This Study Will Focus on Advance Care Planning Among Patients With Life-limiting IllnessesNCT02017548

Default Options in Advance Directives

A study testing Life-extension default advance directive and Comfort default advance directive in people with This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses, run by University of Pennsylvania at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses
What is being tested?: Life-extension default advance directive and Comfort default advance directive
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 4 sitesUnited States
Study dates: Jan 2014to Nov 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 or older
Fluent in English
Has seen current physician at least once prior to current visit
Resident of Pennsylvania or New Jersey
One or more of the following diagnoses:
Amyotrophic lateral sclerosis

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Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
Stage C or D hepatocellular carcinoma
Stage IV renal cell carcinoma
Stage IV or V chronic kidney disease
Mesothelioma or any malignancy metastatic to the pleura
Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months

Who cannot join

Currently listed for or being considered for solid organ transplant
Patients with a previously signed advance directive or living will.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
The Perelman Center for Advance Medicine
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Conditions: This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses
Being tested: Life-extension default advance directive, Comfort default advance directive
Keywords: advance directives, advance care planning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Life-extension default advance directiveBehavioural
Comfort default advance directiveBehavioural

Study groups in NCT02017548
Study group	Role	What they receive
Life-extension default	Experimental	Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs. comfort oriented care) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections. It also will state that upon discharge from the hospital, long-term care (vs. hospice care) will be provided unless the patient chooses otherwise. Receives: Behavioral: Life-extension default advance directive
Comfort default	Experimental	Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs. life extension) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections. It also will state that upon discharge from the hospital, hospice care (vs. long-term care) will be provided unless the patient chooses otherwise. Receives: Behavioral: Comfort default advance directive
Standard advance directive	No intervention	Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.

What is being measured

The primary outcome is the main question the study is designed to answer.

Hospital free days
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research. As the name describes, HFDs represent the number of days alive and not in an acute care facility. Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative. To bolster confidence in the results, we will evaluate two key variations on the theme. First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home. We will also evaluate HFDs within a defined period of follow-up - 6 months in this case. This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients
Measured: 6 months

Secondary outcomes (10)

Hospital and ICU admissions
The numbers of admissions will be analyzed as count data. From the dates of hospital and ICU admissions, we will calculate the proportion of each patient's total survival time during study follow-up that was spent in the hospital or ICU.
Measured: up to 1 year
Costs of care
We will combine all costs of inpatient and outpatient hospice, hospital stays, and life-sustaining procedures. The perspective will be that of all potential payers. Costs will be inflated to the date on which analyses are performed using the U.S. gross domestic product deflator
Measured: up to 1 year
Hospice utilization
We will analyze hospice utilization in 2 ways: (a) time from advance directive completion to hospice enrollment; and (b) duration of hospice utilization prior to death.
Measured: up to 1 year
Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
We will record selections that patients made on their advance directives about 4 specific life-sustaining interventions. Utilizing data from the Pennsylvania Healthcare Cost Containment Consortium and the New Jersey Department of Health and Senior Services, we will be able to determine which patients received each intervention. Thus, we will be able to reliably evaluate the proportions of patients who received unwanted interventions. Because we cannot determine the denominator of patients with indications for these interventions, we will not evaluate the proportions of patients who went without desired services.
Measured: up to 1 year
Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
Patients will indicate on their advance directives forms their selections for post-hospitalization care. We will utilize data from the Pennsylvania Health Care Cost Containment Consortium and New Jersey Department of Health and Senior Services to asses if the care patient indicate is the care they receive.
Measured: up to 1 year
Decision conflict
The decision conflict scale is a well-validated instrument used to assess patients' certainty in making healthcare decisions. The DCS will be sent home with consenting patients to complete and return along with their advance directive forms and an instruction sheet explaining to patients that they should complete their advance directive forms first, followed by the DCS, and both should be mailed to the research team in the provided stamped envelope.
Measured: up to 1 year
Decision satisfaction
Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
Measured: up to 1 year
Quality of Life using the McGill Quality of Life (MQOL) instrument.
The MQOL is a well-Validated and widely used scale designed specifically for patients with serious illnesses. The MQOL can be completed by family members on behalf of patients who have lost the capacity to complete it themselves. Thus, we will have surrogates (the individuals identified on patients' advance directive forms as their appointed healthcare agents) complete the MQOL for incapacitated patients to minimize missing data.
Measured: up to 1 year
Surrogates' Perception of the quality of death and dying
Because we are recruiting patients with serious life-limiting illnesses, we anticipate that some patients will die over the course of this study period. We will speak with surrogates of deceased patients to assess their perceived quality of death and dying using Prigerson's Quality of Death measure.
Measured: within 3 months of patient death
Post-traumatic stress in surrogates
The risk of post-traumatic stress disorder in surrogates among deceased patients will be assessed using the Impact of Events Scale. The IES is a valid and reliable scale that has been used frequently to assess PTSD risk among family members of critically ill patients.
Measured: within 3 months of patient death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2016

First posted20 Dec 2013 (estimated)
Study startJan 2014
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for This Study Will Focus on Advance Care Planning Among Patients With Life-limiting IllnessesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 270 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02017548
Sponsor's protocol ID: UPenn 819325
Status last verified: Mar 2019
First submitted: 16 Dec 2013
Last updated: 1 Apr 2019
Results posted: No
Data monitoring committee: Yes

Publications

Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
PubMed 32227179
Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.
PubMed 27266769

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Default Options in Advance Directives
ClinicalTrials.gov ID: NCT02017548
Acronym / sponsor ID: UPenn 819325
Conditions: This Study Will Focus on Advance Care Planning Among Patients With Life-limiting Illnesses
Keywords: advance directives, advance care planning
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (estimated)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: University of Pittsburgh
Study start: Jan 2014 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 20 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Life-extension default	Experimental	Behavioral: Life-extension default advance directiveSubjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs. comfort oriented care) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections. It also will state that upon discharge from the hospital, long-term care (vs. hospice care) will be provided unless the patient chooses otherwise.
Comfort default	Experimental	Behavioral: Comfort default advance directiveSubjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs. life extension) unless the subject specifies otherwise. The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections. It also will state that upon discharge from the hospital, hospice care (vs. long-term care) will be provided unless the patient chooses otherwise.
Standard advance directive	No intervention	–Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Age 18 or older
Fluent in English
Has seen current physician at least once prior to current visit
Resident of Pennsylvania or New Jersey
One or more of the following diagnoses:

Key exclusion criteria (2 listed)

Currently listed for or being considered for solid organ transplant
Patients with a previously signed advance directive or living will.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Life-extension default advance directive	Behavioural	Life-extension default
Comfort default advance directive	Behavioural	Comfort default

Primary outcome

Hospital free days
Time frame: 6 months
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research. As the name describes, HFDs represent the number of days alive and not in an acute care facility. Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative. To bolster confidence in the results, we will evaluate two key variations on the theme. First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home. We will also evaluate HFDs within a defined period of follow-up - 6 months in this case. This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients

10 secondary outcomes

Hospital and ICU admissions
Time frame: up to 1 year
Costs of care
Time frame: up to 1 year
Hospice utilization
Time frame: up to 1 year
Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
Time frame: up to 1 year
Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
Time frame: up to 1 year
Decision conflict
Time frame: up to 1 year
Decision satisfaction
Time frame: up to 1 year
Quality of Life using the McGill Quality of Life (MQOL) instrument.
Time frame: up to 1 year
Surrogates' Perception of the quality of death and dying
Time frame: within 3 months of patient death
Post-traumatic stress in surrogates
Time frame: within 3 months of patient death

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
Derived from this study: PubMed 32227179Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
Derived from this study: PubMed 27266769Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott D. Halpern, MD, PhD principal investigator

University of Pennsylvania

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital free days (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02017548, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.