The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

Study Overview
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Quality Improvement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline Analysis<br>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)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome for Depression | patient reported outcome of The Effects of Your MS (PHQ-9) | every 12 weeks for a period of 36 months | 
| Clinic Outcome for Anxiety | patient reported outcome of Neuro-QOL: Anxiety survey | every 12 weeks for a period of 36 months | 
| Clinic Outcomes on Cognitive Function | patient reported outcome of Neuro-QOL: Cognitive Function survey | every 12 weeks for a period of 36 months | 
| Clinic Outcomes on mobility | 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 | 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 | 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 | 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 | 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 | patient reported outcome of Neuro-QOL: Sleep Disturbance survey | every 12 weeks for a period of 36 months | 
| Clinic Outcomes for communication | 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 | patient reported outcome of Vitamin D Level survey | every 12 weeks for a period of 36 months | 
| Clinic Outcomes for fatigue | 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 | 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 | 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 | 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 | 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 | patient reported outcome of the Daily Symptoms survey | every 12 weeks for a period of 36 months | 
| Medical History | data regarding medical history reported by the patient | every 12 weeks for a period of 36 months | 
| Hospitalization | data regarding hospitalization reported by the patient | every 12 weeks for a period of 36 months | 
| Demographic information | data regarding demographics reported by the patient | every 12 weeks for a period of 36 months | 
| Medication | survey data regarding medication use reported by the patient | every 12 weeks for a period of 36 months | 
| MRI utilization | survey data regarding number of MRIs reported by the patient | every 12 weeks for a period of 36 months | 
| Exercise | survey data regarding daily exercise | collected daily and summarized annually. | 
| 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. | every 12 weeks for a period of 36 months | 
| System level measure of Health Care Quality | Patient determined disease steps survey | every 12 weeks for a period of 36 months |