NCT01362855

Brief 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 decisions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 16, 2020

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

May 20, 2011

Last Update Submit

December 11, 2020

Conditions

Keywords

Advance Care PlanningEnd of lifeKnowledge translationGoals of careAdvance directiveLiving will

Outcome Measures

Primary Outcomes (1)

  • Extent of Implementation of ACP

    a. 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?

    Year 3

Secondary Outcomes (4)

  • Effect of an audit and feedback process plus tailored interventions ACP

    Year 3

  • Impact of ACP on patient/family satisfaction

    Year 3

  • ACP components associated with overall satisfaction

    Year 3

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

    Year 3

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peter Lougheed Hospital

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W4, Canada

Location

Vancouver Hospital

Vancouver, British Columbia, V5Z 1C6, Canada

Location

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St.Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Critical IllnessPulmonary Disease, Chronic ObstructiveHeart FailureFibrosisNeoplasmsDeath

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseHeart DiseasesCardiovascular Diseases

Study Officials

  • Daren K Heyland, MD, MSc

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Clinical Evaluation Reserach Unit

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 30, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

December 16, 2020

Record last verified: 2015-02

Locations