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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT02445937
Collaborator
(none)
848
Enrollment
2
Locations
2
Arms
51.6
Actual Duration (Months)
424
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: PARTNER II
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
848 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped Wedge DesignStepped 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 :
Jun 1, 2015
Actual Primary Completion Date :
Sep 18, 2019
Actual Study Completion Date :
Sep 18, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Communication (QOC) scale [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 UPMC Hamot Erie Pennsylvania United States 16550
2 UPMC Presby/Shady Pittsburgh Pennsylvania United States 15216

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: Douglas B. White, MD, MAS, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Douglas White, Vice Chair and Professor of Critical Care Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02445937
Other Study ID Numbers:
  • PRO14090204
First Posted:
May 15, 2015
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Keywords provided by Douglas White, Vice Chair and Professor of Critical Care Medicine, University of Pittsburgh
decision making for incapacitated patients
intensive care
surrogate decision making
patient centered care
palliative care
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Oct 15, 2019