Care Guides in the Primary Care Office (Phase II)

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156974
• Other study ID #: 3096-1E
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2019
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2135
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• ages 18-79

• diagnoses of diabetes, hypertension, and/or congestive heart failure

Exclusion Criteria:

• pregnant

• unable to understand randomization process

Related Conditions & MeSH terms

• Chronic Disease
• Congestive Heart Failure
• Diabetes
• Heart Failure
• Hypertension

Intervention

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
• education only
patients receive education about care goals

Locations

Country	Name	City	State
United States	Allina Hospitals and Clinics	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

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: 10.10 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinds of patients who benefit from working with a care guide	demographic, clinical, and attitudinal characteristics of patients who benefit	one year