The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

Improving Quality and Value of Multiple Sclerosis Care at the Microsystem Level: The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

To establish the first systems level continuous quality improvement (CQI) collaborative for multiple sclerosis (MS) in the United States, to conduct benchmarking analyses and assessments of geographic variation in MS care quality and value, and study the effect of CQI interventions on improvement of selected performance (quality) indicators.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Quality Improvement

Detailed Description

This is a three year study which employed a step-wedge randomized design which exposed three of four participating centers to a healthcare QI intervention during the 3 year period. Each of the centers exposed to an intervention served as its own control during a baseline pre-intervention period during the first year of the study. The fourth site served as a longitudinal control for comparison to the other three centers exposed to a QI intervention.

• Study Type: Interventional
• Enrollment (Actual): 694
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates of Greater Orlando
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Multiple Sclerosis Center
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Concord Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Multiple Sclerosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18 years or older with documented clinically confirmed MS who are followed by one of the participating MS centers.

Exclusion Criteria:

• Candidates will be excluded from study entry if they are unable or unwilling to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline Analysis; To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers.
Experimental: The effect of continuous quality improvements (CQI); To study the comparative improvement of selected primary process performance indicators (DMT and MRI process measures) over a 3 year period (Years 2-3) in microsystems receiving CQI interventions versus those not receiving CQI intervention, and between two different CQI intervention types (IHI Breakthrough Series and Patient Centered Medical Home).	Other: Quality Improvement; Randomly selected sites will receive one of two system level improvement approaches; 1) patient centered specialty medical home certification 2) IHI Breakthrough Series improvement approach with professional improvement coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease modifying therapy utilization	The percentage of eligible MS patients on disease modifying therapy (DMT access), which is operationally defined as the total number of eligible patients on DMT/the total number of patients seen per quarter at a participating center for whom DMT is an appropriate treatment option.	every 12 weeks for a period of 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome for Depression	patient reported outcome of The Effects of Your MS (PHQ-9)	every 12 weeks for a period of 36 months
Clinic Outcome for Anxiety	patient reported outcome of Neuro-QOL: Anxiety survey	every 12 weeks for a period of 36 months
Clinic Outcomes on Cognitive Function	patient reported outcome of Neuro-QOL: Cognitive Function survey	every 12 weeks for a period of 36 months
Clinic Outcomes on mobility	patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey	every 12 weeks for a period of 36 months
Clinic Outcomes on fine motor skills and activities of daily living	patient reported outcome of Neuro-QOL: Upper Extremity Function (Fine Motor, ADL) survey	every 12 weeks for a period of 36 months
Clinic Outcomes on stigma associated with MS	patient reported outcome of Neuro-QOL: Stigma survey	every 12 weeks for a period of 36 months
Clinic Outcomes on ability to participate in social roles and activities	patient reported outcome of Neuro-QOL: Ability to Participate in Social Roles and Activities survey	every 12 weeks for a period of 36 months
Clinic Outcomes on satisfaction with social roles and activities	patient reported outcome of Neuro-QOL: Satisfaction with Social Roles and Activities survey	every 12 weeks for a period of 36 months
Clinic Outcomes for sleep disturbance	patient reported outcome of Neuro-QOL: Sleep Disturbance survey	every 12 weeks for a period of 36 months
Clinic Outcomes for communication	patient reported outcome of Neuro-QOL: Communication survey	every 12 weeks for a period of 36 months
Clinic Outcomes for Vitamin D levels in MS patients	patient reported outcome of Vitamin D Level survey	every 12 weeks for a period of 36 months
Clinic Outcomes for fatigue	patient reported outcome of PROMIS Fatigue MS survey	every 12 weeks for a period of 36 months
Clinic Outcomes for assesment of patient health status	patient reported outcome of Brief Appraisal Inventory survey	every 12 weeks for a period of 36 months
Clinic Outcomes for satisfaction of treatment by medication	patient reported outcome of Treatment Satisfaction Questionnaire for Medication (TSQM-9) survey	every 12 weeks for a period of 36 months
Clinic Outcomes for the effects of MS on the patient	patient reported outcome of The Effects of Your MS (PDDS) survey	every 12 weeks for a period of 36 months
Clinic Outcomes for the presence of a MS relapse	patient reported outcome of My MS Relapse Evaluation survey	every 12 weeks for a period of 36 months
Clinic Outcomes reporting of MS patient daily symptoms	patient reported outcome of the Daily Symptoms survey	every 12 weeks for a period of 36 months
Medical History	data regarding medical history reported by the patient	every 12 weeks for a period of 36 months
Hospitalization	data regarding hospitalization reported by the patient	every 12 weeks for a period of 36 months
Demographic information	data regarding demographics reported by the patient	every 12 weeks for a period of 36 months
Medication	survey data regarding medication use reported by the patient	every 12 weeks for a period of 36 months
MRI utilization	survey data regarding number of MRIs reported by the patient	every 12 weeks for a period of 36 months
Exercise	survey data regarding daily exercise	collected daily and summarized annually.
System level measure the patient experience for ambulatory care.	Health care quality assessment collected through the Aggregated Clinician and Group Survey to assess patient experience in ambulatory care.	every 12 weeks for a period of 36 months
System level measure of Health Care Quality	Patient determined disease steps survey	every 12 weeks for a period of 36 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Concord Hospital; MGH Multiple Sclerosis Clinic; University of Vermont Multiple Sclerosis Center; Neurology Associates Multiple Sclerosis Center of Greater Orlando
• Investigators: Principal Investigator: Brant J Oliver, PhD, Dartmouth Hitchock

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: D16181; US-MSG-15-10917 (Other Grant/Funding Number: Biogen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No