E-health Implementation (Iowa) | NCT03954184

NCT03954184

Secondary IDs

ID	Type	Description	Link
A195010	Other Identifier	UW-Madison
ENGR/INDUSTRIAL ENGR	Other Identifier	UW Madison
1R01DA044159-01A1	U.S. NIH Grant/Contract		View source
3R01DA044159-02S1	U.S. NIH Grant/Contract		View source
Protocol version: 02-15-2021	Other Identifier	Advarra
2020-0833	Other Identifier	UW Madison (ceded)

Status Module

Sponsor/Collaborators Module

Name	Class
University of Iowa	OTHER
Iowa Department of Public Health	UNKNOWN
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAU/Control	No Intervention	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	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIATx-TI with Product Training/On-line Support	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	45 months
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.	45 months

Secondary Outcomes

Measure	Description	Time Frame
Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.	Retention rates of eligible participants	Collected monthly during months 13 - 45
Adoption: Number of Days Each Counselor Used the A-CHESS

Other Outcomes

Measure	Description	Time Frame
Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic	Online survey	M34-37
Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Todd Molfenter, Ph.D.	University of Wisconisn-Madison	Principal Investigator
David Gustafson, Ph.D.	University of Wisconsin, Madison	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Zion Recovery Services		Adel	Iowa	50003	United States
Prairie Ridge Integrated Behavioral Healthcare

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37579096	Result	Fleddermann K, Molfenter T, Vjorn O, Horst J, Hulsey J, Kelly B, Zawislak K, Gustafson DH, Gicquelais RE. Patient Preferences for Mobile Health Applications to Support Recovery. J Addict Med. 2023 Jul-Aug 01;17(4):394-400. doi: 10.1097/ADM.0000000000001137. Epub 2023 Jan 18.
34720585	Result	Fleddermann K, Molfenter T, Jacobson N, Horst J, Roosa MR, Boss D, Ross JC, Preuss E, Gustafson DH. Clinician Perspectives on Barriers and Facilitators to Implementing e-Health Technology in Substance Use Disorder (SUD) Treatment Facilities. Subst Abuse. 2021 Oct 26;15:11782218211053360. doi: 10.1177/11782218211053360. eCollection 2021.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	NIATx-TI Framework

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 15, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

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

FG00011086 subjects20 units

FG00112573 subjects21 units

For each of our sites (19 control and 21 intervention) we have population data collected from Iowa department of public health and each site.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age was collected from the Iowa department of public health as well as the sites.

Patient participants and counselors were counted separately.

Mean

Standard Deviation

years

Participants

Title	Denominators	Categories
Participants	ParticipantsBG00010472 ParticipantsBG00112379 ParticipantsBG00222851 ClinicsBG000

Sex/Gender, Customized

Gender was collected for patients from the Iowa department of public health. For counselors this data was gathered from the sites.

Gender was collected for patients and counselors separately.

Count of Participants

Participants

Title	Denominators	Categories
Patients: Genderqueer/Other	ParticipantsBG00010472 ParticipantsBG00112379 ParticipantsBG002

Ethnicity (NIH/OMB)

Ethnicity was collected for patients from the Iowa department of public health. For counselors this data was gathered from the sites.

Patients and counselors were analyzed separately. The numbers analyzed in each arm for each row do add up to the overall number analyzed.

Count of Participants

Participants

Title	Denominators	Categories
Patients	ParticipantsBG00010472 ParticipantsBG00112379 ParticipantsBG002

Region of Enrollment

Number

participants

Participants

Units	Counts
Participants	BG00010586 BG00112573 BG00223159

Average # of admissions

Mean

Standard Deviation

Number of admissions

Participants

Units	Counts
Participants	BG00010586 BG00112573 BG00223159

Site location (rural v urban)

Number

Number of sites

Clinics

Units	Counts
Participants	BG00010586 BG00112573 BG00223159

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Mean

Standard Error

Mean number of clinics

45 months

Clinics

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00010586 OG00112573
Clinics	OG00019 OG001

Title

Denominators

Categories

Title	Measurements
	OG0000.039± 0.029 OG0010.171± 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.

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

Posted

Mean

Standard Deviation

Days

45 months

Clinics

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

Retention rates of eligible participants

This data was not collected

Posted

Collected monthly during months 13 - 45

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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

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

Posted

Mean

Standard Deviation

days

45 months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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)

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

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.

Not all sites completed surveys at each time point

Posted

Mean

Standard Deviation

score on a scale

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

Clinics

ID	Title	Description
OG000	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.
OG001	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.

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.

Not all sites completed all surveys

Posted

Mean

Standard Deviation

score on a scale

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

Clinics

ID	Title	Description
OG000	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.
OG001	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.

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.

Not all sites completed all surveys

Posted

Mean

Standard Deviation

units on a scale

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

Clinics

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Count of Units

Clinics

Collected during months 7, 18, 30, and 42, month 42 reported

Clinics

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

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

Online survey

Not Posted

M34-37

Participants

Other Pre-specified

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

Online survey

Not Posted

M34-37

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	10,586	0	10,586	0	10,586
EG001	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.	0	12,573	0	12,573	0	12,573

ID	Term
D019966	Substance-Related Disorders

ClinicsBG00019
ClinicsBG00121
ClinicsBG00240

ClinicsBG00019
ClinicsBG00121
ClinicsBG00240

Units	Counts
Participants	OG000110 OG001193

Units	Counts
Participants	OG00010586 OG00112573
Clinics	OG00017 OG00120

Units	Counts
Participants	OG00010586 OG00112573
Clinics	OG00017 OG00121

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders