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临床试验/NCT03480854
NCT03480854已完成不适用

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

Dartmouth-Hitchcock Medical Center4 个研究点 分布在 1 个国家目标入组 694 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
694
试验地点
4
主要终点
Disease modifying therapy utilization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 years or older with documented clinically confirmed MS who are followed by one of the participating MS centers.

排除标准

  • •Candidates will be excluded from study entry if they are unable or unwilling to provide informed consent.

研究组 & 干预措施

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).

干预措施: Quality Improvement (Other)

结局指标

主要结局

Disease modifying therapy utilization

时间窗: 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.

次要结局

  • Clinic Outcome for Anxiety(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for Vitamin D levels in MS patients(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for fatigue(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for the effects of MS on the patient(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for the presence of a MS relapse(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for satisfaction of treatment by medication(every 12 weeks for a period of 36 months)
  • Clinical outcome for Depression(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on Cognitive Function(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on fine motor skills and activities of daily living(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on stigma associated with MS(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on ability to participate in social roles and activities(every 12 weeks for a period of 36 months)
  • Clinic Outcomes reporting of MS patient daily symptoms(every 12 weeks for a period of 36 months)
  • Medical History(every 12 weeks for a period of 36 months)
  • MRI utilization(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for communication(every 12 weeks for a period of 36 months)
  • Hospitalization(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on mobility(every 12 weeks for a period of 36 months)
  • Clinic Outcomes on satisfaction with social roles and activities(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for sleep disturbance(every 12 weeks for a period of 36 months)
  • Clinic Outcomes for assesment of patient health status(every 12 weeks for a period of 36 months)
  • Demographic information(every 12 weeks for a period of 36 months)
  • Exercise(collected daily and summarized annually.)
  • System level measure of Health Care Quality(every 12 weeks for a period of 36 months)
  • Medication(every 12 weeks for a period of 36 months)
  • System level measure the patient experience for ambulatory care.(every 12 weeks for a period of 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brant J. Oliver

Assistant Professor

Dartmouth-Hitchcock Medical Center

研究点 (4)

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