Trial record 9 of 17 for:    "Advance Directives" | Open Studies

Advance Care Planning Evaluation in Hospitalized Elderly Patients (ACCEPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01362855
First received: May 20, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Extent of Implementation of ACP [ Time Frame: Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of an audit and feedback process plus tailored interventions ACP [ Time Frame: Year 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 20, 2011
Last Updated: January 28, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by 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
Critical Illness
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014