The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

NCT03480854 | Completed

• 2 other identifiers: D16181US-MSG-15-10917
• Study Type: interventional
• Target: 694
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Clinical outcome for Depression

  every 12 weeks for a period of 36 months

• Clinic Outcome for Anxiety

  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 mobility

  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

Study Arms (2)

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).

Other: Quality Improvement

Interventions

Quality Improvement OTHER

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.

The effect of continuous quality improvements (CQI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• MGH Multiple Sclerosis Clinic: collaborator
• University of Vermont: collaborator
• Neurology Associates Multiple Sclerosis Center of Greater Orlando: collaborator
• Concord Hospital: collaborator

Study Sites (4)

Neurology Associates of Greater Orlando

Maitland, Florida, 32751, United States

Location

Massachusetts General Hospital Multiple Sclerosis Center

Boston, Massachusetts, 02114, United States

Location

Concord Hospital

Concord, New Hampshire, 03301, United States

Location

University of Vermont Multiple Sclerosis Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Study Officials

• Brant J Oliver, PhD

  Dartmouth Hitchock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: March 29, 2018
• Study Start: July 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)