CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 237 enrolled
Drug / intervention
Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04979546
NCT04979546N/ACompleted

Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial

University of Alberta·interventional·Posted Jul 28, 2021·Updated Sep 19, 2024

In Brief

A clinical study evaluating Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist and Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist for Multiple Sclerosis and 3 related conditions. Completed, enrolled 237 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 28, 2021
Enrollment StartNov 4, 2021
Primary CompletionApr 3, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.9 years ago

Interventions

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

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.

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

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.