NCT03085264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

March 14, 2017

Last Update Submit

February 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30 day readmission rate

    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 Outcomes (5)

  • Emergency Department Visit Rate

    Monthly for 24 months

  • Show Rate for Primary Care Provider/ Specialist Appointments

    Monthly for 24 months

  • Patient Satisfaction Post-CHW Intervention

    Monthly for 24 months

  • Primary Care Provider Satisfaction Post CHW Intervention

    Monthly for 24 months

  • Rates of patient depression/isolation

    Monthly for 24 months

Study Arms (2)

Community Health Worker

EXPERIMENTAL

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

Behavioral: Community Health Worker

Usual Care

NO INTERVENTION

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

Interventions

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

Community Health Worker

Eligibility Criteria

Age18 Years - 109 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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.

    PMID: 24515422BACKGROUND
  • 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.

  • 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.

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Jocelyn A Carter, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 21, 2017

Study Start

April 7, 2017

Primary Completion

May 30, 2019

Study Completion

October 30, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations