Care Guides in the Primary Care Office (Phase II)

NCT ID: NCT01156974

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

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.

Conditions

Diabetes; Hypertension; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

care guide

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

Group Type: EXPERIMENTAL

education and care guide

Intervention Type: BEHAVIORAL

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

no care guide

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

Group Type: ACTIVE_COMPARATOR

education only

Intervention Type: BEHAVIORAL

patients receive education about care goals

Interventions

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

Intervention Type: BEHAVIORAL

education only

patients receive education about care goals

Intervention Type: BEHAVIORAL

Other Intervention Names

Active care management

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnant
• unable to understand randomization process

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard F Adair, MD

Role: PRINCIPAL_INVESTIGATOR

Allina Health System

Locations

Allina Hospitals and Clinics

Minneapolis, Minnesota, United States

Countries

United States

References

Adair R, Christianson J, Wholey DR, White K, Town R, Lee S, Britt H, Lund P, Lukasewycz A, Elumba D. Care guides: employing nonclinical laypersons to help primary care teams manage chronic disease. J Ambul Care Manage. 2012 Jan-Mar;35(1):27-37. doi: 10.1097/JAC.0b013e31823b0fbe.

Reference Type: RESULT

PMID: 22156953 (View on PubMed)

Adair R, Wholey DR, Christianson J, White KM, Britt H, Lee S. Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial. Ann Intern Med. 2013 Aug 6;159(3):176-84. doi: 10.7326/0003-4819-159-3-201308060-00007.

Reference Type: RESULT

PMID: 23922063 (View on PubMed)

Wholey DR, White KM, Adair R, Christianson JB, Lee S, Elumba D. Care guides: an examination of occupational conflict and role relationships in primary care. Health Care Manage Rev. 2013 Oct-Dec;38(4):272-83. doi: 10.1097/HMR.0b013e31825f3df9.

Reference Type: RESULT

PMID: 22728580 (View on PubMed)

Other Identifiers

3096-1E

Identifier Type: -

Identifier Source: org_study_id