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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts Coalition for the Prevention of Medical Errors
Institute for Healthcare Improvement
Massachusetts Medical Society
Healthcare for All
CRICO
Coverys
Information provided by (Responsible Party):
Madeleine Biondolillo, Massachusetts Department of Health
ClinicalTrials.gov Identifier:
NCT01758315
First received: December 3, 2012
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Medical Malpractice
Patient Safety
Other: Training and in-office coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Medical Malpractice and Patient Safety Proposal

Resource links provided by NLM:


Further study details as provided by Massachusetts Department of Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Number of abnormal lab or test results with improper clinical follow-up [ Time Frame: Baseline and 15 Months ] [ Designated as safety issue: Yes ]
  • Number of specialist referral recommendations with improper clinical follow-up [ Time Frame: Baseline and 15 Months ] [ Designated as safety issue: Yes ]
  • Number of contraindicated medication prescriptions [ Time Frame: Baseline and 15 Months ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758315

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Massachusetts Department of Public Health
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Massachusetts Department of Health
Brigham and Women's Hospital
Massachusetts Coalition for the Prevention of Medical Errors
Institute for Healthcare Improvement
Massachusetts Medical Society
Healthcare for All
CRICO
Coverys
Investigators
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
  More Information

No publications provided

Responsible Party: Madeleine Biondolillo, Director of the Bureau of Health Care Safety and Quality, Massachusetts Department of Health
ClinicalTrials.gov Identifier: NCT01758315     History of Changes
Other Study ID Numbers: AHRQ HS10-021, 1R18HS019508-01
Study First Received: December 3, 2012
Last Updated: December 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Department of Health:
Ambulatory
Outpatient
Malpractice
Quality Improvement
Patient Safety

ClinicalTrials.gov processed this record on November 20, 2014