The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

NCT ID: NCT03480854

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

694 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Baseline Analysis

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Quality Improvement

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MGH Multiple Sclerosis Clinic

UNKNOWN

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role collaborator

Neurology Associates Multiple Sclerosis Center of Greater Orlando

UNKNOWN

Sponsor Role collaborator

Concord Hospital

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brant J. Oliver

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brant J Oliver, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Hitchock

Locations

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Neurology Associates of Greater Orlando

Maitland, Florida, United States

Site Status

Massachusetts General Hospital Multiple Sclerosis Center

Boston, Massachusetts, United States

Site Status

Concord Hospital

Concord, New Hampshire, United States

Site Status

University of Vermont Multiple Sclerosis Center

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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US-MSG-15-10917

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D16181

Identifier Type: -

Identifier Source: org_study_id

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