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Community Health Worker Intervention to Improve Post-Hospital Outcomes (CHW)

Primary Purpose

Chronic Disease (Physical), Mental Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy at Home
Services as Usual
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease (Physical) focused on measuring 30-day readmission, primary care, community health worker, health education

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Services as Usual

Arm Description

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.

Subjects receive medical services as usual.

Outcomes

Primary Outcome Measures

Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
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).
Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
This is a dichotomous indicator variable that reports the completion of a patient's visit to an outpatient primary care provider

Secondary Outcome Measures

Patient Activation Measure
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.
Perceived Competence for Health Maintenance Questionnaire
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.
Short Form Health Survey
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.
Health Care Climate Questionnaire
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.
Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
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.
Patient Satisfaction Questionnaire
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.
Patient Health Questionnaire-2
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.
Generalized Anxiety Disorder 2-item Questionnaire
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.

Full Information

First Posted
July 11, 2019
Last Updated
April 26, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)
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1. Study Identification

Unique Protocol Identification Number
NCT04028609
Brief Title
Community Health Worker Intervention to Improve Post-Hospital Outcomes
Acronym
CHW
Official Title
Community Health Worker and Certified Peer Specialist Intervention to Improve Post-Hospital Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 prevented further enrollment
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease (Physical), Mental Disorder
Keywords
30-day readmission, primary care, community health worker, health education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention includes 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.
Masking
Outcomes Assessor
Masking Description
Research interviewers were blinded to study condition.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Services as Usual
Arm Type
Active Comparator
Arm Description
Subjects receive medical services as usual.
Intervention Type
Behavioral
Intervention Name(s)
Healthy at Home
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Services as Usual
Intervention Description
Routine medical services
Primary Outcome Measure Information:
Title
Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
Description
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).
Time Frame
30 days post discharge
Title
Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
Description
This is a dichotomous indicator variable that reports the completion of a patient's visit to an outpatient primary care provider
Time Frame
during the 30 days period following discharge
Secondary Outcome Measure Information:
Title
Patient Activation Measure
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Perceived Competence for Health Maintenance Questionnaire
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Short Form Health Survey
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Health Care Climate Questionnaire
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Patient Satisfaction Questionnaire
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Patient Health Questionnaire-2
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)
Title
Generalized Anxiety Disorder 2-item Questionnaire
Description
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.
Time Frame
study entry (pre-intervention), 30 days post discharge (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Cook, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago, Department of Psychiatry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26348316
Citation
Cook JA, Mueser KT. Community health workers: Potential allies for the field of psychiatric rehabilitation? Psychiatr Rehabil J. 2015 Sep;38(3):207-9. doi: 10.1037/prj0000164.
Results Reference
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Community Health Worker Intervention to Improve Post-Hospital Outcomes

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