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Clinical Trials/NCT03480854
NCT03480854CompletedNot Applicable

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

Dartmouth-Hitchcock Medical Center4 sites in 1 country694 target enrollmentStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
694
Locations
4
Primary Endpoint
Disease modifying therapy utilization

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Baseline Analysis

No Intervention

To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers.

The effect of continuous quality improvements (CQI)

Experimental

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).

Intervention: Quality Improvement (Other)

Outcomes

Primary Outcomes

Disease modifying therapy utilization

Time Frame: every 12 weeks for a period of 36 months

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.

Secondary Outcomes

  • Clinic Outcome for Anxiety(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for Vitamin D levels in MS patients(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for fatigue(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for the effects of MS on the patient(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for the presence of a MS relapse(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for satisfaction of treatment by medication(every 12 weeks for a period of 36 months)
  • Clinical outcome for Depression(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on Cognitive Function(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on fine motor skills and activities of daily living(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on stigma associated with MS(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on ability to participate in social roles and activities(every 12 weeks for a period of 36 months)
  • Clinic Outcomes reporting of MS patient daily symptoms(every 12 weeks for a period of 36 months)
  • Medical History(every 12 weeks for a period of 36 months)
  • MRI utilization(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for communication(every 12 weeks for a period of 36 months)
  • Hospitalization(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on mobility(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on satisfaction with social roles and activities(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for sleep disturbance(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for assesment of patient health status(every 12 weeks for a period of 36 months)
  • Demographic information(every 12 weeks for a period of 36 months)
  • Exercise(collected daily and summarized annually.)
  • System level measure of Health Care Quality(every 12 weeks for a period of 36 months)
  • Medication(every 12 weeks for a period of 36 months)
  • System level measure the patient experience for ambulatory care.(every 12 weeks for a period of 36 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brant J. Oliver

Assistant Professor

Dartmouth-Hitchcock Medical Center

Study Sites (4)

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