Multiple SclerosisNCT03480854
The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative
A study testing Quality Improvement in people with Multiple Sclerosis, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Quality Improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with documented clinically confirmed MS who are followed by one of the participating MS centers.
Who cannot join
- Candidates will be excluded from study entry if they are unable or unwilling to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Multiple Sclerosis Center
Boston, Massachusetts, 02114
University of Vermont Multiple Sclerosis Center
Burlington, Vermont, 05401
Concord Hospital
Concord, New Hampshire, 03301
Neurology Associates of Greater Orlando
Maitland, Florida, 32751
About this study
Official title: Improving Quality and Value of Multiple Sclerosis Care at the Microsystem Level: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Quality Improvement
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality ImprovementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Analysis | No intervention | To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers. |
| The effect of continuous quality improvements (CQI) | Experimental | 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). Receives: Other: Quality Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 12 weeks for a period of 36 months
Secondary outcomes (25)
Clinical outcome for Depression
patient reported outcome of The Effects of Your MS (PHQ-9)
Measured: every 12 weeks for a period of 36 months
Clinic Outcome for Anxiety
patient reported outcome of Neuro-QOL: Anxiety survey
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes on Cognitive Function
patient reported outcome of Neuro-QOL: Cognitive Function survey
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes on mobility
patient reported outcome of Neuro-QOL: Lower Extremity Function (Mobility) survey
Measured: 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
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes on stigma associated with MS
patient reported outcome of Neuro-QOL: Stigma survey
Measured: 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
Measured: 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
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes for sleep disturbance
patient reported outcome of Neuro-QOL: Sleep Disturbance survey
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes for communication
patient reported outcome of Neuro-QOL: Communication survey
Measured: 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
Measured: every 12 weeks for a period of 36 months
Clinic Outcomes for fatigue
patient reported outcome of PROMIS Fatigue MS survey
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: every 12 weeks for a period of 36 months
Medical History
data regarding medical history reported by the patient
Measured: every 12 weeks for a period of 36 months
Hospitalization
data regarding hospitalization reported by the patient
Measured: every 12 weeks for a period of 36 months
Demographic information
data regarding demographics reported by the patient
Measured: every 12 weeks for a period of 36 months
Medication
survey data regarding medication use reported by the patient
Measured: every 12 weeks for a period of 36 months
MRI utilization
survey data regarding number of MRIs reported by the patient
Measured: every 12 weeks for a period of 36 months
Exercise
survey data regarding daily exercise
Measured: 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.
Measured: every 12 weeks for a period of 36 months
System level measure of Health Care Quality
Patient determined disease steps survey
Measured: every 12 weeks for a period of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MGH Multiple Sclerosis Clinic, University of Vermont, Neurology Associates Multiple Sclerosis Center of Greater Orlando, Concord Hospital
- Responsible party
- Principal investigator, Brant J. Oliver, Dartmouth-Hitchcock Medical Center
- Investigators
- Brant J Oliver, PhD, Principal investigator, Dartmouth Hitchock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480854
- Sponsor's protocol ID
- D16181
- Other IDs
- US-MSG-15-10917
- Status last verified
- May 2021
- First submitted
- 18 May 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality and Value of Multiple Sclerosis Care at the Microsystem Level: The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative
- ClinicalTrials.gov ID
- NCT03480854
- Acronym / sponsor ID
- D16181
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- MGH Multiple Sclerosis Clinic, University of Vermont, Neurology Associates Multiple Sclerosis Center of Greater Orlando, Concord Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Baseline Analysis | No intervention | –To conduct studies of variation in performance across microsystems and to utilize benchmarking analyses to identify top performers. |
| The effect of continuous quality improvements (CQI) | Experimental | Other: Quality ImprovementTo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older with documented clinically confirmed MS who are followed by one of the participating MS centers.
Key exclusion criteria (1 listed)
- Candidates will be excluded from study entry if they are unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality ImprovementRandomly 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. | Other | The effect of continuous quality improvements (CQI) |
Primary outcome
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.
25 secondary outcomes
Clinical outcome for Depression
Time frame: every 12 weeks for a period of 36 months
Clinic Outcome for Anxiety
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on Cognitive Function
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on mobility
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on fine motor skills and activities of daily living
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on stigma associated with MS
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on ability to participate in social roles and activities
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes on satisfaction with social roles and activities
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for sleep disturbance
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for communication
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for Vitamin D levels in MS patients
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for fatigue
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for assesment of patient health status
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for satisfaction of treatment by medication
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for the effects of MS on the patient
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes for the presence of a MS relapse
Time frame: every 12 weeks for a period of 36 months
Clinic Outcomes reporting of MS patient daily symptoms
Time frame: every 12 weeks for a period of 36 months
Medical History
Time frame: every 12 weeks for a period of 36 months
Hospitalization
Time frame: every 12 weeks for a period of 36 months
Demographic information
Time frame: every 12 weeks for a period of 36 months
Medication
Time frame: every 12 weeks for a period of 36 months
MRI utilization
Time frame: every 12 weeks for a period of 36 months
Exercise
Time frame: collected daily and summarized annually.
System level measure the patient experience for ambulatory care.
Time frame: every 12 weeks for a period of 36 months
System level measure of Health Care Quality
Time frame: every 12 weeks for a period of 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brant J Oliver, PhD principal investigator
Dartmouth Hitchock
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement in people with Multiple Sclerosis, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease modifying therapy utilization (time frame: every 12 weeks for a period of 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.