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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299791
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Ochin, Inc.
Virginia Garcia Memorial Health Center
Multnomah County Health Department
Oregon Health and Science University
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Cardiovascular Diseases Other: ALL Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4856 participants
Allocation: Randomized
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

Arm Intervention/treatment
Active Comparator: Early Intervention
6 study clinics received the ALL intervention starting 6/1/11
Other: 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

Active Comparator: Late implementation
5 study clinics received the ALL intervention starting 6/1/12
Other: ALL
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none, for study CHCs

Information from the National Library of Medicine

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


Sponsors and Collaborators
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Ochin, Inc.
Virginia Garcia Memorial Health Center
Multnomah County Health Department
Oregon Health and Science University
Investigators
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Principal Investigator: Rachel Gold, PhD, MPH Kaiser Permanente
Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02299791    
Other Study ID Numbers: 1R18HL095481-01A1 ( U.S. NIH Grant/Contract )
1R18HL095481-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2014    Key Record Dates
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kaiser Permanente:
clinic-level interventions
quality improvement
translational medical research
community health centers
Additional relevant MeSH terms:
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Cardiovascular Diseases