Trial Outcomes & Findings for E-health Implementation (Iowa) (NCT NCT03954184)

Last Updated: 2025-02-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23659 participants

Primary outcome timeframe

45 months

Results posted on

2025-02-07

Participant Flow

Participants (SUD clinic sites) funded by the Iowa Department of Health and Human Services (formerly Iowa Department of Public Health) were recruited between May 2019 and April 2020.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	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.	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. 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.
Overall Study STARTED	11086 20	12573 21
Overall Study Patients	10972 20	12379 21
Overall Study Counselors	114 20	194 21
Overall Study COMPLETED	10586 19	12573 21
Overall Study NOT COMPLETED	500 1	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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. 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.
Overall Study Lost to Follow-up	500	0

Baseline Characteristics

Patient participants and counselors were counted separately.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAU/Control n=19 Clinics 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.	NIATx-TI Framework n=21 Clinics 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. 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.
Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App	0.039 Mean number of clinics Standard Error 0.029	0.171 Mean number of clinics Standard Error 0.041

PRIMARY outcome

Timeframe: 45 months

Population: 6 sites are excluded from the analysis because they are comprised entirely of patients without activated accounts.

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.

Outcome measures

Outcome measures
Measure	TAU/Control n=14 Clinics 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.	NIATx-TI Framework n=20 Clinics 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. 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.
Reach: As Assessed by the Number of Days That Participants Use the A-CHESS	0.161 Days Standard Deviation 0.466	1.845 Days Standard Deviation 1.487

SECONDARY outcome

Timeframe: Collected monthly during months 13 - 45

Population: This data was not collected

Retention rates of eligible participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 45 months

Population: Those counselors that did not use RISE at least once were not included in this calculation.

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

Outcome measures

Outcome measures
Measure	TAU/Control n=89 Participants 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.	NIATx-TI Framework n=100 Participants 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. 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.
Adoption: Number of Days Each Counselor Used the A-CHESS	1.81 days Standard Deviation 2.52	19.11 days Standard Deviation 62.68

SECONDARY outcome

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

Population: Any counselor who had the opportunity to have patients connected to them in the app is counted in the overall number

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

Outcome measures

Outcome measures
Measure	TAU/Control n=110 Participants 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.	NIATx-TI Framework n=193 Participants 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. 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.
Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs	24 Participants	84 Participants

SECONDARY outcome

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

Population: Not all sites completed surveys at each time point

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.

Outcome measures

Outcome measures
Measure	TAU/Control n=17 Clinics 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.	NIATx-TI Framework n=20 Clinics 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. 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.
A-CHESS/NIATx Implementation Fidelity (Survey) Survey 2	2.26 score on a scale Standard Deviation 0.55	2.91 score on a scale Standard Deviation 0.51
A-CHESS/NIATx Implementation Fidelity (Survey) Survey 3	2.20 score on a scale Standard Deviation 0.63	2.91 score on a scale Standard Deviation 0.55

SECONDARY outcome

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

Population: Not all sites completed all surveys

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.

Outcome measures

Outcome measures
Measure	TAU/Control n=17 Clinics 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.	NIATx-TI Framework n=20 Clinics 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. 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.
Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) Survey 2	2.99 score on a scale Standard Deviation 0.58	3.17 score on a scale Standard Deviation 0.50
Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) Survey 3	2.73 score on a scale Standard Deviation 0.75	3.28 score on a scale Standard Deviation 0.40

SECONDARY outcome

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

Population: Not all sites completed all surveys

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.

Outcome measures

Outcome measures
Measure	TAU/Control n=17 Clinics 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.	NIATx-TI Framework n=21 Clinics 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. 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.
Financial Resource Availability (Survey) Survey 1	2.68 units on a scale Standard Deviation 0.73	3.41 units on a scale Standard Deviation 0.57
Financial Resource Availability (Survey) Survey 2	2.77 units on a scale Standard Deviation 0.83	3.13 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TAU/Control n=19 Clinics 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.	NIATx-TI Framework n=21 Clinics 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. 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.
Difference in Number of Admissions in Rural vs. Urban Location Rural	1 Clinics	3 Clinics
Difference in Number of Admissions in Rural vs. Urban Location Urban	17 Clinics	17 Clinics
Difference in Number of Admissions in Rural vs. Urban Location Half Rural/ Half Urban	1 Clinics	1 Clinics

OTHER_PRE_SPECIFIED outcome

Timeframe: M34-37

Online survey

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: M34-37

Online survey

Outcome measures

Outcome data not reported

Adverse Events

TAU/Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NIATx-TI Framework

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Todd Molfenter, PhD

University of Wisconsin - Madison

Phone: 608-262-1685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TAU/Control n=19 Clinics 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.	NIATx-TI Framework n=21 Clinics 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. 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.	Total n=40 Clinics Total of all reporting groups
Age, Continuous Participants	34.8 years STANDARD_DEVIATION 12.2 • n=10472 Participants • Patient participants and counselors were counted separately.	36.0 years STANDARD_DEVIATION 12.4 • n=12379 Participants • Patient participants and counselors were counted separately.	35.5 years STANDARD_DEVIATION 12.3 • n=22851 Participants • Patient participants and counselors were counted separately.
Age, Continuous Counselors	42.4 years STANDARD_DEVIATION 11.5 • n=114 Participants • Patient participants and counselors were counted separately.	45.1 years STANDARD_DEVIATION 12.4 • n=194 Participants • Patient participants and counselors were counted separately.	44.3 years STANDARD_DEVIATION 12.2 • n=308 Participants • Patient participants and counselors were counted separately.
Sex/Gender, Customized Patients: Genderqueer/Other	5 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	73 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	78 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Patients: Man	5192 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	7623 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	12815 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Patients: Refused/Unknown	2564 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	445 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	3009 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Patients: Transgender Man	5 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	3 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	8 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Patients: Transgender Woman	3 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	6 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	9 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Patients: Woman	2703 Participants n=10472 Participants • Gender was collected for patients and counselors separately.	4229 Participants n=12379 Participants • Gender was collected for patients and counselors separately.	6932 Participants n=22851 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Genderqueer/Other	0 Participants n=114 Participants • Gender was collected for patients and counselors separately.	0 Participants n=194 Participants • Gender was collected for patients and counselors separately.	0 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Man	10 Participants n=114 Participants • Gender was collected for patients and counselors separately.	48 Participants n=194 Participants • Gender was collected for patients and counselors separately.	58 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Refused/Unknown	3 Participants n=114 Participants • Gender was collected for patients and counselors separately.	30 Participants n=194 Participants • Gender was collected for patients and counselors separately.	33 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Transgender Man	0 Participants n=114 Participants • Gender was collected for patients and counselors separately.	0 Participants n=194 Participants • Gender was collected for patients and counselors separately.	0 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Transgender Woman	0 Participants n=114 Participants • Gender was collected for patients and counselors separately.	0 Participants n=194 Participants • Gender was collected for patients and counselors separately.	0 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Sex/Gender, Customized Counselors: Woman	101 Participants n=114 Participants • Gender was collected for patients and counselors separately.	116 Participants n=194 Participants • Gender was collected for patients and counselors separately.	217 Participants n=308 Participants • Gender was collected for patients and counselors separately.
Ethnicity (NIH/OMB) Patients · Hispanic or Latino	926 Participants n=10472 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	674 Participants n=12379 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	1600 Participants n=22851 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Ethnicity (NIH/OMB) Patients · Not Hispanic or Latino	8920 Participants n=10472 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	11212 Participants n=12379 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	20132 Participants n=22851 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Ethnicity (NIH/OMB) Patients · Unknown or Not Reported	626 Participants n=10472 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	493 Participants n=12379 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	1119 Participants n=22851 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Ethnicity (NIH/OMB) Counselors · Hispanic or Latino	2 Participants n=114 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	6 Participants n=194 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	8 Participants n=308 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Ethnicity (NIH/OMB) Counselors · Not Hispanic or Latino	98 Participants n=114 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	118 Participants n=194 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	216 Participants n=308 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Ethnicity (NIH/OMB) Counselors · Unknown or Not Reported	14 Participants n=114 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	70 Participants n=194 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.	84 Participants n=308 Participants • Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.
Region of Enrollment United States	10586 participants n=10586 Participants	12573 participants n=12573 Participants	23159 participants n=23159 Participants
Average # of admissions	68.2 Number of admissions STANDARD_DEVIATION 82.6 • n=10586 Participants	78.3 Number of admissions STANDARD_DEVIATION 111.6 • n=12573 Participants	73.5 Number of admissions STANDARD_DEVIATION 97.8 • n=23159 Participants
Site location (rural v urban) Rural	1 Number of sites n=19 Clinics	3 Number of sites n=21 Clinics	4 Number of sites n=40 Clinics
Site location (rural v urban) Urban	17 Number of sites n=19 Clinics	17 Number of sites n=21 Clinics	34 Number of sites n=40 Clinics
Site location (rural v urban) Half Rural/ Half Urban	1 Number of sites n=19 Clinics	1 Number of sites n=21 Clinics	2 Number of sites n=40 Clinics