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PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness

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ClinicalTrials.gov Identifier: NCT02445937
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a comparative, effectiveness trial with the overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis; and 4) structured communication at care transitions about patient's health care preferences and goals. The investigators propose to begin deployment of the PARTNERII program in the spring of 2015 enrolling 690 patients and 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals:

  1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication.
  2. To decrease the psychological burden on family members acting as surrogates.
  3. Lower costs: To reduce total health care costs by increasing the use of palliative care and hospice services and decreasing unwanted readmissions near the end of life.

Condition or disease Intervention/treatment
Anxiety Depression Other: ICU Family Communication Behavioral: PARTNER II

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: ICU Family Communication
The Comparator group for this Comparison Effectiveness Trial will receive an ICU Family Communication intervention delivered by key nurse/social workers within the ICU. The nurse/social worker interventionist will have received 4hours of training designed to aid in clinician-family communication. The nurse/social worker will touch base with families daily, attend to emotion, and facilitate a clinician-family meeting on or before day 4 of the ICU admission with at least the MD and family and nurse/social worker who acts as their advocate.
Other: ICU Family Communication
The Comparator group for this Comparison Effectiveness Trial will receive an ICU Family Communication intervention delivered by key nurse/social workers within the ICU. The nurse/social worker interventionist will have received 4hours of training designed to aid in clinician-family communication. The nurse/social worker will touch base with families daily, attend to emotion, and facilitate a clinician-family meeting on or before day 4 of the ICU admission with at least the MD and family and nurse/social worker who acts as their advocate.
Experimental: Behavioral: The PARTNER II Intervention
The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.
Behavioral: PARTNER II
The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.


Outcome Measures

Primary Outcome Measures :
  1. Symptom burden of anxiety and depression measured using the Hospital Anxiety and Depression Scale [ Time Frame: At 6 months ]
    The investigators 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

  2. Symptoms of post-traumatic stress measured using the Impact of Events Scale [ Time Frame: At 6 months ]
    The investigators 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.


Secondary Outcome Measures :
  1. Decisional Regret measured using the Decision Regret Scale [ Time Frame: At 6 months ]
    The investigators 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.

  2. Quality of communication measured using the Quality of Communication (QOC) scale [ Time Frame: At 6 months ]
    The investigators 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.

  3. Quality of end-of-life care measured using the After-Death Bereaved Family Interview [ Time Frame: At 6 months ]
    The investigators 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.

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

  5. Mortality measured using hospital records, 6 month follow-up with surrogates, and the National Death Index [ Time Frame: At 6 months ]
    The investigators 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.

  6. Functional Status measured using the Katz Activities of Daily Living Scale [ Time Frame: At 6 months ]
    The investigators will assess functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months


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

  2. Health care utilization measured using hospital records and standardized interviews [ Time Frame: Inclusive of index hospitalization and 6 months follow up ]
    The investigators will assess patient health care utilization using hospital records and through validated methods to assess utilization using standardized interviews.

  3. Hospital Length of Stay [ Time Frame: Participants will be followed for duration of hosptial stay, an expected average of 4 weeks ]
    The investigators will assess hospital length of stay.


Eligibility Criteria

Information from the National Library of Medicine

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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

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): NCT02445937


Contacts
Contact: Douglas B. White, MD,MAS 412-647-8060 whitedb@upmc.edu
Contact: Elke B Brown, MD 412-864-0760 brownep@upmc.edu

Locations
United States, Pennsylvania
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16550
Contact: Joseph Darby, MD    412-647-8413    darbyjm@ccm.upmc.edu   
Contact: Anne-Marie Shields, MSN    412-647-9102    shieldsa@upmc.edu   
UPMC Presby/Shady Recruiting
Pittsburgh, Pennsylvania, United States, 15216
Contact: Douglas B White, MD, MAS    412-864-3757    whitedb@upmc.edu   
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, Vice Chair and Professor of Critical Care Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02445937     History of Changes
Other Study ID Numbers: PRO14090204
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Keywords provided by Douglas White, University of Pittsburgh:
decision making for incapacitated patients
intensive care
surrogate decision making
patient centered care
palliative care