Accepted for/Published in: JMIR Formative Research
Date Submitted: Sep 18, 2023
Date Accepted: Nov 24, 2023
A Closed-loop Digital Health Tool to Improve Depression Care in Multiple Sclerosis: Iterative Design and Cross-Sectional Pilot RCT Impact on Depression Care
ABSTRACT
Background:
People living with Multiple Sclerosis (PwMS) face a higher likelihood of being diagnosed with a depressive disorder than the general population. Though many low-cost screening tools and evidence-based interventions including medications exist, depression in PwMS is under-reported, under-ascertained by clinicians, and under-treated.
Objective:
The goal of the current project was to design a closed-loop tool to improve depression care for these patients. It would support regular depression screening, tie into the clinician at the point of care, and support shared decisionmaking and comprehensive follow up. After an initial development phase, the project involved a proof-of-concept pilot randomized clinical trial (RCT) validation phase and a detailed human-centered design (HCD) phase.
Methods:
During an initial development phase, the technological infrastructure of a clinician-facing point-of-care clinical dashboard for MS management (BRIDGE) was leveraged to incorporate features that would support depression screening and comprehensive care (MS CATCH prototype). This linked a patient survey, in-basket messages, and the clinician dashboard. During the Pilot RCT phase, a convenience sample of 50 adults with MS recruited from a single MS Center with PHQ-9 scores of 5-19 (mild to moderately severe depression) were enrolled. During the routine MS visit, their clinicians were either asked vs. not asked, to use MS CATCH to review their scores, and care outcomes were collected. During the HCD phase, MS CATCH components were iteratively modified based on feedback from stakeholders: PwMS, MS clinicians, interprofessional experts.
Results:
MS CATCH is a closed-loop tool linking three distinct features designed to support mood reporting and ascertainment, comprehensive evidence-based management, and ultimately clinician and patient self-management behaviors likely to lead to sustained depression relief. In the pilot RCT (n=50 visits), visits in which the clinician was randomized to use MS CATCH had a greater percentage of notes documenting a discussion of depressive symptoms than the visits when MS CATCH was not used (75% vs. 34.6%, X2 P= 0.0042). During the HCD phase, 45 PwMS and clinicians/other experts participated in the design and refinement. The final testing round included 20 PwMS and 10 clinicians including five not affiliated with our health system. Most scoring targets for likeability, usability, including perceived ease of use and perceived effectiveness, were met. Net Promoter Scale was 50 for patients and 40 for clinicians.
Conclusions:
Created with extensive stakeholder feedback, MS CATCH is a closed-loop system aimed to increase communication about depression between PwMS and their clinicians, and ultimately improve depression care. Pilot findings showed evidence of enhanced communication. Stakeholders also advised on trial design features of a full year-long DOD-funded feasibility and efficacy trial, now underway. Clinical Trial: Ethics and dissemination. University of California, San Francisco Institutional Review Board. The pilot RCT is registered under 18-26148 and the HCD process is registered under Aim 1 of the full trial, 22-36620. Trial registration. The MS CATCH RCT is registered with clinicialtrials.gov: NCT05865405.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.