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

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ClinicalTrials.gov Identifier: NCT01844492
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas White, 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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: The PARTNER Intervention Other: ICU Usual Care Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Patient and Family Centered Care in Advanced Critical Illness
Actual Study Start Date : July 23, 2012
Actual Primary Completion Date : February 18, 2016
Actual Study Completion Date : February 18, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Mortality [ Time Frame: At 6 months ]
    Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844492


Locations
United States, Pennsylvania
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Douglas B. White, MD,MAS University of Pittsburgh

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas White, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01844492     History of Changes
Other Study ID Numbers: PRO13020304
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Douglas White, University of Pittsburgh:
decision making for incapacitated patients
intensive care
surrogate decision making
patient centered care
Palliative Care
End of Life
Quality of Communication

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes