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OpenTrials
Completed

NCT Number: NCT02299791

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.

Exclusion criteria

  • none, for study CHCs

Treatment and study plan

ALL

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Multnomah County Health Department
  • National Heart, Lung, and Blood Institute (NHLBI)
  • OCHIN, Inc.
  • Oregon Health and Science University
  • Virginia Garcia Memorial Health Center

Registry information

Acronym: ALL

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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