Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction (PROMISES)
|ClinicalTrials.gov Identifier: NCT01758315|
Recruitment Status : Unknown
Verified December 2012 by Madeleine Biondolillo, Massachusetts Department of Health.
Recruitment status was: Enrolling by invitation
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Medical Malpractice Patient Safety||Other: Training and in-office coaching||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Medical Malpractice and Patient Safety Proposal|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
Experimental: Improvement Sessions
We will implement a context-sensitive collaborative improvement model that will emphasize training and in-office coaching by quality improvement, efficiency and safety experts, as well as shared learning methods to develop, test and implement changes in the following four key risk areas: medication management; test and lab results management; follow-up and referral management; and communication - within and between practices as well as with patients.
Other: Training and in-office coaching
Participating practices will be coached to perform rapid, small-scale tests of change and to iteratively improve performance of problem-prone care systems, as well as to imbed simple measurement in routine daily work streams to guide improvement efforts. The sixteen intervention practices will serve as realistic research laboratories to help advance malpractice risk prevention and patient safety in specific areas by refining tools and strategies for smaller practices.
No Intervention: Control
Control practices will not receive training or in-office coaching.
- 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 [ Time Frame: 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
- Number of abnormal lab or test results with improper clinical follow-up [ Time Frame: Baseline and 15 Months ]
- Number of specialist referral recommendations with improper clinical follow-up [ Time Frame: Baseline and 15 Months ]
- Number of contraindicated medication prescriptions [ Time Frame: Baseline and 15 Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758315
|United States, Massachusetts|
|Massachusetts Department of Public Health|
|Boston, Massachusetts, United States, 02111|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02120|
|Principal Investigator:||Madeleine Biondolillo, MD||Massachusetts Department of Health|
|Study Chair:||Gordon Schiff, MD||Brigham and Women's Hospital|
|Study Director:||Nicholas Leydon, MPH||Massachusetts Department of Health|