Clinical trial NCT03954184: E-health Implementation (Iowa)
Official title: Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Iowa Department of Public Health
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-17
Enrollment: 23659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Must be 18+ years old
* Understand English
* Have a SUD diagnosis
* Have access to a smartphone

Exclusion Criteria:

Primary outcomes:
measure: Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App
timeFrame: 45 months
measure: Reach: As Assessed by the Number of Days That Participants Use the A-CHESS
timeFrame: 45 months
Secondary outcomes:
measure: Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.
timeFrame: Collected monthly during months 13 - 45
measure: Adoption: Number of Days Each Counselor Used the A-CHESS
timeFrame: 45 months
measure: Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs
timeFrame: Collected twice during study; starting M22 - 31 and M35-44
measure: A-CHESS/NIATx Implementation Fidelity (Survey)
timeFrame: Collected twice during study; approx. M14 - 25 and M32 - 43
measure: Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)
timeFrame: Collected twice during study; approx. M14 - 25 and M32 - 43
measure: Financial Resource Availability (Survey)
timeFrame: Collected twice during study; starting M22 - 31 and M35-44
measure: Difference in Number of Admissions in Rural vs. Urban Location
timeFrame: Collected during months 7, 18, 30, and 42, month 42 reported
Other outcomes:
measure: Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic
timeFrame: M34-37
measure: Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic
timeFrame: M34-37
Locations:
city: Adel
country: United States
facility: Zion Recovery Services
state: Iowa
city: Algona
country: United States
facility: Prairie Ridge Integrated Behavioral Healthcare
state: Iowa
city: Ames
country: United States
facility: Community and Family Resources
state: Iowa
city: Anamosa
country: United States
facility: Area Substance Abuse Council
state: Iowa
city: Ankeny
country: United States
facility: UCS Healthcare
state: Iowa
city: Atlantic
country: United States
facility: Zion Recovery Services
state: Iowa
city: Belle Plaine
country: United States
facility: Area Substance Abuse Council
state: Iowa
city: Boone
country: United States
facility: Community and Family Resources
state: Iowa
city: Burlington
country: United States
facility: Alcohol and Drug Dependency Services (ADDS)
state: Iowa
city: Cedar Rapids
country: United States
facility: Area Substance Abuse Council
state: Iowa
city: Charles City
country: United States
facility: Prairie Ridge Integrated Behavioral Healthcare
state: Iowa
city: Cherokee
country: United States
facility: Jackson Recovery Centers
state: Iowa
city: Clarence
country: United States
facility: Prelude Behavioral Health Services
state: Iowa
city: Clarinda
country: United States
facility: Zion Recovery Services
state: Iowa
city: Clarion
country: United States
facility: Community and Family Resources
state: Iowa
city: Council Bluffs
country: United States
facility: Heartland Family Services
state: Iowa
city: De Witt
country: United States
facility: Area Substance Abuse Council
state: Iowa
city: Denison
country: United States
facility: Jackson Recovery Centers
state: Iowa
city: Des Moines
country: United States
facility: UCS Healthcare
state: Iowa
city: Des Moines
country: United States
facility: House of Mercy
state: Iowa
city: Des Moines
country: United States
facility: Prelude Behavioral Health Services
state: Iowa
city: Dubuque
country: United States
facility: Substance Abuse Services Center
state: Iowa
city: Forest City
country: United States
facility: Prairie Ridge Integrated Behavioral Healthcare
state: Iowa
city: Fort Dodge
country: United States
facility: Community and Family Resources
state: Iowa
city: Glenwood
country: United States
facility: Heartland Family Services
state: Iowa
city: Greenfield
country: United States
facility: Zion Recovery Services
state: Iowa
city: Hampton
country: United States
facility: Prairie Ridge Integrated Behavioral Healthcare
state: Iowa
city: Humboldt
country: United States
facility: Community and Family Resources
state: Iowa
city: Indianola
country: United States
facility: House of Mercy
state: Iowa
city: Iowa City
country: United States
facility: Prelude Behavioral Services
state: Iowa
city: Keokuk
country: United States
facility: ADDS
state: Iowa
city: Knoxville
country: United States
facility: UCS Healthcare
state: Iowa
city: Le Mars
country: United States
facility: Jackson Recovery Centers
state: Iowa
city: Logan
country: United States
facility: Heartland Family Services
state: Iowa
city: Maquoketa
country: United States
facility: Area Substance Abuse Council
state: Iowa
city: Marengo
country: United States
facility: Prelude Behavioral Health Services
state: Iowa
city: Mason City
country: United States
facility: Prairie Ridge Integrated Behavioral Healthcare
state: Iowa
city: Mount Pleasant
country: United States
facility: ADDS
state: Iowa
city: Newton
country: United States
facility: House of Mercy
state: Iowa
city: Perry
country: United States
facility: Zion Recovery Services
state: Iowa
city: Pocahontas
country: United States
facility: Community and Family Resources
state: Iowa
city: Red Oak
country: United States
facility: Zion Recovery Services
state: Iowa
city: Rockwell City
country: United States
facility: Community and Family Resources
state: Iowa
city: Shenandoah
country: United States
facility: Zion Recovery Services
state: Iowa
city: Sioux City
country: United States
facility: Jackson Recovery Centers
state: Iowa
city: Tipton
country: United States
facility: Prelude Behavioral Services
state: Iowa
city: Vinton
country: United States
facility: Area Substance ABuse Council
state: Iowa
city: Wapello
country: United States
facility: ADDS
state: Iowa
city: Webster City
country: United States
facility: Community and Family Resources
state: Iowa
Study officials:
affiliation: University of Wisconisn-Madison
name: Todd Molfenter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: David Gustafson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleddermann K, Molfenter T, Vjorn O, Horst J, Hulsey J, Kelly B, Zawislak K, Gustafson DH, Gicquelais RE. Patient Preferences for Mobile Health Applications to Support Recovery. J Addict Med. 2023 Jul-Aug 01;17(4):394-400. doi: 10.1097/ADM.0000000000001137. Epub 2023 Jan 18.
citation: Fleddermann K, Molfenter T, Jacobson N, Horst J, Roosa MR, Boss D, Ross JC, Preuss E, Gustafson DH. Clinician Perspectives on Barriers and Facilitators to Implementing e-Health Technology in Substance Use Disorder (SUD) Treatment Facilities. Subst Abuse. 2021 Oct 26;15:11782218211053360. doi: 10.1177/11782218211053360. eCollection 2021.
citation: Gustafson D Sr, Horst J, Boss D, Fleddermann K, Jacobson N, Roosa M, Ross JC, Gicquelais R, Vjorn O, Siegler T, Molfenter T. Implementation of Smartphone Systems to Improve Quality of Life for People With Substance Use Disorder: Interim Report on a Randomized Controlled Trial. JMIR Hum Factors. 2022 Jul 14;9(3):e35125. doi: 10.2196/35125.
citation: White VM, Molfenter T, Gustafson DH, Horst J, Greller R, Gustafson DH Jr, Kim JS, Preuss E, Cody O, Pisitthakarm P, Toy A. NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol. Implement Sci. 2020 Oct 23;15(1):94. doi: 10.1186/s13012-020-01053-4.