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E-health Implementation (Iowa)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIATx-TI with Product Training/On-line Support
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

  • Zion Recovery Services
  • Prairie Ridge Integrated Behavioral Healthcare
  • Community and Family Resources
  • Area Substance Abuse Council
  • UCS Healthcare
  • Zion Recovery Services
  • Area Substance Abuse Council
  • Community and Family Resources
  • Alcohol and Drug Dependency Services (ADDS)
  • Area Substance Abuse Council
  • Prairie Ridge Integrated Behavioral Healthcare
  • Jackson Recovery Centers
  • Prelude Behavioral Health Services
  • Zion Recovery Services
  • Community and Family Resources
  • Heartland Family Services
  • Area Substance Abuse Council
  • Jackson Recovery Centers
  • UCS Healthcare
  • House of Mercy
  • Prelude Behavioral Health Services
  • Substance Abuse Services Center
  • Prairie Ridge Integrated Behavioral Healthcare
  • Community and Family Resources
  • Heartland Family Services
  • Zion Recovery Services
  • Prairie Ridge Integrated Behavioral Healthcare
  • Community and Family Resources
  • House of Mercy
  • Prelude Behavioral Services
  • ADDS
  • UCS Healthcare
  • Jackson Recovery Centers
  • Heartland Family Services
  • Area Substance Abuse Council
  • Prelude Behavioral Health Services
  • Prairie Ridge Integrated Behavioral Healthcare
  • ADDS
  • House of Mercy
  • Zion Recovery Services
  • Community and Family Resources
  • Zion Recovery Services
  • Community and Family Resources
  • Zion Recovery Services
  • Jackson Recovery Centers
  • Prelude Behavioral Services
  • Area Substance ABuse Council
  • ADDS
  • Community and Family Resources

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TAU/Control

NIATx-TI Framework

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reach: As assessed by the percentage of participants that download the A-CHESS app
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.
Reach: As assessed by the number of days that participants use the A-CHESS
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

Effectiveness of A-CHESS as assessed by the retention rate of eligible participants.
Retention rates of eligible participants
Adoption: Number of days each counselor used the A-CHESS
Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs
Adoption - The percentage of counselors using A-CHESS will be assessed via the organizational survey and A-CHESS logs
Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)
A-CHESS/NIATx Implementation Fidelity (Survey)
Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.
Organizational readiness of participating organizations as assessed by Organizational Change Manager (Survey)
Survey data on the organizational readiness of participating organizations.
Financial Resource Availability (Survey)
Survey data on how the organization's financial resource availability affects A-CHESS implementation.
Difference in number of admissions in rural vs. urban location
Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location

Full Information

First Posted
May 10, 2019
Last Updated
July 13, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
University of Iowa, Iowa Department of Public Health, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03954184
Brief Title
E-health Implementation (Iowa)
Official Title
Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
University of Iowa, Iowa Department of Public Health, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU/Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
NIATx-TI Framework
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NIATx-TI with Product Training/On-line Support
Intervention Description
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 Measure Information:
Title
Reach: As assessed by the percentage of participants that download the A-CHESS app
Description
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.
Time Frame
Monthly, up to 52 months
Title
Reach: As assessed by the number of days that participants use the A-CHESS
Description
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.
Time Frame
Monthly, up to 52 months
Secondary Outcome Measure Information:
Title
Effectiveness of A-CHESS as assessed by the retention rate of eligible participants.
Description
Retention rates of eligible participants
Time Frame
Collected monthly during months 13 - 52
Title
Adoption: Number of days each counselor used the A-CHESS
Description
Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs
Time Frame
Monthly, up to 52 months
Title
Adoption - The percentage of counselors using A-CHESS will be assessed via the organizational survey and A-CHESS logs
Description
Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)
Time Frame
Collected twice during study; starting M22 - 31 and M35-44
Title
A-CHESS/NIATx Implementation Fidelity (Survey)
Description
Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process.
Time Frame
Collected twice during study; approx. M14 - 25 and M32 - 43
Title
Organizational readiness of participating organizations as assessed by Organizational Change Manager (Survey)
Description
Survey data on the organizational readiness of participating organizations.
Time Frame
Collected twice during study; approx. M14 - 25 and M32 - 43
Title
Financial Resource Availability (Survey)
Description
Survey data on how the organization's financial resource availability affects A-CHESS implementation.
Time Frame
Collected twice during study; starting M22 - 31 and M35-44
Title
Difference in number of admissions in rural vs. urban location
Description
Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location
Time Frame
Collected during months 7, 18, 30, and 42
Other Pre-specified Outcome Measures:
Title
Supplement 1 - Understand impact of ACHESS on pt anxiety and loneliness during COVID-19 pandemic
Description
Online survey
Time Frame
M34-37
Title
Supplement 2 - Understand how treatment organizations and staff used ACHESS during COVID pandemic
Description
Online survey
Time Frame
M34-37

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be 18+ years old Understand English Have a SUD diagnosis Have access to a smartphone Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Molfenter, Ph.D.
Organizational Affiliation
University of Wisconisn-Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Gustafson, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zion Recovery Services
City
Adel
State/Province
Iowa
ZIP/Postal Code
50003
Country
United States
Facility Name
Prairie Ridge Integrated Behavioral Healthcare
City
Algona
State/Province
Iowa
ZIP/Postal Code
50511
Country
United States
Facility Name
Community and Family Resources
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Area Substance Abuse Council
City
Anamosa
State/Province
Iowa
ZIP/Postal Code
53305
Country
United States
Facility Name
UCS Healthcare
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50021
Country
United States
Facility Name
Zion Recovery Services
City
Atlantic
State/Province
Iowa
ZIP/Postal Code
50022
Country
United States
Facility Name
Area Substance Abuse Council
City
Belle Plaine
State/Province
Iowa
ZIP/Postal Code
52208
Country
United States
Facility Name
Community and Family Resources
City
Boone
State/Province
Iowa
ZIP/Postal Code
50036
Country
United States
Facility Name
Alcohol and Drug Dependency Services (ADDS)
City
Burlington
State/Province
Iowa
ZIP/Postal Code
52601
Country
United States
Facility Name
Area Substance Abuse Council
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52404
Country
United States
Facility Name
Prairie Ridge Integrated Behavioral Healthcare
City
Charles City
State/Province
Iowa
ZIP/Postal Code
50616
Country
United States
Facility Name
Jackson Recovery Centers
City
Cherokee
State/Province
Iowa
ZIP/Postal Code
51012
Country
United States
Facility Name
Prelude Behavioral Health Services
City
Clarence
State/Province
Iowa
ZIP/Postal Code
52216
Country
United States
Facility Name
Zion Recovery Services
City
Clarinda
State/Province
Iowa
ZIP/Postal Code
51632
Country
United States
Facility Name
Community and Family Resources
City
Clarion
State/Province
Iowa
ZIP/Postal Code
50525
Country
United States
Facility Name
Heartland Family Services
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Area Substance Abuse Council
City
De Witt
State/Province
Iowa
ZIP/Postal Code
52742
Country
United States
Facility Name
Jackson Recovery Centers
City
Denison
State/Province
Iowa
ZIP/Postal Code
51442
Country
United States
Facility Name
UCS Healthcare
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50310
Country
United States
Facility Name
House of Mercy
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Prelude Behavioral Health Services
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50317
Country
United States
Facility Name
Substance Abuse Services Center
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Prairie Ridge Integrated Behavioral Healthcare
City
Forest City
State/Province
Iowa
ZIP/Postal Code
50436
Country
United States
Facility Name
Community and Family Resources
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Facility Name
Heartland Family Services
City
Glenwood
State/Province
Iowa
ZIP/Postal Code
51534
Country
United States
Facility Name
Zion Recovery Services
City
Greenfield
State/Province
Iowa
ZIP/Postal Code
50849
Country
United States
Facility Name
Prairie Ridge Integrated Behavioral Healthcare
City
Hampton
State/Province
Iowa
ZIP/Postal Code
50441
Country
United States
Facility Name
Community and Family Resources
City
Humboldt
State/Province
Iowa
ZIP/Postal Code
50548
Country
United States
Facility Name
House of Mercy
City
Indianola
State/Province
Iowa
ZIP/Postal Code
50125
Country
United States
Facility Name
Prelude Behavioral Services
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
ADDS
City
Keokuk
State/Province
Iowa
ZIP/Postal Code
52362
Country
United States
Facility Name
UCS Healthcare
City
Knoxville
State/Province
Iowa
ZIP/Postal Code
50138
Country
United States
Facility Name
Jackson Recovery Centers
City
Le Mars
State/Province
Iowa
ZIP/Postal Code
51031
Country
United States
Facility Name
Heartland Family Services
City
Logan
State/Province
Iowa
ZIP/Postal Code
51546
Country
United States
Facility Name
Area Substance Abuse Council
City
Maquoketa
State/Province
Iowa
ZIP/Postal Code
52060
Country
United States
Facility Name
Prelude Behavioral Health Services
City
Marengo
State/Province
Iowa
ZIP/Postal Code
52301
Country
United States
Facility Name
Prairie Ridge Integrated Behavioral Healthcare
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
ADDS
City
Mount Pleasant
State/Province
Iowa
ZIP/Postal Code
52641
Country
United States
Facility Name
House of Mercy
City
Newton
State/Province
Iowa
ZIP/Postal Code
50208
Country
United States
Facility Name
Zion Recovery Services
City
Perry
State/Province
Iowa
ZIP/Postal Code
50220
Country
United States
Facility Name
Community and Family Resources
City
Pocahontas
State/Province
Iowa
ZIP/Postal Code
50574
Country
United States
Facility Name
Zion Recovery Services
City
Red Oak
State/Province
Iowa
ZIP/Postal Code
51566
Country
United States
Facility Name
Community and Family Resources
City
Rockwell City
State/Province
Iowa
ZIP/Postal Code
50579
Country
United States
Facility Name
Zion Recovery Services
City
Shenandoah
State/Province
Iowa
ZIP/Postal Code
51601
Country
United States
Facility Name
Jackson Recovery Centers
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Prelude Behavioral Services
City
Tipton
State/Province
Iowa
ZIP/Postal Code
52772
Country
United States
Facility Name
Area Substance ABuse Council
City
Vinton
State/Province
Iowa
ZIP/Postal Code
52349
Country
United States
Facility Name
ADDS
City
Wapello
State/Province
Iowa
ZIP/Postal Code
52632
Country
United States
Facility Name
Community and Family Resources
City
Webster City
State/Province
Iowa
ZIP/Postal Code
50595
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35834315
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.
Results Reference
derived
PubMed Identifier
33097097
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.
Results Reference
derived

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E-health Implementation (Iowa)

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