Trial Outcomes & Findings for PCORI-1502-27462 Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment (NCT NCT02623335)
NCT ID: NCT02623335
Last Updated: 2019-10-21
Results Overview
Patient engagement in decision making was measured by coding the transcript for the patient's clinic visit, using a pre-defined coding scheme that focused on the number and types of questions raised in the audio-recorded treatment decision-making visit. The types of questions that were coded were options questions, expectations questions, risks questions and advance directive questions.
COMPLETED
NA
446 participants
Within 2 hours of enrollment in the study
2019-10-21
Participant Flow
Surgeons at 5 sites were recruited by email and in-person contact. After they were consented, their patients were screened for eligibility and approached in clinic to discuss study participation.
Participant milestones
| Measure |
QPL (Question Prompt List) Brochure
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
223
|
|
Overall Study
T0 Audio Recording (Day of Consultation)
|
223
|
222
|
|
Overall Study
T1 Survey (24-48 Hours)
|
216
|
214
|
|
Overall Study
T2 Survey (6-8 Weeks)
|
199
|
192
|
|
Overall Study
T3 Survey (12-14 Weeks)
|
196
|
187
|
|
Overall Study
COMPLETED
|
196
|
187
|
|
Overall Study
NOT COMPLETED
|
27
|
36
|
Reasons for withdrawal
| Measure |
QPL (Question Prompt List) Brochure
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Overall Study
Death
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
15
|
23
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
PCORI-1502-27462 Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
Baseline characteristics by cohort
| Measure |
QPL (Question Prompt List) Brochure
n=223 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=223 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
182 Participants
n=93 Participants
|
199 Participants
n=4 Participants
|
381 Participants
n=27 Participants
|
|
Age, Continuous
|
71.01 years
STANDARD_DEVIATION 6.67 • n=93 Participants
|
72.59 years
STANDARD_DEVIATION 7.34 • n=4 Participants
|
71.8 years
STANDARD_DEVIATION 7.05 • n=27 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
197 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=93 Participants
|
197 Participants
n=4 Participants
|
394 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
360 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
223 participants
n=93 Participants
|
223 participants
n=4 Participants
|
446 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 2 hours of enrollment in the studyPopulation: Due to instances when a full audio recording of the clinic visit was not available, the number of participants analyzed differs from the number of total arm participants.
Patient engagement in decision making was measured by coding the transcript for the patient's clinic visit, using a pre-defined coding scheme that focused on the number and types of questions raised in the audio-recorded treatment decision-making visit. The types of questions that were coded were options questions, expectations questions, risks questions and advance directive questions.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=216 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=219 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
Options question asked (2 or more)
|
68 Participants
|
55 Participants
|
|
Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
Expectations question asked (2 or more)
|
95 Participants
|
89 Participants
|
|
Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
Risks question asked (2 or more)
|
35 Participants
|
36 Participants
|
|
Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised
Advance Directives question asked (1 or more)
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Changes in concerns and well-being were measured using the self-report instrument Measure Yourself Concerns and Well-being (MYCaW) instrument. The minimum value for differences in this scale is -6 and maximum value is 6. Higher scores indicate that problems and concerns have diminished.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=136 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=154 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument
Change in scores between T2 and T1
|
-1.49 change in score on a scale
Standard Deviation 2.76
|
-1.6 change in score on a scale
Standard Deviation 2.41
|
|
Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument
Change in scores between T3 and T1
|
-1.88 change in score on a scale
Standard Deviation 2.66
|
-1.73 change in score on a scale
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: 24-48 hours after enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Perceived self-efficacy in patient-physician interactions was measured by participant self-report, using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale. Maximum value for this scale is 25 and minimum is 0. Higher scores indicate greater self-efficacy.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=208 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=202 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale
|
21.64 score on a scale
Standard Deviation 3.38
|
21.45 score on a scale
Standard Deviation 3.31
|
PRIMARY outcome
Timeframe: 3-4 months post-enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Post-treatment regret was assessed by the following participant self-report survey item: "Looking back, is there anything about your treatment that you would do differently?"
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=205 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=209 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Post-treatment Regret Measured by a Specific Participant Self-report Survey Item
Had regret
|
61 Participants
|
48 Participants
|
|
Post-treatment Regret Measured by a Specific Participant Self-report Survey Item
No regret
|
144 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: 24-48 hours after enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Participant autonomy support was assessed using the self-report measure Health Care Climate Questionnaire (HCCQ). The minimum value for this scale is 1 and the maximum value is 7. Higher scores indicate greater perceived autonomy support.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=208 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=202 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Participant Autonomy Support Measured by Self-report on the HCCQ Instrument
|
6.39 score on a scale
Standard Deviation 0.8
|
6.5 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 6-8 weeks post-enrollment, 3-4 months post-enrollment post-enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Positive scale. The minimum value for this scale is 4 and the maximum is 16. Higher values indicate better well-being.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=179 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=175 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale
6-8 weeks post-enrollment (T2)
|
12.92 score on a scale
Standard Deviation 3.12
|
13.52 score on a scale
Standard Deviation 3.03
|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale
3-4 months post-enrollment post-enrollment (T3)
|
12.95 score on a scale
Standard Deviation 3.05
|
13.64 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6-8 weeks post-enrollment, 3-4 months post-enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Negative scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=179 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=176 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale
6-8 weeks post-enrollment (T2)
|
6.92 score on a scale
Standard Deviation 3.45
|
6.47 score on a scale
Standard Deviation 2.83
|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale
3-4 months post-enrollment (T3)
|
7.05 score on a scale
Standard Deviation 3.67
|
6.25 score on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: 6-8 weeks post-enrollment, 3-4 months post-enrollmentPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.
Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=180 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=180 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale
6-8 weeks post-enrollment (T2)
|
7.57 score on a scale
Standard Deviation 3.57
|
7.18 score on a scale
Standard Deviation 3.43
|
|
Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale
3-4 months post-enrollment post-enrollment (T3)
|
7.18 score on a scale
Standard Deviation 3.5
|
6.76 score on a scale
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: From enrollment to end of data collection 3-4 months laterPopulation: The number of participants analyzed differs from the number of total arm participants due to a low rate of participant drop out from the chart review study activity.
The total number of participants who had surgery during the study period was tracked through a patient chart review.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=220 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=220 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Number of Participants Who Had Surgery During the Study Period
|
135 Participants
|
139 Participants
|
SECONDARY outcome
Timeframe: Within 2 hours of enrollment in the studyPopulation: The number of participants analyzed differs from the number of total arm participants due to a low number of cases where full audio recording of clinic visit was unavailable.
Physician engagement with patient was measured by coding the transcript for the patient's clinic visit, using the Observing Patient Involvement in Decision Making instrument (OPTION) scale. Minimum value for this scale is 0 and maximum is 100. Higher scores indicate increased shared decision making.
Outcome measures
| Measure |
QPL (Question Prompt List) Brochure
n=216 Participants
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
QPL (question prompt list) brochure: The QPL intervention included the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials were mailed in advance of the patient's appointment with an enrolled surgeon.
|
Usual Care
n=219 Participants
The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.
|
|---|---|---|
|
Physician Engagement With Patient Measured by Clinic Visit Transcript Coding Using OPTION Coding System
|
34.26 score on a scale
Standard Deviation 21.56
|
31.03 score on a scale
Standard Deviation 19.84
|
Adverse Events
QPL (Question Prompt List) Brochure
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gretchen Lee Schwarze, MD, MPP, FACS
University of Wisconsin, Madison
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place