Clinical trial NCT01156974: Care Guides in the Primary Care Office (Phase II)
Official title: Care Guides: Can Trained Laypersons Help Manage Chronic Disease? A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Hypertension
Congestive Heart Failure
Keywords: care management
chronic disease
outpatient
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2010-07-05
Enrollment: 2135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnant
* unable to understand randomization process

Primary outcomes:
measure: change in number of care goals met
timeFrame: one year
Secondary outcomes:
measure: Kinds of patients who benefit from working with a care guide
timeFrame: one year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Allina Hospitals and Clinics
state: Minnesota
Study officials:
affiliation: Allina Health System
name: Richard F Adair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.