Trial of Advance Care Planning (ACP) & Goals of Care Designations (GCD) Discussions

NCT02463162 | Completed

• 1 other identifier: Pro00054953
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 15

Brief Summary

The Canadian population is aging and more people are living with advanced chronic diseases. At the end of life (EOL), the use of invasive medical treatments in hospitals is increasing and associated with worse outcomes. Advance Care Planning (ACP) may help improve care at EOL to be the way patients want it. ACP is a process where people think about the various options related to future health care decisions and they may communicate with a verbal or written plan of what care they would want in the EOL. Also, they may nominate a substitute decision maker if they become unable to speak for themselves. A national poll found that few Canadians have thought about or made an ACP. Alberta Health Services has developed two videos (Videos) to help with decision making about ACP and goals of care designations(GCD). GCD are medical orders of care that (a) serve as a communication tool for HCP to assist in rapid decision making; and (b) guide HCP and patients regarding the general intent and locations of care, and interventions that are to be provided. This study will compare ACP behaviours and GCD preferences for participants who have seen the Videos with those who have not and measure the change in those behaviours and preferences at 1, 2 and 3 months. It will also look at the impact of the Videos on health care costs and service use. Participants from five patient groups (metastatic lung cancer, colorectal cancer, gynecological cancer, renal failure, and heart failure) were selected as representative of where ACP should ideally be occurring, and where data on ACP implementation is presently most lacking, and as venues in which this research is most feasible. Collecting information about patients' ACP and GCD preferences may help improve AHS decision making tools and more generally help healthcare leaders plan ways to better engage patients in the ACP process.

Conditions

Advance Care Planning; Goals of Care

Outcome Measures

Primary Outcomes (2)

• Video effectiveness measured by change from baseline in number of participants who have had a conversation with a health care provider about ACP or GCD to 1 month, 2 months and 3 months

  Determine the effectiveness of the Videos by comparing the number of participants who have had a conversation with a health care provider about ACP or GCD between two groups (those who receive the intervention (usual care) and those who watch the videos

  1 month, 2 months and 3 months

• Economic impact of Videos measured by comparing change from 12 months prior to baseline in health care costs to baseline, 1 month, 2 months, 3 months and 12 months after baseline between two groups

  Determine the cost and economic consequences of the Videos by comparing change in health care costs between two groups (those who receive no intervention (usual care) and those who watch the Videos)

  12 months prior to baseline, baseline, 1 month, 2 months, 3 months and 12 months after baseline

Study Arms (2)

Control

NO INTERVENTION

This group will receive "usual care" which is to receive no intervention.

Intervention

EXPERIMENTAL

This group will receive the intervention which is two Conversations Matter videos about Advance Care Planning and Goals of Care Designations respectively

Other: Conversations Matter videos

Interventions

Conversations Matter videos OTHER

2 videos about Advance Care Planning and Goals of Care Designations respectively. These 2 videos were developed by Alberta Health Services and are each 8 minutes long.

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of either:
• heart failure classified as Class III or IV based on New York Heart Association Functional Classification or classified as Stage D based on American Heart Association/American College of Cardiology Heart Failure Classification;
• renal failure and on dialysis; or
• metastatic lung, gastrointestinal (including pancreatic) or gynecological cancer and on chemo, radiation therapy or palliative
• or over
• able to communicate in English
• reside within 100 km of Edmonton or Calgary
• owns a phone

You may not qualify if:

• cognitive impairment which would impact ability to give informed consent
• in crisis
• first visit or in the case of renal patients, in the first month of dialysis
• participated in ACP pilot study
• visual and/or hearing impairment that would impact their ability to see and/or hear the Videos, and/or complete the assessments including the telephone follow-up interviews.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (15)

Peter Lougheed Centre: Heart Function Clinic

Calgary, Alberta, T1Y 6J4, Canada

Location

Sunridge Dialysis Unit: Hemodialysis

Calgary, Alberta, T1Y 7M8, Canada

Location

Southern Alberta Renal Program - Northlands Village Mall, Hemodialysis

Calgary, Alberta, T2L 2J8, Canada

Location

Foothills Medical Centre: Heart Function and Heart Transplant Clinic

Calgary, Alberta, T2N 2T9, Canada

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Sheldon M. Chumir Health Centre: Hemodialysis

Calgary, Alberta, T2R 0X7, Canada

Location

Rockyview General Hospital: Heart Function Clinic

Calgary, Alberta, T2V 1P9, Canada

Location

South Calgary Health Centre: Hemodialysis

Calgary, Alberta, T2X 3W5, Canada

Location

South Health Campus: Heart Function Clinic

Calgary, Alberta, T3M 1M4, Canada

Location

Royal Alexandra Hospital: Renal Insufficiency Clinic and Hemodialysis Unit

Edmonton, Alberta, T5H3V9, Canada

Location

Edmonton General Continuing Care Centre: Hemodialysis

Edmonton, Alberta, T5K 0L4, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Alberta Hospital: Renal Insufficiency Clinic and Hemodialysis Units

Edmonton, Alberta, T6G2B7, Canada

Location

Grey Nuns Community Hospital: Renal Insufficiency Clinic and Hemodialysis Unit

Edmonton, Alberta, T6L 5X8, Canada

Location

Related Publications (1)

• Douglas ML, Simon J, Davison SN, Biondo P, Ghosh S, Kassam A, Fassbender K. Efficacy of Advance Care Planning Videos for Patients: A Randomized Controlled Trial in Cancer, Heart, and Kidney Failure Outpatient Settings. Med Decis Making. 2021 Apr;41(3):292-304. doi: 10.1177/0272989X20985836. Epub 2021 Jan 15.

  PMID: 33451263 DERIVED

Study Officials

• Konrad Fassbender, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Sara Davison, MD, MHSc (Bioethics)

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Jessica Simon, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CA (15)