Community Health Worker Intervention to Improve Post-Hospital Outcomes

NCT04028609 | Terminated

• 2 other identifiers: 2018-071590RT5038a
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease (Physical); Mental Disorder

Keywords

30-day readmission; primary care; community health worker; health education

Outcome Measures

Primary Outcomes (2)

• 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).

  30 days post discharge

• 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

  during the 30 days period following discharge

Secondary Outcomes (8)

• Patient Activation Measure

  study entry (pre-intervention), 30 days post discharge (post intervention)

• Perceived Competence for Health Maintenance Questionnaire

  study entry (pre-intervention), 30 days post discharge (post intervention)

• Short Form Health Survey

  study entry (pre-intervention), 30 days post discharge (post intervention)

• Health Care Climate Questionnaire

  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

  study entry (pre-intervention), 30 days post discharge (post intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Healthy at Home

Services as Usual

ACTIVE COMPARATOR

Subjects receive medical services as usual.

Other: Services as Usual

Interventions

Healthy at Home BEHAVIORAL

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

Services as Usual OTHER

Routine medical services

Services as Usual

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

University of Illinois at Chicago, Department of Psychiatry

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 26348316 BACKGROUND

MeSH Terms

Conditions

Chronic Disease; Mental Disorders; Health Education

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Judith Cook, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research interviewers were blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 22, 2019
• Study Start: September 12, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)