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临床试验/NCT01758315
NCT01758315Unknown不适用

Medical Malpractice and Patient Safety Proposal

Massachusetts Department of Health4 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
213
试验地点
4
主要终点
Staff and patient survey response distribution related to lab test result tracking, referral follow-up, medication management, and communication with patients and among practice staff

研究概览

简要总结

The purpose of the Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction (PROMISES) project is to assemble a high-level Massachusetts consortium to test the impact of powerful quality improvement techniques to accomplish innovations and improvements in high risk ambulatory malpractice areas. We will target problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test ordering and results management 3) follow-up and referral management.

详细描述

Reducing medical malpractice in ambulatory care represents a priority area that has been relatively neglected in the face of more dramatic and costly inpatient errors. Given shifts in care, increasing stresses on office practices, growing evidence of unreliable office processes, and recent experience of our malpractice insurance carriers, neither complacency nor resignation to the problems of ensuring safe patient-centered office care can be justified. Working with the two leading malpractice insurers in Massachusetts, we have assembled a consortium to improve patient safety and decrease malpractice risk in ambulatory practice-the Proactive Reduction in Outpatient Malpractice: Improving Safety, Efficiency and Satisfaction (PROMISES) project. We work with leading quality improvement and safety experts to employ state-of-the art approaches and tools to achieve breakthrough changes in demonstration practices. The project has the following three specific aims:

AIM 1. Apply evidence from malpractice claims to identify key failure modes contributing to ambulatory medical errors and malpractice suits in order to redesign systems and care processes to prevent, minimize, and mitigate such errors in a group of Massachusetts primary care practices. We will target problem-prone processes in 3 areas of identified risk: 1) medication management, 2) test ordering and results management 3) follow-up and referral management.

AIM 2. Transform communication culture, processes and outcomes in demonstration practices to become more patient and family-centered, particularly around proactively seeking out, hearing, handling, and learning from patients' safety experiences, concerns and complaints.

AIM 3. In conjunction with key Massachusetts policy leaders, liability insurers, clinical, academic, quality improvement and consumer organizations, we will evaluate and disseminate the lessons learned and share successful intervention tools and strategies statewide with a broader audience of practices, practitioners, payers, and policy makers. The intervention would be designed as a randomized control trial comparing 16 demonstration practices with 9 control practices, each with 2-5 primary care providers recruited by the malpractice insurers. We will measure the effects of the improvement efforts using rigorous quantitative and qualitative data from staff interviews, patient surveys and chart review. We will then spread the successful tools, improvements, and lessons statewide.

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

入选标准

  • Primary Subjects: staff members of small to medium-sized primary care (internal medicine or family medicine) practices in Massachusetts with adult, English-speaking patients.
  • Secondary Subjects: English-speaking adults who receive care at an enrolled intervention or control office practice.

排除标准

  • Non-English-speaking

结局指标

主要结局

Staff and patient survey response distribution related to lab test result tracking, referral follow-up, medication management, and communication with patients and among practice staff

时间窗: Baseline and 15 months

Evidence of change in the distribution of staff and patient survey responses related to lab test result tracking, referral follow-up, medication management, and communication with patients and among practice staff

次要结局

  • Number of abnormal lab or test results with improper clinical follow-up(Baseline and 15 Months)
  • Number of specialist referral recommendations with improper clinical follow-up(Baseline and 15 Months)
  • Number of contraindicated medication prescriptions(Baseline and 15 Months)

研究者

发起方
Massachusetts Department of Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Madeleine Biondolillo

Director of the Bureau of Health Care Safety and Quality

Massachusetts Department of Health

研究点 (4)

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