A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis (MS-CATCH)

A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis

Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in Patients With Multiple Sclerosis: Closing the Gaps in Depression Care for People With MS By Closing the Information Loop

The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.

MS-CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with Multiple Sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. It consists of a simple tool used by the patient to improve mood reporting. This then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. This dashboard launches straight from the patient's electronic health record (EHR). MS-CATCH was designed using extensive human-centered design in all phases of development, and HIPAA compliant REDCap for electronic data capture. While the tool requires institutional approvals to launch within the UCSF EHR, the design elements could be readily repurposed using these technologies to support other institutions' requirements. Each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the COM-B (Capability, Opportunity, and Motivation to change Behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.

Both arm 1 and arm 2 groups of participants will receive at least 6 months of MS CATCH tool intervention, with arm 1 receiving 12 months of intervention

Participants in arm 1 will receive 12 months of use of the MS CATCH tool. This will include in-visit interventions and monthly questionnaires.

Participants in arm 2 will receive 6 months "usual care" followed by 6 months of MS CATCH tool intervention. These first 6 months will be used to assess the definition of "usual care".

Participants will respond to a set of surveys every month to increase communication on mood with their clinician.

This will be measured by calculating the percentage patients who use the tool during the initial month of the study

The percentage patients who continued to use the patient-facing tool at least quarterly (used the tool at least once every 3 months)

The percentage of the clinician-patient dyads in Arm 1 who use the in-visit dashboard at the 12M clinical visit.

The percentage depression-reporting prompts responded to per participant on their patient-facing tool

Percent of visits where mood screening was documented by the clinician for arm 1 vs. percent of visits where mood screening was documented by the clinician for arm 2. This will be compared in the electronic health record for the baseline visits.

Percent of visits where mood screening was documented by the clinician for arm 1 vs. percent of visits where mood screening was documented by the clinician for arm 2. This will be compared in the electronic health record for the 6 month visits.

The percent of interventions recommended at each visit that were completed by the following 6 month visit. (completed interventions/total interventions recommended *100)

The percent of interventions recommended at each visit that were completed by the following 6 month visit. (completed interventions/total interventions recommended *100)

The completion of clinician recommended interventions that were completed by the following 6 month visit, tallied according to this scale: 0 = No interventions recommended, or no follow through by patient = 1 intervention recommended, and follow through on 1 intervention, or 2+ interventions recommended, and patient follow through on 1 intervention = 2+ interventions recommended, and patient follow through on 2+ interventions

The completion of clinician recommended interventions that were completed by the following 6 month visit, tallied according to this scale: 0 = No interventions recommended, or no follow through by patient = 1 intervention recommended, and follow through on 1 intervention, or 2+ interventions recommended, and patient follow through on 1 intervention = 2+ interventions recommended, and patient follow through on 2+ interventions

Changes in HADS-D over the first 6 months of the study. The HADS-D questionnaire ranges from 0-21, with a higher score indicating more impairment.

The trial retention, or how many participants choose to remain in the study will be observed at the 3, 6, 9, and 12 month timepoints. Final reporting of these measures will be at the end of the 12 month period.

Evaluate patient PHQ-9 scores. The PHQ-9 questionnaire ranges from 0-20, with a higher score indicating more severe depressive symptoms.

Evaluate patient MINI scores. The MINI assesses for 17 of the most common mental health disorders. The MINI is a "yes"/"no" screener, with certain answer choices leading to a most likely diagnosis. A score of 3 or more most likely correlates to depressive symptoms.

Changes in patient reported self efficacy at managing a chronic disease will be quantified between arms 1 and 2. This will be addressed in the final exit interview with participants after the study is completed. Our health literacy expert will generate a questionnaire based on major themes uncovered in Aim 1 along with consultation with psychiatry and inclusion experts.

Inclusion Criteria: Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18 Ages 18 to 80 PHQ-9 score of 5-19 Any MS therapy, or no treatment California resident to enable clinical telemedicine visits if warranted during the study visit Exclusion Criteria: Cognitive dexterity or visual impairment that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to adhere to the study protocol Inability to provide informed consent Psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder

The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.

Qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement