Advance Care Planning Clinical Trial
Official title:
Effectiveness and Economic Impact of Advance Care Planning and Goals of Care Designations Discussions: A Randomized Controlled Trial
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.
Background: Respecting patients' preferences for treatment is a key component of high
quality end of life care. Alberta Health Services (AHS) has developed tools for public,
patient and healthcare provider (HCP) engagement and education (such as guidebooks, videos,
and HCP training modules) to support widespread engagement in advance care planning (ACP)
and determining Goals of Care Designation (GCD). However, none of these knowledge
translation (KT) tools have been validated and they have not been tailored to reflect
barriers in the local context.
ACP is defined as a communication process where people plan for a time when they cannot make
medical decisions for themselves. It includes thinking about and communicating their
preferences for future healthcare, which can include conversations with family and
healthcare providers, choosing and documenting an alternate decision maker, and/or
documenting preferences for healthcare for use in the event that person loses capacity for
medical decision-making. These discussions can occur both informally and formally. Goals of
Care Designations (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. Decisions
about goals of care usually arise over time through conversations between patients, family
members and the health care team.
This randomized controlled trial (RCT) will focus on the two Conversations Matter Video
decision-aids developed by AHS for people and their families. The first video is an 8-minute
video that describes the 5-steps of the ACP process. The second video is a 8-minute video
that illustrates the resuscitative, medical and comfort levels of care outlined in the
Alberta GCD policy.
Scope: This protocol relates to two of the research activities designed to evaluate the
impact of ACP/GCD. The first is an RCT to evaluate the effectiveness of two videos about ACP
and GCD. Participants will be recruited from settings where ACP should ideally be occurring,
and where data on ACP implementation is presently most lacking. The overall aim of the RCT
is to evaluate and refine these existing knowledge translation (KT) tools to optimize the
quality and frequency of patient education about and engagement in ACP and determining goals
of care.
The second activity measures the economic impact of the Videos in these patient populations.
A significant proportion of health care resources are consumed at end of life. ACP, which
emphasizes discussions, combined with GCD, may have a greater impact than advance directives
alone. To be clear, the primary goal of ACP is not about cost containment, but rather, to
shift a culture of care toward a patient- and family-centered approach to medical
decision-making. Prospective data collection and analysis will give insight into personal
and intangible costs. It will allow for relatively precise measurement of health care
savings, and thereby inform health care systems on anticipated savings and prescribe shift
of funding necessary for appropriate resourcing in parts of the health care system that may
see increased activity because of ACP, while also improving quality of patient-centred
outcomes.
Methods: The RCT will be an in-person intervention and survey at baseline, follow-up
telephone survey at one month and two months, and in-person survey at three months. At
baseline, researchers will assess function and ask about demographic information, quality of
life, advance care planning (ACP), and goals of care (GC) preferences and goals of care
designation orders (GCD). Participants will then be randomized between two arms:
1. control or "usual care"; and
2. intervention whereby participant views two videos about ACP and GCD, respectively
(Videos).
Surveys will be administered by research staff. The baseline intervention and survey will
take approximately 30 to 65 minutes, depending on which arm the participant is randomized
to, and be collected from up to 240 participants. At one, two and three months, follow up
surveys will be administered to collect data about health care services utilized, health
care costs incurred, and discussions about ACP and GC with their health care providers,
lawyers, financial advisors and/or clergy in the preceding month. The one and two month
surveys will be approximately 10-20 minutes in length. Three-month follow-up surveys will
collect data about ACP, GC preferences and GCD and will be approximately 20-40 minutes in
length. Researchers will also collect data from participants' electronic medical health
records about their diagnosis and co-morbidities, health services utilization and costs at
12 months prior to baseline, baseline and approximately 12 months after baseline.
Objectives:
1. Determine the effectiveness of the Videos by comparing the change from baseline to 1, 2
and 3 months of the number of participants who have had a conversation with a health
care provider about ACP or GCD between two groups, namely: those who receive no
intervention (usual care) and those who watch the Videos.
2. Determine the cost and economic consequences of the Videos by comparing the change from
12 months prior to baseline to and including baseline, to 1 month, 2, months, 3 months
and 12 months following baseline in health care utilization and costs between the two
groups described in Objective 1.
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