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

Obesity Clinical Trial

Official title:

Community Health Worker Support to Help Patients Control Chronic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900470
• Other study ID #: IRB 817488
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: May 2, 2017
• Start date: July 2013
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: February 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma/COPD With Tobacco Dependence
• Chronic Disease
• Diabetes
• Hypertension
• Obesity
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalizations at 12 months	Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.	12 months after enrollment
Other	Medical Adherence	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.	Six months after enrollment
Primary	Change in standardized score	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	Six months after enrollment
Secondary	Goal achievement	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	Six months after enrollment
Secondary	SF-12	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.	Six months after enrollment,
Secondary	CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)	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.	Six months after enrollment
Secondary	Hospitalization	Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.	6 months after enrollment
Secondary	Patient Activation	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.	Six months after enrollment