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Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01900470
First received: July 11, 2013
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Obesity Diabetes Hypertension Asthma/COPD With Tobacco Dependence Behavioral: CHW Goal Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community Health Worker Support to Help Patients Control Chronic Disease

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Goal achievement [ Time Frame: Six months after enrollment ]
    Six months after enrollment, patients in the IMPaCT group will have higher proportion of patients who achieve their individualized chronic disease management goal compared with usual care

  • SF-12 [ Time Frame: Six months after enrollment, ]
    Six months after enrollment, patients in the IMPaCT group will greater improvements in their self-rated health (as measured by mean change in MCS and PCS of the SF-12) than patients receiving usual care.

  • CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care) [ Time Frame: Six months after enrollment ]
    Six months after enrollment, the IMPaCT arm will have higher perceived quality of patient-centered medical care (as measured by the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey) than the usual care arm. Specifically, we will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care.

  • Hospitalization [ Time Frame: 6 months after enrollment ]
    Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.

  • Patient Activation [ Time Frame: Six months after enrollment ]
    Six months after enrollment, patients in the IMPaCT arm will have greater improvements in their activation (as measured by mean change in PAM score) compared with patients in the usual care arm.


Other Outcome Measures:
  • Hospitalizations at 12 months [ Time Frame: 12 months after enrollment ]
    Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.

  • Medical Adherence [ Time Frame: Six months after enrollment ]
    Six months after enrollment, patients in the IMPaCT arm will have higher levels of adherence to medical recommendations than the usual care arm, as measured by the Medical Outcomes Study (MOS) Measures of Patient Adherence.


Enrollment: 302
Study Start Date: July 2013
Study Completion Date: February 2017
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHW Goal Support
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.
Behavioral: CHW Goal Support
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 Partners 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.
Other Name: IMPaCT
No Intervention: Usual Primary Care
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
  • 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900470

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Shreya Kangovi University of Pennsylvania
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01900470     History of Changes
Other Study ID Numbers: IRB 817488
Study First Received: July 11, 2013
Last Updated: May 2, 2017

Keywords provided by University of Pennsylvania:
Multiple chronic conditions

Additional relevant MeSH terms:
Chronic Disease
Tobacco Use Disorder
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017