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

NCT05365867 | Completed

• 2 other identifiers: STUDY000026665R18HS027750
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

mHealth among people experiencing homelessness

Outcome Measures

Primary Outcomes (1)

• Number of emergency department (ED) and hospital visits

  Number of ED and hospital visits data will come from medical records from the local health information exchange.

  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).

Secondary Outcomes (4)

• Medication Adherence

  Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.

• Social Support

  Social support will be measured at baseline and 3 months and 6 months post-enrollment.

• Psychological Distress

  Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.

• Social Needs Attainment

  Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.

Other Outcomes (2)

• Process measures in iCAN group

  Process measures will be collected at 1, 3, 5, and 6 months post-enrollment visits in the iCAN group.

• Technology and Case Manager Assessment

  The technology and case manager assessment will occur at the 6-month post-enrollment visit.

Study Arms (2)

iCAN Group

EXPERIMENTAL

iCAN is comprised of text messaging, GPS technology, preloaded apps, and telephone case management integrated within a community-based navigation center. Participants will receive 3 - 5 messages daily regarding medication adherence and appointment reminders, general health messages, motivational messages, and as needed messages for local information (e.g., weather updates). Within 48 - 72 hours of enrollment, participants will be called on their study phone by the study case manager for an intake assessment that will take 30 - 45 minutes in duration. The purpose of the assessment is to identify relevant health and social needs that the case manager can assist the participant in addressing by connecting with other medical and social services in the community. Within 48 - 72 hours of notification of a ED or hospital visit the iCAN case manager will call the participant on the study phone to assess care coordination needs for managing discharge instructions.

Behavioral: iCAN Group

Usual Care Control (UCC)

NO INTERVENTION

Participants randomized to the UCC group will have access to their personal phones and use it in the usual manner with no installment of apps, text messages, or case manager interventions. Since the majority of PEH have a cell phone of some type, this will allow us to compare the intervention to how PEH typically use their cell phones. Also, the UCC will have access to all of the services available at any of the enrollment sites but no formal interaction from the iCAN case manager and no option of text messaging with the iCAN case manager.

Interventions

iCAN Group BEHAVIORAL

See description in iCAN study arm.

iCAN Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• University of Maryland: collaborator
• Sunrise Navigation Center: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Trinity Center

Austin, Texas, 78701, United States

Location

Sunrise Navigation Center

Austin, Texas, 78745, United States

Location

Charlie Center

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician is masked to who is in the intervention or usual care group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 9, 2022
• Study Start: May 17, 2022
• Primary Completion: December 18, 2023
• Study Completion: June 18, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)