Community Health Worker Care Transitions Study (CCAT)

February 21, 2020 updated by: Jocelyn Carter, Massachusetts General Hospital

Implementing 30-day Post- Discharge Community Health Worker Pairings for Patients at High-Risk for Readmission (C-CAT Study)

This study focuses on pairing community health workers (CHWs) with patients that are high risk for readmission prior to hospital discharge in order to assess differences in hospital readmission rates, ED visits, patient satisfaction and provider satisfaction as compared to patients without community health worker pairings at discharge.

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.

Detailed Description

This study is a randomized controlled trial of 1200 adult patients admitted to internal medicine units that will examine the effectiveness of pairing patients that are high risk for readmission with community health workers at the time of hospital discharge on hospital readmission rates, emergency room visits, adherence to post-discharge medical appontments, and satisfaction with care. During this study, community health workers will partner with patients for 30 days after discharge from the hospital to address barriers to care via phone contacts, home visits, and accompanying patients to medical appointments/other non-clinical supportive care.

AIM 1) Determine if patients randomly assigned to the intervention group have lower rates of hospital readmission than the control group at the end of the intervention.

Hypothesis 1.1 Study participants in the intervention group will have lower rates of post-discharge thirty day readmission than the study participants in the control group at the end of the intervention.

AIM 2) Determine if patients randomly assigned to the intervention group will have less emergency room visits than the control group at the end of the intervention

Hypothesis 2.1 Study participants in the intervention group will have less emergency room visits than the study participants in the control group at the end of the intervention.

AIM 3) Determine if patients randomly assigned to the intervention group have more adherence to post-discharge appointments that study group participants in the control group at the end of the intervention

Hypothesis: 3.1 Study participants in the intervention group will have higher rates of attendance at post-discharge medical appointments than the study participants in the control group at the end of the intervention.

AIM 4) Determine if patients randomly assigned to the intervention group have higher levels of patient psychosocial support and satisfaction with post-discharge care than the control group

Hypothesis 4.1: Study participants in the intervention group will have higher levels of patient psychosocial support and satisfaction with post-discharge care than the study participants in the control group at the end of the intervention.

AIM 5) Determine if Primary Care Physicians of patients randomly assigned to the intervention group have higher levels of satisfaction with post-discharge care than Primary Care Providers of patients in the control group

Hypothesis 5.1: Primary Care Physicians of patients randomly assigned to the intervention group have higher levels of satisfaction with post-discharge care than Primary Care Providers of patients in the control group

After reviewing the fact sheet and consenting to enrollment by signing the informed consent form, patients will randomized to the intervention or control groups of the study.

STUDY PROCEDURES

Intervention Arm Group:

Patients randomized to the intervention group will be paired with community health workers prior to discharge from the hospital and patient- centered program goals will be established. A patient questionnaire (10-15 minutes) will be administered to intervention study participants by a study coordinator prior to discharge. A chart review will be performed for all intervention group participants by study coordinators prior to patient discharge. Patient-CHW pairings will continue for thirty days post-discharge and will include phone contacts, home visits, accompanying patients to medical appointments and other non-clinical supportive care. Both intervention group participants and primary care providers (PCPs) of intervention study participants will complete questionnaires 30-60 days after hospital discharge to assess certain patient ( 10 minute questionnaire; via phone) and primary care provider ( 5 minute questionnaire via email) perceptions (Please see Aim 4 and Aim 5). CHWs will document patient encounters in a REDCap database and complete patient care notes in EPIC. All intervention study participants readmitted within thirty days of prior discharge will be administered a readmission questionnaire by study coordinators. A chart review for readmitted study participants will also be performed by study staff. A REDCap database will be used to store all questionnaire and chart review data. Readmission rates, ED visits, PCP appointment compliance, patient/ PCP will be tracked.

Control Arm Group:

Those randomized to the control group will receive usual care without a community heath worker pairing. A patient questionnaire (10-15 minutes) will be administered to intervention study participants by a study coordinator prior to discharge. A chart review will be performed for all control group participants by study coordinators prior to patient discharge. Both control group participants and primary care providers (PCPs) of intervention study participants will complete questionnaires 30-60 days after hospital discharge to assess certain patient ( 10 minute questionnaire; via phone) and primary care provider ( 5 minute questionnaire via email) perceptions (Please see Aim 4 and Aim 5). A REDCap database will be used to store all questionnaire and chart review data. Readmission rates, ED visits, PCP appointment compliance, patient/ PCP perceptions will be tracked.

Three groups of research subjects will be assessed: the intervention study group, the control study group, and the PCPs of the patients enrolled in the study.

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.
600

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

18 years to 109 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria will include the following: enrollment in a Partners Risk Contract; agreement to participate in the study with ability to consent to enrollment, working phone number for patient contact and patient address of residence within 15 mile radius on MGH 55 Fruit Street, Boston, MA.

Exclusion Criteria:

  • Exclusion criteria will include a lack of capacity to consent to enrollment ( including prisoner status) or lack of cognitive ability to complete the survey, living outside of a 15 mile radius of the MGH 55 Fruit street location and having a primary care provider outside the MGH system.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Community Health Worker
Patients are paired with community health workers for 30 days after hospital discharge to assist with patient care
Behavioral: Community Health Worker
Community Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance
No Intervention: Usual Care
Patients are not paired with community health workers for 30 days after hospital discharge to assist with patient care

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
30 day readmission rate
Time Frame: 1 month ( for 24 months)
The number of patients readmitted within 30 days of being discharged from studied medical units during a given month/ the number of patients discharged from studied medical units during a given month
1 month ( for 24 months)

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
Emergency Department Visit Rate
Time Frame: Monthly for 24 months
The number of patient emergency department visits after discharged from studied medical units during a given month/ the number of patient emergency department visits after discharge from studied medical units during a given month
Monthly for 24 months
Show Rate for Primary Care Provider/ Specialist Appointments
Time Frame: Monthly for 24 months
The number of primary care provider/specialist appointments attended by patients discharged from studied medical units during a given month/ The number of primary care provider/specialist appointments expected to be attended by patients discharged from studied medical units during a given month
Monthly for 24 months
Patient Satisfaction Post-CHW Intervention
Time Frame: Monthly for 24 months
The number of patients receiving the community health worker intervention indicating they were very satisfied with CHW-patient pairing experience via questionnare/ The number of patients receiving the community health worker intervention that completed the post-CHW intervention questionnaire
Monthly for 24 months
Primary Care Provider Satisfaction Post CHW Intervention
Time Frame: Monthly for 24 months
The number of primary care providers of patients receiving the community health worker intervention indicating they were very satisfied with CHW-patient pairing experience via questionnare/ The number of primary care providers of patients receiving the community health worker intervention that completed the post-CHW intervention questionnaire
Monthly for 24 months
Rates of patient depression/isolation
Time Frame: Monthly for 24 months
The number of patients receiving the community health worker intervention indicating they were depressed or felt isolated via questionnare/ The number of patients receiving the community health worker intervention that completed the post-CHW intervention questionnaire
Monthly for 24 months

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.
Massachusetts General Hospital

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: Jocelyn A Carter, M.D., Massachusetts General Hospital

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 (Actual)

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.
April 7, 2017

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 30, 2019

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.
October 30, 2019

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).
March 14, 2017

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.
March 14, 2017

First Posted (Actual)

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.
March 21, 2017

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.
February 24, 2020

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.
February 21, 2020

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.
February 1, 2020

More Information

Terms related to this study

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.
  • 2017A050810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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