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

NCT04979546 | Completed

• 1 other identifier: Pro00111593
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Anxiety; Depression; Patient Satisfaction

Keywords

patient reported outcome measures, consultant satisfaction shared decision-making

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Difference in Change in the Euro Quality of Life Measurement (EQ5D)

  12 months

• Difference in Change in the Modified Fatigue Impact Scale (MFIS) score

  12 months

• Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)

  12 months

• The Patient Determined Disease Steps (PDDS) Stability of Score

  12 months

• Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)

  12 months

Study Arms (2)

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.

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.

Other: Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist

Interventions

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

Intensive PROMs Intervention Arm

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Related Publications (54)

• 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.

  PMID: 2282225 BACKGROUND

• Fiest 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.

  PMID: 26856938 BACKGROUND

• Fisk 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.

  PMID: 8180914 BACKGROUND

• Forbes 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.

  PMID: 16502752 BACKGROUND

• Honarmand 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.

  PMID: 19965520 BACKGROUND

• Jones 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.

  PMID: 22860028 BACKGROUND

• Kuspinar 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.

  PMID: 24846760 BACKGROUND

• Montanari 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.

  PMID: 27084226 BACKGROUND

• Nourbakhsh 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.

  PMID: 27416110 BACKGROUND

• Ponzio 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.

  PMID: 31812039 BACKGROUND

• Puhan 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.

  PMID: 18597689 BACKGROUND

• Puhan 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.

  PMID: 18279510 BACKGROUND

• Amankwah 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.

  PMID: 28273039 BACKGROUND

• GBD 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.

  PMID: 30879893 BACKGROUND

• Hobart 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.

  PMID: 30381987 BACKGROUND

• Forcino RC, Barr PJ, O'Malley AJ, Arend R, Castaldo MG, Ozanne EM, Percac-Lima S, Stults CD, Tai-Seale M, Thompson R, Elwyn G. Using CollaboRATE, a brief patient-reported measure of shared decision making: Results from three clinical settings in the United States. Health Expect. 2018 Feb;21(1):82-89. doi: 10.1111/hex.12588. Epub 2017 Jul 5.

  PMID: 28678426 BACKGROUND

• Sjonnesen K, Berzins S, Fiest KM, M Bulloch AG, Metz LM, Thombs BD, Patten SB. Evaluation of the 9-item Patient Health Questionnaire (PHQ-9) as an assessment instrument for symptoms of depression in patients with multiple sclerosis. Postgrad Med. 2012 Sep;124(5):69-77. doi: 10.3810/pgm.2012.09.2595.

  PMID: 23095427 BACKGROUND

• Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

  PMID: 23768763 BACKGROUND

• Hohol MJ, Orav EJ, Weiner HL. Disease steps in multiple sclerosis: a longitudinal study comparing disease steps and EDSS to evaluate disease progression. Mult Scler. 1999 Oct;5(5):349-54. doi: 10.1177/135245859900500508.

  PMID: 10516779 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• McKay KA, Ernstsson O, Manouchehrinia A, Olsson T, Hillert J. Determinants of quality of life in pediatric- and adult-onset multiple sclerosis. Neurology. 2020 Mar 3;94(9):e932-e941. doi: 10.1212/WNL.0000000000008667. Epub 2019 Nov 15.

  PMID: 31732567 BACKGROUND

• Strober LB, Bruce JM, Arnett PA, Alschuler KN, DeLuca J, Chiaravalloti N, Lebkuecher A, Di Benedetto M, Cozart J, Thelen J, Guty E, Roman CAF. Tired of not knowing what that fatigue score means? Normative data of the Modified Fatigue Impact Scale (MFIS). Mult Scler Relat Disord. 2020 Nov;46:102576. doi: 10.1016/j.msard.2020.102576. Epub 2020 Oct 13.

  PMID: 33296974 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004 Oct;10(5):589-95. doi: 10.1191/1352458504ms1085oa.

  PMID: 15471378 BACKGROUND

• Learmonth YC, Motl RW, Sandroff BM, Pula JH, Cadavid D. Validation of patient determined disease steps (PDDS) scale scores in persons with multiple sclerosis. BMC Neurol. 2013 Apr 25;13:37. doi: 10.1186/1471-2377-13-37.

  PMID: 23617555 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Williams KG, Sanderson M, Jette N, Patten SB. Validity of the Patient Health Questionnaire-9 in neurologic populations. Neurol Clin Pract. 2020 Jun;10(3):190-198. doi: 10.1212/CPJ.0000000000000748. Epub 2020 Apr 13.

  PMID: 32642320 BACKGROUND

• Patten SB, Burton JM, Fiest KM, Wiebe S, Bulloch AG, Koch M, Dobson KS, Metz LM, Maxwell CJ, Jette N. Validity of four screening scales for major depression in MS. Mult Scler. 2015 Jul;21(8):1064-71. doi: 10.1177/1352458514559297. Epub 2015 Jan 12.

  PMID: 25583846 BACKGROUND

• Olascoaga J. [Quality of life and multiple sclerosis]. Rev Neurol. 2010 Sep 1;51(5):279-88. Spanish.

  PMID: 20669127 BACKGROUND

• Rothwell PM, McDowell Z, Wong CK, Dorman PJ. Doctors and patients don't agree: cross sectional study of patients' and doctors' perceptions and assessments of disability in multiple sclerosis. BMJ. 1997 May 31;314(7094):1580-3. doi: 10.1136/bmj.314.7094.1580.

  PMID: 9169401 BACKGROUND

• Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.

  PMID: 7613530 BACKGROUND

• Hobart J. Rating scales for neurologists. J Neurol Neurosurg Psychiatry. 2003 Dec;74 Suppl 4(Suppl 4):iv22-iv26. doi: 10.1136/jnnp.74.suppl_4.iv22. No abstract available.

  PMID: 14645463 BACKGROUND

• Fayers, P. M. and D. Machin. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes [Internet]. Chichester (England); Hoboken (NJ): John Wiley & Sons, 2007 [cited 2021 June 29]. Available from: https://onlinelibrary.wiley.com/doi/book/10.1002/9780470024522

  BACKGROUND

• Carroll CA, Fairman KA, Lage MJ. Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data. BMC Health Serv Res. 2014 Jul 2;14:286. doi: 10.1186/1472-6963-14-286.

  PMID: 24986083 BACKGROUND

• Coleman CI, Sidovar MF, Roberts MS, Kohn C. Impact of mobility impairment on indirect costs and health-related quality of life in multiple sclerosis. PLoS One. 2013;8(1):e54756. doi: 10.1371/journal.pone.0054756. Epub 2013 Jan 23.

  PMID: 23355896 BACKGROUND

• Ney JP, Johnson B, Knabel T, Craft K, Kaufman J. Neurologist ambulatory care, health care utilization, and costs in a large commercial dataset. Neurology. 2016 Jan 26;86(4):367-74. doi: 10.1212/WNL.0000000000002276. Epub 2015 Dec 23.

  PMID: 26701378 BACKGROUND

• The Lancet Neurology. Patient-reported outcomes in the spotlight. Lancet Neurol. 2019 Nov;18(11):981. doi: 10.1016/S1474-4422(19)30357-6. No abstract available.

  PMID: 31609205 BACKGROUND

• Ponzio M, Gerzeli S, Brichetto G, Bezzini D, Mancardi GL, Zaratin P, Battaglia MA. Economic impact of multiple sclerosis in Italy: focus on rehabilitation costs. Neurol Sci. 2015 Feb;36(2):227-34. doi: 10.1007/s10072-014-1925-z. Epub 2014 Aug 11.

  PMID: 25109816 BACKGROUND

• Prescott JD, Factor S, Pill M, Levi GW. Descriptive analysis of the direct medical costs of multiple sclerosis in 2004 using administrative claims in a large nationwide database. J Manag Care Pharm. 2007 Jan-Feb;13(1):44-52. doi: 10.18553/jmcp.2007.13.1.44.

  PMID: 17269836 BACKGROUND

• Borreani C, Bianchi E, Pietrolongo E, Rossi I, Cilia S, Giuntoli M, Giordano A, Confalonieri P, Lugaresi A, Patti F, Grasso MG, de Carvalho LL, Palmisano L, Zaratin P, Battaglia MA, Solari A; PeNSAMI project. Unmet needs of people with severe multiple sclerosis and their carers: qualitative findings for a home-based intervention. PLoS One. 2014 Oct 6;9(10):e109679. doi: 10.1371/journal.pone.0109679. eCollection 2014.

  PMID: 25286321 BACKGROUND

• Buchanan RJ, Huang C. Informal caregivers assisting people with multiple sclerosis: factors associated with the strength of the caregiver/care recipient relationship. Int J MS Care. 2011 Winter;13(4):177-87. doi: 10.7224/1537-2073-13.4.177.

  PMID: 24453723 BACKGROUND

• 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.

  PMID: 24453707 BACKGROUND

• 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.

  PMID: 21515103 BACKGROUND

• Lorefice L, Mura G, Coni G, Fenu G, Sardu C, Frau J, Coghe G, Melis M, Marrosu MG, Cocco E. What do multiple sclerosis patients and their caregivers perceive as unmet needs? BMC Neurol. 2013 Nov 15;13:177. doi: 10.1186/1471-2377-13-177.

  PMID: 24237586 BACKGROUND

• Matti AI, McCarl H, Klaer P, Keane MC, Chen CS. Multiple sclerosis: patients' information sources and needs on disease symptoms and management. Patient Prefer Adherence. 2010 Jun 24;4:157-61. doi: 10.2147/ppa.s10824.

  PMID: 20622916 BACKGROUND

• Mehr SR, Zimmerman MP. Reviewing the Unmet Needs of Patients with Multiple Sclerosis. Am Health Drug Benefits. 2015 Nov;8(8):426-31.

  PMID: 26702334 BACKGROUND

• Ponzio M, Tacchino A, Zaratin P, Vaccaro C, Battaglia MA. Unmet care needs of people with a neurological chronic disease: a cross-sectional study in Italy on Multiple Sclerosis. Eur J Public Health. 2015 Oct;25(5):775-80. doi: 10.1093/eurpub/ckv065. Epub 2015 Mar 30.

  PMID: 25829501 BACKGROUND

• Solaro C, Ponzio M, Moran E, Tanganelli P, Pizio R, Ribizzi G, Venturi S, Mancardi GL, Battaglia MA. The changing face of multiple sclerosis: Prevalence and incidence in an aging population. Mult Scler. 2015 Sep;21(10):1244-50. doi: 10.1177/1352458514561904. Epub 2015 Jan 12.

  PMID: 25583850 BACKGROUND

• Strupp J, Romotzky V, Galushko M, Golla H, Voltz R. Palliative care for severely affected patients with multiple sclerosis: when and why? Results of a Delphi survey of health care professionals. J Palliat Med. 2014 Oct;17(10):1128-36. doi: 10.1089/jpm.2013.0667. Epub 2014 Jul 28.

  PMID: 25068391 BACKGROUND

• Young L, Healey K, Charlton M, Schmid K, Zabad R, Wester R. A home-based comprehensive care model in patients with Multiple Sclerosis: A study pre-protocol. F1000Res. 2015 Sep 18;4:872. doi: 10.12688/f1000research.7040.1. eCollection 2015.

  PMID: 26673815 BACKGROUND

• Wynia K, Annema C, Nissen H, De Keyser J, Middel B. Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients. BMC Health Serv Res. 2010 May 27;10:142. doi: 10.1186/1472-6963-10-142.

  PMID: 20507600 BACKGROUND

• 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.

  PMID: 40656127 DERIVED

• 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.

  PMID: 40339265 DERIVED

• 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.

  PMID: 36732694 DERIVED

Related 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

MeSH Terms

Conditions

Multiple Sclerosis; Anxiety Disorders; Depression; Patient Satisfaction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 28, 2021
• Study Start: November 4, 2021
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)