Advance Care Planning
Conditions
Brief summary
The investigators aim to assess the influence of default options in advance directives on older patients selections of life- extending therapies and to determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life-extending therapies by manipulating the default options of advance directives given to patients in with severe respiratory disease
Detailed description
The project is designed to document that default options influence terminally ill patients end-of-life decisions (in this case, adults with advance forms of lung disease) and that our team can recruit and retain patients in a study of advance care planning. In addition, because a larger-scale randomized clinical trial will require that the investigators alert participants to the range of possible default options, the investigators must also determine the effects that this alerting will have on their selections of life-extending therapies. Therefore, the investigators seek to achieve three aims: (1) assess the influence of default options in advance directives on patients selections of life-extending therapies; (2) determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life extending therapies; and (3) document the feasibility of recruiting and retaining patients with advanced lung diseases from university-based clinical settings into a randomized trial of default options in advance directives.
Interventions
OTHERAdvance Directive Forms
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, they will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Sponsors
University of Pittsburgh
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), non-small-cell lung cancer, or other interstitial or fibrotic lung disease * Neither listed for nor considering solid organ transplantation * Anticipated survival of less than 2 years * Must be fluent and literate in English
Exclusion criteria
* Diagnosis of small-cell lung cancer or other respiratory diseases for which life extending medical therapies may be available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Select Palliative Care Options | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Advance Care Planning. | Two months after AD completion | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 40 |
| Forced Choice Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention. | 43 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Completed Advance Directive | Became Ineligible | 3 | 0 | 1 |
| Completed Advance Directive | Death | 3 | 2 | 2 |
| 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 |
| Recruited | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Positive Default | Negative Default | Forced Choice | Total |
|---|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 8.5 | 64.8 years STANDARD_DEVIATION 8.61 | 64.4 years STANDARD_DEVIATION 7.12 | 64.63 years STANDARD_DEVIATION 8.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 10 Participants | 14 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 34 Participants | 28 Participants | 29 Participants | 91 Participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 28 Participants | 76 Participants |
| Sex: Female, Male Male | 24 Participants | 17 Participants | 15 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 40 | 0 / 43 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Proportion of Subjects Who Select Palliative Care Options
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.
Time frame: 6 months
Population: This number was based on the number of participants who returned completed advance directive forms in each group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Positive Default | Proportion of Subjects Who Select Palliative Care Options | 31 percentage who select palliative care |
| Negative Default | Proportion of Subjects Who Select Palliative Care Options | 50 percentage who select palliative care |
| Forced Choice | Proportion of Subjects Who Select Palliative Care Options | 47 percentage who select palliative care |
Secondary
Patient Satisfaction With Advance Care Planning.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Positive Default | Patient Satisfaction With Advance Care Planning. | 4.51 units on a scale |
| Negative Default | Patient Satisfaction With Advance Care Planning. | 4.61 units on a scale |
| Forced Choice | Patient Satisfaction With Advance Care Planning. | 4.56 units on a scale |