Study Results
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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COMPLETED
NA
600 participants
INTERVENTIONAL
2017-04-07
2019-10-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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
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
Usual Care
Patients are not paired with community health workers for 30 days after hospital discharge to assist with patient care
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
Eligibility Criteria
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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.
18 Years
109 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Jocelyn Carter
Principle 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
Countries
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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.
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.
Other Identifiers
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2017A050810
Identifier Type: -
Identifier Source: org_study_id
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