The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480854
• Other study ID #: D16181
• Secondary ID: US-MSG-15-10917
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 694
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Multiple Sclerosis Center	Boston	Massachusetts
United States	University of Vermont Multiple Sclerosis Center	Burlington	Vermont
United States	Concord Hospital	Concord	New Hampshire
United States	Neurology Associates of Greater Orlando	Maitland	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Concord Hospital, MGH Multiple Sclerosis Clinic, Neurology Associates Multiple Sclerosis Center of Greater Orlando, University of Vermont Multiple Sclerosis Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical outcome for Depression	patient reported outcome of The Effects of Your MS (PHQ-9)	every 12 weeks for a period of 36 months
Secondary	Clinic Outcome for Anxiety	patient reported outcome of Neuro-QOL: Anxiety survey	every 12 weeks for a period of 36 months
Secondary	Clinic Outcomes on Cognitive Function	patient reported outcome of Neuro-QOL: Cognitive Function survey	every 12 weeks for a period of 36 months
Secondary	Clinic Outcomes on mobility	patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey	every 12 weeks for a period of 36 months
Secondary	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
Secondary	Clinic Outcomes on stigma associated with MS	patient reported outcome of Neuro-QOL: Stigma survey	every 12 weeks for a period of 36 months
Secondary	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
Secondary	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
Secondary	Clinic Outcomes for sleep disturbance	patient reported outcome of Neuro-QOL: Sleep Disturbance survey	every 12 weeks for a period of 36 months
Secondary	Clinic Outcomes for communication	patient reported outcome of Neuro-QOL: Communication survey	every 12 weeks for a period of 36 months
Secondary	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
Secondary	Clinic Outcomes for fatigue	patient reported outcome of PROMIS Fatigue MS survey	every 12 weeks for a period of 36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medical History	data regarding medical history reported by the patient	every 12 weeks for a period of 36 months
Secondary	Hospitalization	data regarding hospitalization reported by the patient	every 12 weeks for a period of 36 months
Secondary	Demographic information	data regarding demographics reported by the patient	every 12 weeks for a period of 36 months
Secondary	Medication	survey data regarding medication use reported by the patient	every 12 weeks for a period of 36 months
Secondary	MRI utilization	survey data regarding number of MRIs reported by the patient	every 12 weeks for a period of 36 months
Secondary	Exercise	survey data regarding daily exercise	collected daily and summarized annually.
Secondary	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
Secondary	System level measure of Health Care Quality	Patient determined disease steps survey	every 12 weeks for a period of 36 months