Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics (ALL)
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|ClinicalTrials.gov Identifier: NCT02299791|
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Cardiovascular Diseases||Other: ALL||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4856 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Active Comparator: Early Intervention
6 study clinics received the ALL intervention starting 6/1/11
This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
Active Comparator: Late implementation
5 study clinics received the ALL intervention starting 6/1/12
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
- Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both [ Time Frame: Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299791
|Principal Investigator:||Rachel Gold, PhD, MPH||Kaiser Permanente|