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Critical IllnessACCEPTNCT01362855

Advance Care Planning Evaluation in Hospitalized Elderly Patients

An observational study of Critical Illness and Chronic Obstructive Lung Disease, run by Daren K. Heyland at 9 sites in Canada.

Completed

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

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
How many people
503 participants
Where
9 sitesCanada
Study dates
Sep 2011to May 2015
Phase
Observational
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: We will enroll patients who are at high risk of dying and/or their families (where available).

Who may be able to join

  • 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.

Who cannot join

  • Non-English speaking patient/family member
  • Patient with cognitive impairment

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • Peter Lougheed Hospital

    Calgary, Alberta, T1Y 6J4

  • Foothills Medical Centre

    Calgary, Alberta

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Hamilton General Hospital

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W4

  • Vancouver Hospital

    Vancouver, British Columbia, V5Z 1C6

  • St Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • St.Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Advance Care Planning Evaluation in Hospitalized Elderly Patients: A Multicenter, Prospective Study

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.

Read the 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).

Keywords
Advance Care Planning, End of life, Knowledge translation, Goals of care, Advance directive, Living will
Medical subject headings
Critical Illness, Pulmonary Disease, Chronic Obstructive, Heart Failure, Fibrosis, Neoplasms, Death

What is being measured

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

  1. Extent of Implementation of ACP

    1. Does the patient have an advance directive or living will or some other written document expressing their wishes? b.patient and/or family been informed of the patients' prognosis? c.Has the patient and/or family been informed about the expected benefits and burdens of various treatment options? d.Has the patient considered how s/he wants to live in the final stages of life and what kinds of medical treatments they would want or not want? e.Have they discussed this with their family? A health care provider? g.Has there been a discussion about their goals of care with their health care provider? If so, are they aware of them? h.Has there been a decision made about medical treatments at the end of life? If so, what role did the patient/family play in that decision-making and was this consistent with their preferred role? i.Is there documentation in the medical record of the overall goals of care?

    Measured: Year 3

Secondary outcomes (4)

  1. Effect of an audit and feedback process plus tailored interventions ACP

    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?

    Measured: Year 3

  2. Impact of ACP on patient/family satisfaction

    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?

    Measured: Year 3

  3. ACP components associated with overall satisfaction

    Which components of ACP are more strongly associated with overall satisfaction with EOL communication and decision making?

    Measured: Year 3

  4. Comparison of sites with low vs high system level implementation of ACP on satisfaction

    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?

    Measured: Year 3

Timeline

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

  1. First posted30 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2015
  4. Study completionMay 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362855
Sponsor's protocol ID
ACCEPT Study
Acronym
ACCEPT
Status last verified
Feb 2015
First submitted
20 May 2011
Last updated
16 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • Heyland DK, Heyland R, Dodek P, You JJ, Sinuff T, Hiebert T, Jiang X, Day AG; ACCEPT Study Team and the Canadian Researchers at the End of Life Network (CARENET). Discordance between patients' stated values and treatment preferences for end-of-life care: results of a multicentre survey. BMJ Support Palliat Care. 2017 Sep;7(3):292-299. doi: 10.1136/bmjspcare-2015-001056. Epub 2016 Oct 6.

    PubMed 28827369

  • Heyland DK, Dodek P, You JJ, Sinuff T, Hiebert T, Tayler C, Jiang X, Simon J, Downar J; ACCEPT Study Team and the Canadian Researchers at the End of Life Network (CARENET). Validation of quality indicators for end-of-life communication: results of a multicentre survey. CMAJ. 2017 Jul 31;189(30):E980-E989. doi: 10.1503/cmaj.160515.

    PubMed 28760834

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Chronic Obstructive Lung Disease, run by Daren K. Heyland at 9 sites in Canada.

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 7 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. 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.

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?

Extent of Implementation of ACP (time frame: Year 3). 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 NCT01362855, which also lists 2 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 16 Dec 2020.

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