Clinical trial NCT01758315: Proactive Reduction of Outpatient Malpractice: Increasing Safety, Efficiency, and Satisfaction
Official title: Medical Malpractice and Patient Safety Proposal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Malpractice
Patient Safety
Keywords: Ambulatory
Outpatient
Malpractice
Quality Improvement
Patient Safety
Lead sponsor: Massachusetts Department of Health
Sponsor class: OTHER_GOV
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts Coalition for the Prevention of Medical Errors
name: Institute for Healthcare Improvement
name: Massachusetts Medical Society
name: Healthcare for All
name: Crico
name: Coverys
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-01-01
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and 15 months
Secondary outcomes:
measure: Number of abnormal lab or test results with improper clinical follow-up
timeFrame: Baseline and 15 Months
measure: Number of specialist referral recommendations with improper clinical follow-up
timeFrame: Baseline and 15 Months
measure: Number of contraindicated medication prescriptions
timeFrame: Baseline and 15 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Department of Public Health
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts Department of Health
name: Madeleine Biondolillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Gordon Schiff, MD
role: STUDY_CHAIR
affiliation: Massachusetts Department of Health
name: Nicholas Leydon, MPH
role: STUDY_DIRECTOR
References: