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

NCT01758315 | Unknown DMC

• 2 other identifiers: AHRQ HS10-0211R18HS019508-01
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 2

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.

Conditions

Medical Malpractice; Patient Safety

Keywords

Ambulatory; Outpatient; Malpractice; Quality Improvement; Patient Safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of abnormal lab or test results with improper clinical follow-up

  Baseline and 15 Months

• Number of specialist referral recommendations with improper clinical follow-up

  Baseline and 15 Months

• Number of contraindicated medication prescriptions

  Baseline and 15 Months

Study Arms (2)

Improvement Sessions

EXPERIMENTAL

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

Control

NO INTERVENTION

Control practices will not receive training or in-office coaching.

Interventions

Training and in-office coaching OTHER

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.

Improvement Sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-English-speaking

Sponsors & Collaborators

• Massachusetts Department of Health: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts Coalition for the Prevention of Medical Errors: collaborator
• Institute for Healthcare Improvement: collaborator
• Massachusetts Medical Society: collaborator
• Healthcare for All: collaborator
• Crico: collaborator
• Coverys: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Massachusetts Department of Public Health

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Study Officials

• Madeleine Biondolillo, MD

  Massachusetts Department of Health

  PRINCIPAL INVESTIGATOR

• Gordon Schiff, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Nicholas Leydon, MPH

  Massachusetts Department of Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Bureau of Health Care Safety and Quality

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: January 1, 2013
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 1, 2013

Record last verified: 2012-12

Locations

US (2)