Care Guides in the Primary Care Office (Phase II)

Allina Health System

Status and phase: Completed; Phase 2

Conditions: Hypertension; Diabetes; Congestive Heart Failure

Treatments: Behavioral: education and care guide; Behavioral: education only

Study type: Interventional

Funder types: Other

Identifiers

NCT01156974

3096-1E

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,135 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnant
• unable to understand randomization process

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,135 participants in 2 patient groups

care guide

Experimental group

Description:

patients receive education about care goals and work with a care guide to achieve goals

Treatment:

Behavioral: education and care guide

no care guide

Active Comparator group

Description:

patients receive education about care goals and usual care to achieve goals

Treatment:

Behavioral: education only