Clinical trial NCT04028609: Community Health Worker Intervention to Improve Post-Hospital Outcomes
Official title: Community Health Worker and Certified Peer Specialist Intervention to Improve Post-Hospital Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Disease (Physical)
Mental Disorder
Keywords: 30-day readmission
primary care
community health worker
health education
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2019-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Federal Center for Medicare and Medicaid Services' measure of unplanned readmissions that occur within 30 days of discharge from an initial admission
timeFrame: 30 days post discharge
measure: Federal Center for Medicare and Medicaid Services' measure of completion of a outpatient visit with primary care provider
timeFrame: during the 30 days period following discharge
Secondary outcomes:
measure: Patient Activation Measure
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Perceived Competence for Health Maintenance Questionnaire
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Short Form Health Survey
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Health Care Climate Questionnaire
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Center for Disease Control and Prevention's National Health and Nutrition Examination Survey of Usual Source of Medical Care
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Patient Satisfaction Questionnaire
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Patient Health Questionnaire-2
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
measure: Generalized Anxiety Disorder 2-item Questionnaire
timeFrame: study entry (pre-intervention), 30 days post discharge (post intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago, Department of Psychiatry
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Judith Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.