Integrating Palliative and Critical Care (IPACC) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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An ICU Intervention to Improve End-of-Life Care

Conditions
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Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Local Champions
* Behavioral: Institution Feedback
* Behavioral: Academic Detailing
* Behavioral: Institutional Forms


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Inability to read English well enough to complete the surveys Under 18 years of age.

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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No

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial | |
| Experimental: Intervention Arm<br>6 community hospital ICUs receiving 5-component intervention. | Behavioral: Education<br>* We include information about end-of-life decision-making, communication skills, pain and symptom management, and withdrawal of life support. The primary methods of delivery will be a grand rounds lecture by one of the physician investigators and the viewing of an educational video for nurses and respiratory therapists. The content of the educational components will be structured to cover four topics: the principles of decision-making about end-of-life care in the ICU; communication with patients, families and the ICU team; pain and symptom management; and, the principles and practice of withdrawal of life support.<br>Behavioral: Local Champions<br>* We identify physicians, nurses and other clinicians from each hospital to serve as the local champions. The role of the local champions is to help implement the intervention and be a role model for end-of-life care in the ICU. Local champions participate in interactive education and training sessions with the investigators and the other local champions from their institution to discuss barriers to good end-of-life care at their location and to strategize about how to overcome those barriers.<br>Behavioral: Institution Feedback<br>* We provide feedback to the institution from the hospital specific family satisfaction data we collect. All feedback is presented as aggregated data for the institution without any personal identifiers.<br>Behavioral: Academic Detailing<br>* Study staff meet with ICU directors with 4 goals. The first goal is to familiarize the director with the educational content of the intervention. Secondly, the results of the family satisfaction data collected are shared without identifying information. The aggregated results of the other participating hospitals are disclosed, also without identifiers. Third, we elicit and discuss the institution-specific barriers to providing high quality end-of-life care in the ICU. Lastly, we hope that by educating the directors we can engage these clinical leaders to serve as role models in their institutions.<br>Behavioral: Institutional Forms<br>* We have developed a set of orders that encompass the various aspects of withdrawing life support from patients. Individual department directors at each hospital will decide if they want to implement a similar order form at their institution and whether they want to modify the form to fit their specific institutional needs. In addition to the order forms, we encourage hospitals to develop a family pamphlets and resources that can be given to families to provide education about the intensive care unit experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-of-life issues, Talking with your doctor, Coping with chronic illness