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Completed

NCT Number: NCT03954184

E-health Implementation (Iowa)

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zion Recovery Services, Adel, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

NIATx-TI with Product Training/On-line Support

Behavioral

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 outcomes

  1. Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App

    Time frame: 45 months

    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.

  2. Reach: As Assessed by the Number of Days That Participants Use the A-CHESS

    Time frame: 45 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 outcomes

  1. Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.

    Time frame: Collected monthly during months 13 - 45

    Retention rates of eligible participants

  2. Adoption: Number of Days Each Counselor Used the A-CHESS

    Time frame: 45 months

    Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs

  3. 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

    Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)

  4. A-CHESS/NIATx Implementation Fidelity (Survey)

    Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43

    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.

  5. Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)

    Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43

    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.

  6. Financial Resource Availability (Survey)

    Time frame: Collected twice during study; starting M22 - 31 and M35-44

    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.

  7. Difference in Number of Admissions in Rural vs. Urban Location

    Time frame: Collected during months 7, 18, 30, and 42, month 42 reported

    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.

Other outcomes

  1. Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic

    Time frame: M34-37

    Online survey

  2. Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic

    Time frame: M34-37

    Online survey

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Iowa Department of Public Health
  • National Institute on Drug Abuse (NIDA)
  • University of Iowa

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 17, 2019
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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