Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction

Patient Safety Clinical Trial

— PROMISES  

Official title:

Medical Malpractice and Patient Safety Proposal

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01758315
• Other study ID #: AHRQ HS10-021
• Secondary ID: 1R18HS019508-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 3, 2012
• Last updated: December 24, 2012
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: Massachusetts Department of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 213
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non-English-speaking

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical Malpractice
• Patient Safety

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts Department of Public Health	Boston	Massachusetts

Sponsors (9)

Lead Sponsor	Collaborator
Massachusetts Department of Health	Agency for Healthcare Research and Quality (AHRQ), Brigham and Women's Hospital, Coverys, CRICO, Healthcare for All, Institute for Healthcare Improvement, Massachusetts Coalition for the Prevention of Medical Errors, Massachusetts Medical Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline and 15 months	Yes
Secondary	Number of abnormal lab or test results with improper clinical follow-up		Baseline and 15 Months	Yes
Secondary	Number of specialist referral recommendations with improper clinical follow-up		Baseline and 15 Months	Yes
Secondary	Number of contraindicated medication prescriptions		Baseline and 15 Months	Yes