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

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ClinicalTrials.gov Identifier: NCT03954184
Recruitment Status : Active, not recruiting
First Posted : May 17, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
University of Iowa
Iowa Department of Public Health
Information provided by (Responsible Party):
University of Wisconsin, Madison

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


Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: NIATx-TI with Product Training/On-line Support Not Applicable

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.1 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.2, 3 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.4 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 assessment5 and patient simulation.6 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.7 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
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.
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.
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.




Primary Outcome Measures :
  1. Adoption: Number of days each counselor used the A-CHESS [ Time Frame: Monthly, up to 44 months ]
    Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs

  2. Adoption - The percentage of counselors using A-CHESS will be assessed via the organizational survey and A-CHESS logs [ Time Frame: Monthly, up to 44 months ]
    Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention) To increase survey completion rates for the organizational surveys, we conduct follow-up phone calls and e-mails with the change leaders at Week 1 of post-survey distribution to assure the survey receipt, then at Weeks 4 and 12-post survey distribution if surveys are not complete.

  3. Adoption: Percentage of counselors referring participants to A-CHESS [ Time Frame: Monthly, up to 44 months ]
    Percentage of counselors referring participants to A-CHESS

  4. Adoption: Percentage of counselors not referring participants to A-CHESS [ Time Frame: Monthly, up to 44 months ]
    Percentage of counselors not referring participants to A-CHESS

  5. Reach: As assessed by the percentage of participants that download the A-CHESS app [ Time Frame: Monthly, up to 44 months ]
    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.

  6. Reach: As assessed by the number of days that participants use the A-CHESS [ Time Frame: Monthly, up to 44 months ]
    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.


Secondary Outcome Measures :
  1. Effectiveness of A-CHESS as assessed by the retention rate of eligible participants. [ Time Frame: Collected monthly during months 8 - 47 ]
    Retention rates of eligible participants

  2. A-CHESS Implementation Fidelity (Survey) [ Time Frame: Collected during months 8 & 17. ]
    Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.

  3. Organizational readiness of participating organizations as assessed by Organizational Change Manager (Survey) [ Time Frame: Collected during months 8 & 17. ]
    Survey data on the organizational readiness of participating organizations.

  4. Financial Resource Availability (Survey) [ Time Frame: Collected during months 8 & 17. ]
    Survey data on how the organization's financial resource availability affects A-CHESS implementation.

  5. Difference in number of admissions in rural vs. urban location [ Time Frame: Collected during months 7, 18, 30, and 42 ]
    Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954184


  Show 49 Study Locations
Sponsors and Collaborators
University of Wisconsin, Madison
University of Iowa
Iowa Department of Public Health
Investigators
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Principal Investigator: Todd Molfenter, Ph.D. University of Wisconisn-Madison
Principal Investigator: David Gustafson, Ph.D. University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03954184     History of Changes
Other Study ID Numbers: 2018-0997
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders