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

Primary Purpose

Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness, Medication Adherence, Social Support

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCAN Group
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness focused on measuring mHealth among people experiencing homelessness

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Trinity CenterRecruiting
  • Sunrise Navigation CenterRecruiting
  • Charlie CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCAN Group

Usual Care Control (UCC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Medication Adherence
Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, a 9-item scale that measures medication adherence for chronic conditions.
Social Support
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.
Psychological Distress
The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.
Social Needs Attainment
Three questions will be used to assess changes in housing and employment status and receipt of benefits.

Full Information

First Posted
May 3, 2022
Last Updated
April 24, 2023
Sponsor
University of Texas at Austin
Collaborators
University of Maryland, Sunrise Navigation Center, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05365867
Brief Title
Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals
Acronym
iCAN
Official Title
mHealth Technology to Connect and Empower People Experiencing Homelessness to Improve Health and Social Need Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
University of Maryland, Sunrise Navigation Center, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
The biostatistician is masked to who is in the intervention or usual care group.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCAN Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Control (UCC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iCAN Group
Intervention Description
See description in iCAN study arm.
Primary Outcome Measure Information:
Title
Number of emergency department (ED) and hospital visits
Description
Number of ED and hospital visits data will come from medical records from the local health information exchange.
Time Frame
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 Outcome Measure Information:
Title
Medication Adherence
Description
Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, a 9-item scale that measures medication adherence for chronic conditions.
Time Frame
Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.
Title
Social Support
Description
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.
Time Frame
Social support will be measured at baseline and 3 months and 6 months post-enrollment.
Title
Psychological Distress
Description
The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.
Time Frame
Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.
Title
Social Needs Attainment
Description
Three questions will be used to assess changes in housing and employment status and receipt of benefits.
Time Frame
Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.
Other Pre-specified Outcome Measures:
Title
Process measures in iCAN group
Description
A number of process measures will be collected in the iCAN group. Process measures will include percentage of valid responses to text message surveys, number of case manager telephone consultations, description of type and number of case manager interventions, number of times case manager uses GPS to locate a participant, and technology issues/concerns.
Time Frame
Process measures will be collected at 1, 3, 5, and 6 months post-enrollment visits in the iCAN group.
Title
Technology and Case Manager Assessment
Description
At the end of the study, participants in the iCAN group will complete a modification of the Technology Acceptance Questionnaire to evaluate the acceptance of the mobile health technology and integration of case manager.
Time Frame
The technology and case manager assessment will occur at the 6-month post-enrollment visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leticia R Moczygemba, PharmD, PhD
Phone
5127737924
Email
lrmoczygemba@austin.utexas.edu
Facility Information:
Facility Name
Trinity Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Britz
Facility Name
Sunrise Navigation Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hilbelink
Facility Name
Charlie Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Hargrave

12. IPD Sharing Statement

Plan to Share IPD
No

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

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