University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, 15261, United States
NCT Number: NCT01844492
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15261, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
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.
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.
Time frame: At 6 months
Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.
Time frame: At 6 months
Functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.
Time frame: Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.
We will assess hospital length of stay.
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.
University of Pittsburgh
Other
Acronym: PARTNER
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