Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463162
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2015-05-28
Brief Title:
Trial of Advance Care Planning ACP Goals of Care Designations GCD Discussions
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Effectiveness and Economic Impact of Advance Care Planning and Goals of Care Designations Discussions A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 designationsGCD 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
Alberta Health Services has developed two videos Videos to help with decision making about ACP and goals of care designationsGCD 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
Detailed Description:
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 andor 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 ACPGCD 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 andor 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
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 andor 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 ACPGCD 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None