Care Guides in the Primary Care Office (Phase II)

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes, Hypertension, Congestive Heart Failure

Intervention / Treatment
-----------------
* Behavioral: education and care guide
* Behavioral: education only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-79 diagnoses of diabetes, hypertension, and/or congestive heart failure Exclusion Criteria: pregnant unable to understand randomization process

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in number of care goals met | Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinds of patients who benefit from working with a care guide | demographic, clinical, and attitudinal characteristics of patients who benefit | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
care management, chronic disease, outpatient