An interventional study of Clinical Decision Aid in Depression, sponsored by Aifred Health Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Aifred Health Inc. · Not applicable, Interventional, and Device feasibility
The Clinical Decision Aid (CDA) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be presented to the physician who will then make a treatment choice.
Hypothesis 1. There will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and CDA.
Hypothesis 2. Physicians will not subjectively report that using the CDA and study software increased the length of their appointments.
Hypothesis 3. At least 66% of patients and 66% of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater trust).
Hypothesis 4. At least 66% of patients and 66% of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater usability).
Hypothesis 5. At least 70% of physicians and 65% of patients will still be using the application regularly by the end of the study. For physicians, regularly will be defined as the application being used in every study-related visit. For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week.
Exploratory hypothesis: Based on our machine learning results to date, we expect between 40-50% of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks. This is exploratory, and the study is not necessarily powered to demonstrate this.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 17 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Aifred Health Inc. as lead sponsor.
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Exclusion Criteria:
Device: Clinical Decision Aid
The Clinical Decision Aid is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of all possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be ordered by efficacy and presented to the physician. Lifestyle interventions, such as exercise or mindfulness, which have an evidence base, but do not require formal regulatory approval, will also be outputted. The system will additionally produce a side effect profile for each pharmacological treatment recommended, including known side effects, modified by a prediction about which side effects may be more likely for a given individual based on their individual characteristics.
Subjective length of outpatient visits
Time frame: Through study completion, 6 months
Objective length of outpatient visits
Time frame: Through study completion, 6 months
Physician retention rates
Time frame: Through study completion, 6 months
Patient retention rates
Time frame: Through study completion, 6 months
Patient self-rated experience using the study software
We will be using our Clinical Decision Aid Feasibility Questionnaire (Version 1), a descriptive questionnaire with 5-point Likert scales (with higher values representing better outcomes) and narrative questions about experience using the tool.
Time frame: Through study completion, 6 months
Plan to share: Yes
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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