Trial Outcomes & Findings for Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families (NCT NCT02489799)
NCT ID: NCT02489799
Last Updated: 2017-08-29
Results Overview
The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Approximately one week after study enrollment.
Results posted on
2017-08-29
Participant Flow
Participant milestones
| Measure |
Intervention
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
Presurgical Consent Visit (V2)
|
40
|
39
|
|
Overall Study
Postsurgical One Week Visit (V3)
|
40
|
39
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Intervention
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Failure to Maintain Eligibility
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families
Baseline characteristics by cohort
| Measure |
Intervention
n=45 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=47 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Diagnosis
Pancreatic Cancer
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Primary Diagnosis
Colon Cancer
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Primary Diagnosis
Hepatobiliary and other Gastrointestinal Cancer
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Primary Diagnosis
Gynecological Cancers
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Primary Diagnosis
Sarcoma
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Primary Diagnosis
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately one week after study enrollment.Population: Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference.
The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.
Outcome measures
| Measure |
Intervention
n=30 Recordings
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Recordings
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Measured ACP Content in the Presurgical Consent Visit
Death (Long-Term)
|
6 Recordings
|
5 Recordings
|
|
Measured ACP Content in the Presurgical Consent Visit
Goals
|
10 Recordings
|
8 Recordings
|
|
Measured ACP Content in the Presurgical Consent Visit
Video
|
2 Recordings
|
1 Recordings
|
|
Measured ACP Content in the Presurgical Consent Visit
Alternate Medical Decision Maker
|
7 Recordings
|
3 Recordings
|
PRIMARY outcome
Timeframe: Approximately one week after study enrollment.Population: Audio recordings of a presurgical consent visit conversation between a surgeon and patient.
The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual's dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.
Outcome measures
| Measure |
Intervention
n=30 Audio Recordings
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Audio Recordings
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Measured Patient Centeredness in the Presurgical Consent Visit
|
0.70 Patient Centeredness Score
Standard Deviation 0.34
|
0.69 Patient Centeredness Score
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Enrollment, one week after enrollment, one week after surgery, one month after surgeryPopulation: At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.
This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).
Outcome measures
| Measure |
Intervention
n=45 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=47 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
Baseline Visit (V1)
|
9.4 units on a scale
Standard Deviation 5.1
|
9.9 units on a scale
Standard Deviation 5.7
|
|
Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
Presurgical Consent Visit (V2)
|
9.4 units on a scale
Standard Deviation 7.0
|
9.3 units on a scale
Standard Deviation 5.5
|
|
Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
Postsurgical One Week Visit (V3)
|
11.5 units on a scale
Standard Deviation 6.8
|
13.0 units on a scale
Standard Deviation 8.2
|
|
Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4)
|
9.6 units on a scale
Standard Deviation 7.1
|
10.9 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Enrollment, one week after enrollment, one week after surgery, one month after surgeryPopulation: At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.
This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was "Cure my medical condition." We have reported the number of participants in each group who selected this goal at each time point.
Outcome measures
| Measure |
Intervention
n=45 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=47 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Iowa Goals of Care Across Study Arms Throughout the Study Period
Baseline Visit (V1)
|
43 Participants
|
46 Participants
|
|
Iowa Goals of Care Across Study Arms Throughout the Study Period
Presurgical Consent Visit (V2)
|
33 Participants
|
29 Participants
|
|
Iowa Goals of Care Across Study Arms Throughout the Study Period
Postsurgical One Week Visit (V3)
|
34 Participants
|
34 Participants
|
|
Iowa Goals of Care Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4)
|
34 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: One week after enrollmentThis Likert scale evaluates respondent beliefs about the helpfulness of the video.
Outcome measures
| Measure |
Intervention
n=34 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Helpfulness of the Video Across Study Arms
Very Helpful
|
14 Participants
|
12 Participants
|
|
Helpfulness of the Video Across Study Arms
Somewhat Helpful
|
14 Participants
|
9 Participants
|
|
Helpfulness of the Video Across Study Arms
A Little Helpful
|
6 Participants
|
2 Participants
|
|
Helpfulness of the Video Across Study Arms
Not Helpful
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: One week after enrollmentThis Likert scale evaluates respondent beliefs about their comfort in viewing the video.
Outcome measures
| Measure |
Intervention
n=34 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Comfort With the Video Across Study Arms
Very Comfortable
|
25 Participants
|
22 Participants
|
|
Comfort With the Video Across Study Arms
Somewhat Comfortable
|
7 Participants
|
8 Participants
|
|
Comfort With the Video Across Study Arms
Somewhat Uncomfortable
|
2 Participants
|
1 Participants
|
|
Comfort With the Video Across Study Arms
Very Uncomfortable
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One week after enrollmentThis Likert scale evaluates respondent beliefs about whether they would recommend the video to others.
Outcome measures
| Measure |
Intervention
n=34 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Recommendation of the Video to Others Across Study Arms
Definitely Recommend
|
21 Participants
|
16 Participants
|
|
Recommendation of the Video to Others Across Study Arms
Probably Recommend
|
11 Participants
|
10 Participants
|
|
Recommendation of the Video to Others Across Study Arms
Probably Would Not Recommend
|
2 Participants
|
4 Participants
|
|
Recommendation of the Video to Others Across Study Arms
Definitely Would Not Recommend
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: One week after enrollmentPopulation: In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients.
The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.
Outcome measures
| Measure |
Intervention
n=34 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=31 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Patient and Provider Satisfaction Scores Across Study Arms
Patient Self-Reported Satisfaction
|
27.2 units on a scale
Standard Deviation 5.6
|
27.8 units on a scale
Standard Deviation 4.5
|
|
Patient and Provider Satisfaction Scores Across Study Arms
Surgeon Self-Reported Satisfaction
|
24.9 units on a scale
Standard Deviation 2.9
|
24.1 units on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Enrollment, one month after surgeryPopulation: At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.
This tracks which participants report having named a surrogate decision maker
Outcome measures
| Measure |
Intervention
n=45 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=47 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
Baseline Visit (V1) · Have Not Identified a Medical Decision Maker
|
9 Participants
|
11 Participants
|
|
Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
Baseline Visit (V1) · Have Identified a Medical Decision Maker
|
36 Participants
|
36 Participants
|
|
Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4) · Have Not Identified a Medical Decision Maker
|
2 Participants
|
0 Participants
|
|
Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4) · Have Identified a Medical Decision Maker
|
34 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Enrollment, one month after surgeryPopulation: This question was only asked to participants who reported having designated a medical decision maker.
This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.
Outcome measures
| Measure |
Intervention
n=45 Participants
Advance care planning video
Advance care planning video: This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
|
Control
n=47 Participants
Control video - no advance care planning content
Control video: This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
|
|---|---|---|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Baseline Visit (V1) · No
|
6 Participants
|
7 Participants
|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Baseline Visit (V1) · Yes, over 6 months ago
|
4 Participants
|
6 Participants
|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Baseline Visit (V1) · Yes, within the last 6 months
|
26 Participants
|
23 Participants
|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4) · No
|
2 Participants
|
3 Participants
|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4) · Yes, over 6 months ago
|
0 Participants
|
5 Participants
|
|
Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period
Postsurgical One Month Visit (V4) · Yes, within the last 6 months
|
32 Participants
|
30 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Aslakson, M.D., Ph.D.
The Johns Hopkins University School of Medicine
Phone: 410-955-9082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place