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Completed

NCT Number: NCT02445937

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hamot, Erie, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARTNER II

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 15, 2015
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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