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Clinical Trials/NCT02445937
NCT02445937
Completed
N/A

Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs

University of Pittsburgh2 sites in 1 country848 target enrollmentJune 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Pittsburgh
Enrollment
848
Locations
2
Primary Endpoint
Quality of Communication (QOC) scale
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals:

  1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication.
  2. To decrease the psychological burden on family members acting as surrogates.
  3. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.
Registry
clinicaltrials.gov
Start Date
June 1, 2015
End Date
September 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas White

Vice Chair and Professor of Critical Care Medicine

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • Surrogate decision maker for ICU patient in one of 5 UPMC ICU's

Exclusion Criteria

  • Non-English Speaking
  • Surrogate's loved one is for organ transplantation
  • Not physically able to participate in family meeting

Outcomes

Primary Outcomes

Quality of Communication (QOC) scale

Time Frame: At 6 months

We will assess quality of communication in family members in a telephone interview 6 months after enrollment using the validated13 item Quality of Communication Scale.

Secondary Outcomes

  • Hospital Anxiety and Depression Scale(At 6 months)
  • Patient-Centeredness of Care Scale(At 6 months)
  • Intensive Care Unit Length of Stay(Participants will be followed for duration of ICU stay, an expected average of 21 days)
  • Impact of Events Scale(At 6 months)
  • Decision Regret Scale(At 6 months)

Study Sites (2)

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