- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028609
Community Health Worker Intervention to Improve Post-Hospital Outcomes (CHW)
April 26, 2023 updated by: Judith A. Cook, University of Illinois at Chicago
Community Health Worker and Certified Peer Specialist Intervention to Improve Post-Hospital Outcomes
This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness.
The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study will test the efficacy of a brief intervention delivered to adults with co-occurring medical and mental health conditions by community health workers designed to avoid 30-day readmissions following medical hospitalization.
Adult inpatients of a university hospital will be randomly assigned to the intervention plus services as usual versus services as usual alone, and assessed at baseline and 30 days following discharge.
Chi square will be used to assess the primary outcome of admission within 30 days of discharge and changes in patient activation, mental health symptoms, medication adherence, and perceived competence for health maintenance.
Also examined will be study condition differences in post-discharge inpatient service utilization and cost.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- 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 Contact
- Name: Judith A Cook, PhD
- Phone Number: 312-355-3921
- Email: jcook@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago, Department of Psychiatry
-
-
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
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- receiving inpatient treatment for chronic medical condition
- evidence of a mental health diagnosis
- age 21- 60 years
- expected to return to community residence
- residing within a 30-mile radius of the hospital
- expected to remain in hospital for 2 or more days
- able to provide informed consent
Exclusion Criteria:
- terminally ill
- unable to communicate in English
- expected to be discharged to skilled facility or nursing home
- participating in another transitional care intervention
- hospitalized for behavioral health disorder
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Subjects receive an intervention with 4 components: development of a personal health plan; review and support for medication adherence; connection with primary care provider within 30 days; and education about clinical indicators that call for immediate intervention.
|
In addition to receiving medical services as usual, subjects receive services from Community Healthy Workers during the transition from the hospital to their community residence.
|
Active Comparator: Services as Usual
Subjects receive medical services as usual.
|
Routine medical services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
Time Frame: 30 days post discharge
|
This is a dichotomous indicator variable that reports the occurrence of an inpatient admission to the hospital within 30 days of discharge from a previous hospitalization.
Score ranges from 0 (no readmission) to 1 (readmission).
|
30 days post discharge
|
Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
Time Frame: during the 30 days period following discharge
|
This is a dichotomous indicator variable that reports the completion of a patient's visit to an outpatient primary care provider
|
during the 30 days period following discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation Measure
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
|
This scale measures the construct of a person's self-perceived ability to engage in health care.
Items assess patients' self-perceived level of knowledge, skill, and confidence in their ability to manage their own health.
Total score ranges from 13 to 52 with higher values indicating greater activation.
Total score is calculated by summing items to create a raw score which is then divided by the number of items answered and multiplied by 13 and transformed to a Z score based on calibration tables.
|
study entry (pre-intervention), 30 days post discharge (post intervention)
|
Perceived Competence for Health Maintenance Questionnaire
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
|
This scale measures the construct of self rated ability to manage one's health condition, engage in routine health care, and recover from a medical condition.
Total score ranges from 1 to 7 with higher values indicating greater competence.
Total score is calculated by averaging scores of the 4 items.
|
study entry (pre-intervention), 30 days post discharge (post intervention)
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Short Form Health Survey
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
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This scale measures the construct of self-reported physical and emotional health by asking about functioning (e.g., climbing stairs, doing housework) and emotional well-being (e.g., feeling calm and peaceful, being downhearted or blue).
Total score ranges from 12 to 44 with higher values indicating better health.
Total score is the sum of all item responses.
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study entry (pre-intervention), 30 days post discharge (post intervention)
|
Health Care Climate Questionnaire
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
|
This scale measures the construct of a patients' perception of their medical care as as providing needed information, acknowledging their feelings, and supporting their autonomy.
Total score ranges from 1 to 7 with higher values indicating greater autonomy.
Total score is calculated by averaging the item scores.
|
study entry (pre-intervention), 30 days post discharge (post intervention)
|
Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
|
These items from a national household survey ask respondents about their access to and type of usual source of medical care.
Both items are categorical self-report questions designed to yield descriptive information with no scoring.
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study entry (pre-intervention), 30 days post discharge (post intervention)
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Patient Satisfaction Questionnaire
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
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This a questionnaire that measures the construct of patients' satisfaction with their medical provider by asking them to rate their doctor's communication, time spent, and overall satisfaction.
Total score ranges from 6 to 30 with higher values indicating greater satisfaction.
Total score is calculated by adding the item scores.
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study entry (pre-intervention), 30 days post discharge (post intervention)
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Patient Health Questionnaire-2
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
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This is a screening questionnaire for depression and anhedonia that measures the extent to which respondents report that they are sad, hopeless, and have little interest in doing things.
Total score ranges from 0 to 6 with higher values indicating greater likelihood of depressive disorder.
Total score is calculated by adding the 2 item scores.
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study entry (pre-intervention), 30 days post discharge (post intervention)
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Generalized Anxiety Disorder 2-item Questionnaire
Time Frame: study entry (pre-intervention), 30 days post discharge (post intervention)
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This is a screening questionnaire for generalized anxiety disorder that measures the extent to which respondents report that they are nervous, anxious, or continually worried.
Total score ranges from 0 to 6 with higher values indicating greater likelihood of generalized anxiety disorder.
Total score is calculated by adding the 2 item scores.
|
study entry (pre-intervention), 30 days post discharge (post intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Judith Cook, PhD, University of Illinois at Chicago
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.
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)
September 12, 2019
Primary Completion (Actual)
March 9, 2020
Study Completion (Actual)
March 9, 2020
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
July 18, 2019
First Posted (Actual)
July 22, 2019
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0715
- 90RT5038a (Other Grant/Funding Number: National Institute Disability Independent Living Rehab)
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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