NCT04122989

Brief Summary

This study evaluates a novel shared decision making tool for multiple sclerosis (MS). Half the patients will be given access to MS-SUPPORT before their scheduled appointment with their healthcare provider, the other half will not be given access.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

October 8, 2019

Last Update Submit

May 3, 2022

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Start/Switch DMT

    Proportion of MS patients that switch or start a disease modifying therapy (DMT).

    Quarterly during the 12 month follow-up after the index HCP visit.

Secondary Outcomes (6)

  • Patient-provider communication

    Measured once, up to 2 months after the index HCP visit.

  • Adherence to DMT

    Quarterly, up to 12 month follow-up after the index HCP visit.

  • Decision Quality

    Quarterly, up to 12 month follow-up after the index HCP visit.

  • Quality of Life--Healthy Days Core Module

    Quarterly, up to 12 month follow-up after the index HCP visit.

  • CAHPS Quality of Care

    Measured once, up to 2 months after the index HCP visit.

  • +1 more secondary outcomes

Study Arms (2)

MS-SUPPORT

EXPERIMENTAL

Group receives access to an online shared decision making tool (an interactive decision aid) for multiple sclerosis.

Other: MS-SUPPORT

Control

NO INTERVENTION

Usual care

Interventions

MS-SUPPORTOTHER

MS-SUPPORT is a shared decision making tool designed to be used by patients and providers.

MS-SUPPORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read and write in English
  • Live within the United States and receive MS care in the USA
  • years or older
  • Having a diagnosis of a relapsing form of MS, including Relapsing Remitting Multiple Sclerosis (RRMS), active secondary progressive MS, and Clinically Isolated Syndrome (CIS)
  • Having access to the internet
  • Having a valid email address
  • Have a healthcare provider who is managing their MS
  • Having an upcoming appointment with an MS healthcare provider to manage their MS within the next 12 weeks

You may not qualify if:

  • Unable or unwilling to give informed consent
  • For HCPs:
  • English-speaking
  • Any HCP who manages a participating patient's MS
  • Unable or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shared Decision Making Resources

Georgetown, Maine, 04548, United States

Location

Related Publications (8)

  • Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.

    PMID: 12900105BACKGROUND

  • Moriarty DG, Zack MM, Kobau R. The Centers for Disease Control and Prevention's Healthy Days Measures - population tracking of perceived physical and mental health over time. Health Qual Life Outcomes. 2003 Sep 2;1:37. doi: 10.1186/1477-7525-1-37.

    PMID: 14498988BACKGROUND

  • Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.

    PMID: 24625035BACKGROUND

  • Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.

    PMID: 16908462BACKGROUND

  • Pieterse AH, de Vries M, Kunneman M, Stiggelbout AM, Feldman-Stewart D. Theory-informed design of values clarification methods: a cognitive psychological perspective on patient health-related decision making. Soc Sci Med. 2013 Jan;77:156-63. doi: 10.1016/j.socscimed.2012.11.020. Epub 2012 Nov 27.

    PMID: 23219164BACKGROUND

  • Reynolds MW, Stephen R, Seaman C, Rajagopalan K. Persistence and adherence to disease modifying drugs among patients with multiple sclerosis. Curr Med Res Opin. 2010 Mar;26(3):663-74. doi: 10.1185/03007990903554257.

    PMID: 20070144BACKGROUND

  • Col NF, Solomon AJ, Springmann V, Garbin CP, Ionete C, Pbert L, Alvarez E, Tierman B, Hopson A, Kutz C, Berrios Morales I, Griffin C, Phillips G, Ngo LH. Whose Preferences Matter? A Patient-Centered Approach for Eliciting Treatment Goals. Med Decis Making. 2018 Jan;38(1):44-55. doi: 10.1177/0272989X17724434. Epub 2017 Aug 14.

    PMID: 28806143RESULT

  • Col NF, Solomon AJ, Springmann V, Ionete C, Alvarez E, Tierman B, Kutz C, Morales IB, Griffin C, Ngo LH, Jones DE, Phillips G, Hopson A, Pbert L. Evaluation of a Novel Preference Assessment Tool for Patients with Multiple Sclerosis. Int J MS Care. 2018 Nov-Dec;20(6):260-267. doi: 10.7224/1537-2073.2017-021.

    PMID: 30568563RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nananda Col, MD, MPH, MPP

    Shared Decision Making Resources

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial, with 1:1 randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

November 12, 2019

Primary Completion

October 26, 2020

Study Completion

December 23, 2021

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

We will share all Individual Participant Data (IPD) that underlie results in a publication, ensuring that such data are deidentified.

Time Frame
Upon publication and for 1 year thereafter
Access Criteria
Contact the PI

Locations

US(1)