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Completed

NCT Number: NCT00685893

Integrating Palliative and Critical Care (IPACC) Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Overlake Hospital Medical Center, Bellevue, Washington, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

Behavioral

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.

Local Champions

Behavioral

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.

Institution Feedback

Behavioral

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.

academic detailing

Behavioral

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.

Institutional Forms

Behavioral

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.

Primary outcomes

  1. Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.

    Time frame: 5 years

Secondary outcomes

  1. Total score of the QODD, as assessed by nurses

    Time frame: 5 years

  2. Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members

    Time frame: 5 years

  3. Indicators of quality of end-of-life care as assessed by standardized medical record review.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

An ICU Intervention to Improve End-of-Life Care

Acronym: IPACC

Important dates

Study start
2003
Primary completion
2008
Study completion
2010
First posted
May 29, 2008
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.