E-health Implementation (Iowa)

Substance Use Disorders Clinical Trial

Official title:

Testing of a Patient-centered E-health Implementation Model in Addiction Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954184
• Other study ID #: 2018-0997
• Secondary ID: A195010ENGR/INDU
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will test a technology adoption framework to increase use of the A-CHESS smartphone app. The project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI.

Terms - A-CHESS: Addiction Comprehensive Health Enhancement Support System NIATx-TI: Network for the Improvement of Addiction Treatment-Technology Implementation

Description:

Patient-centered e-health has failed to achieve its promise despite considerable consumer interest in technology and research supporting its potential. E-health adoption rates in healthcare are poor, with specialty substance use disorder (SUD) treatment having the lowest technology adoption rate of any sector. Implementation science can address this emerging gap in the e-health field by augmenting existing models, that explain organizational and individual e-health behaviors retrospectively, with prospective models that can guide implementation. The organizational planning discipline, with its decades of research, could provide a cross-disciplinary "jump start" to developing an e-health implementation model for health organizations. Henry Mintzberg, a respected pioneer in this field, describes 2 beneficial approaches to planning: the deliberate approach, which is grounded in pre-implementation planning, and the emergent approach that is grounded in adapting to the environment as the plan is implemented. The proposed e-health implementation model, called the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework, incorporates both approaches.

NIATx-TI was piloted in the Iowa Rural Health Information Technology Initiative (IRHIT) with 14 of Iowa's 105 SUD treatment sites and resulted in a 2-fold increase in patients receiving distance treatment. The framework's deliberate component includes using an organizational technology assessment and patient simulation. These tools identify and address assets and barriers to incorporate into the technology's implementation protocol. The framework's emergent component includes using a project team to uncover and prioritize implementation barriers as they arise, develop changes to address identified barriers, and monitor selected adoption measures, while receiving monthly coaching.

This project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI. While e-health spans many modalities and health disciplines, this project will focus on the implementing Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app developed by our Center for a disease that affects 21.5 million and kills 136,000 Americans annually: substance use disorder. A mobile app was selected, as opposed to another e-health technology, because of the near ubiquitous daily use of mobile technology and because mobile e-health adoption requires supportive participation of both health centers and patients.

In response to the COVID-19 pandemic, the study team added a study component focused on describing how patients are responding to receiving remote treatment (e.g., telehealth). The study team will also seek to understand how using A-CHESS mitigates COVID-19 associated anxiety and loneliness among those with substance use disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18+ years old

• Understand English

• Have a SUD diagnosis

• Have access to a smartphone

Exclusion Criteria:

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• NIATx-TI with Product Training/On-line Support
NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework.

Locations

Country	Name	City	State
United States	Zion Recovery Services	Adel	Iowa
United States	Prairie Ridge Integrated Behavioral Healthcare	Algona	Iowa
United States	Community and Family Resources	Ames	Iowa
United States	Area Substance Abuse Council	Anamosa	Iowa
United States	UCS Healthcare	Ankeny	Iowa
United States	Zion Recovery Services	Atlantic	Iowa
United States	Area Substance Abuse Council	Belle Plaine	Iowa
United States	Community and Family Resources	Boone	Iowa
United States	Alcohol and Drug Dependency Services (ADDS)	Burlington	Iowa
United States	Area Substance Abuse Council	Cedar Rapids	Iowa
United States	Prairie Ridge Integrated Behavioral Healthcare	Charles City	Iowa
United States	Jackson Recovery Centers	Cherokee	Iowa
United States	Prelude Behavioral Health Services	Clarence	Iowa
United States	Zion Recovery Services	Clarinda	Iowa
United States	Community and Family Resources	Clarion	Iowa
United States	Heartland Family Services	Council Bluffs	Iowa
United States	Area Substance Abuse Council	De Witt	Iowa
United States	Jackson Recovery Centers	Denison	Iowa
United States	House of Mercy	Des Moines	Iowa
United States	Prelude Behavioral Health Services	Des Moines	Iowa
United States	UCS Healthcare	Des Moines	Iowa
United States	Substance Abuse Services Center	Dubuque	Iowa
United States	Prairie Ridge Integrated Behavioral Healthcare	Forest City	Iowa
United States	Community and Family Resources	Fort Dodge	Iowa
United States	Heartland Family Services	Glenwood	Iowa
United States	Zion Recovery Services	Greenfield	Iowa
United States	Prairie Ridge Integrated Behavioral Healthcare	Hampton	Iowa
United States	Community and Family Resources	Humboldt	Iowa
United States	House of Mercy	Indianola	Iowa
United States	Prelude Behavioral Services	Iowa City	Iowa
United States	ADDS	Keokuk	Iowa
United States	UCS Healthcare	Knoxville	Iowa
United States	Jackson Recovery Centers	Le Mars	Iowa
United States	Heartland Family Services	Logan	Iowa
United States	Area Substance Abuse Council	Maquoketa	Iowa
United States	Prelude Behavioral Health Services	Marengo	Iowa
United States	Prairie Ridge Integrated Behavioral Healthcare	Mason City	Iowa
United States	ADDS	Mount Pleasant	Iowa
United States	House of Mercy	Newton	Iowa
United States	Zion Recovery Services	Perry	Iowa
United States	Community and Family Resources	Pocahontas	Iowa
United States	Zion Recovery Services	Red Oak	Iowa
United States	Community and Family Resources	Rockwell City	Iowa
United States	Zion Recovery Services	Shenandoah	Iowa
United States	Jackson Recovery Centers	Sioux City	Iowa
United States	Prelude Behavioral Services	Tipton	Iowa
United States	Area Substance ABuse Council	Vinton	Iowa
United States	ADDS	Wapello	Iowa
United States	Community and Family Resources	Webster City	Iowa

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Iowa Department of Public Health, National Institute on Drug Abuse (NIDA), University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Supplement 1 - Understand impact of ACHESS on pt anxiety and loneliness during COVID-19 pandemic	Online survey	M34-37
Other	Supplement 2 - Understand how treatment organizations and staff used ACHESS during COVID pandemic	Online survey	M34-37
Primary	Reach: As assessed by the percentage of participants that download the A-CHESS app	The percentage of participants that download the A-CHESS app will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.	Monthly, up to 52 months
Primary	Reach: As assessed by the number of days that participants use the A-CHESS	The frequency of use of A-CHESS by each participant will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.	Monthly, up to 52 months
Secondary	Effectiveness of A-CHESS as assessed by the retention rate of eligible participants.	Retention rates of eligible participants	Collected monthly during months 13 - 52
Secondary	Adoption: Number of days each counselor used the A-CHESS	Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs	Monthly, up to 52 months
Secondary	Adoption - The percentage of counselors using A-CHESS will be assessed via the organizational survey and A-CHESS logs	Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)	Collected twice during study; starting M22 - 31 and M35-44
Secondary	A-CHESS/NIATx Implementation Fidelity (Survey)	Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.	Collected twice during study; approx. M14 - 25 and M32 - 43
Secondary	Organizational readiness of participating organizations as assessed by Organizational Change Manager (Survey)	Survey data on the organizational readiness of participating organizations.	Collected twice during study; approx. M14 - 25 and M32 - 43
Secondary	Financial Resource Availability (Survey)	Survey data on how the organization's financial resource availability affects A-CHESS implementation.	Collected twice during study; starting M22 - 31 and M35-44
Secondary	Difference in number of admissions in rural vs. urban location	Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location	Collected during months 7, 18, 30, and 42