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Clinical Trials/NCT01900470
NCT01900470CompletedNot Applicable

Community Health Worker Support to Help Patients Control Chronic Disease

University of Pennsylvania1 site in 1 country302 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
302
Locations
1
Primary Endpoint
Change in standardized score

Study Overview

Brief Summary

The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
  • •Home ZIP code including ANY of the following:
  • •2 or more of the following conditions:
  • •Obesity (BMI greater than 30),
  • •HTN (ICD9 relating to HTN in EMR),
  • •DM (ICD9 relating to DM in EMR),
  • •Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
  • •Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
  • •Patients who have scheduled appointments in the future.

Exclusion Criteria

  • •Will not provide informed consent for this study.
  • •Does not have the capacity to provide informed consent for this study.
  • •Previously enrolled in this study

Arms & Interventions

CHW Goal Support

Experimental

IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients. 3) IMPaCT CHWs conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals. As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits. 4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm. This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.

Intervention: CHW Goal Support (Behavioral)

Usual Primary Care

No Intervention

Patients will be encouraged to make follow-up appointments as needed with their primary care clinic for support towards their health goals. During these appointments, clinicians will help patients determine progress made on existing proximal goals, adjust goals based on self-efficacy, and help patients to create new proximal goals as needed. They will also work with PCPs to adjust medications when appropriate, provide health behavior education and make referrals to community-based services based on patient need.

Outcomes

Primary Outcomes

Change in standardized score

Time Frame: Six months after enrollment

Six months after enrollment, the IMPaCT arm will have a higher (more negative) mean change in standardized score for chronic disease outcome of interest compared with usual care

Secondary Outcomes

  • Patient Activation(Six months after enrollment)
  • Goal achievement(Six months after enrollment)
  • SF-12(Six months after enrollment,)
  • CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)(Six months after enrollment)
  • Hospitalization(6 months after enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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