Care Guides in the Primary Care Office (Phase II)

Sponsor

Allina Health System (Other)

Overall Status

Completed

CT.gov ID

NCT01156974

Collaborator

(none)

2,135

Enrollment

Location

Arms

Duration (Months)

101.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Hypertension Congestive Heart Failure	Behavioral: education and care guide Behavioral: education only	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

2135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: care guide patients receive education about care goals and work with a care guide to achieve goals	Behavioral: education and care guide Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals Other Names: Active care management
Active Comparator: no care guide patients receive education about care goals and usual care to achieve goals	Behavioral: education only patients receive education about care goals

Arm

Intervention/Treatment

Experimental: care guide

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

Behavioral: education and care guide

Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals

Other Names:

Active care management

Active Comparator: no care guide

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

Behavioral: education only

patients receive education about care goals

Outcome Measures

Primary Outcome Measures

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

Kinds of patients who benefit from working with a care guide [one year]
demographic, clinical, and attitudinal characteristics of patients who benefit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

pregnant
unable to understand randomization process

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allina Hospitals and Clinics	Minneapolis	Minnesota	United States	55407

Sponsors and Collaborators

Allina Health System

Investigators

Principal Investigator: Richard F Adair, MD, Allina Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allina Health System

ClinicalTrials.gov Identifier:

NCT01156974

Other Study ID Numbers:

3096-1E

First Posted:

Jul 5, 2010

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Keywords provided by Allina Health System

care management

chronic disease

outpatient

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Apr 8, 2019