Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals

Not Applicable

Completed

• Conditions: Medication Adherence; Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness; Social Support; Pyschological Distress; Attainment of Social Needs (i.e., Housing, Employment, Receipt of Benefits)

• Registration Number: NCT05365867
• Lead Sponsor: University of Texas at Austin

Brief Summary

People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Study Start: 2022-05-17
• Primary Completion: 2023-12-18
• Study Completion: 2024-06-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18 years old Homeless (defined as where the person slept most nights in past 30 days (street, shelters, transitional housing, doubling-up with family or friends) Currently own a cell phone with service or use phone with wifi (when available) at baseline Currently prescribed ≥ 2 medications for chronic medical conditions (self-report) Diagnosis of at least two chronic health conditions (self-report): e.g., hypertension, diabetes, depression
• 2 hospitalizations or ED visits in the last 6 months (self-report) Score of at least 4 on the REALM-SF health literacy measure Score > 17 on the Mini-Mental State Exam

Exclusion Criteria

Unable to communicate verbally in English. This is an exclusion criteria because the text messaging, apps, procedures and measures are not validated in in other languages.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of emergency department (ED) and hospital visits	Number of ED and hospital visits from baseline to 6 months post-enrollment (primary outcome), and from 6 months post-enrollment to 12 months post-enrollment (sustained impact of the intervention).	Number of ED and hospital visits data will come from medical records from the local health information exchange.

Secondary Outcome Measures

Name	Time	Method
Social Needs Attainment	Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.	Three questions will be used to assess changes in housing and employment status and receipt of benefits.
Social Support	Social support will be measured at baseline and 3 months and 6 months post-enrollment.	Social support will be measured using the modified 8-item Medical Outcomes Study Social Support Survey, a valid and reliable tool in multiple groups across various conditions.
Medication Adherence	Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.	Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, a 9-item scale that measures medication adherence for chronic conditions.
Psychological Distress	Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.	The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.

Trial Locations

Locations (3)

Trinity Center; 🇺🇸 Austin, Texas, United States

Sunrise Navigation Center; 🇺🇸 Austin, Texas, United States

Charlie Center; 🇺🇸 Austin, Texas, United States