Clinical trial NCT03480854: The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative
Official title: Improving Quality and Value of Multiple Sclerosis Care at the Microsystem Level: The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: MGH Multiple Sclerosis Clinic
name: University of Vermont
name: Neurology Associates Multiple Sclerosis Center of Greater Orlando
name: Concord Hospital
First posted: 2018-03-29
Enrollment: 694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-part prospective study to be conducted over 3 years with option to extend to 5 years. In Year 1, we will gather baseline performance data from participating MS clinics (microsystems), create a combined MSCQI systems-level database, and conduct analyses of performance variation and benchmarking. In the second part of the study (Years 2-3), we will investigate the effect of Continuous Quality Improvement interventions on primary endpoints and selected secondary measures.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease modifying therapy utilization
timeFrame: every 12 weeks for a period of 36 months
Secondary outcomes:
measure: Clinical outcome for Depression
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcome for Anxiety
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on Cognitive Function
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on mobility
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on fine motor skills and activities of daily living
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on stigma associated with MS
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on ability to participate in social roles and activities
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes on satisfaction with social roles and activities
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for sleep disturbance
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for communication
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for Vitamin D levels in MS patients
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for fatigue
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for assesment of patient health status
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for satisfaction of treatment by medication
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for the effects of MS on the patient
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes for the presence of a MS relapse
timeFrame: every 12 weeks for a period of 36 months
measure: Clinic Outcomes reporting of MS patient daily symptoms
timeFrame: every 12 weeks for a period of 36 months
measure: Medical History
timeFrame: every 12 weeks for a period of 36 months
measure: Hospitalization
timeFrame: every 12 weeks for a period of 36 months
measure: Demographic information
timeFrame: every 12 weeks for a period of 36 months
measure: Medication
timeFrame: every 12 weeks for a period of 36 months
measure: MRI utilization
timeFrame: every 12 weeks for a period of 36 months
measure: Exercise
timeFrame: collected daily and summarized annually.
measure: System level measure the patient experience for ambulatory care.
timeFrame: every 12 weeks for a period of 36 months
measure: System level measure of Health Care Quality
timeFrame: every 12 weeks for a period of 36 months
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Neurology Associates of Greater Orlando
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Multiple Sclerosis Center
state: Massachusetts
city: Concord
country: United States
facility: Concord Hospital
state: New Hampshire
city: Burlington
country: United States
facility: University of Vermont Multiple Sclerosis Center
state: Vermont
Study officials:
affiliation: Dartmouth Hitchock
name: Brant J Oliver, PhD
role: PRINCIPAL_INVESTIGATOR
References: