HospitalismCCATNCT03085264
Community Health Worker Care Transitions Study
A study testing Community Health Worker in people with Hospitalism, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 109 yearsHealthy volunteers can take part
- Conditions the study is for
- Hospitalism
- What is being tested?
- Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 109 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospitalism
- Being tested
- Community Health Worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerBehavioural
Community Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker | Experimental | Patients are paired with community health workers for 30 days after hospital discharge to assist with patient care Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month ( for 24 months)
Secondary outcomes (5)
Emergency Department Visit Rate
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
Measured: Monthly for 24 months
Show Rate for Primary Care Provider/ Specialist Appointments
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
Measured: Monthly for 24 months
Patient Satisfaction Post-CHW Intervention
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
Measured: Monthly for 24 months
Primary Care Provider Satisfaction Post CHW Intervention
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
Measured: Monthly for 24 months
Rates of patient depression/isolation
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
Measured: Monthly for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start7 Apr 2017
- Primary completion30 May 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HospitalismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Carter, Massachusetts General Hospital
- Investigators
- Jocelyn A Carter, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085264
- Sponsor's protocol ID
- 2017A050810
- Acronym
- CCAT
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24515422Carter 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.
PubMed 34014324Carter 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.
PubMed 30291997
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing 30-day Post- Discharge Community Health Worker Pairings for Patients at High-Risk for Readmission (C-CAT Study)
- ClinicalTrials.gov ID
- NCT03085264
- Acronym / sponsor ID
- CCAT / 2017A050810
- Conditions
- Hospitalism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker | Experimental | Behavioral: Community Health WorkerPatients are paired with community health workers for 30 days after hospital discharge to assist with patient care |
| Usual Care | No intervention | –Patients are not paired with community health workers for 30 days after hospital discharge to assist with patient care |
Who may qualify
- Ages
- 18 to 109 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health WorkerCommunity Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance | Behavioural | Community Health Worker |
Primary outcome
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
5 secondary outcomes
Emergency Department Visit Rate
Time frame: Monthly for 24 months
Show Rate for Primary Care Provider/ Specialist Appointments
Time frame: Monthly for 24 months
Patient Satisfaction Post-CHW Intervention
Time frame: Monthly for 24 months
Primary Care Provider Satisfaction Post CHW Intervention
Time frame: Monthly for 24 months
Rates of patient depression/isolation
Time frame: Monthly for 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 24515422Kangovi 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.
- Derived from this study: PubMed 34014324Carter 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.
- Derived from this study: PubMed 30291997Carter 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.
- Individual participant dataSharing planned: No
Related trials for Hospitalism
Recruiting
Immersive Sensory Projections for Hospitalized Patients
Hospitalism
Recruiting
Mindfulness-Based Emotion Regulation Training for Hospitalized Children
Fear, Child, Only
Not yet recruiting
IVC Collapsibility Index or CVP as a Predictor of Fluid Responsiveness in Pediatric Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn A Carter, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker in people with Hospitalism, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day readmission rate (time frame: 1 month ( for 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085264, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.