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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 : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas White, University of Pittsburgh

Brief Summary:

This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. 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. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 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. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: PARTNER II Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped Wedge Design
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
Actual Study Start Date : June 1, 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

Arm Intervention/treatment
No Intervention: Control
The control group will receive usual care, in which the frequency and content of physician-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: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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 as assessed by abstraction of this information from the medical record.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Mortality [ Time Frame: At 6 months ]
    We will assess hospital mortality and 6-month 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.

  2. 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.

  3. Hospital Length of Stay [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 4 weeks. ]
    We will assess hospital length of stay by abstraction of this information from the medical record at hospital discharge.

  4. Total Hospitalization costs [ Time Frame: Inclusive of index hospitalization ]
    We will measure total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records.

  5. 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 validated methods to assess utilization using 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): 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

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: June 19, 2018
Last Verified: June 2018

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