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Completed

NCT Number: NCT03480854

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology Associates of Greater Orlando, Maitland, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality Improvement

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Clinic Outcome for Anxiety

    Time frame: every 12 weeks for a period of 36 months

    patient reported outcome of Neuro-QOL: Anxiety survey

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Clinic Outcomes for communication

    Time frame: every 12 weeks for a period of 36 months

    patient reported outcome of Neuro-QOL: Communication survey

  11. 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

  12. Clinic Outcomes for fatigue

    Time frame: every 12 weeks for a period of 36 months

    patient reported outcome of PROMIS Fatigue MS survey

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Medical History

    Time frame: every 12 weeks for a period of 36 months

    data regarding medical history reported by the patient

  19. Hospitalization

    Time frame: every 12 weeks for a period of 36 months

    data regarding hospitalization reported by the patient

  20. Demographic information

    Time frame: every 12 weeks for a period of 36 months

    data regarding demographics reported by the patient

  21. Medication

    Time frame: every 12 weeks for a period of 36 months

    survey data regarding medication use reported by the patient

  22. MRI utilization

    Time frame: every 12 weeks for a period of 36 months

    survey data regarding number of MRIs reported by the patient

  23. Exercise

    Time frame: collected daily and summarized annually.

    survey data regarding daily exercise

  24. 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.

  25. System level measure of Health Care Quality

    Time frame: every 12 weeks for a period of 36 months

    Patient determined disease steps survey

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Concord Hospital
  • MGH Multiple Sclerosis Clinic
  • Neurology Associates Multiple Sclerosis Center of Greater Orlando
  • University of Vermont

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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