E-health Implementation (Iowa)

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03954184
Collaborator
University of Iowa (Other), Iowa Department of Public Health (Other), National Institute on Drug Abuse (NIDA) (NIH)
39
49
2
45.9
0.8
0

Study Details

Study Description

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
  • Behavioral: NIATx-TI with Product Training/On-line Support
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 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 :
Sep 3, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Reach: As assessed by the percentage of participants that download the A-CHESS app [Monthly, up to 52 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.

  2. Reach: As assessed by the number of days that participants use the A-CHESS [Monthly, up to 52 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. [Collected monthly during months 13 - 52]

    Retention rates of eligible participants

  2. Adoption: Number of days each counselor used the A-CHESS [Monthly, up to 52 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 [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) [Collected twice during study; approx. M14 - 25 and M32 - 43]

    Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.

  5. Organizational readiness of participating organizations as assessed by Organizational Change Manager (Survey) [Collected twice during study; approx. M14 - 25 and M32 - 43]

    Survey data on the organizational readiness of participating organizations.

  6. Financial Resource Availability (Survey) [Collected twice during study; starting M22 - 31 and M35-44]

    Survey data on how the organization's financial resource availability affects A-CHESS implementation.

  7. Difference in number of admissions in rural vs. urban location [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

Other Outcome Measures

  1. Supplement 1 - Understand impact of ACHESS on pt anxiety and loneliness during COVID-19 pandemic [M34-37]

    Online survey

  2. Supplement 2 - Understand how treatment organizations and staff used ACHESS during COVID pandemic [M34-37]

    Online survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Must be 18+ years old

  • Understand English

  • Have a SUD diagnosis

  • Have access to a smartphone

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zion Recovery Services Adel Iowa United States 50003
2 Prairie Ridge Integrated Behavioral Healthcare Algona Iowa United States 50511
3 Community and Family Resources Ames Iowa United States 50010
4 Area Substance Abuse Council Anamosa Iowa United States 53305
5 UCS Healthcare Ankeny Iowa United States 50021
6 Zion Recovery Services Atlantic Iowa United States 50022
7 Area Substance Abuse Council Belle Plaine Iowa United States 52208
8 Community and Family Resources Boone Iowa United States 50036
9 Alcohol and Drug Dependency Services (ADDS) Burlington Iowa United States 52601
10 Area Substance Abuse Council Cedar Rapids Iowa United States 52404
11 Prairie Ridge Integrated Behavioral Healthcare Charles City Iowa United States 50616
12 Jackson Recovery Centers Cherokee Iowa United States 51012
13 Prelude Behavioral Health Services Clarence Iowa United States 52216
14 Zion Recovery Services Clarinda Iowa United States 51632
15 Community and Family Resources Clarion Iowa United States 50525
16 Heartland Family Services Council Bluffs Iowa United States 51503
17 Area Substance Abuse Council De Witt Iowa United States 52742
18 Jackson Recovery Centers Denison Iowa United States 51442
19 UCS Healthcare Des Moines Iowa United States 50310
20 House of Mercy Des Moines Iowa United States 50314
21 Prelude Behavioral Health Services Des Moines Iowa United States 50317
22 Substance Abuse Services Center Dubuque Iowa United States 52001
23 Prairie Ridge Integrated Behavioral Healthcare Forest City Iowa United States 50436
24 Community and Family Resources Fort Dodge Iowa United States 50501
25 Heartland Family Services Glenwood Iowa United States 51534
26 Zion Recovery Services Greenfield Iowa United States 50849
27 Prairie Ridge Integrated Behavioral Healthcare Hampton Iowa United States 50441
28 Community and Family Resources Humboldt Iowa United States 50548
29 House of Mercy Indianola Iowa United States 50125
30 Prelude Behavioral Services Iowa City Iowa United States 52240
31 ADDS Keokuk Iowa United States 52362
32 UCS Healthcare Knoxville Iowa United States 50138
33 Jackson Recovery Centers Le Mars Iowa United States 51031
34 Heartland Family Services Logan Iowa United States 51546
35 Area Substance Abuse Council Maquoketa Iowa United States 52060
36 Prelude Behavioral Health Services Marengo Iowa United States 52301
37 Prairie Ridge Integrated Behavioral Healthcare Mason City Iowa United States 50401
38 ADDS Mount Pleasant Iowa United States 52641
39 House of Mercy Newton Iowa United States 50208
40 Zion Recovery Services Perry Iowa United States 50220
41 Community and Family Resources Pocahontas Iowa United States 50574
42 Zion Recovery Services Red Oak Iowa United States 51566
43 Community and Family Resources Rockwell City Iowa United States 50579
44 Zion Recovery Services Shenandoah Iowa United States 51601
45 Jackson Recovery Centers Sioux City Iowa United States 51101
46 Prelude Behavioral Services Tipton Iowa United States 52772
47 Area Substance ABuse Council Vinton Iowa United States 52349
48 ADDS Wapello Iowa United States 52632
49 Community and Family Resources Webster City Iowa United States 50595

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Todd Molfenter, Ph.D., University of Wisconisn-Madison
  • Principal Investigator: David Gustafson, Ph.D., University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT03954184
Other Study ID Numbers:
  • 2018-0997
  • A195010
  • ENGR/INDUSTRIAL ENGR
  • 1R01DA044159-01A1
  • 3R01DA044159-02S1
  • Protocol version: 02-15-2021
  • 2020-0833
First Posted:
May 17, 2019
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022