention from an integrated care setting into Community Health Centers (CHCs) by measuring changes in diabetes mellitus (DM) population prescription rates for the medications, using a pre-post comparison within clinics and a staggered, randomized implementation across clinics.

Detailed Description
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The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. Multiple mechanisms supported this intervention at KP. The investigators implemented ALL in 11 Community Health Centers (CHC) in the Portland, Oregon metropolitan area. To our knowledge, this was the first clinical trial testing the translation and implementation of a successful quality improvement (QI) initiative from a private, integrated care setting into CHCs. 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.

Official Title
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Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics

Conditions
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Diabetes Mellitus, Cardiovascular Diseases

Intervention / Treatment
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* Other: ALL
* Other: ALL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc. Exclusion Criteria: none, for study CHCs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Intervention<br>6 study clinics received the ALL intervention starting 6/1/11 | Other: ALL<br>* This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below. EHR tools to expedite identification a. EHR automated point-of-care alerts (Best Practice Alerts) EHR tools to expedite prescribing EHR order sets EHR text shortcuts for notation patient education materials (handout, poster) EHR-based outreach support tools a. EHR registries<br>|
| Active Comparator: Late implementation<br>5 study clinics received the ALL intervention starting 6/1/12 | Other: ALL<br>* These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both | Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin. | Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinic-level interventions, quality improvement, translational medical research, community health centers