Skip to main content
OpenTrials
Completed

NCT Number: NCT01844492

Improving Patient and Family Centered Care in Advanced Critical Illness

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 experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) 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]

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; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Centers

Pittsburgh, Pennsylvania, 15261, United States

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

The PARTNER Intervention

Behavioral

The PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building) consists of: 1) institution of a clinical pathway for family support overseen by ICU staff nurses; 2) advanced communication skills training for ICU staff nurses; 3) a multifaceted strategy to support implementation of the clinical pathway for family support.

ICU Usual Care Control

Other

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.

Primary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: At 6 months

    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).

Secondary outcomes

  1. Quality of Communication (QOC) scale

    Time frame: At 6 months

    Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale.

  2. Patient-and Family Centeredness of Care Scale

    Time frame: At 6 months

    Patient and Family -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.

    Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records.

  4. Total Hospitalization costs

    Time frame: Duration of hospital stay, an expected average of 4 weeks

    Total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records. We will stratify this analysis by the patient's vital status at hospital discharge.

  5. Impact of Events Scale of Care 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.

Other outcomes

  1. Mortality

    Time frame: At 6 months

    Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.

  2. Katz Activities of Daily Living Scale

    Time frame: At 6 months

    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 hosptial stay, an expected average of 4 weeks.

    We will assess hospital length of stay.

  4. 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 standardized interviews with surrogates at 6 months.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: PARTNER

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 1, 2013
Registry last updated
Mar 20, 2018

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.

Published trials that share one or more normalized conditions with this study.