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Trial record 37 of 43 for:    "multiple sclerosis" AND "vitamin D"

The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

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ClinicalTrials.gov Identifier: NCT03480854
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
MGH Multiple Sclerosis Clinic
University of Vermont Multiple Sclerosis Center
Neurology Associates Multiple Sclerosis Center of Greater Orlando
Concord Hospital
Information provided by (Responsible Party):
Brant J. Oliver, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Quality Improvement Not Applicable

Detailed Description:
This is a three year study which will employ a step-wedge randomized design which will expose three of four participating centers to a healthcare QI intervention during the 3 year period. Each of the centers exposed to an intervention will serve as its own control during a baseline pre-intervention period during the first year of the study. The fourth site will serve as a longitudinal control for comparison to the other three centers exposed to a QI intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Quality and Value of Multiple Sclerosis Care at the Microsystem Level: The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480854


Contacts
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Contact: Amy E Hall, MS 603-653-6871 amy.e.hall@hitchcock.org

Locations
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United States, Florida
Neurology Associates of Greater Orlando Recruiting
Maitland, Florida, United States, 32751
Contact: Kelly Holly, BSN    407-647-5996 ext 204    neurologyassoc@hotmail.com   
Principal Investigator: Patricia Pagnotta, ARNP         
United States, Massachusetts
Massachusetts General Hospital Multiple Sclerosis Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sarah F Rapaport, BS    617-724-3133    NMACHADO@mgh.harvard.edu   
Principal Investigator: Eric Klawiter, MD         
United States, New Hampshire
Concord Hospital Recruiting
Concord, New Hampshire, United States, 03301
Contact: Ann Cabot, DO    603-224-6691    acabot@crhc.org   
Contact: Pamela Skilton    603-224-6691      
United States, Vermont
University of Vermont Multiple Sclerosis Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Roman Pettigrew, BS    802-847-4589    roman.pettigrew@uvmhealth.org   
Principal Investigator: Andrew Solomon, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
MGH Multiple Sclerosis Clinic
University of Vermont Multiple Sclerosis Center
Neurology Associates Multiple Sclerosis Center of Greater Orlando
Concord Hospital
Investigators
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Principal Investigator: Brant J Oliver, PhD Dartmouth Hitchock

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Responsible Party: Brant J. Oliver, Assistant Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03480854     History of Changes
Other Study ID Numbers: D16181
US-MSG-15-10917 ( Other Grant/Funding Number: Biogen )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases