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Advance Care Planning Evaluation in Hospitalized Elderly Patients (ACCEPT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362855
First Posted: May 30, 2011
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
  Purpose

The purpose of the study is to inform decision-makers of the best strategies to implement advanced care planning (ACP).

An advanced care plan (ACP) is a verbal or written instruction describing what kind of care an individual would want (or not want)if they are no longer able speak for themselves to make health care decisions.


Condition
Critical Illness Chronic Obstructive Lung Disease Congestive Heart Failure Cirrhosis Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Advance Care Planning Evaluation in Hospitalized Elderly Patients: A Multicenter, Prospective Study

Further study details as provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Extent of Implementation of ACP [ Time Frame: Year 3 ]

Secondary Outcome Measures:
  • Effect of an audit and feedback process plus tailored interventions ACP [ Time Frame: Year 3 ]
    Compared to baseline, what is the effect of an audit and feedback process coupled with tailored interventions on use of and satisfaction with ACP at the site level?

  • Impact of ACP on patient/family satisfaction [ Time Frame: Year 3 ]
    Compared to those patients who have not undergone an ACP process upon enrolment, what is the impact of ACP on patient/family satisfaction with care, use of life-sustaining technologies, and hospital resources during index hospital admission and long-term health care utilization?

  • ACP components associated with overall satisfaction [ Time Frame: Year 3 ]
    Which components of ACP are more strongly associated with overall satisfaction with EOL communication and decision making?

  • Comparison of sites with low vs high system level implementation of ACP on satisfaction [ Time Frame: Year 3 ]
    At baseline, compared to sites with low degrees of system level implementation, do sites with higher levels of system level integration have a higher prevalence of ACP and greater satisfaction with EOL communication and decision-making?


Estimated Enrollment: 900
Study Start Date: September 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Advance Care Planning (ACP) may offer some assistance with reducing health care costs for older Canadians and yet, at the same time, improving quality of care. ACP is the process by which a person considers options about future health care decisions and identifies their wishes. ACP has been shown to increase the quality of life of dying patients, improve the experience of family members, and decrease health care costs.

There have been initiatives leading to the development and implementation of system-wide strategies to increase ACP, however there has been no evaluation of the effectiveness of these efforts from the perspective of patients and families. Many questions pertaining to barriers and facilitators to implementation and impact of ACP on outcomes in Canada remain.

The investigators propose to conduct a perspective audit of current practice related to ACP in elderly patients at high-risk for dying and their families. The investigators will determine the extent to which these patients and families have engaged in ACP, what barriers and facilitators they preceive, and how satisfied they are with communication and decision making at the end of life. Informed by a baseline evaluation of site strengths, weaknesses and barriers, the investigators propose to develop tailored interventions to enable participating sites to improve their success with ACP during the entire study period. By repeating the audit and feedback cycle annually, the investigators will enable sites to make continuous efforts to improve their performance and be able to evaluate the effect of our audit/feedback/tailored intervention strategy compared to baseline. Additionally, for those patients who have engaged in ACP activities, the investigators can compare their outcomes to those who have not.

The overall goal of this study is to inform decision-makers as the best strategies to implement advance care planning (ACP).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We will enroll patients who are at high risk of dying and/or their families (where available).
Criteria

Inclusion Criteria:

  • 55 years or older with one or more of the following diagnoses:

    • Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L.
    • Congestive heart failure - New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%.
    • Cirrhosis - confirmed by imaging studies or documentation of esophageal varices and one of three conditions: a) hepatic coma, b) Child's class C liver disease, or c) Child's class B liver disease with gastrointestinal bleeding.
    • Cancer - metastatic cancer or stage IV lymphoma.
    • End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness) OR
  • Any patient 80 years of age or older admitted to hospital from the community because of an acute medical or surgical condition.

Exclusion Criteria:

  • Non-English speaking patient/family member
  • Patient with cognitive impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362855


Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Daren K Heyland, MD, MSc    613-549-6666 ext 4847    dkh2@queensu.ca   
Contact: Jennifer Korol    613-548-6051    korolj@kgh.kari.net   
Principal Investigator: Daren K Heyland, MD, MSc         
Sponsors and Collaborators
Daren K. Heyland
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Daren K Heyland, MD, MSc Queen's University
  More Information

Responsible Party: Daren K. Heyland, Director, Clinical Evaluation Reserach Unit, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01362855     History of Changes
Other Study ID Numbers: ACCEPT Study
First Submitted: May 20, 2011
First Posted: May 30, 2011
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital:
Advance Care Planning
End of life
Knowledge translation
Goals of care
Advance directive
Lining will

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Critical Illness
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes