NCT03954184

E-health Implementation (Iowa)

Completed NA Results posted Last updated 7 February 2025

What this trial tests

NA trial testing NIATx-TI with Product Training/On-line Support in Substance Use Disorders in 23,659 participants. Completed in 30 June 2023.

Timeline

3 September 2019

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	23,659
Start date	3 September 2019
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	49 locations across United States

Drugs / interventions tested

• NIATx-TI with Product Training/On-line Support

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
TAU/Control	0.039	± 0.029
NIATx-TI Framework	0.171	± 0.041

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

Group	Value	95% CI
TAU/Control	0.161	± 0.466
NIATx-TI Framework	1.845	± 1.487

Adoption: Number of Days Each Counselor Used the A-CHESS Secondary · 45 months

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

Group	Value	95% CI
TAU/Control	1.81	± 2.52
NIATx-TI Framework	19.11	± 62.68

Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs Secondary · 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)

Group	Value	95% CI
TAU/Control	24
NIATx-TI Framework	84

A-CHESS/NIATx Implementation Fidelity (Survey) Secondary · 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.

Survey 2

Group	Value	95% CI
TAU/Control	2.26	± 0.55
NIATx-TI Framework	2.91	± 0.51

Survey 3

Group	Value	95% CI
TAU/Control	2.20	± 0.63
NIATx-TI Framework	2.91	± 0.55

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

Survey 2

Group	Value	95% CI
TAU/Control	2.99	± 0.58
NIATx-TI Framework	3.17	± 0.50

Survey 3

Group	Value	95% CI
TAU/Control	2.73	± 0.75
NIATx-TI Framework	3.28	± 0.40

Financial Resource Availability (Survey) Secondary · 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.

Survey 1

Group	Value	95% CI
TAU/Control	2.68	± 0.73
NIATx-TI Framework	3.41	± 0.57

Survey 2

Group	Value	95% CI
TAU/Control	2.77	± 0.83
NIATx-TI Framework	3.13	± 0.87

Difference in Number of Admissions in Rural vs. Urban Location Secondary · 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.

Group	Value	95% CI
TAU/Control	1
NIATx-TI Framework	3
TAU/Control	17
NIATx-TI Framework	17
TAU/Control	1
NIATx-TI Framework	1

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient Preferences for Mobile Health Applications to Support Recovery.
   Fleddermann K, Fleddermann K, Molfenter T, Molfenter T, et al · · 2023 · cited 7× · PMID 37579096 · DOI 10.1097/adm.0000000000001137
2. NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol.
   White VM, Molfenter T, Gustafson DH, Horst J, et al · · 2020 · cited 3× · PMID 33097097 · DOI 10.1186/s13012-020-01053-4
3. Implementation of Smartphone Systems to Improve Quality of Life for People With Substance Use Disorder: Interim Report on a Randomized Controlled Trial.
   Gustafson D, Horst J, Boss D, Fleddermann K, et al · · 2022 · cited 2× · PMID 35834315 · DOI 10.2196/35125