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

NCT ID: NCT05365867

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2024-06-18

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

iCAN Group

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.

Group Type: EXPERIMENTAL

iCAN Group

Intervention Type: BEHAVIORAL

See description in iCAN study arm.

Usual Care Control (UCC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iCAN Group

See description in iCAN study arm.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

Sunrise Navigation Center

UNKNOWN

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Trinity Center

Austin, Texas, United States

Sunrise Navigation Center

Austin, Texas, United States

Charlie Center

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R18HS027750

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

STUDY000026665

Identifier Type: -

Identifier Source: org_study_id