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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01844492

Collaborator

(none)

1,420

Enrollment

Location

Arms

42.9

Actual Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression	Behavioral: The PARTNER Intervention Other: ICU Usual Care Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1420 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-upSample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Improving Patient and Family Centered Care in Advanced Critical Illness

Actual Study Start Date :

Jul 23, 2012

Actual Primary Completion Date :

Feb 18, 2016

Actual Study Completion Date :

Feb 18, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ICU Usual Care Control described below	Other: ICU Usual Care Control 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.
Experimental: The PARTNER Intervention described below	Behavioral: The PARTNER Intervention 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.

Arm

Intervention/Treatment

Active Comparator: ICU Usual Care Control

described below

Other: ICU Usual Care Control

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.

Experimental: The PARTNER Intervention

described below

Behavioral: The PARTNER Intervention

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.

Outcome Measures

Primary Outcome Measures

Hospital Anxiety and Depression Scale [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 Outcome Measures

Quality of Communication (QOC) scale [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.
Patient-and Family Centeredness of Care Scale [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.
Intensive Care Unit Length of Stay [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.
Total Hospitalization costs [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.
Impact of Events Scale of Care Scale [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 Outcome Measures

Mortality [At 6 months]
Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.
Katz Activities of Daily Living Scale [At 6 months]
Functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.
Hospital Length of Stay [Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.]
We will assess hospital length of stay.
6-month health care utilization [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.