Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis
NCT ID: NCT04979546
Last Updated: 2024-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
237 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-04
Study Completion Date
2024-04-03
Brief Summary
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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.
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.
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Detailed Description
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Multiple sclerosis (MS) is a disease that can affect physical, cognitive, psychological, and social functioning. Patient reported outcomes measures (PROMs) are playing an increasingly important role in healthcare as they give patients the opportunity to describe the quality and the impact of care from their perspective in a consistent and systematic way. PROMs are important in optimizing the management of people with MS (PwMS) in providing the patient's perspective of their disease. Additionally, use of PROMs between clinic visits could provide real-time information about how well patients are doing between visits, in a disease with episodic disability and with symptoms that fluctuate over time. Electronic data capture could help overcome these difficulties, as patients will have the flexibility to provide the information from anywhere and the data will automatically be saved in an electronic database that can be accessed anytime by patients and their healthcare providers. This will allow patients to be fully informed about their condition, be more engaged in their care, track their progress, and receive any notifications or alerts regarding their care. It will also allow healthcare providers to systematically track the patient's progress, better prepare for their visit and provide care based on their individual needs - the epitome of patient-centred care. Even though such information could help clinicians provide patient-centred care and patients track their progress, it is not collected on a routine basis during clinical care due to time limitations, and system issues within clinics amongst other factors.
The investigators' objective is to evaluate the impact of the systematic and more frequent use of PROMs in PwMS on depression and anxiety levels and satisfaction with care.
The investigators will be conducting a randomized controlled trial with the participant as the unit of randomization. They will include PwMS (relapsing-remitting, secondary progressive, primary progressive, etc.) who are being managed by an Alberta-based neurologist in the Northern and Central regions. Recruited participants will be randomized 1:1 to an interventional group or a control group. The interventional group will complete PROM questionnaires at baseline, 6 months, and 12 months in addition to their treating neurologist alerted to and having access to their questionnaire results and text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?"; the control group will complete PROM questionnaires at baseline and at 12 months, and while their neurologist will be able to view their text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?", the neurologist will not have routine access to their PROM questionnaire results.
All participants will be asked to complete the following validated PROMs questionnaires at intervals designated by their assigned experimental group:
1. Hospital Anxiety and Depression Scale (HADS) score
2. Quality of Life as measured by EuroQol Five-Dimensions (EQ5D) questionnaire
3. Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
4. The Patient Determined Disease Steps (PDDS)
5. Patient Health Questionnaire-9 (PHQ-9)
6. 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?"
For both groups, critical absolute scores or decrement in subsequent scores as measured by the aforementioned questionnaires will trigger an automated secured email alert to the patient's treating neurologist. Critical PROM scores are defined as:
1. EQ5D index value ≤ 0.48 at any time OR decrease in index value ≥ 0.26 on subsequent testing to capture those with a substantial decrease in their score over time.
2. MFIS absolute total score ≥ 58 at any time OR increase in absolute total score ≥ 17 on subsequent testing to capture those with a substantial increase in their score over time.
3. HADS score with an absolute score ≥ 11 in either depression or anxiety category at any time, OR increase in depression or anxiety score ≥ 4 on subsequent testing.
4. PDDS ≥ 3 at first testing - trigger to notify with gait impairment but not requiring aid yet, OR increase of score ≥ 1 on subsequent measurements.
5. PHQ-9 score of ≥ 10 at any time OR increase in score by ≥ 6 on subsequent testing.
All groups will also be asked to complete the Consultation Satisfaction Questionnaire (CSQ) as a measure of provider satisfaction, and the CollaboRATE survey as a measure of shared decision-making, at baseline, and at end of the study at 12 months.
Patient providers will additionally be asked to fill out an exit survey at the end of the study, assessing their opinion on the subjective effectiveness of implementing PROM questionnaires and the open ended text response to care of PwMS. Seven questions assessed on a Likert scale from 1-5 (strongly disagree to strongly agree), one question as a multiple choice response, and one open ended response will be assessed on the exit survey.
The investigators' objective is to evaluate the impact of the systematic and more frequent use of PROMs in PwMS on depression and anxiety levels and satisfaction with care.
The investigators will be conducting a randomized controlled trial with the participant as the unit of randomization. They will include PwMS (relapsing-remitting, secondary progressive, primary progressive, etc.) who are being managed by an Alberta-based neurologist in the Northern and Central regions. Recruited participants will be randomized 1:1 to an interventional group or a control group. The interventional group will complete PROM questionnaires at baseline, 6 months, and 12 months in addition to their treating neurologist alerted to and having access to their questionnaire results and text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?"; the control group will complete PROM questionnaires at baseline and at 12 months, and while their neurologist will be able to view their text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?", the neurologist will not have routine access to their PROM questionnaire results.
All participants will be asked to complete the following validated PROMs questionnaires at intervals designated by their assigned experimental group:
1. Hospital Anxiety and Depression Scale (HADS) score
2. Quality of Life as measured by EuroQol Five-Dimensions (EQ5D) questionnaire
3. Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
4. The Patient Determined Disease Steps (PDDS)
5. Patient Health Questionnaire-9 (PHQ-9)
6. 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?"
For both groups, critical absolute scores or decrement in subsequent scores as measured by the aforementioned questionnaires will trigger an automated secured email alert to the patient's treating neurologist. Critical PROM scores are defined as:
1. EQ5D index value ≤ 0.48 at any time OR decrease in index value ≥ 0.26 on subsequent testing to capture those with a substantial decrease in their score over time.
2. MFIS absolute total score ≥ 58 at any time OR increase in absolute total score ≥ 17 on subsequent testing to capture those with a substantial increase in their score over time.
3. HADS score with an absolute score ≥ 11 in either depression or anxiety category at any time, OR increase in depression or anxiety score ≥ 4 on subsequent testing.
4. PDDS ≥ 3 at first testing - trigger to notify with gait impairment but not requiring aid yet, OR increase of score ≥ 1 on subsequent measurements.
5. PHQ-9 score of ≥ 10 at any time OR increase in score by ≥ 6 on subsequent testing.
All groups will also be asked to complete the Consultation Satisfaction Questionnaire (CSQ) as a measure of provider satisfaction, and the CollaboRATE survey as a measure of shared decision-making, at baseline, and at end of the study at 12 months.
Patient providers will additionally be asked to fill out an exit survey at the end of the study, assessing their opinion on the subjective effectiveness of implementing PROM questionnaires and the open ended text response to care of PwMS. Seven questions assessed on a Likert scale from 1-5 (strongly disagree to strongly agree), one question as a multiple choice response, and one open ended response will be assessed on the exit survey.
Conditions
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Multiple Sclerosis
Anxiety
Depression
Patient Satisfaction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Intervention group: All participants randomized to the intervention group will be asked to complete PROM questionnaires at baseline, 6 months and 12 months (12 month study duration). Their treating neurologist will view the participant scores in addition to the text response to the 3-item prompt.
Control group: those in the control group will complete the same questionnaires at baseline and at 12 months. 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.
Control group: those in the control group will complete the same questionnaires at baseline and at 12 months. 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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
The participants will know if they have been randomized to the intensive arm or the control arm, by whether they are completing PROMs every 6 months versus 1 year. The treating neurologists will know which arm their patients are enrolled into by whether they receive all PROM measurements every 6 months on their patients versus solely a text response of the "top 3 things their patient would like their neurologist to know" at that time.
Data analysis will be anonymized and aggregated for the research team in analysis.
Data analysis will be anonymized and aggregated for the research team in analysis.
Study Groups
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Intensive PROMs Intervention Arm
The intervention group will be asked to complete PROM questionnaires at baseline, 6 months, and 12 months via an online web-based delivery system. 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. Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.
Group Type
EXPERIMENTAL
Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist
Intervention Type
OTHER
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.
Control Arm
The control group will be asked to complete PROM questionnaires at baseline and 12 months via an online web-based delivery system. 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 (unless critical values are reached on questionnaires - see below). Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.
Group Type
ACTIVE_COMPARATOR
Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Persons with multiple sclerosis \[relapsing-remitting, secondary progressive, primary progressive, etc.\] being managed by a Northern or Central Alberta-based neurologist.
* Able/willing to complete informed consent and the questionnaires.
* Able to use a computer.
* Greater or equal to the age of 18 years old.
* English-speaking.
* Able/willing to complete informed consent and the questionnaires.
* Able to use a computer.
* Greater or equal to the age of 18 years old.
* English-speaking.
Exclusion Criteria
* Unwilling/unable to provide consent.
* Unwilling/unable to complete the questionnaires.
* Does not speak English.
* Under the age of 18.
* Has a central nervous system inflammatory disorder other than MS.
* PwMS not being managed by the participating neurologist (a neurologist practicing in Northern and Central Alberta).
* Unwilling/unable to complete the questionnaires.
* Does not speak English.
* Under the age of 18.
* Has a central nervous system inflammatory disorder other than MS.
* PwMS not being managed by the participating neurologist (a neurologist practicing in Northern and Central Alberta).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital Foundation
OTHER
Sponsor Role
collaborator
University of Alberta
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University of Alberta
Edmonton, Alberta, Canada
Site Status
Countries
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Canada
References
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Holland NJ, Schneider DM, Rapp R, Kalb RC. Meeting the needs of people with primary progressive multiple sclerosis, their families, and the health-care community. Int J MS Care. 2011 Summer;13(2):65-74. doi: 10.7224/1537-2073-13.2.65.
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Le Fort M, Wiertlewski S, Bernard I, Bernier C, Bonnemain B, Moreau C, Nicolas-Chouet C, Pavillon T, Tanguy E, Villard A, Bertout P, Bodic P, Desjobert S, Kieny P, Lejeune P, Lombrail P; RESEP-Loire. Multiple sclerosis and access to healthcare in the Pays de la Loire region: preliminary study based on 130 self-applied double questionnaires. Ann Phys Rehabil Med. 2011 May;54(3):156-71. doi: 10.1016/j.rehab.2011.02.005. Epub 2011 Apr 6. English, French.
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Chu NY, Jamali A, Al Hamarneh YN, Watson KE, Tsuyuki RT, Smyth PS. Provider Experiences With Systematically Administered Patient-Reported Outcome Measures in Multiple Sclerosis: A Qualitative Sub-Study. Neurol Clin Pract. 2025 Aug;15(4):e200486. doi: 10.1212/CPJ.0000000000200486. Epub 2025 Jul 11.
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Chu NY, Yushko L, Pan B, Hamarneh YNA, Watson KE, Tsuyuki RT, Smyth P. Evaluating the impact of systematic reporting of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a randomized controlled trial. Mult Scler Relat Disord. 2025 Jul;99:106502. doi: 10.1016/j.msard.2025.106502. Epub 2025 May 4.
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Chu NY, Watson KE, Al Hamarneh YN, Yushko L, Tsuyuki RT, Smyth P. Evaluating the impact of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial. BMC Neurol. 2023 Feb 2;23(1):53. doi: 10.1186/s12883-023-03090-0.
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DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
https://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf
Atlas of MS 2013: mapping MS around the world (2013) Retrieved June 20, 2021
http://open.alberta.ca/publications/9781460108574
The way forward: Alberta\'s multiple sclerosis partnership (2013). Retrieved June 30, 2021
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00111593
Identifier Type: -
Identifier Source: org_study_id
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