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

May 2, 2017 updated by: University of Pennsylvania

Community Health Worker Support to Help Patients Control Chronic Disease

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Six months after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Six months after enrollment
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.
Six months after enrollment,
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.
Six months after enrollment
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.
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.
Six months after enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Six months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shreya Kangovi, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 817488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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