Multiple Sclerosis
Conditions
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.
Interventions
OTHERQuality 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.
Sponsors
MGH Multiple Sclerosis Clinic
University of Vermont
Neurology Associates Multiple Sclerosis Center of Greater Orlando
Concord Hospital
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease modifying therapy utilization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome for Depression | every 12 weeks for a period of 36 months | patient reported outcome of The Effects of Your MS (PHQ-9) |
| Clinic Outcomes on Cognitive Function | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Cognitive Function survey |
| Clinic Outcomes on mobility | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey |
| Clinic Outcomes on fine motor skills and activities of daily living | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Upper Extremity Function (Fine Motor, ADL) survey |
| Clinic Outcomes on stigma associated with MS | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Stigma survey |
| Clinic Outcomes on ability to participate in social roles and activities | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Ability to Participate in Social Roles and Activities survey |
| Clinic Outcomes on satisfaction with social roles and activities | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Satisfaction with Social Roles and Activities survey |
| Clinic Outcomes for sleep disturbance | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Sleep Disturbance survey |
| Clinic Outcomes for communication | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Communication survey |
| Clinic Outcomes for Vitamin D levels in MS patients | every 12 weeks for a period of 36 months | patient reported outcome of Vitamin D Level survey |
| Clinic Outcomes for fatigue | every 12 weeks for a period of 36 months | patient reported outcome of PROMIS Fatigue MS survey |
| Clinic Outcomes for assesment of patient health status | every 12 weeks for a period of 36 months | patient reported outcome of Brief Appraisal Inventory survey |
| Clinic Outcome for Anxiety | every 12 weeks for a period of 36 months | patient reported outcome of Neuro-QOL: Anxiety survey |
| Clinic Outcomes for the effects of MS on the patient | every 12 weeks for a period of 36 months | patient reported outcome of The Effects of Your MS (PDDS) survey |
| Clinic Outcomes for the presence of a MS relapse | every 12 weeks for a period of 36 months | patient reported outcome of My MS Relapse Evaluation survey |
| Clinic Outcomes reporting of MS patient daily symptoms | every 12 weeks for a period of 36 months | patient reported outcome of the Daily Symptoms survey |
| Medical History | every 12 weeks for a period of 36 months | data regarding medical history reported by the patient |
| Hospitalization | every 12 weeks for a period of 36 months | data regarding hospitalization reported by the patient |
| Demographic information | every 12 weeks for a period of 36 months | data regarding demographics reported by the patient |
| Medication | every 12 weeks for a period of 36 months | survey data regarding medication use reported by the patient |
| MRI utilization | every 12 weeks for a period of 36 months | survey data regarding number of MRIs reported by the patient |
| Exercise | collected daily and summarized annually. | survey data regarding daily exercise |
| System level measure the patient experience for ambulatory care. | 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. |
| System level measure of Health Care Quality | every 12 weeks for a period of 36 months | Patient determined disease steps survey |
| Clinic Outcomes for satisfaction of treatment by medication | every 12 weeks for a period of 36 months | patient reported outcome of Treatment Satisfaction Questionnaire for Medication (TSQM-9) survey |
Countries
United States
Outcome results
None listed