Care Guides in the Primary Care Office (Phase II)

Phase 2

Completed

• Conditions: Hypertension; Diabetes; Congestive Heart Failure
• Interventions: Behavioral: education and care guide; Behavioral: education only

• Registration Number: NCT01156974
• Lead Sponsor: Allina Health System

Brief Summary

Trained lay persons ("care guides") working with chronic disease patients and their providers can help outpatients with diabetes, hypertension, and congestive heart failure achieve standard clinical care goals

Detailed Description

In a randomized parallel group multi-site trial looking at achievement of standard recommended treatment goals at baseline and one year later by 2135 patients with diabetes, hypertension, and congestive heart failure, we tested the hypothesis that adding a lay person with brief training to usual care would improve clinical outcomes. These "care guides" were culturally matched to patients served, similar to community health workers, but were located in 6 diverse primary care health clinics where they could meet patients face-to-face. They were asked to assist communication in both directions between providers and patients, taking advantage of their status as non-authority figures. They were given two weeks' training about these diseases and behavior change theory. This intervention was designed to be low cost, easy to implement, and to integrate into rather than change clinic work flow.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2135

Inclusion Criteria

• ages 18-79
• diagnoses of diabetes, hypertension, and/or congestive heart failure

Exclusion Criteria

• pregnant
• unable to understand randomization process

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
care guide	education and care guide	patients receive education about care goals and work with a care guide to achieve goals
no care guide	education only	patients receive education about care goals and usual care to achieve goals

Primary Outcome Measures

Name	Time	Method
change in number of care goals met	one year	Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.

Secondary Outcome Measures

Name	Time	Method
Kinds of patients who benefit from working with a care guide	one year	demographic, clinical, and attitudinal characteristics of patients who benefit

Trial Locations

Locations (1)

Allina Hospitals and Clinics; 🇺🇸 Minneapolis, Minnesota, United States