Substance Use DisordersNCT03954184
E-health Implementation (Iowa)
A study testing NIATx-TI with Product Training/On-line Support in people with Substance Use Disorders, run by University of Wisconsin, Madison at 49 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- NIATx-TI with Product Training/On-line Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,659 participants
- Where
- 49 sitesUnited States
- Study dates
- 3 Sep 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18+ years old
- Understand English
- Have a SUD diagnosis
- Have access to a smartphone
Who cannot join
None listed.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Zion Recovery Services
Adel, Iowa, 50003
Prairie Ridge Integrated Behavioral Healthcare
Algona, Iowa, 50511
Community and Family Resources
Ames, Iowa, 50010
Area Substance Abuse Council
Anamosa, Iowa, 53305
UCS Healthcare
Ankeny, Iowa, 50021
Zion Recovery Services
Atlantic, Iowa, 50022
Area Substance Abuse Council
Belle Plaine, Iowa, 52208
Community and Family Resources
Boone, Iowa, 50036
Alcohol and Drug Dependency Services (ADDS)
Burlington, Iowa, 52601
Area Substance Abuse Council
Cedar Rapids, Iowa, 52404
Prairie Ridge Integrated Behavioral Healthcare
Charles City, Iowa, 50616
Jackson Recovery Centers
Cherokee, Iowa, 51012
Prelude Behavioral Health Services
Clarence, Iowa, 52216
Zion Recovery Services
Clarinda, Iowa, 51632
Community and Family Resources
Clarion, Iowa, 50525
Heartland Family Services
Council Bluffs, Iowa, 51503
Area Substance Abuse Council
De Witt, Iowa, 52742
Jackson Recovery Centers
Denison, Iowa, 51442
UCS Healthcare
Des Moines, Iowa, 50310
House of Mercy
Des Moines, Iowa, 50314
Prelude Behavioral Health Services
Des Moines, Iowa, 50317
Substance Abuse Services Center
Dubuque, Iowa, 52001
Prairie Ridge Integrated Behavioral Healthcare
Forest City, Iowa, 50436
Community and Family Resources
Fort Dodge, Iowa, 50501
Heartland Family Services
Glenwood, Iowa, 51534
Zion Recovery Services
Greenfield, Iowa, 50849
Prairie Ridge Integrated Behavioral Healthcare
Hampton, Iowa, 50441
Community and Family Resources
Humboldt, Iowa, 50548
House of Mercy
Indianola, Iowa, 50125
Prelude Behavioral Services
Iowa City, Iowa, 52240
ADDS
Keokuk, Iowa, 52362
UCS Healthcare
Knoxville, Iowa, 50138
Jackson Recovery Centers
Le Mars, Iowa, 51031
Heartland Family Services
Logan, Iowa, 51546
Area Substance Abuse Council
Maquoketa, Iowa, 52060
Prelude Behavioral Health Services
Marengo, Iowa, 52301
Prairie Ridge Integrated Behavioral Healthcare
Mason City, Iowa, 50401
ADDS
Mount Pleasant, Iowa, 52641
House of Mercy
Newton, Iowa, 50208
Zion Recovery Services
Perry, Iowa, 50220
Community and Family Resources
Pocahontas, Iowa, 50574
Zion Recovery Services
Red Oak, Iowa, 51566
Community and Family Resources
Rockwell City, Iowa, 50579
Zion Recovery Services
Shenandoah, Iowa, 51601
Jackson Recovery Centers
Sioux City, Iowa, 51101
Prelude Behavioral Services
Tipton, Iowa, 52772
Area Substance ABuse Council
Vinton, Iowa, 52349
ADDS
Wapello, Iowa, 52632
Community and Family Resources
Webster City, Iowa, 50595
About this study
Official title: Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
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
Read the 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
- Substance Use Disorders
- Being tested
- NIATx-TI with Product Training/On-line Support
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIATx-TI with Product Training/On-line SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: NIATx-TI with Product Training/On-line Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 45 months
Secondary outcomes (7)
Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.
Retention rates of eligible participants
Measured: Collected monthly during months 13 - 45
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
Measured: 45 months
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)
Measured: Collected twice during study; starting M22 - 31 and M35-44
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.
Measured: Collected twice during study; approx. M14 - 25 and M32 - 43
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.
Measured: Collected twice during study; approx. M14 - 25 and M32 - 43
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.
Measured: Collected twice during study; starting M22 - 31 and M35-44
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.
Measured: Collected during months 7, 18, 30, and 42, month 42 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start3 Sep 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Iowa Department of Public Health, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Todd Molfenter, Ph.D., Principal investigator, University of Wisconisn-MadisonDavid Gustafson, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954184
- Sponsor's protocol ID
- 2018-0997
- Other IDs
- A195010, ENGR/INDUSTRIAL ENGR, 1R01DA044159-01A1, 3R01DA044159-02S1, Protocol version: 02-15-2021, 2020-0833
- Status last verified
- Feb 2025
- First submitted
- 10 May 2019
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37579096Fleddermann 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.
PubMed 34720585Gustafson 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.
PubMed 35834315White 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.
PubMed 33097097
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of a Patient-centered E-health Implementation Model in Addiction Treatment
- ClinicalTrials.gov ID
- NCT03954184
- Acronym / sponsor ID
- 2018-0997
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23,659 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Iowa, Iowa Department of Public Health, National Institute on Drug Abuse (NIDA)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: NIATx-TI with Product Training/On-line SupportSites 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18+ years old
- Understand English
- Have a SUD diagnosis
- Have access to a smartphone
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIATx-TI with Product Training/On-line SupportNIATx-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. | Behavioural | NIATx-TI Framework |
Primary outcome
Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App
Time frame: 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.
Reach: As Assessed by the Number of Days That Participants Use the A-CHESS
Time frame: 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.
7 secondary outcomes
Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.
Time frame: Collected monthly during months 13 - 45
Adoption: Number of Days Each Counselor Used the A-CHESS
Time frame: 45 months
Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs
Time frame: Collected twice during study; starting M22 - 31 and M35-44
A-CHESS/NIATx Implementation Fidelity (Survey)
Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43
Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)
Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43
Financial Resource Availability (Survey)
Time frame: Collected twice during study; starting M22 - 31 and M35-44
Difference in Number of Admissions in Rural vs. Urban Location
Time frame: Collected during months 7, 18, 30, and 42, month 42 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37579096Fleddermann 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.
- Results publication: PubMed 34720585Fleddermann 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.
- Derived from this study: PubMed 35834315Gustafson 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.
- Derived from this study: PubMed 33097097White 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Molfenter, Ph.D. principal investigator
University of Wisconisn-Madison
David Gustafson, Ph.D. principal investigator
University of Wisconsin, Madison
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIATx-TI with Product Training/On-line Support in people with Substance Use Disorders, run by University of Wisconsin, Madison at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App (time frame: 45 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954184, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.