search
Back to results

Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers

Primary Purpose

HIV, Substance Use, Care Coordination

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordination Intervention
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 HIV focused on measuring mHealth, implementation, PrEP, digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must:

    • be at least 18 years of age,
    • provide either HIV care or substance abuse treatment [e.g., physicians, residents, psychologists, mid-level providers],
    • be employed at a participating recruitment site, and (d) able to provide informed consent.

Exclusion Criteria:

  • Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.

Sites / Locations

  • The University of Texas Dell Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Care Coordination Intervention

Arm Description

The care coordination intervention will consist of a mobile application designed for treatment providers, an interagency communication protocol, and a series of cross-training in HIV and addiction issues.

Outcomes

Primary Outcome Measures

Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale

Secondary Outcome Measures

Acceptability of the Care Coordination Intervention
Acceptability will assessed using satisfaction ratings.
Usability of the Mobile Application
Usability will be assessed through quantifying online usage patterns.
Change in frequency and quantity of communication
Data will be extracted through the online dashboard to examine change in communication between providers at the two participating clinics.
Provider Perception Inventory will assess change in provider-related stigma
This questionnaire measures health service providers' stigma in regards to HIV, substance use, and sexual risk behavior.
Implementation Climate Scale
This scale will measure the degree to which there is a strategic organizational climate supportive of the intervention implementation in each participating clinic.
Change in Patient Treatment Retention in both HIV and Substance Use Services
Data will be extracted through the online dashboard to examine change in appointment attendance for patients enrolled in treatment at the participating HIV and substance use clinic.

Full Information

First Posted
August 23, 2016
Last Updated
July 22, 2022
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT02906215
Brief Title
Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers
Official Title
Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

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
Many people living with HIV use illicit drugs and require treatment for both HIV and drug use, however, many barriers exist which prevent integration of dual care services. This study will develop a novel intervention aimed at the provider-level which will combine an evidence-based training model with use of mobile technology to improve care coordination between providers at HIV clinics and substance use treatment facilities. If proven effective, this intervention may be widely disseminated and easily implemented into existing clinic structures, thereby improving care coordination among providers and linkage to dual treatment for HIV-infected people who use drugs.
Detailed Description
Drug use is associated with poor linkages to HIV care, reduced retention in care, increased sexual risk behavior, and decreased adherence to medications, leading to inferior clinical outcomes, and increased HIV transmission. HIV-infected people who use drugs (HPWUD) have higher rates of co-occurring psychiatric and medical diagnoses, resulting in increased utilization of services. Many structural and systemic barriers impede the integration of treatment for HIV and substance use (SU). The use of a mobile application combined with an evidence-based training model offers an innovative approach to improving care coordination and linking patients to care in need of dual treatment. A mhealth application delivered via tablet device provides a unique channel to link HIV and SU treatment providers located at off-site clinics. This study will be a Stage I pilot and feasibility study that will be the first to use a theory-based model of care coordination to develop a Care Coordination Intervention (CCI) for treatment providers serving HPWUD. This study seeks to develop a secure mobile technology platform that will: (a) enable rapid communication among providers at multiple clinics, (b) improve linkage to dual care, and (c) improve coordination of patient services. The CCI will also utilize an evidence-based training model to increase provider knowledge in relevant HIV, PrEP, and SU issues. The proposed method of integrating dual care for patients is expected to be an efficient and easily disseminable platform for integrating HIV/SU care that will facilitate communication between providers at multiple clinics and allow for efficient management of patient treatment referrals and service utilization. This project will examine acceptability, feasibility, and sustainability potential using mixed-methods. A three-phase, top-down research approach to adapt, refine, and pilot test the intervention will be conducted. Phase 1 will include individual interviews with key stakeholders and audits of referral and communication processes within each clinic. Phase 2 will include development of the CCI. The investigators will conduct a functionality test and conduct a series of interviews with key stakeholders to inform iterative revision of the CCI. During Phase 3, the investigators will train providers in the CCI and evaluate the feasibility, acceptability, and sustainability potential among HIV and SU treatment providers located at two different clinics via a pre-, post-test design. Data will be gathered at the organizational-, provider-, and patient-levels. Compared to pre-implementation of the CCI in both clinics, the investigators expect that post-implementation data will result in: (H1) greater satisfaction of care coordination at the provider level; (H2) increased frequency and improved quality of interagency communications; (H3) enhanced interagency professional relationships; and (H4) increased dual care retention at the patient level. The long-term goal is to expand the availability of sustainable interventions to improve coordination of HIV and SU treatment services. Data from this research will form the basis of a future multisite R01 proposal for this early career, new investigator applicant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance Use, Care Coordination
Keywords
mHealth, implementation, PrEP, digital health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care Coordination Intervention
Arm Type
Experimental
Arm Description
The care coordination intervention will consist of a mobile application designed for treatment providers, an interagency communication protocol, and a series of cross-training in HIV and addiction issues.
Intervention Type
Behavioral
Intervention Name(s)
Care Coordination Intervention
Intervention Description
cross-training in HIV/PrEP and substance use, plus a digital health tool to improve evidence-based screening, brief intervention, referral to treatment, and patient management across HIV, PrEP, and addiction treatment providers
Primary Outcome Measure Information:
Title
Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale
Time Frame
1-, 3-, and 6-months
Secondary Outcome Measure Information:
Title
Acceptability of the Care Coordination Intervention
Description
Acceptability will assessed using satisfaction ratings.
Time Frame
6-months
Title
Usability of the Mobile Application
Description
Usability will be assessed through quantifying online usage patterns.
Time Frame
6-months
Title
Change in frequency and quantity of communication
Description
Data will be extracted through the online dashboard to examine change in communication between providers at the two participating clinics.
Time Frame
1-, 3-, and 6-months
Title
Provider Perception Inventory will assess change in provider-related stigma
Description
This questionnaire measures health service providers' stigma in regards to HIV, substance use, and sexual risk behavior.
Time Frame
1-, 3-, and 6-months
Title
Implementation Climate Scale
Description
This scale will measure the degree to which there is a strategic organizational climate supportive of the intervention implementation in each participating clinic.
Time Frame
Baseline
Title
Change in Patient Treatment Retention in both HIV and Substance Use Services
Description
Data will be extracted through the online dashboard to examine change in appointment attendance for patients enrolled in treatment at the participating HIV and substance use clinic.
Time Frame
1-, 3-, and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must: be at least 18 years of age, provide either HIV care or substance abuse treatment [e.g., physicians, residents, psychologists, mid-level providers], be employed at a participating recruitment site, and (d) able to provide informed consent. Exclusion Criteria: Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasey Claborn, PhD
Organizational Affiliation
The University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28288678
Citation
Claborn K, Becker S, Ramsey S, Rich J, Friedmann PD. Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. Addict Sci Clin Pract. 2017 Mar 14;12(1):8. doi: 10.1186/s13722-017-0073-1.
Results Reference
derived

Learn more about this trial

Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers

We'll reach out to this number within 24 hrs