Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04208009 |
| Other study ID # |
19-04020251 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
March 30, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Weill Medical College of Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Advance care planning (ACP) is critical to the provision of quality end-of-life (EoL) care
and has been associated with greater likelihood of patients' EoL wishes being followed.
Despite the importance of engaging in ACP, less than half of cancer patients engage in ACP
and those with low health literacy are at greatest risk of not completing advance directives.
Major limitations of prior work include not effectively improving knowledge of ACP and
patients viewing ACP as irrelevant. The proposed studies aim to address these prior
limitations by developing and pilot testing empirically grounded, novel, easy-to-understand,
and engaging communication tools that apply the medium of animated videos to communicate ACP.
Specifically, the proposed studies will develop and pilot-test four animated videos
(description of ACP; importance of engaging in ACP now; importance of communicating ACP to
loved ones, health care proxies, and providers; and how to communicate wishes and complete
advance directives).
Description:
Engagement in advance care planning (ACP) has been linked across several studies to improving
quality of care at the end of life and is a national priority as indicated by the Oncology
Care Model requiring completion of advanced directives for all cancer patients. The goal of
this Kellen Fellowship Award study is to develop and pilot test a theoretically-grounded,
communication-based intervention designed to promote engagement in ACP and improve rates of
completion of advance directives [living will, health care proxy (HCP), do-not-resuscitate
(DNR) order]. Despite the need for improved knowledge of ACP and engagement in ACP, a 2014
systematic review indicates that only 55% of prior ACP interventions successfully improved
knowledge of ACP.5 These findings highlight the need to develop an ACP intervention that
communicates ACP in an engaging, easy-to-use format designed to increase knowledge of and
engagement in ACP.
The proposed intervention will address these limitations of prior interventions by developing
a communication tool designed to engage cancer patients in ACP using a novel, empirically
grounded communication tool animated videos. Prior research highlights the use of animated
videos more effectively delivering medical information than written instructional materials,
which have been traditionally used in previously developed ACP interventions. One prior study
using a randomized controlled trial (RCT) found that animated videos were one of the most
effective mediums for improving knowledge around patients' informed consent for medical
procedures, being significantly higher than the use of text or no materials. Most notably,
animated messages have been shown to significantly improve attitudes towards colorectal
cancer screening among those with low health literacy as well as recall of information such
that participants' recall of information matched those with high health literacy. Patients
with low health literacy represent a disadvantaged group in regard to ACP as they have the
lowest rates of advance directive completion (12% vs. 49.5% of those with adequate
literacy).9 In summary, the use of animated videos to communicate the essential pieces of
information around ACP and completion of advance directives holds great promise for improving
patient knowledge and engagement in ACP among cancer patients, including those with low
health literacy.
In the proposed study, a series of animated videos will be developed which will discuss: 1)
what ACP is; 2) why patients should complete ACP now; 3) the importance of communicating
wishes to loved ones, health care proxies, and medical team members; and 4) how to
communicate these wishes and complete advance directives. These topics were selected based on
Dr. Shen's preliminary data and prior research10 highlighting that the greatest barriers to
engaging in ACP include: 1) lack of knowledge or awareness, 2) not viewing ACP as relevant to
one's current situation, and 3) concerns around designating a health care proxy and
communicating one's wishes. This study has three specific aims:
Specific Aim 1: To identify usability and acceptability and obtain feedback for modifications
of preliminary animated video content explaining ACP and advance directives using qualitative
interviews with cancer patients.
Specific Aim 2: To develop animated videos on specific components of ACP (description of ACP;
importance of engaging in ACP now; importance of communicating ACP to loved ones, health care
proxies, and providers; and how to communicate wishes and complete advance directives) and
evaluate the feasibility, usability, and acceptability of the intervention.
Specific Aim 3: To evaluate patients' perceived ability to use the animated videos and their
knowledge of and confidence in completing advance directives after viewing the videos.
First, this study will recruit n=15 patients with solid or liquid tumor cancer from oncology
clinics at Weill Cornell Medicine to assess animated videos through initial sketches of
content (called storyboards) using semi-structured interviews. Second, this study will
develop and finalize the animated videos and field-test the intervention in an open trial
among a new sample of cancer patients (n=30) to determine the feasibility, usability,
acceptability, and potential efficacy of the intervention. We will assess outcomes at
baseline and post-intervention.
