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

Study Overview
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Brief Summary
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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: To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication. To decrease the psychological burden on family members acting as surrogates. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.

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

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: PARTNER II


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: Sequential Assignment
Interventional Model Description: Stepped Wedge Design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Communication (QOC) scale | 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. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale | 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). | At 6 months | 
| Patient-Centeredness of Care Scale | We will assess Patient 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 | We will assess the Intensive Care Unit length of stay as assessed by abstraction of this information from the medical record. | Participants will be followed for duration of ICU stay, an expected average of 21 days | 
| Impact of Events 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 | 
| Decision Regret Scale | 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. | 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