Advance Care Planning Evaluation in Hospitalized Elderly Patients

Cancer Clinical Trial

— ACCEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362855
• Other study ID #: ACCEPT Study
• Status: Completed
• Start date: September 2011
• Est. completion date: May 2015

Study information

• Verified date: February 2015
• Source: Clinical Evaluation Research Unit at Kingston General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 decisions.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Lung Disease
• Cirrhosis
• Congestive Heart Failure
• Critical Illness
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Peter Lougheed Hospital	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	St.Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Daren K. Heyland	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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?	Year 3
Secondary	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?	Year 3
Secondary	ACP components associated with overall satisfaction	Which components of ACP are more strongly associated with overall satisfaction with EOL communication and decision making?	Year 3
Secondary	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?	Year 3