Improving Patient and Family Centered Care in Advanced Critical Illness (PARTNER)

March 16, 2018 updated by: Douglas White, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ICU Usual Care Control
described below
Other: ICU Usual Care Control
The control group will receive usual care, in which the frequency and content of clinician-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.
Experimental: The PARTNER Intervention
described below
Behavioral: The PARTNER Intervention
The PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building) consists of: 1) institution of a clinical pathway for family support overseen by ICU staff nurses; 2) advanced communication skills training for ICU staff nurses; 3) a multifaceted strategy to support implementation of the clinical pathway for family support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: 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).
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Communication (QOC) scale
Time Frame: 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.
At 6 months
Patient-and Family Centeredness of Care Scale
Time Frame: 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.
At 6 months
Intensive Care Unit Length of Stay
Time Frame: 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.
Participants will be followed for duration of ICU stay, an expected average of 21 days.
Total Hospitalization costs
Time Frame: 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.
Duration of hospital stay, an expected average of 4 weeks
Impact of Events Scale of Care Scale
Time Frame: 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.
At 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: At 6 months
Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.
At 6 months
Katz Activities of Daily Living Scale
Time Frame: At 6 months
Functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.
At 6 months
Hospital Length of Stay
Time Frame: Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.
We will assess hospital length of stay.
Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.
6-month health care utilization
Time Frame: inclusive of index hospitalization and 6 months follow up
We will assess patient health care utilization using hospital records and through standardized interviews with surrogates at 6 months.
inclusive of index hospitalization and 6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Douglas B. White, MD,MAS, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2012

Primary Completion (Actual)

February 18, 2016

Study Completion (Actual)

February 18, 2016

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13020304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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