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The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality Improvement
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurology Associates of Greater Orlando
  • Massachusetts General Hospital Multiple Sclerosis Center
  • Concord Hospital
  • University of Vermont Multiple Sclerosis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline Analysis

The effect of continuous quality improvements (CQI)

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical outcome for Depression
patient reported outcome of The Effects of Your MS (PHQ-9)
Clinic Outcome for Anxiety
patient reported outcome of Neuro-QOL: Anxiety survey
Clinic Outcomes on Cognitive Function
patient reported outcome of Neuro-QOL: Cognitive Function survey
Clinic Outcomes on mobility
patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey
Clinic Outcomes on fine motor skills and activities of daily living
patient reported outcome of Neuro-QOL: Upper Extremity Function (Fine Motor, ADL) survey
Clinic Outcomes on stigma associated with MS
patient reported outcome of Neuro-QOL: Stigma survey
Clinic Outcomes on ability to participate in social roles and activities
patient reported outcome of Neuro-QOL: Ability to Participate in Social Roles and Activities survey
Clinic Outcomes on satisfaction with social roles and activities
patient reported outcome of Neuro-QOL: Satisfaction with Social Roles and Activities survey
Clinic Outcomes for sleep disturbance
patient reported outcome of Neuro-QOL: Sleep Disturbance survey
Clinic Outcomes for communication
patient reported outcome of Neuro-QOL: Communication survey
Clinic Outcomes for Vitamin D levels in MS patients
patient reported outcome of Vitamin D Level survey
Clinic Outcomes for fatigue
patient reported outcome of PROMIS Fatigue MS survey
Clinic Outcomes for assesment of patient health status
patient reported outcome of Brief Appraisal Inventory survey
Clinic Outcomes for satisfaction of treatment by medication
patient reported outcome of Treatment Satisfaction Questionnaire for Medication (TSQM-9) survey
Clinic Outcomes for the effects of MS on the patient
patient reported outcome of The Effects of Your MS (PDDS) survey
Clinic Outcomes for the presence of a MS relapse
patient reported outcome of My MS Relapse Evaluation survey
Clinic Outcomes reporting of MS patient daily symptoms
patient reported outcome of the Daily Symptoms survey
Medical History
data regarding medical history reported by the patient
Hospitalization
data regarding hospitalization reported by the patient
Demographic information
data regarding demographics reported by the patient
Medication
survey data regarding medication use reported by the patient
MRI utilization
survey data regarding number of MRIs reported by the patient
Exercise
survey data regarding daily exercise
System level measure the patient experience for ambulatory care.
Health care quality assessment collected through the Aggregated Clinician and Group Survey to assess patient experience in ambulatory care.
System level measure of Health Care Quality
Patient determined disease steps survey

Full Information

First Posted
May 18, 2017
Last Updated
May 5, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
MGH Multiple Sclerosis Clinic, University of Vermont Multiple Sclerosis Center, Neurology Associates Multiple Sclerosis Center of Greater Orlando, Concord Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03480854
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
MGH Multiple Sclerosis Clinic, University of Vermont Multiple Sclerosis Center, Neurology Associates Multiple Sclerosis Center of Greater Orlando, Concord Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
694 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline Analysis
Arm Type
No Intervention
Arm Description
To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers.
Arm Title
The effect of continuous quality improvements (CQI)
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Quality Improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease modifying therapy utilization
Description
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.
Time Frame
every 12 weeks for a period of 36 months
Secondary Outcome Measure Information:
Title
Clinical outcome for Depression
Description
patient reported outcome of The Effects of Your MS (PHQ-9)
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcome for Anxiety
Description
patient reported outcome of Neuro-QOL: Anxiety survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on Cognitive Function
Description
patient reported outcome of Neuro-QOL: Cognitive Function survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on mobility
Description
patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on fine motor skills and activities of daily living
Description
patient reported outcome of Neuro-QOL: Upper Extremity Function (Fine Motor, ADL) survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on stigma associated with MS
Description
patient reported outcome of Neuro-QOL: Stigma survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on ability to participate in social roles and activities
Description
patient reported outcome of Neuro-QOL: Ability to Participate in Social Roles and Activities survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes on satisfaction with social roles and activities
Description
patient reported outcome of Neuro-QOL: Satisfaction with Social Roles and Activities survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for sleep disturbance
Description
patient reported outcome of Neuro-QOL: Sleep Disturbance survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for communication
Description
patient reported outcome of Neuro-QOL: Communication survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for Vitamin D levels in MS patients
Description
patient reported outcome of Vitamin D Level survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for fatigue
Description
patient reported outcome of PROMIS Fatigue MS survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for assesment of patient health status
Description
patient reported outcome of Brief Appraisal Inventory survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for satisfaction of treatment by medication
Description
patient reported outcome of Treatment Satisfaction Questionnaire for Medication (TSQM-9) survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for the effects of MS on the patient
Description
patient reported outcome of The Effects of Your MS (PDDS) survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes for the presence of a MS relapse
Description
patient reported outcome of My MS Relapse Evaluation survey
Time Frame
every 12 weeks for a period of 36 months
Title
Clinic Outcomes reporting of MS patient daily symptoms
Description
patient reported outcome of the Daily Symptoms survey
Time Frame
every 12 weeks for a period of 36 months
Title
Medical History
Description
data regarding medical history reported by the patient
Time Frame
every 12 weeks for a period of 36 months
Title
Hospitalization
Description
data regarding hospitalization reported by the patient
Time Frame
every 12 weeks for a period of 36 months
Title
Demographic information
Description
data regarding demographics reported by the patient
Time Frame
every 12 weeks for a period of 36 months
Title
Medication
Description
survey data regarding medication use reported by the patient
Time Frame
every 12 weeks for a period of 36 months
Title
MRI utilization
Description
survey data regarding number of MRIs reported by the patient
Time Frame
every 12 weeks for a period of 36 months
Title
Exercise
Description
survey data regarding daily exercise
Time Frame
collected daily and summarized annually.
Title
System level measure the patient experience for ambulatory care.
Description
Health care quality assessment collected through the Aggregated Clinician and Group Survey to assess patient experience in ambulatory care.
Time Frame
every 12 weeks for a period of 36 months
Title
System level measure of Health Care Quality
Description
Patient determined disease steps survey
Time Frame
every 12 weeks for a period of 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brant J Oliver, PhD
Organizational Affiliation
Dartmouth Hitchock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology Associates of Greater Orlando
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Massachusetts General Hospital Multiple Sclerosis Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
University of Vermont Multiple Sclerosis Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

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