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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus
• Intervention / Treatment: Other: ALL; Other: ALL

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.

• Study Type: Interventional
• Enrollment (Actual): 4856
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none, for study CHCs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; EHR tools to expedite identificationa. EHR automated point-of-care alerts (Best Practice Alerts); EHR tools to expedite prescribingEHR order setsEHR text shortcuts for notationpatient education materials (handout, poster); EHR-based outreach support tools a. EHR registries; Other: ALL; These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
Active Comparator: Late implementation; 5 study clinics received the ALL intervention starting 6/1/12	Other: ALL; This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.; EHR tools to expedite identificationa. EHR automated point-of-care alerts (Best Practice Alerts); EHR tools to expedite prescribingEHR order setsEHR text shortcuts for notationpatient education materials (handout, poster); EHR-based outreach support tools a. EHR registries; Other: ALL; These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Oregon Health and Science University; Multnomah County Health Department; OCHIN, Inc.; Virginia Garcia Memorial Health Center
• Investigators: Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• 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 Underserved. 2012 Aug;23(3 Suppl):236-46. doi: 10.1353/hpu.2012.0132.
• Gold R, Bunce A, Cowburn S, Davis JV, Hollombe C, Nelson CA, Puro J, Muench J, Hill C, Jaworski V, Mercer M, Howard C, Perrin N, DeVoe J. Cardiovascular care guideline implementation in community health centers in Oregon: a mixed-methods analysis of real-world barriers and challenges. BMC Health Serv Res. 2017 Apr 5;17(1):253. doi: 10.1186/s12913-017-2194-3.
• Gold R, Bunce AE, Cohen DJ, Hollombe C, Nelson CA, Proctor EK, Pope JA, DeVoe JE. Reporting on the Strategies Needed to Implement Proven Interventions: An Example From a "Real-World" Cross-Setting Implementation Study. Mayo Clin Proc. 2016 Aug;91(8):1074-83. doi: 10.1016/j.mayocp.2016.03.014. Epub 2016 Apr 23.
• Gold R, Nelson C, Cowburn S, Bunce A, Hollombe C, Davis J, Muench J, Hill C, Mital M, Puro J, Perrin N, Nichols G, Turner A, Mercer M, Jaworski V, Howard C, Abiles E, Shah A, Dudl J, Chan W, DeVoe J. Feasibility and impact of implementing a private care system's diabetes quality improvement intervention in the safety net: a cluster-randomized trial. Implement Sci. 2015 Jun 10;10:83. doi: 10.1186/s13012-015-0259-4.

Helpful Links

• PubMed

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: quality improvement; clinic-level interventions; translational medical research; community health centers
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1R18HL095481-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No