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

Community Health Worker Support to Help Patients Control Chronic Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900470
Enrollment
302
Registered
2013-07-16
Start date
2013-07-31
Completion date
2017-02-28
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma/COPD With Tobacco Dependence, Diabetes, Hypertension, Obesity

Keywords

Multiple chronic conditions

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.

Interventions

BEHAVIORALCHW 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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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: 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

Design outcomes

Primary

MeasureTime frameDescription
Change in standardized scoreSix months after enrollmentSix 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

MeasureTime frameDescription
Goal achievementSix months after enrollmentSix 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-12Six 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)Six months after enrollmentSix 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.
Hospitalization6 months after enrollmentPatients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.
Patient ActivationSix months after enrollmentSix 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

MeasureTime frameDescription
Hospitalizations at 12 months12 months after enrollmentPatients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.
Medical AdherenceSix months after enrollmentSix 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026