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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Douglas White, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Douglas White, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01844492
First received: April 19, 2013
Last updated: May 3, 2017
Last verified: May 2017
  Purpose

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 struggle in the role of surrogate, 2)leading to lasting psychological distress associated with the ICU experience 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]

The long term goal of the investigators research program is to develop, test, and disseminate strategies to improve surrogate decision making for incapacitated patients and to mitigate adverse psychological outcomes among surrogates. 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; 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, and 4) increases use of palliative care services for patients with a poor prognosis. The investigators 2-year pilot study documented that the intervention is feasible, sustainable, and is associated with shorter ICU length of stay and cost savings. The objective of this proposal, which is the next step in pursuit of the long term goal, 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 Intervention
Anxiety Depression Behavioral: The PARTNER Intervention Other: ICU Usual Care Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Patient and Family Centered Care in Advanced Critical Illness

Resource links provided by NLM:


Further study details as provided by Douglas White, University of Pittsburgh:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: At 6 months ]
    We will assess 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) across treatment groups.


Secondary Outcome Measures:
  • Impact of Events 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 across treatment groups.

  • Decision Regret Scale [ Time Frame: At 6 months ]
    We will assess Decisional Regret by family members in a telephone interview 6 months after enrollment using the validated 5 item Decision Regret Scale across treatment groups.

  • Quality of Communication (QOC) scale [ Time Frame: At 6 months ]
    We will assess quality of communication in family members in a telephone interview 6 months after enrollment using the validated13 item Quality of Communication Scale across treatment groups.

  • After-Death Bereaved Family Interview [ Time Frame: At 6 months ]
    We will assess quality of end-of-life care using the After-Death Bereaved Family Interview, a validated measure completed by family after a patient's death.

  • Patient-Perceived Patient-Centeredness of Care Scale [ Time Frame: At 6 months ]
    We will assess Patient Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates.

  • Mortality [ Time Frame: At 6 months. ]
    We will assess mortality using hospital records, 6 month follow-up with surrogates, and the National Death Index in cases in which participants are lost to telephone follow up.

  • Katz Activities of Daily Living Scale [ Time Frame: At 6 months ]
    We will assess functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months


Other Outcome Measures:
  • Intensive Care Unit Length of Stay [ Time Frame: Participants will be followed for duration of ICU stay, an expected average of 21 days. ]
    We will assess the Intensive Care Unit length of stay.

  • 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 validated methods to assess utilization using standardized interviews.

  • 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.


Estimated Enrollment: 1000
Study Start Date: April 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
In general terms, the PARTNER intervention gives 1) new leadership responsibilities and advanced communication training to the local nurse leaders and social work members of the ICU team and 2) makes systems-level changes to reliably achieve desired care practices. One PARTNER interventionist is assigned as the "main support" for each family, and, through detailed hand-offs and introductions, the ICU's other interventionists fill in when needed. The interdisciplinary intervention 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; 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, and 4) increases use of palliative care services for patients with a poor prognosis.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844492

Contacts
Contact: Douglas B. White, MD, MAS 412-647-8060 whitedb@upmc.edu
Contact: Anne-Marie Shields, MSN,RN 412-647-9102 shieldsa@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Douglas B. White, MS, MAS    412-647-8060      
Contact: Anne-Marie Shields, MSN,RN    412-647-9102    shieldsa@upmc.edu   
Principal Investigator: Douglas B. White, MD, MAS         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Douglas B. White, MD,MAS University of Pittsburgh
  More Information

Publications:

Responsible Party: Douglas White, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01844492     History of Changes
Other Study ID Numbers: PRO13020304
Study First Received: April 19, 2013
Last Updated: May 3, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017