Clinical trial NCT02445937: PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness
Official title: Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: decision making for incapacitated patients
intensive care
surrogate decision making
patient centered care
palliative care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Design
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Quality of Communication (QOC) scale
timeFrame: At 6 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: At 6 months
measure: Patient-Centeredness of Care Scale
timeFrame: At 6 months
measure: Intensive Care Unit Length of Stay
timeFrame: Participants will be followed for duration of ICU stay, an expected average of 21 days
measure: Impact of Events Scale
timeFrame: At 6 months
measure: Decision Regret Scale
timeFrame: At 6 months
Other outcomes:
measure: Mortality
timeFrame: At 6 months
measure: Katz Activities of Daily Living Scale
timeFrame: At 6 months
measure: Hospital Length of Stay
timeFrame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks.
measure: Total Hospitalization costs
timeFrame: Inclusive of index hospitalization
measure: 6-month health care utilization
timeFrame: Inclusive of index hospitalization and 6 months follow up
Locations:
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presby/Shady
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas B. White, MD, MAS
role: PRINCIPAL_INVESTIGATOR
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