Trial Outcomes & Findings for The Influence of Default Options in Advance Directives (NCT NCT01346176)

Last Updated: 2016-02-03

Results Overview

The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

6 months

Results posted on

2016-02-03

Participant Flow

Recruitment took place in outpatient clinics at the Pereleman Center for Advanced Medicine at the University of Pennsylvania. Recruitment occurred from May 2010 - Feb 2012. No recruitment occurred between Oct 2010 - Jan 2011 while the first research nurse transitioned responsibilities to the second research nurse.

9,378 patients were assessed for eligibility. 9,246 were excluded. 8,299 did not meet inclusion criteria, 391 already had an advance directive, 322 were either missed in clinic, cancelled their appointments, or were hospitalized, 181 declined participation, 43 had their participation deferred by their physician

Participant milestones

Participant milestones
Measure	Positive Default Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Negative Default Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Forced Choice Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
Recruited STARTED	49	40	43
Recruited COMPLETED	48	40	43
Recruited NOT COMPLETED	1	0	0
Completed Advance Directive STARTED	48	40	43
Completed Advance Directive COMPLETED	35	26	33
Completed Advance Directive NOT COMPLETED	13	14	10
Completed Satisfaction Survey STARTED	35	26	33
Completed Satisfaction Survey COMPLETED	29	22	27
Completed Satisfaction Survey NOT COMPLETED	6	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Positive Default Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Negative Default Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Forced Choice Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
Recruited Protocol Violation	1	0	0
Completed Advance Directive Death	3	2	2
Completed Advance Directive Became Ineligible	3	0	1
Completed Advance Directive Other reason did not complete AD	7	12	7
Completed Satisfaction Survey Death	3	0	2
Completed Satisfaction Survey Lost to Follow-up	3	4	4

Baseline Characteristics

The Influence of Default Options in Advance Directives

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Default n=49 Participants Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Negative Default n=40 Participants Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Forced Choice n=43 Participants Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.	Total n=132 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 8.50 • n=5 Participants	64.8 years STANDARD_DEVIATION 8.61 • n=7 Participants	64.4 years STANDARD_DEVIATION 7.12 • n=5 Participants	64.63 years STANDARD_DEVIATION 8.05 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	91 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This number was based on the number of participants who returned completed advance directive forms in each group

Outcome measures

Outcome measures
Measure	Positive Default n=48 Participants Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Negative Default n=40 Participants Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Forced Choice n=43 Participants Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
Proportion of Subjects Who Select Palliative Care Options	31 percentage who select palliative care Interval 19.0 to 46.0	50 percentage who select palliative care Interval 34.0 to 66.0	47 percentage who select palliative care Interval 31.0 to 62.0

SECONDARY outcome

Timeframe: Two months after AD completion

Population: These numbers reflect the number of patients who completed and returned and advance directive as well as completed a satisfaction interview and questionnaire with a research associate.

Patients' satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients' group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.

Outcome measures

Outcome measures
Measure	Positive Default n=29 Participants Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections	Negative Default n=22 Participants Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections	Forced Choice n=27 Participants Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
Patient Satisfaction With Advance Care Planning.	4.51 units on a scale Interval 1.0 to 5.0	4.61 units on a scale Interval 1.0 to 5.0	4.56 units on a scale Interval 1.0 to 5.0

Adverse Events

Forced Choice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Default

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Positive Default

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Forced Choice n=49 participants at risk	Negative Default n=40 participants at risk	Positive Default n=43 participants at risk
Investigations Serious adverse events not reported	— 0/0	— 0/0	— 0/0

Other adverse events

Adverse event data not reported

Additional Information

Scott D. Halpern

University of Pennsylvania School of Medicine

Phone: 215.573.9461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place