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

Medical Malpractice and Patient Safety Proposal

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01758315
Acronym
PROMISES
Enrollment
213
Registered
2013-01-01
Start date
2010-07-31
Completion date
2013-06-30
Last updated
2013-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Malpractice, Patient Safety

Keywords

Ambulatory, Outpatient, Malpractice, Quality Improvement, Patient Safety

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.

Interventions

OTHERTraining 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.

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Massachusetts Coalition for the Prevention of Medical Errors
CollaboratorOTHER
Institute for Healthcare Improvement
CollaboratorOTHER
Massachusetts Medical Society
CollaboratorOTHER
Healthcare for All
CollaboratorUNKNOWN
Crico
CollaboratorOTHER
Coverys
CollaboratorUNKNOWN
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Massachusetts Department of Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Staff and patient survey response distribution related to lab test result tracking, referral follow-up, medication management, and communication with patients and among practice staffBaseline and 15 monthsEvidence 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

Secondary

MeasureTime frame
Number of abnormal lab or test results with improper clinical follow-upBaseline and 15 Months
Number of specialist referral recommendations with improper clinical follow-upBaseline and 15 Months
Number of contraindicated medication prescriptionsBaseline and 15 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026