CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 848 enrolled
Drug / intervention
PARTNER IIbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02445937
NCT02445937N/ACompleted

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

University of Pittsburgh·interventional·Posted May 15, 2015·Updated Oct 15, 2019

In Brief

A clinical study evaluating PARTNER II for Anxiety and Depression. Completed, enrolled 848 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety, Depression
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 15, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 18, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.1 years ago

Interventions

PARTNER IIbehavioral

The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.