Integrating Palliative and Critical Care (IPACC) Study

Phase 3

Completed

• Conditions: Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU
• Interventions: Behavioral: Education; Behavioral: Local Champions; Behavioral: Institution Feedback; Behavioral: Academic Detailing; Behavioral: Institutional Forms

• Registration Number: NCT00685893
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this research study is to evaluate an intervention to improve the care given to patients who are dying in the intensive care unit (ICU) and their families. This study is a multi-center randomized trial of a multi-faceted quality improvement intervention designed to improve the quality of palliative and end-of-life care in the ICU setting. The intervention targets the hospital and the outcome evaluation occurs at the level of the individual patient and family with surveys completed by family members and nurses as well as standardized medical record review.

Detailed Description

Because of the severity of illness, the intensive care unit (ICU) is a setting where death is prevalent and where the majority of deaths involve decisions to withhold or withdraw life-sustaining therapies. There is substantial data to suggest that the quality of end-of-life care in the ICU is poor. Many patients die with moderate to severe pain, physicians are often unaware of patients' wishes regarding end-of-life care, and the care patients' receive is often not consistent with their treatment preferences. Our study aims to evaluate the effectiveness of a multi-faceted intervention to improve the quality of care for patients dying in, or shortly after a stay in, the ICU using a randomized controlled study of 12 hospitals. In addition we plan to examine the variability in, and predictors of, the quality of dying and end-of-life care in community hospital ICUs with the purpose of identifying the current quality of end-of-life care and the institutional, clinician, and patient factors associated with the quality of this care. We will evaluate the successful and unsuccessful components of the intervention and describe the institutional and clinician facilitators and barriers to the intervention's implementation, with a focus on identifying interventions to improve care for the dying at other sites.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2008-03
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-29
• Study Completion: 2010-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3498

Inclusion Criteria

• patients, family members, nurses, and clinician evaluators

Patients are eligible if they are:

• in the ICU for a minimum of 6 hours AND,
• if they die in an ICU or within 24 hours of transfer out of the ICU.

Family members or significant others are eligible if:

• they were involved with the patient who has died.

Nurses are eligible if:

• they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.

Clinicians are eligible to evaluate the intervention components if they:

• work in a study ICU AND
• participate in any of the intervention components.

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Exclusion Criteria

• Inability to read English well enough to complete the surveys
• Under 18 years of age.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Education	6 community hospital ICUs receiving 5-component intervention.
Intervention Arm	Local Champions	6 community hospital ICUs receiving 5-component intervention.
Intervention Arm	Institution Feedback	6 community hospital ICUs receiving 5-component intervention.
Intervention Arm	Academic Detailing	6 community hospital ICUs receiving 5-component intervention.
Intervention Arm	Institutional Forms	6 community hospital ICUs receiving 5-component intervention.

Primary Outcome Measures

Name	Time	Method
Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.	5 years

Secondary Outcome Measures

Name	Time	Method
Total score of the QODD, as assessed by nurses	5 years
Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members	5 years
Indicators of quality of end-of-life care as assessed by standardized medical record review.	5 years

Trial Locations

Locations (15)

Overlake Hospital Medical Center; 🇺🇸 Bellevue, Washington, United States

Evergreen Hospital Medical Center; 🇺🇸 Kirkland, Washington, United States

Stevens Hospital; 🇺🇸 Edmonds, Washington, United States

Highline Medical Center; 🇺🇸 Burien, Washington, United States

Harrison Memorial Hospital; 🇺🇸 Bremerton, Washington, United States

Valley Medical Center; 🇺🇸 Renton, Washington, United States

Swedish Medical Center; Ballard Campus; 🇺🇸 Seattle, Washington, United States

Veteran's Affairs Puget Sound HCS; 🇺🇸 Seattle, Washington, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

University of Washington; Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center; Cherry Hill Campus; 🇺🇸 Seattle, Washington, United States

Northwest Hospital Medical Center; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center; First Hill Campus; 🇺🇸 Seattle, Washington, United States

Saint Joseph Hospital; 🇺🇸 Tacoma, Washington, United States

University of Washington; UW Medical Center; 🇺🇸 Seattle, Washington, United States