Community Health Worker Care Transitions Study

NCT ID: NCT03085264

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hospitalism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Community Health Worker

Patients are paired with community health workers for 30 days after hospital discharge to assist with patient care

Group Type EXPERIMENTAL

Community Health Worker

Intervention Type BEHAVIORAL

Community Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance

Usual Care

Patients are not paired with community health workers for 30 days after hospital discharge to assist with patient care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

109 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jocelyn Carter

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jocelyn A Carter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.

Reference Type BACKGROUND
PMID: 24515422 (View on PubMed)

Carter J, Hassan S, Walton A, Yu L, Donelan K, Thorndike AN. Effect of Community Health Workers on 30-Day Hospital Readmissions in an Accountable Care Organization Population: A Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e2110936. doi: 10.1001/jamanetworkopen.2021.10936.

Reference Type DERIVED
PMID: 34014324 (View on PubMed)

Carter J, Walton A, Donelan K, Thorndike A. Implementing community health worker-patient pairings at the time of hospital discharge: A randomized control trial. Contemp Clin Trials. 2018 Nov;74:32-37. doi: 10.1016/j.cct.2018.09.013. Epub 2018 Oct 4.

Reference Type DERIVED
PMID: 30291997 (View on PubMed)

Other Identifiers

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2017A050810

Identifier Type: -

Identifier Source: org_study_id

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