- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06561581
Acuity Functional Impact and Implementation Outcomes Evaluation
August 15, 2024 updated by: Experiad LLC
This study will test feature enhancements to a behavioral therapy data collection software (Motivity) that will add a new clinical decision support module, called Acuity.
Acuity is a Quality Improvement (QI) intervention targeted at Behavior Analysts (BAs) and Behavior Technicians (BTs) that aims to improve the delivery of autism behavioral therapy.
Subjects will be staff recruited from existing Motivity customers.
Study Overview
Detailed Description
Acuity is intended to provide significant improvements in treatment planning, progress tracking, trend monitoring, and dosage management.
If successful, Acuity will provide Applied Behavior Analysis (ABA) practitioners with a higher level of real-time insight into their clinical data, enabling more efficient and productive treatment.
Research has shown that first-generation systems fall short in supporting overworked BAs who are overwhelmed with data.
Acuity will address critical shortfalls by enabling more agile corrective actions and data-driven planning across multiple aspects of treatment, providing practitioners with new levels of rigorous, real-time insight into their clinical data.
Acuity will help BAs establish and adhere to realistic treatment timelines, and will proactively alert the BA to noteworthy trends in the data as they occur, such as learner performance issues, missed dosages, and significant changes in tracked behaviors.
In doing so, Acuity will support more responsive and effective treatment.
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Experiad LLC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Behavior Analysts and Behavior Technicians treating kids with autism
- Must be employed by one of the autism treatment clinics that have agreed to participate in the study.
- Must be employed by Experiad customers who are using Motivity software as part of their practice.
Exclusion Criteria:
- All people not listed above
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Acuity-Basic
|
Enhancement to Motivity product for clinical decision support
Other Names:
|
|
Experimental: Acuity-Enhanced
|
Enhancement to Motivity product for clinical decision support
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with improved estimation of Trials to Criterion and Time (days) to Criterion
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
|
Does Acuity make initial timeline estimates for sets of targets more accurate?
|
through study completion, expected to be 18 months from the start of retroactive observation period
|
|
Increased frequency of changes to programs and prescribed dosages, resulting in reduced Trials to Criterion and Time to Criterion.
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
|
Does Acuity result in corrective action being taken more quickly for programs that are off schedule or targets that are exhibiting performance issues?
|
through study completion, expected to be 18 months from the start of retroactive observation period
|
|
Increased adherence to prescribed dosage
Time Frame: through study completion, expected to be 18 months from the start of retroactive observation period
|
Does Acuity result in increased adherence to prescribed dosage, as measured by system
|
through study completion, expected to be 18 months from the start of retroactive observation period
|
|
Number of participants who find Acuity and its components practical and possible to use, assessed by qualitative measures and system usage tracking
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Feasibility - To what extent are Acuity and its components practical or possible to use?
|
at the end of the study, expected to be 18 months from the start of retroactive observation period
|
|
Proportion of clinics and providers that actively use Acuity, assessed by system usage tracking.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Adoption - What proportion of clinics and providers are willing to use Acuity and how well do they represent the population of clinics and providers?
|
at the end of the study, expected to be 18 months from the start of retroactive observation period
|
|
Number of BAs & BTs who utilize Acuity as intended to provide learners with accurate treatment plans, and achieve expected results, as measured by system usage and qualitative assessment.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Fidelity - the degree to which BAs and BTs use the system as expected, including dosage adherence, treatment planning accuracy, and timely protocol modification.
|
at the end of the study, expected to be 18 months from the start of retroactive observation period
|
|
Majority of BAs and BTs rate Acuity and its components as attractive, agreeable, or palatable.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Acceptability, as measured by SUS score and SUS Items 1, 5, 6 & 8 collected via online survey at the end of O0 & O1 from both arms.
|
at the end of the study, expected to be 18 months from the start of retroactive observation period
|
|
Frequency at which Acuity and its components are rated as suitable, fitting, or proper for achieving the goals set forth in treatment plans, as measured by surveys.
Time Frame: at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Appropriateness - Same measures captured for all primary & secondary research questions in the Functional Impact Evaluation.
Brief online survey with Likert scaled items focused on the providers' assessment of how well Acuity and its components are matched to the challenges of planning and executing Treatment Plans.
|
at the end of the study, expected to be 18 months from the start of retroactive observation period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2024
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
August 9, 2024
First Submitted That Met QC Criteria
August 15, 2024
First Posted (Actual)
August 20, 2024
Study Record Updates
Last Update Posted (Actual)
August 20, 2024
Last Update Submitted That Met QC Criteria
August 15, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Acuity-Study-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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