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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The PARTNER Intervention
ICU Usual Care Control
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ICU Usual Care Control

The PARTNER Intervention

Arm Description

described below

described below

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale
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

Quality of Communication (QOC) scale
Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale.
Patient-and Family Centeredness of Care Scale
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
Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records.
Total Hospitalization costs
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.
Impact of Events Scale of Care Scale
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.

Full Information

First Posted
April 19, 2013
Last Updated
March 16, 2018
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01844492
Brief Title
Improving Patient and Family Centered Care in Advanced Critical Illness
Acronym
PARTNER
Official Title
Improving Patient and Family Centered Care in Advanced Critical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 23, 2012 (Actual)
Primary Completion Date
February 18, 2016 (Actual)
Study Completion Date
February 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICU Usual Care Control
Arm Type
Active Comparator
Arm Description
described below
Arm Title
The PARTNER Intervention
Arm Type
Experimental
Arm Description
described below
Intervention Type
Behavioral
Intervention Name(s)
The PARTNER Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ICU Usual Care Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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).
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Quality of Communication (QOC) scale
Description
Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale.
Time Frame
At 6 months
Title
Patient-and Family Centeredness of Care Scale
Description
Patient and Family -Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates.
Time Frame
At 6 months
Title
Intensive Care Unit Length of Stay
Description
Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records.
Time Frame
Participants will be followed for duration of ICU stay, an expected average of 21 days.
Title
Total Hospitalization costs
Description
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.
Time Frame
Duration of hospital stay, an expected average of 4 weeks
Title
Impact of Events Scale of Care Scale
Description
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.
Time Frame
At 6 months
Other Pre-specified Outcome Measures:
Title
Mortality
Description
Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.
Time Frame
At 6 months
Title
Katz Activities of Daily Living Scale
Description
Functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.
Time Frame
At 6 months
Title
Hospital Length of Stay
Description
We will assess hospital length of stay.
Time Frame
Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.
Title
6-month health care utilization
Description
We will assess patient health care utilization using hospital records and through standardized interviews with surrogates at 6 months.
Time Frame
inclusive of index hospitalization and 6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas B. White, MD,MAS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

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derived

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Improving Patient and Family Centered Care in Advanced Critical Illness

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