Clinical trial NCT04979546: Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis
Official title: Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Anxiety
Depression
Patient Satisfaction
Keywords: patient reported outcome measures, consultant satisfaction shared decision-making
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University Hospital Foundation
First posted: 2021-07-28
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores
timeFrame: 12 months
measure: Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores
timeFrame: 12 months
Secondary outcomes:
measure: Difference in Change in the Euro Quality of Life Measurement (EQ5D)
timeFrame: 12 months
measure: Difference in Change in the Modified Fatigue Impact Scale (MFIS) score
timeFrame: 12 months
measure: Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)
timeFrame: 12 months
measure: The Patient Determined Disease Steps (PDDS) Stability of Score
timeFrame: 12 months
measure: Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months
measure: Difference in change in the CollaboRATE shared decision-making survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
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