Improving Patient and Family Centered Care in Advanced Critical Illness

Study Overview
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Brief Summary
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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.

Official Title
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Improving Patient and Family Centered Care in Advanced Critical Illness

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: The PARTNER Intervention
* Other: ICU Usual Care Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICU Usual Care Control<br>described below | Other: ICU Usual Care Control<br>* 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.<br>|
| Experimental: The PARTNER Intervention<br>described below | Behavioral: The PARTNER Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale | 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). | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Communication (QOC) scale | Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale. | At 6 months | 
| Patient-and Family Centeredness of Care Scale | Patient and Family -Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates. | At 6 months | 
| Intensive Care Unit Length of Stay | Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records. | Participants will be followed for duration of ICU stay, an expected average of 21 days. | 
| Total Hospitalization costs | 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. | Duration of hospital stay, an expected average of 4 weeks | 
| Impact of Events Scale of Care Scale | 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. | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making for incapacitated patients, intensive care, surrogate decision making, patient centered care, Palliative Care, End of Life, Quality of Communication