Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICUPhase 3IPACCNCT00685893

Integrating Palliative and Critical Care (IPACC) Study

A Phase 3 study testing Education, Local Champions and Institution Feedback in people with Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU, run by University of Washington at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU
What is being tested?: Education, Local Champions and Institution Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,498 participants
Where: 15 sitesUnited States
Study dates: Jun 2003to Oct 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Overlake Hospital Medical Center
Bellevue, Washington, 98004
Harrison Memorial Hospital
Bremerton, Washington, 98310
Highline Medical Center
Burien, Washington, 98166
Stevens Hospital
Edmonds, Washington, 98056
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
Valley Medical Center
Renton, Washington, 98058
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Washington; Harborview Medical Center
Seattle, Washington, 98104
Swedish Medical Center; Ballard Campus
Seattle, Washington, 98107
Veteran's Affairs Puget Sound HCS
Seattle, Washington, 98108
Swedish Medical Center; Cherry Hill Campus
Seattle, Washington, 98112
Swedish Medical Center; First Hill Campus
Seattle, Washington, 98122
Northwest Hospital Medical Center
Seattle, Washington, 98133
University of Washington; UW Medical Center
Seattle, Washington, 98195
Saint Joseph Hospital
Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: An ICU Intervention to Improve End-of-Life Care

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.

Read the 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.

Conditions: Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU
Being tested: Education, Local Champions, Institution Feedback, Academic Detailing, Institutional Forms
Keywords: End-of-life issues, Talking with your doctor, Coping with chronic illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EducationBehavioural
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 ChampionsBehavioural
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 FeedbackBehavioural
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 DetailingBehavioural
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 FormsBehavioural
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.

Study groups in NCT00685893
Study group	Role	What they receive
Control Arm	No intervention	6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial
Intervention Arm	Experimental	6 community hospital ICUs receiving 5-component intervention. Receives: Behavioral: Education; Behavioral: Local Champions; Behavioral: Institution Feedback; Behavioral: Academic Detailing; Behavioral: Institutional Forms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Oct 2010

First posted29 May 2008 (estimated)
Study startJun 2003
Primary completionMar 2008
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICUStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,498 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00685893
Sponsor's protocol ID: 23503-G
Other IDs: R01NR005226
Acronym: IPACC
Status last verified: Jun 2013
First submitted: 27 May 2008
Last updated: 27 Jun 2013
Results posted: No
Data monitoring committee: Yes

Publications

Treece PD, Engelberg RA, Shannon SE, Nielsen EL, Braungardt T, Rubenfeld GD, Steinberg KP, Curtis JR. Integrating palliative and critical care: description of an intervention. Crit Care Med. 2006 Nov;34(11 Suppl):S380-7. doi: 10.1097/01.CCM.0000237045.12925.09.
PubMed 17057602
Curtis JR, Treece PD, Nielsen EL, Downey L, Shannon SE, Braungardt T, Owens D, Steinberg KP, Engelberg RA. Integrating palliative and critical care: evaluation of a quality-improvement intervention. Am J Respir Crit Care Med. 2008 Aug 1;178(3):269-75. doi: 10.1164/rccm.200802-272OC. Epub 2008 May 14.
PubMed 18480429
Curtis JR, Nielsen EL, Treece PD, Downey L, Dotolo D, Shannon SE, Back AL, Rubenfeld GD, Engelberg RA. Effect of a quality-improvement intervention on end-of-life care in the intensive care unit: a randomized trial. Am J Respir Crit Care Med. 2011 Feb 1;183(3):348-55. doi: 10.1164/rccm.201006-1004OC. Epub 2010 Sep 10.
PubMed 20833820
Brown CE, Engelberg RA, Nielsen EL, Curtis JR. Palliative Care for Patients Dying in the Intensive Care Unit with Chronic Lung Disease Compared with Metastatic Cancer. Ann Am Thorac Soc. 2016 May;13(5):684-9. doi: 10.1513/AnnalsATS.201510-667OC.
PubMed 26784137
Ramos KJ, Downey L, Nielsen EL, Treece PD, Shannon SE, Curtis JR, Engelberg RA. Using Nurse Ratings of Physician Communication in the ICU To Identify Potential Targets for Interventions To Improve End-of-Life Care. J Palliat Med. 2016 Mar;19(3):292-9. doi: 10.1089/jpm.2015.0155. Epub 2015 Dec 18.
PubMed 26685082
Lee JJ, Long AC, Curtis JR, Engelberg RA. The Influence of Race/Ethnicity and Education on Family Ratings of the Quality of Dying in the ICU. J Pain Symptom Manage. 2016 Jan;51(1):9-16. doi: 10.1016/j.jpainsymman.2015.08.008. Epub 2015 Sep 16.
PubMed 26384556
Johnson JR, Engelberg RA, Nielsen EL, Kross EK, Smith NL, Hanada JC, Doll O'Mahoney SK, Curtis JR. The association of spiritual care providers' activities with family members' satisfaction with care after a death in the ICU*. Crit Care Med. 2014 Sep;42(9):1991-2000. doi: 10.1097/CCM.0000000000000412.
PubMed 24797373
Kross EK, Engelberg RA, Downey L, Cuschieri J, Hallman MR, Longstreth WT Jr, Tirschwell DL, Curtis JR. Differences in end-of-life care in the ICU across patients cared for by medicine, surgery, neurology, and neurosurgery physicians. Chest. 2014 Feb;145(2):313-321. doi: 10.1378/chest.13-1351.
PubMed 24114410
DeCato TW, Engelberg RA, Downey L, Nielsen EL, Treece PD, Back AL, Shannon SE, Kross EK, Curtis JR. Hospital variation and temporal trends in palliative and end-of-life care in the ICU. Crit Care Med. 2013 Jun;41(6):1405-11. doi: 10.1097/CCM.0b013e318287f289.
PubMed 23518869
Kross EK, Nielsen EL, Curtis JR, Engelberg RA. Survey burden for family members surveyed about end-of-life care in the intensive care unit. J Pain Symptom Manage. 2012 Nov;44(5):671-80. doi: 10.1016/j.jpainsymman.2011.11.008. Epub 2012 Jul 3.
PubMed 22762964
Osborn TR, Curtis JR, Nielsen EL, Back AL, Shannon SE, Engelberg RA. Identifying elements of ICU care that families report as important but unsatisfactory: decision-making, control, and ICU atmosphere. Chest. 2012 Nov;142(5):1185-1192. doi: 10.1378/chest.11-3277.
PubMed 22661455
Muni S, Engelberg RA, Treece PD, Dotolo D, Curtis JR. The influence of race/ethnicity and socioeconomic status on end-of-life care in the ICU. Chest. 2011 May;139(5):1025-1033. doi: 10.1378/chest.10-3011. Epub 2011 Feb 3.
PubMed 21292758
Gries CJ, Engelberg RA, Kross EK, Zatzick D, Nielsen EL, Downey L, Curtis JR. Predictors of symptoms of posttraumatic stress and depression in family members after patient death in the ICU. Chest. 2010 Feb;137(2):280-7. doi: 10.1378/chest.09-1291. Epub 2009 Sep 17.
PubMed 19762549
Kross EK, Engelberg RA, Shannon SE, Curtis JR. Potential for response bias in family surveys about end-of-life care in the ICU. Chest. 2009 Dec;136(6):1496-1502. doi: 10.1378/chest.09-0589. Epub 2009 Jul 17.
PubMed 19617402

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An ICU Intervention to Improve End-of-Life Care
ClinicalTrials.gov ID: NCT00685893
Acronym / sponsor ID: IPACC / 23503-G
Conditions: Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU
Keywords: End-of-life issues, Talking with your doctor, Coping with chronic illness
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,498 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: Jun 2003
Primary completion: Mar 2008 (actual)
Study completion: Oct 2010 (actual)
First posted: 29 May 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Arm	No intervention	–6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial
Intervention Arm	Experimental	Behavioral: Education, Behavioral: Local Champions, Behavioral: Institution Feedback, Behavioral: Academic Detailing, Behavioral: Institutional Forms6 community hospital ICUs receiving 5-component intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

patients, family members, nurses, and clinician evaluators
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.
they were involved with the patient who has died.
they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EducationWe 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.	Behavioural	Intervention Arm
Local ChampionsWe 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.	Behavioural	Intervention Arm
Institution FeedbackWe 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.	Behavioural	Intervention Arm
Academic DetailingStudy 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.	Behavioural	Intervention Arm
Institutional FormsWe 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.	Behavioural	Intervention Arm

Primary outcome

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

3 secondary outcomes

Total score of the QODD, as assessed by nurses
Time frame: 5 years
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
Indicators of quality of end-of-life care as assessed by standardized medical record review.
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
Background: PubMed 17057602Treece PD, Engelberg RA, Shannon SE, Nielsen EL, Braungardt T, Rubenfeld GD, Steinberg KP, Curtis JR. Integrating palliative and critical care: description of an intervention. Crit Care Med. 2006 Nov;34(11 Suppl):S380-7. doi: 10.1097/01.CCM.0000237045.12925.09.
Background: PubMed 18480429Curtis JR, Treece PD, Nielsen EL, Downey L, Shannon SE, Braungardt T, Owens D, Steinberg KP, Engelberg RA. Integrating palliative and critical care: evaluation of a quality-improvement intervention. Am J Respir Crit Care Med. 2008 Aug 1;178(3):269-75. doi: 10.1164/rccm.200802-272OC. Epub 2008 May 14.
Results publication: PubMed 20833820Curtis JR, Nielsen EL, Treece PD, Downey L, Dotolo D, Shannon SE, Back AL, Rubenfeld GD, Engelberg RA. Effect of a quality-improvement intervention on end-of-life care in the intensive care unit: a randomized trial. Am J Respir Crit Care Med. 2011 Feb 1;183(3):348-55. doi: 10.1164/rccm.201006-1004OC. Epub 2010 Sep 10.
Derived from this study: PubMed 26784137Brown CE, Engelberg RA, Nielsen EL, Curtis JR. Palliative Care for Patients Dying in the Intensive Care Unit with Chronic Lung Disease Compared with Metastatic Cancer. Ann Am Thorac Soc. 2016 May;13(5):684-9. doi: 10.1513/AnnalsATS.201510-667OC.
Derived from this study: PubMed 26685082Ramos KJ, Downey L, Nielsen EL, Treece PD, Shannon SE, Curtis JR, Engelberg RA. Using Nurse Ratings of Physician Communication in the ICU To Identify Potential Targets for Interventions To Improve End-of-Life Care. J Palliat Med. 2016 Mar;19(3):292-9. doi: 10.1089/jpm.2015.0155. Epub 2015 Dec 18.
Derived from this study: PubMed 26384556Lee JJ, Long AC, Curtis JR, Engelberg RA. The Influence of Race/Ethnicity and Education on Family Ratings of the Quality of Dying in the ICU. J Pain Symptom Manage. 2016 Jan;51(1):9-16. doi: 10.1016/j.jpainsymman.2015.08.008. Epub 2015 Sep 16.
Derived from this study: PubMed 24797373Johnson JR, Engelberg RA, Nielsen EL, Kross EK, Smith NL, Hanada JC, Doll O'Mahoney SK, Curtis JR. The association of spiritual care providers' activities with family members' satisfaction with care after a death in the ICU*. Crit Care Med. 2014 Sep;42(9):1991-2000. doi: 10.1097/CCM.0000000000000412.
Derived from this study: PubMed 24114410Kross EK, Engelberg RA, Downey L, Cuschieri J, Hallman MR, Longstreth WT Jr, Tirschwell DL, Curtis JR. Differences in end-of-life care in the ICU across patients cared for by medicine, surgery, neurology, and neurosurgery physicians. Chest. 2014 Feb;145(2):313-321. doi: 10.1378/chest.13-1351.
Derived from this study: PubMed 23518869DeCato TW, Engelberg RA, Downey L, Nielsen EL, Treece PD, Back AL, Shannon SE, Kross EK, Curtis JR. Hospital variation and temporal trends in palliative and end-of-life care in the ICU. Crit Care Med. 2013 Jun;41(6):1405-11. doi: 10.1097/CCM.0b013e318287f289.
Derived from this study: PubMed 22762964Kross EK, Nielsen EL, Curtis JR, Engelberg RA. Survey burden for family members surveyed about end-of-life care in the intensive care unit. J Pain Symptom Manage. 2012 Nov;44(5):671-80. doi: 10.1016/j.jpainsymman.2011.11.008. Epub 2012 Jul 3.
Derived from this study: PubMed 22661455Osborn TR, Curtis JR, Nielsen EL, Back AL, Shannon SE, Engelberg RA. Identifying elements of ICU care that families report as important but unsatisfactory: decision-making, control, and ICU atmosphere. Chest. 2012 Nov;142(5):1185-1192. doi: 10.1378/chest.11-3277.
Derived from this study: PubMed 21292758Muni S, Engelberg RA, Treece PD, Dotolo D, Curtis JR. The influence of race/ethnicity and socioeconomic status on end-of-life care in the ICU. Chest. 2011 May;139(5):1025-1033. doi: 10.1378/chest.10-3011. Epub 2011 Feb 3.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. Randall Curtis, MD, MPH principal investigator

University of Washington; Division of Pulmonary and Critical Care

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00685893, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.