Multiple SclerosisNCT04979546
Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis
A study testing 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 in people with Multiple Sclerosis and Anxiety, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Anxiety, Depression
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2021to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial
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.
Read the 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:
- Hospital Anxiety and Depression Scale (HADS) score
- Quality of Life as measured by EuroQol Five-Dimensions (EQ5D) questionnaire
- Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
- The Patient Determined Disease Steps (PDDS)
- Patient Health Questionnaire-9 (PHQ-9)
- 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:
- 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.
- 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.
- 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.
- PDDS ≥ 3 at first testing - trigger to notify with gait impairment but not requiring aid yet, OR increase of score ≥ 1 on subsequent measurements.
- 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
- Multiple Sclerosis, Anxiety, Depression, Patient Satisfaction
- Being tested
- Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist, Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist
- Keywords
- patient reported outcome measures, consultant satisfaction shared decision-making
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders, Depression, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive PROMs Intervention Arm | Experimental | 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. Receives: Other: Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist |
| Control Arm | Active comparator | 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. Receives: Other: Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start4 Nov 2021
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979546
- Sponsor's protocol ID
- Pro00111593
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data available to other researchers. We plan to analyze outcomes and publish the data as aggregated, anonymized data.
Publications
Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.
PubMed 2282225Fiest KM, Walker JR, Bernstein CN, Graff LA, Zarychanski R, Abou-Setta AM, Patten SB, Sareen J, Bolton JM, Marriott JJ, Fisk JD, Singer A, Marrie RA; CIHR Team Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Systematic review and meta-analysis of interventions for depression and anxiety in persons with multiple sclerosis. Mult Scler Relat Disord. 2016 Jan;5:12-26. doi: 10.1016/j.msard.2015.10.004. Epub 2015 Oct 19.
PubMed 26856938Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci. 1994 Feb;21(1):9-14.
PubMed 8180914Forbes A, While A, Mathes L, Griffiths P. Health problems and health-related quality of life in people with multiple sclerosis. Clin Rehabil. 2006 Jan;20(1):67-78. doi: 10.1191/0269215506cr880oa.
PubMed 16502752Honarmand K, Feinstein A. Validation of the Hospital Anxiety and Depression Scale for use with multiple sclerosis patients. Mult Scler. 2009 Dec;15(12):1518-24. doi: 10.1177/1352458509347150. Epub 2009 Nov 13.
PubMed 19965520Jones KH, Ford DV, Jones PA, John A, Middleton RM, Lockhart-Jones H, Osborne LA, Noble JG. A large-scale study of anxiety and depression in people with Multiple Sclerosis: a survey via the web portal of the UK MS Register. PLoS One. 2012;7(7):e41910. doi: 10.1371/journal.pone.0041910. Epub 2012 Jul 30.
PubMed 22860028Kuspinar A, Mayo NE. A review of the psychometric properties of generic utility measures in multiple sclerosis. Pharmacoeconomics. 2014 Aug;32(8):759-73. doi: 10.1007/s40273-014-0167-5.
PubMed 24846760Montanari E, Rottoli M, Maimone D, Confalonieri P, Plewnia K, Frigo M, Francia A, Pala A, Losignore NA, Ragonese P, Veneziano A; POSIDONIA study group. A 12-month prospective, observational study evaluating the impact of disease-modifying treatment on emotional burden in recently-diagnosed multiple sclerosis patients: The POSIDONIA study. J Neurol Sci. 2016 May 15;364:105-9. doi: 10.1016/j.jns.2016.02.047. Epub 2016 Feb 20.
PubMed 27084226Nourbakhsh B, Julian L, Waubant E. Fatigue and depression predict quality of life in patients with early multiple sclerosis: a longitudinal study. Eur J Neurol. 2016 Sep;23(9):1482-6. doi: 10.1111/ene.13102. Epub 2016 Jul 14.
PubMed 27416110Ponzio M, Tacchino A, Vaccaro C, Traversa S, Brichetto G, Battaglia MA, Uccelli MM. Unmet needs influence health-related quality of life in people with multiple sclerosis. Mult Scler Relat Disord. 2020 Feb;38:101877. doi: 10.1016/j.msard.2019.101877. Epub 2019 Nov 29.
PubMed 31812039Puhan MA, Frey M, Buchi S, Schunemann HJ. The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2008 Jul 2;6:46. doi: 10.1186/1477-7525-6-46.
PubMed 18597689Puhan MA, Gaspoz JM, Bridevaux PO, Schindler C, Ackermann-Liebrich U, Rochat T, Gerbase MW. Comparing a disease-specific and a generic health-related quality of life instrument in subjects with asthma from the general population. Health Qual Life Outcomes. 2008 Feb 15;6:15. doi: 10.1186/1477-7525-6-15.
PubMed 18279510Amankwah N, Marrie RA, Bancej C, Garner R, Manuel DG, Wall R, Fines P, Bernier J, Tu K, Reimer K. Multiple sclerosis in Canada 2011 to 2031: results of a microsimulation modelling study of epidemiological and economic impacts. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):37-48. doi: 10.24095/hpcdp.37.2.02.
PubMed 28273039GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Hobart J, Bowen A, Pepper G, Crofts H, Eberhard L, Berger T, Boyko A, Boz C, Butzkueven H, Celius EG, Drulovic J, Flores J, Horakova D, Lebrun-Frenay C, Marrie RA, Overell J, Piehl F, Rasmussen PV, Sa MJ, Sirbu CA, Skromne E, Torkildsen O, van Pesch V, Vollmer T, Zakaria M, Ziemssen T, Giovannoni G. International consensus on quality standards for brain health-focused care in multiple sclerosis. Mult Scler. 2019 Nov;25(13):1809-1818. doi: 10.1177/1352458518809326. Epub 2018 Nov 1.
PubMed 30381987
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04979546
- Acronym / sponsor ID
- Pro00111593
- Conditions
- Multiple Sclerosis, Anxiety, Depression, Patient Satisfaction
- Keywords
- patient reported outcome measures, consultant satisfaction shared decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University Hospital Foundation
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hospital Anxiety and Depression Scale (HADS) score
- Quality of Life as measured by EuroQol Five-Dimensions (EQ5D) questionnaire
- Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
- The Patient Determined Disease Steps (PDDS)
- Patient Health Questionnaire-9 (PHQ-9)
- 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:
- 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.
- 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.
- 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.
- PDDS ≥ 3 at first testing - trigger to notify with gait impairment but not requiring aid yet, OR increase of score ≥ 1 on subsequent measurements.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intensive PROMs Intervention Arm | Experimental | Other: Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating NeurologistThe 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. |
| Control Arm | Active comparator | Other: Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating NeurologistThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating NeurologistBaseline, 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 | Intensive PROMs Intervention Arm |
| Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating NeurologistBaseline 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. | Other | Control Arm |
Primary outcome
Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores
Time frame: 12 months
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.
Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores
Time frame: 12 months
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.
6 secondary outcomes
Difference in Change in the Euro Quality of Life Measurement (EQ5D)
Time frame: 12 months
Difference in Change in the Modified Fatigue Impact Scale (MFIS) score
Time frame: 12 months
Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)
Time frame: 12 months
The Patient Determined Disease Steps (PDDS) Stability of Score
Time frame: 12 months
Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months
Difference in change in the CollaboRATE shared decision-making survey
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 2282225Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.
- Background: PubMed 26856938Fiest KM, Walker JR, Bernstein CN, Graff LA, Zarychanski R, Abou-Setta AM, Patten SB, Sareen J, Bolton JM, Marriott JJ, Fisk JD, Singer A, Marrie RA; CIHR Team Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Systematic review and meta-analysis of interventions for depression and anxiety in persons with multiple sclerosis. Mult Scler Relat Disord. 2016 Jan;5:12-26. doi: 10.1016/j.msard.2015.10.004. Epub 2015 Oct 19.
- Background: PubMed 8180914Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci. 1994 Feb;21(1):9-14.
- Background: PubMed 16502752Forbes A, While A, Mathes L, Griffiths P. Health problems and health-related quality of life in people with multiple sclerosis. Clin Rehabil. 2006 Jan;20(1):67-78. doi: 10.1191/0269215506cr880oa.
- Background: PubMed 19965520Honarmand K, Feinstein A. Validation of the Hospital Anxiety and Depression Scale for use with multiple sclerosis patients. Mult Scler. 2009 Dec;15(12):1518-24. doi: 10.1177/1352458509347150. Epub 2009 Nov 13.
- Background: PubMed 22860028Jones KH, Ford DV, Jones PA, John A, Middleton RM, Lockhart-Jones H, Osborne LA, Noble JG. A large-scale study of anxiety and depression in people with Multiple Sclerosis: a survey via the web portal of the UK MS Register. PLoS One. 2012;7(7):e41910. doi: 10.1371/journal.pone.0041910. Epub 2012 Jul 30.
- Background: PubMed 24846760Kuspinar A, Mayo NE. A review of the psychometric properties of generic utility measures in multiple sclerosis. Pharmacoeconomics. 2014 Aug;32(8):759-73. doi: 10.1007/s40273-014-0167-5.
- Background: PubMed 27084226Montanari E, Rottoli M, Maimone D, Confalonieri P, Plewnia K, Frigo M, Francia A, Pala A, Losignore NA, Ragonese P, Veneziano A; POSIDONIA study group. A 12-month prospective, observational study evaluating the impact of disease-modifying treatment on emotional burden in recently-diagnosed multiple sclerosis patients: The POSIDONIA study. J Neurol Sci. 2016 May 15;364:105-9. doi: 10.1016/j.jns.2016.02.047. Epub 2016 Feb 20.
- Background: PubMed 27416110Nourbakhsh B, Julian L, Waubant E. Fatigue and depression predict quality of life in patients with early multiple sclerosis: a longitudinal study. Eur J Neurol. 2016 Sep;23(9):1482-6. doi: 10.1111/ene.13102. Epub 2016 Jul 14.
- Background: PubMed 31812039Ponzio M, Tacchino A, Vaccaro C, Traversa S, Brichetto G, Battaglia MA, Uccelli MM. Unmet needs influence health-related quality of life in people with multiple sclerosis. Mult Scler Relat Disord. 2020 Feb;38:101877. doi: 10.1016/j.msard.2019.101877. Epub 2019 Nov 29.
- Background: PubMed 18597689Puhan MA, Frey M, Buchi S, Schunemann HJ. The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2008 Jul 2;6:46. doi: 10.1186/1477-7525-6-46.
- Background: PubMed 18279510Puhan MA, Gaspoz JM, Bridevaux PO, Schindler C, Ackermann-Liebrich U, Rochat T, Gerbase MW. Comparing a disease-specific and a generic health-related quality of life instrument in subjects with asthma from the general population. Health Qual Life Outcomes. 2008 Feb 15;6:15. doi: 10.1186/1477-7525-6-15.
- Atlas of MS 2013: mapping MS around the world (2013) Retrieved June 20, 2021Link provided by the sponsor.
- The way forward: Alberta\'s multiple sclerosis partnership (2013). Retrieved June 30, 2021Link provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers. We plan to analyze outcomes and publish the data as aggregated, anonymized data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Multiple Sclerosis and Anxiety, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979546, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.