Improving Patient and Family Centered Care in Advanced Critical Illness

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Other: ICU Usual Care Control; Behavioral: The PARTNER Intervention

• Registration Number: NCT01844492
• Lead Sponsor: University of Pittsburgh

Brief Summary

One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\]

In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-05-01
• Primary Completion: 2016-02-18
• Study Completion: 2016-02-18
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1420

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICU Usual Care Control	ICU Usual Care Control	described below
The PARTNER Intervention	The PARTNER Intervention	described below

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	At 6 months	Symptom burden of anxiety and depression in family members in a telephone interview 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS).

Secondary Outcome Measures

Name	Time	Method
Total Hospitalization costs	Duration of hospital stay, an expected average of 4 weeks	Total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records. We will stratify this analysis by the patient's vital status at hospital discharge.
Patient-and Family Centeredness of Care Scale	At 6 months	Patient and Family -Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates.
Intensive Care Unit Length of Stay	Participants will be followed for duration of ICU stay, an expected average of 21 days.	Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records.
Impact of Events Scale of Care Scale	At 6 months	We will assess symptoms of post-traumatic stress in family members in a telephone interview 6 months after enrollment using the validated 22 item Impact of Events Scale.
Quality of Communication (QOC) scale	At 6 months	Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale.

Trial Locations

Locations (1)

University of Pittsburgh Medical Centers; 🇺🇸 Pittsburgh, Pennsylvania, United States