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

Cardiovascular Diseases Clinical Trial

— ALL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299791
• Other study ID #: 1R18HL095481-01A1
• Secondary ID: 1R18HL095481-01A
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: October 2, 2017
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4856
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none, for study CHCs

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus

Intervention

Other:
• ALL
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
• ALL
These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Kaiser Permanente	Multnomah County Health Department, National Heart, Lung, and Blood Institute (NHLBI), Ochin, Inc., Oregon Health and Science University, Virginia Garcia Memorial Health Center

References & Publications (1)

Gold R, Muench J, Hill C, Turner A, Mital M, Milano C, Shah A, Nelson C, DeVoe JE, Nichols GA. Collaborative development of a randomized study to adapt a diabetes quality improvement initiative for federally qualified health centers. J Health Care Poor Un — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   PubMed