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E-health Implementation (Iowa)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03954184
Enrollment
23659
Registered
2019-05-17
Start date
2019-09-03
Completion date
2023-06-30
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

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.

Interventions

BEHAVIORALNIATx-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.

Sponsors

University of Iowa
CollaboratorOTHER
Iowa Department of Public Health
CollaboratorUNKNOWN
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App45 monthsThe 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.
Reach: As Assessed by the Number of Days That Participants Use the A-CHESS45 monthsThe 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

MeasureTime frameDescription
Adoption: Number of Days Each Counselor Used the A-CHESS45 monthsNumber 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 LogsCollected twice during study; starting M22 - 31 and M35-44Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)
Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)Collected twice during study; approx. M14 - 25 and M32 - 43Survey 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.
Financial Resource Availability (Survey)Collected twice during study; starting M22 - 31 and M35-44Survey 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.
Difference in Number of Admissions in Rural vs. Urban LocationCollected during months 7, 18, 30, and 42, month 42 reportedStatistical 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.
A-CHESS/NIATx Implementation Fidelity (Survey)Collected twice during study; approx. M14 - 25 and M32 - 43Survey 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.
Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.Collected monthly during months 13 - 45Retention rates of eligible participants

Other

MeasureTime frameDescription
Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 PandemicM34-37Online survey
Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID PandemicM34-37Online survey

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
10,586
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.
19
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.
12,573
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.
21
Total23,199

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up5000

Baseline characteristics

CharacteristicTAU/ControlNIATx-TI FrameworkTotal
Age, Continuous
Counselors
42.4 years
STANDARD_DEVIATION 11.5
45.1 years
STANDARD_DEVIATION 12.4
44.3 years
STANDARD_DEVIATION 12.2
Age, Continuous
Participants
34.8 years
STANDARD_DEVIATION 12.2
36.0 years
STANDARD_DEVIATION 12.4
35.5 years
STANDARD_DEVIATION 12.3
Average # of admissions68.2 Number of admissions
STANDARD_DEVIATION 82.6
78.3 Number of admissions
STANDARD_DEVIATION 111.6
73.5 Number of admissions
STANDARD_DEVIATION 97.8
Ethnicity (NIH/OMB)
Counselors
Hispanic or Latino
2 Participants6 Participants8 Participants
Ethnicity (NIH/OMB)
Counselors
Not Hispanic or Latino
98 Participants118 Participants216 Participants
Ethnicity (NIH/OMB)
Counselors
Unknown or Not Reported
14 Participants70 Participants84 Participants
Ethnicity (NIH/OMB)
Patients
Hispanic or Latino
926 Participants674 Participants1600 Participants
Ethnicity (NIH/OMB)
Patients
Not Hispanic or Latino
8920 Participants11212 Participants20132 Participants
Ethnicity (NIH/OMB)
Patients
Unknown or Not Reported
626 Participants493 Participants1119 Participants
Region of Enrollment
United States
10586 participants12573 participants23159 participants
Sex/Gender, Customized
Counselors: Genderqueer/Other
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Counselors: Man
10 Participants48 Participants58 Participants
Sex/Gender, Customized
Counselors: Refused/Unknown
3 Participants30 Participants33 Participants
Sex/Gender, Customized
Counselors: Transgender Man
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Counselors: Transgender Woman
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Counselors: Woman
101 Participants116 Participants217 Participants
Sex/Gender, Customized
Patients: Genderqueer/Other
5 Participants73 Participants78 Participants
Sex/Gender, Customized
Patients: Man
5192 Participants7623 Participants12815 Participants
Sex/Gender, Customized
Patients: Refused/Unknown
2564 Participants445 Participants3009 Participants
Sex/Gender, Customized
Patients: Transgender Man
5 Participants3 Participants8 Participants
Sex/Gender, Customized
Patients: Transgender Woman
3 Participants6 Participants9 Participants
Sex/Gender, Customized
Patients: Woman
2703 Participants4229 Participants6932 Participants
Site location (rural v urban)
Half Rural/ Half Urban
1 Number of sites1 Number of sites2 Number of sites
Site location (rural v urban)
Rural
1 Number of sites3 Number of sites4 Number of sites
Site location (rural v urban)
Urban
17 Number of sites17 Number of sites34 Number of sites

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 10,5860 / 12,573
other
Total, other adverse events
0 / 10,5860 / 12,573
serious
Total, serious adverse events
0 / 10,5860 / 12,573

Outcome results

Primary

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

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.

Time frame: 45 months

ArmMeasureValue (MEAN)Dispersion
TAU/ControlReach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App0.039 Mean number of clinicsStandard Error 0.029
NIATx-TI FrameworkReach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App0.171 Mean number of clinicsStandard Error 0.041
Primary

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.

Time frame: 45 months

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

ArmMeasureValue (MEAN)Dispersion
TAU/ControlReach: As Assessed by the Number of Days That Participants Use the A-CHESS0.161 DaysStandard Deviation 0.466
NIATx-TI FrameworkReach: As Assessed by the Number of Days That Participants Use the A-CHESS1.845 DaysStandard Deviation 1.487
Secondary

A-CHESS/NIATx Implementation Fidelity (Survey)

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.

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

Population: Not all sites completed surveys at each time point

ArmMeasureGroupValue (MEAN)Dispersion
TAU/ControlA-CHESS/NIATx Implementation Fidelity (Survey)Survey 22.26 score on a scaleStandard Deviation 0.55
TAU/ControlA-CHESS/NIATx Implementation Fidelity (Survey)Survey 32.20 score on a scaleStandard Deviation 0.63
NIATx-TI FrameworkA-CHESS/NIATx Implementation Fidelity (Survey)Survey 22.91 score on a scaleStandard Deviation 0.51
NIATx-TI FrameworkA-CHESS/NIATx Implementation Fidelity (Survey)Survey 32.91 score on a scaleStandard Deviation 0.55
Secondary

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

Time frame: 45 months

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

ArmMeasureValue (MEAN)Dispersion
TAU/ControlAdoption: Number of Days Each Counselor Used the A-CHESS1.81 daysStandard Deviation 2.52
NIATx-TI FrameworkAdoption: Number of Days Each Counselor Used the A-CHESS19.11 daysStandard Deviation 62.68
Secondary

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)

Time frame: 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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAU/ControlAdoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs24 Participants
NIATx-TI FrameworkAdoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs84 Participants
Secondary

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. The number of clinics located in a rural area was counted. The number of clinics in an urban location were counted.

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

ArmMeasureCategoryValue (COUNT_OF_UNITS)
TAU/ControlDifference in Number of Admissions in Rural vs. Urban LocationRural1 Clinics
TAU/ControlDifference in Number of Admissions in Rural vs. Urban LocationUrban17 Clinics
TAU/ControlDifference in Number of Admissions in Rural vs. Urban LocationHalf Rural/ Half Urban1 Clinics
NIATx-TI FrameworkDifference in Number of Admissions in Rural vs. Urban LocationRural3 Clinics
NIATx-TI FrameworkDifference in Number of Admissions in Rural vs. Urban LocationUrban17 Clinics
NIATx-TI FrameworkDifference in Number of Admissions in Rural vs. Urban LocationHalf Rural/ Half Urban1 Clinics
Secondary

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

Retention rates of eligible participants

Time frame: Collected monthly during months 13 - 45

Population: This data was not collected

Secondary

Financial Resource Availability (Survey)

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.

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

Population: Not all sites completed all surveys

ArmMeasureGroupValue (MEAN)Dispersion
TAU/ControlFinancial Resource Availability (Survey)Survey 12.68 units on a scaleStandard Deviation 0.73
TAU/ControlFinancial Resource Availability (Survey)Survey 22.77 units on a scaleStandard Deviation 0.83
NIATx-TI FrameworkFinancial Resource Availability (Survey)Survey 13.41 units on a scaleStandard Deviation 0.57
NIATx-TI FrameworkFinancial Resource Availability (Survey)Survey 23.13 units on a scaleStandard Deviation 0.87
Secondary

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

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.

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

Population: Not all sites completed all surveys

ArmMeasureGroupValue (MEAN)Dispersion
TAU/ControlOrganizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)Survey 22.99 score on a scaleStandard Deviation 0.58
TAU/ControlOrganizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)Survey 32.73 score on a scaleStandard Deviation 0.75
NIATx-TI FrameworkOrganizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)Survey 23.17 score on a scaleStandard Deviation 0.5
NIATx-TI FrameworkOrganizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)Survey 33.28 score on a scaleStandard Deviation 0.4
Other Pre-specified

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

Online survey

Time frame: M34-37

Other Pre-specified

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

Online survey

Time frame: M34-37

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026