The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

May 5, 2021 updated by: Brant J. Oliver, Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
694

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Maitland, Florida, United States, 32751
        • Neurology Associates of Greater Orlando
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Multiple Sclerosis Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Concord Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Multiple Sclerosis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Baseline Analysis
To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers.
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
every 12 weeks for a period of 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical outcome for Depression
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of The Effects of Your MS (PHQ-9)
every 12 weeks for a period of 36 months
Clinic Outcome for Anxiety
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Anxiety survey
every 12 weeks for a period of 36 months
Clinic Outcomes on Cognitive Function
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Cognitive Function survey
every 12 weeks for a period of 36 months
Clinic Outcomes on mobility
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey
every 12 weeks for a period of 36 months
Clinic Outcomes on fine motor skills and activities of daily living
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Upper Extremity Function (Fine Motor, ADL) survey
every 12 weeks for a period of 36 months
Clinic Outcomes on stigma associated with MS
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Stigma survey
every 12 weeks for a period of 36 months
Clinic Outcomes on ability to participate in social roles and activities
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Ability to Participate in Social Roles and Activities survey
every 12 weeks for a period of 36 months
Clinic Outcomes on satisfaction with social roles and activities
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Satisfaction with Social Roles and Activities survey
every 12 weeks for a period of 36 months
Clinic Outcomes for sleep disturbance
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Sleep Disturbance survey
every 12 weeks for a period of 36 months
Clinic Outcomes for communication
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Neuro-QOL: Communication survey
every 12 weeks for a period of 36 months
Clinic Outcomes for Vitamin D levels in MS patients
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Vitamin D Level survey
every 12 weeks for a period of 36 months
Clinic Outcomes for fatigue
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of PROMIS Fatigue MS survey
every 12 weeks for a period of 36 months
Clinic Outcomes for assesment of patient health status
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Brief Appraisal Inventory survey
every 12 weeks for a period of 36 months
Clinic Outcomes for satisfaction of treatment by medication
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of Treatment Satisfaction Questionnaire for Medication (TSQM-9) survey
every 12 weeks for a period of 36 months
Clinic Outcomes for the effects of MS on the patient
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of The Effects of Your MS (PDDS) survey
every 12 weeks for a period of 36 months
Clinic Outcomes for the presence of a MS relapse
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of My MS Relapse Evaluation survey
every 12 weeks for a period of 36 months
Clinic Outcomes reporting of MS patient daily symptoms
Time Frame: every 12 weeks for a period of 36 months
patient reported outcome of the Daily Symptoms survey
every 12 weeks for a period of 36 months
Medical History
Time Frame: every 12 weeks for a period of 36 months
data regarding medical history reported by the patient
every 12 weeks for a period of 36 months
Hospitalization
Time Frame: every 12 weeks for a period of 36 months
data regarding hospitalization reported by the patient
every 12 weeks for a period of 36 months
Demographic information
Time Frame: every 12 weeks for a period of 36 months
data regarding demographics reported by the patient
every 12 weeks for a period of 36 months
Medication
Time Frame: every 12 weeks for a period of 36 months
survey data regarding medication use reported by the patient
every 12 weeks for a period of 36 months
MRI utilization
Time Frame: every 12 weeks for a period of 36 months
survey data regarding number of MRIs reported by the patient
every 12 weeks for a period of 36 months
Exercise
Time Frame: collected daily and summarized annually.
survey data regarding daily exercise
collected daily and summarized annually.
System level measure the patient experience for ambulatory care.
Time Frame: every 12 weeks for a period of 36 months
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
System level measure of Health Care Quality
Time Frame: every 12 weeks for a period of 36 months
Patient determined disease steps survey
every 12 weeks for a period of 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Concord Hospital
MGH Multiple Sclerosis Clinic
University of Vermont Multiple Sclerosis Center
Neurology Associates Multiple Sclerosis Center of Greater Orlando

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brant J Oliver, PhD, Dartmouth Hitchock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D16181
  • US-MSG-15-10917 (Other Grant/Funding Number: Biogen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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