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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979546
• Other study ID #: Pro00111593
• Status: Completed
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Multiple Sclerosis
• Patient Satisfaction
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	University Hospital Foundation

Country where clinical trial is conducted

Canada, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores	Hospital Anxiety & Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis (Jones et al, PLoS One 2012). Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome.; Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein (Mult Scler, 2009) [Baseline scores and standard deviation (SD)] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.	12 months
Primary	Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores	Hospital Anxiety & Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis (Jones et al, PLoS One 2012). Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome.; Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein (Mult Scler, 2009) [Baseline scores and standard deviation (SD)] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.	12 months
Secondary	Difference in Change in the Euro Quality of Life Measurement (EQ5D)	The EQ5D quality of life measure is used in the MS population (Kuspinar & Mayo, Pharmacoeconomics 2014), and is the main quality of life measure preferred by Alberta Health Services. There is a descriptive element to the EQ5D that represents values around the level of reported problems in each of the 5 domains, with higher scores being worse. The 5 domains are around (1) mobility; (2) self-care; (3) usual activities; (4) pain/discomfort; and (5) anxiety/depression. The index is calculated by deducting the appropriate weights from 1 and comparing to population norms in a value set.	12 months
Secondary	Difference in Change in the Modified Fatigue Impact Scale (MFIS) score	Fatigue is one of the most common symptoms for people with MS. The MSIF is a standard, validated measurement of fatigue in MS (Fisk et al, Can J Neurol Sci 1994). The MFIS is a self-report instrument in which participants are asked to rate how often fatigue has affected them in the previous 4 weeks in relation to statements (0 = never to 4 = almost always). Items on the MFIS can be aggregated into subscales (physical, cognitive and psychosocial) as well as into a total MFIS score. The total MFIS score can be a minimum of 0 to 84, computed by adding the scores on the physical, cognitive and psychosocial subscales.	12 months
Secondary	Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)	Participants' satisfaction with the level of care provided to them will be measured at 6 months using the validated Consultant Satisfaction Questionnaire (CSQ) (Baker, Br J Gen Pract 1990). CSQ consists of 18 Likert scale questions, ranging from 1= strongly disagree to 5 = strongly agree, with the higher score indicating higher patient satisfaction. Satisfaction with healthcare provider care will be measured by the overall mean score of the consultation satisfaction questionnaire (CSQ) completed at the 6 month follow-up visit. The CSQ is a self-administered tool with 18 questions using a 5-point Likert scale, ranging from strongly agree to strongly disagree. It measures 3 factors of the healthcare provider interaction: (1) professional aspects; (2) depth of patient relationship with provider; and (3) perceived length of consultation. Higher scores indicate higher satisfaction.	12 months
Secondary	The Patient Determined Disease Steps (PDDS) Stability of Score	The Patient Determined Disease Steps (PDDS) score is a patient reported measure of disability in multiple sclerosis, that has been validated in comparing to the gold standard of MS disability measurement, the Expanded Disability Status Score (EDSS). (Learmouth et al, BMC Neurology 2013; Hohol et al, Mult Scler. 1999)	12 months
Secondary	Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)	PwMS have a high prevalence of depression. The Patient Health Questionnaire-9 (PHQ-9) is a frequently used measure of depression in the MS population. It has been shown to be valid in the MS population (Sjonnesen et al, Postgraduate Medicine 2015)	12 months
Secondary	Difference in change in the CollaboRATE shared decision-making survey	The CollaboRATE is a brief, patient survey that focuses on the patient's perceived input and satisfaction with the shared decision-making process around their health decisions with their health care providers. (Elwyn et al, Patient Educ Couns 2013; Forcino et al, Health Expectations 2018)	12 months

External Links

•   Atlas of MS 2013: mapping MS around the world (2013) Retrieved June 20, 2021
•   The way forward: Alberta's multiple sclerosis partnership (2013). Retrieved June 30, 2021