Cardiovascular Diseases Clinical Trial
Official title:
Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
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.
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.
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