E-health Implementation (Iowa)
Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Adel, Iowa, United States, 50003
- Zion Recovery Services
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Algona, Iowa, United States, 50511
- Prairie Ridge Integrated Behavioral Healthcare
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Ames, Iowa, United States, 50010
- Community and Family Resources
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Anamosa, Iowa, United States, 53305
- Area Substance ABuse Council
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Ankeny, Iowa, United States, 50021
- UCS Healthcare
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Atlantic, Iowa, United States, 50022
- Zion Recovery Services
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Belle Plaine, Iowa, United States, 52208
- Area Substance ABuse Council
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Boone, Iowa, United States, 50036
- Community and Family Resources
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Burlington, Iowa, United States, 52601
- Alcohol and Drug Dependency Services (ADDS)
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Cedar Rapids, Iowa, United States, 52404
- Area Substance ABuse Council
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Charles City, Iowa, United States, 50616
- Prairie Ridge Integrated Behavioral Healthcare
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Cherokee, Iowa, United States, 51012
- Jackson Recovery Centers
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Clarence, Iowa, United States, 52216
- Prelude Behavioral Health Services
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Clarinda, Iowa, United States, 51632
- Zion Recovery Services
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Clarion, Iowa, United States, 50525
- Community and Family Resources
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Council Bluffs, Iowa, United States, 51503
- Heartland Family Services
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De Witt, Iowa, United States, 52742
- Area Substance ABuse Council
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Denison, Iowa, United States, 51442
- Jackson Recovery Centers
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Des Moines, Iowa, United States, 50310
- UCS Healthcare
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Des Moines, Iowa, United States, 50314
- House of Mercy
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Des Moines, Iowa, United States, 50317
- Prelude Behavioral Health Services
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Dubuque, Iowa, United States, 52001
- Substance Abuse Services Center
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Forest City, Iowa, United States, 50436
- Prairie Ridge Integrated Behavioral Healthcare
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Fort Dodge, Iowa, United States, 50501
- Community and Family Resources
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Glenwood, Iowa, United States, 51534
- Heartland Family Services
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Greenfield, Iowa, United States, 50849
- Zion Recovery Services
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Hampton, Iowa, United States, 50441
- Prairie Ridge Integrated Behavioral Healthcare
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Humboldt, Iowa, United States, 50548
- Community and Family Resources
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Indianola, Iowa, United States, 50125
- House of Mercy
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Iowa City, Iowa, United States, 52240
- Prelude Behavioral Services
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Keokuk, Iowa, United States, 52362
- ADDS
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Knoxville, Iowa, United States, 50138
- UCS Healthcare
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Le Mars, Iowa, United States, 51031
- Jackson Recovery Centers
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Logan, Iowa, United States, 51546
- Heartland Family Services
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Maquoketa, Iowa, United States, 52060
- Area Substance ABuse Council
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Marengo, Iowa, United States, 52301
- Prelude Behavioral Health Services
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Mason City, Iowa, United States, 50401
- Prairie Ridge Integrated Behavioral Healthcare
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Mount Pleasant, Iowa, United States, 52641
- ADDS
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Newton, Iowa, United States, 50208
- House of Mercy
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Perry, Iowa, United States, 50220
- Zion Recovery Services
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Pocahontas, Iowa, United States, 50574
- Community and Family Resources
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Red Oak, Iowa, United States, 51566
- Zion Recovery Services
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Rockwell City, Iowa, United States, 50579
- Community and Family Resources
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Shenandoah, Iowa, United States, 51601
- Zion Recovery Services
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Sioux City, Iowa, United States, 51101
- Jackson Recovery Centers
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Tipton, Iowa, United States, 52772
- Prelude Behavioral Services
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Vinton, Iowa, United States, 52349
- Area Substance ABuse Council
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Wapello, Iowa, United States, 52632
- ADDS
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Webster City, Iowa, United States, 50595
- Community and Family Resources
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be 18+ years old
- Understand English
- Have a SUD diagnosis
- Have access to a smartphone
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: TAU/Control
Sites in the Treatment as Usual (TAU)/Control Arm will receive product training/online support.
Sites in the TAU/Control Arm will participate in a one-day product implementation or training session.
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Experimental: NIATx-TI Framework
Sites in the NIATx-TI Arm will receive product training/online support, and training in the NIATx-TI framework.
The NIATx-TI framework will include a pre-implementation (planning) phase, and post-implementation (problem-solving) phase, with training delivered by a NIATx-TI coach.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App
Time Frame: 45 months
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The mean number of clinics with patients who 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.
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45 months
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Reach: As Assessed by the Number of Days That Participants Use the A-CHESS
Time Frame: 45 months
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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.
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45 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.
Time Frame: Collected monthly during months 13 - 45
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Retention rates of eligible participants
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Collected monthly during months 13 - 45
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Adoption: Number of Days Each Counselor Used the A-CHESS
Time Frame: 45 months
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Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs
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45 months
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Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs
Time Frame: Collected twice during study; starting M22 - 31 and M35-44
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Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)
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Collected twice during study; starting M22 - 31 and M35-44
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A-CHESS/NIATx Implementation Fidelity (Survey)
Time Frame: Collected twice during study; approx. M14 - 25 and M32 - 43
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Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.
The Implementation Fidelity survey is a 13 item questionnaire using a 4-point scale where 0 = Not True and 4 = True.
Scores range from 0-52.
Higher scores indicate greater implementation fidelity.
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Collected twice during study; approx. M14 - 25 and M32 - 43
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Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)
Time Frame: Collected twice during study; approx. M14 - 25 and M32 - 43
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Survey data on the organizational readiness of participating organizations.
Organizational Readiness (as measured by Organizational Change Manager) - 5 categories from Not True (0) to True (3) and Don't Know (No score).
Scores range from 0-66.
Higher scores indicate greater readiness for change.
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Collected twice during study; approx. M14 - 25 and M32 - 43
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Financial Resource Availability (Survey)
Time Frame: Collected twice during study; starting M22 - 31 and M35-44
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Survey data on how the organization's financial resource availability affects A-CHESS implementation.
Scored the availability of financial resources on a 5-point scale from 0= Not Ture to 4= True.
Scores range from 0-28.
Higher score indicates greater availability of resources.
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Collected twice during study; starting M22 - 31 and M35-44
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Difference in Number of Admissions in Rural vs. Urban Location
Time Frame: Collected during months 7, 18, 30, and 42, month 42 reported
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Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location.
The number of clinics located in a rural area was counted.
The number of clinics in an urban location were counted.
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Collected during months 7, 18, 30, and 42, month 42 reported
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic
Time Frame: M34-37
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Online survey
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M34-37
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Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic
Time Frame: M34-37
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Online survey
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M34-37
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Todd Molfenter, Ph.D., University of Wisconisn-Madison
- Principal Investigator: David Gustafson, Ph.D., University of Wisconsin, Madison
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0997
- A195010 (Other Identifier: UW Madison)
- ENGR/INDUSTRIAL ENGR (Other Identifier: UW Madison)
- 1R01DA044159-01A1 (U.S. NIH Grant/Contract)
- 3R01DA044159-02S1 (U.S. NIH Grant/Contract)
- Protocol version: 02-15-2021 (Other Identifier: Advarra)
- 2020-0833 (Other Identifier: UW Madison (ceded))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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