Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis

Summary

The proposed trial is a prospective, randomized (1:1) trial plan examining whether more routine and frequent measurement of Patient Related Outcome Measures (PROMs) in the care of patients with MS improves patient depression and anxiety outcomes in addition to patient care satisfaction. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less depression and anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process.

Whether this improves care in patients with MS is currently unknown, and the investigators want to explore this with the current study. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process.

Conditions

• Multiple Sclerosis
• Anxiety
• Depression
• Patient Satisfaction

Interventions

OTHER

Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist

Baseline, 6 months, and 12 months administration of HADS, EQ5D, MFIS, PDDS, PHQ-9 questionnaires in addition to Open ended text response to (limit 280 characters) "What are the top 3 things you would like your MS Neurologist to know about you right now?" Additionally, the treating neurologist will be prompted to view the text response to the 3-item prompt in addition to the PROM questionnaire scores for participants in the interventional group.

OTHER

Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist

Baseline and 12 months administration of HADS, EQ5D, MFIS, PDDS, PHQ-9 questionnaires in addition to Open ended text response to (limit 280 characters) "What are the top 3 things you would like your MS Neurologist to know about you right now?" Additionally, the treating neurologist will only be prompted to view the text response to the 3-item prompt, and will not be able to access the PROM questionnaire scores for participants in the control group.

Sponsors & Collaborators

• University Hospital Foundation

  collaborator OTHER

• University of Alberta

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-04

Primary Completion

2024-04-03

Completion

2024-04-03

Countries

• Canada

Study Locations