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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive default | Experimental | Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections |
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| Negative default | Experimental | Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections |
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| Forced Choice | Experimental | Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advance Directive Forms | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D. Halpern, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Forced Choice | Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recruited |
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| Completed Advance Directive |
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| Completed Satisfaction Survey |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Negative Default |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This number was based on the number of participants who returned completed advance directive forms in each group | Posted | Number | 95% Confidence Interval | percentage who select palliative care | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forced Choice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse events not reported | Investigations | This was a minimal risk study, patients were not at risk for any serious adverse events. Serious adverse events were not collected or reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott D. Halpern | University of Pennsylvania School of Medicine | 215.573.9461 | elcooney@exchange.upenn.edu |
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| Two months after AD completion |
| NOT COMPLETED |
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| NOT COMPLETED |
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Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
| BG002 | Forced Choice | Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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 |
| OG002 | Forced Choice | Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention. |
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| 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. | 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. | Posted | Mean | Full Range | units on a scale | Two months after AD completion |
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| 0 |
| 0 |
| 0 |
| 49 |
| EG001 | Negative Default | 0 | 0 | 0 | 40 |
| EG002 | Positive Default | 0 | 0 | 0 | 43 |
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