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Care Guides in the Primary Care Office (Phase II)

Primary Purpose

Diabetes, Hypertension, Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
education and care guide
education only
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring care management, chronic disease, outpatient

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • unable to understand randomization process

Sites / Locations

  • Allina Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

care guide

no care guide

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 2, 2010
Last Updated
April 4, 2019
Sponsor
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01156974
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Congestive Heart Failure
Keywords
care management, chronic disease, outpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
care guide
Arm Type
Experimental
Arm Description
patients receive education about care goals and work with a care guide to achieve goals
Arm Title
no care guide
Arm Type
Active Comparator
Arm Description
patients receive education about care goals and usual care to achieve goals
Intervention Type
Behavioral
Intervention Name(s)
education and care guide
Other Intervention Name(s)
Active care management
Intervention Description
Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals
Intervention Type
Behavioral
Intervention Name(s)
education only
Intervention Description
patients receive education about care goals
Primary Outcome Measure Information:
Title
change in number of care goals met
Description
Predetermined care goals as recommended by national authorities such as American Diabetes Association, American Heart Association, JNC-7.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Kinds of patients who benefit from working with a care guide
Description
demographic, clinical, and attitudinal characteristics of patients who benefit
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 18-79 diagnoses of diabetes, hypertension, and/or congestive heart failure Exclusion Criteria: pregnant unable to understand randomization process
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F Adair, MD
Organizational Affiliation
Allina Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allina Hospitals and Clinics
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22156953
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.
Results Reference
result
PubMed Identifier
23922063
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.
Results Reference
result
PubMed Identifier
22728580
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.
Results Reference
result

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Care Guides in the Primary Care Office (Phase II)

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