PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness
Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
1 other identifier
interventional
848
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Jun 2015
Longer than P75 for not_applicable anxiety
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2019
CompletedOctober 15, 2019
October 1, 2019
4.3 years
May 13, 2015
October 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Communication (QOC) scale
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.
At 6 months
Secondary Outcomes (5)
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
Other Outcomes (5)
Mortality
At 6 months
Katz Activities of Daily Living Scale
At 6 months
Hospital Length of Stay
Participants will be followed for duration of hospital stay, an expected average of 4 weeks.
- +2 more other outcomes
Study Arms (2)
Control
NO INTERVENTIONThe control group will receive usual care, in which the frequency and content of physician-family communication is determined by the clinical team according to their usual practice. No study ICU has a protocolized approach to family communication and instead clinicians determine the timing and frequency of communication with families. All sites have palliative care services.
Behavioral: The PARTNER II Intervention
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- Surrogate decision maker for ICU patient in one of 5 UPMC ICU's
You may not qualify if:
- Non-English Speaking
- Surrogate's loved one is for organ transplantation
- Not physically able to participate in family meeting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UPMC Hamot
Erie, Pennsylvania, 16550, United States
UPMC Presby/Shady
Pittsburgh, Pennsylvania, 15216, United States
Related Publications (38)
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PMID: 32229520DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas B. White, MD, MAS
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair and Professor of Critical Care Medicine
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 15, 2015
Study Start
June 1, 2015
Primary Completion
September 18, 2019
Study Completion
September 18, 2019
Last Updated
October 15, 2019
Record last verified: 2019-10