End Stage Renal DiseaseNCT02209038
Choice Sets for Advance Directives
A study testing Expanded AD Choice and Expanded Life-sustaining Therapy Choice in people with End Stage Renal Disease, run by University of Pennsylvania at 15 sites in United States.
Trial summary
There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Expanded AD Choice and Expanded Life-sustaining Therapy Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2014to Oct 2015
- 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
- Proficient in English
- Chronic hemodialysis for minimum 90 days
- Does not currently have a living will
Who cannot join
- Blindness
- Cognitive impairment that prohibits subject's provision of informed consent
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lourdes-Camden
Camden, New Jersey, 08103
Market Street DaVita
Philadelphia, Pennsylvania, 19104
Philadelphia 42nd Street DaVita
Philadelphia, Pennsylvania, 19104
Philadelphia PMC-Lombard DaVita
Philadelphia, Pennsylvania, 19104
University City DaVita
Philadelphia, Pennsylvania, 19104
Franklin DaVita
Philadelphia, Pennsylvania, 19106
PDI Walnut Tower DaVita
Philadelphia, Pennsylvania, 19107
Callowhill DaVita
Philadelphia, Pennsylvania, 19123
City Line DaVita
Philadelphia, Pennsylvania, 19131
South Broad Street
Philadelphia, Pennsylvania, 19146
Cottman DaVita
Philadelphia, Pennsylvania, 19149
South Philadelphia DaVita
Philadelphia, Pennsylvania
Radnor DaVita
Radnor, Pennsylvania, 19087
Abington DaVita
Willow Grove, Pennsylvania, 19090
Willow Grove DaVita
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.
Read the detailed description
This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.
- Conditions
- End Stage Renal Disease
- Being tested
- Expanded AD Choice, Expanded Life-sustaining Therapy Choice
- Keywords
- end stage renal disease, hemodialysis, dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded AD ChoiceBehavioural
Expanded Life-sustaining Therapy ChoiceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Expanded AD Choice | Experimental | "Would you like to complete an advance directive with the assistance of any person(s) you choose?"
4 answer choices:
* Yes, I would like to complete a comprehensive version of an advance directive.
* Yes, I would like to complete an expanded version of an advance directive.
* Yes, I would like to complete a brief version of an advance directive.
* No, I do not wish to complete an advance directive. Receives: Behavioral: Expanded AD Choice |
| Standard AD Choice | No intervention | "Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices: * Yes, I would like to complete an AD. * No, I do not wish to complete an advance directive. |
| Expanded Life-sustaining therapy Choice | Experimental | For each hypothetical illness state described in the living will:
4 answer choices:
* No, I would not want life support.
* Yes, I would want life support.
* I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death.
* I do not wish to specify a preference at this time. Receives: Behavioral: Expanded Life-sustaining Therapy Choice |
| Standard Life-sustaining Therapy Choice | No intervention | For each hypothetical illness state described in the living will: 3 answer choices: * No, I would not want life support. * Yes, I would want life support. * I do not wish to specify a preference at this time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
advance directive
return of a completed and signed advance directive
Measured: up to 4 weeks
Secondary outcomes (5)
Medical Outcomes Study Short Form-12v2
change from baseline in Short Form-12v2 score at 3 months
Measured: baseline and 3 months
McGill Quality of Life Questionnaire
change from baseline in McGill Quality of Life Questionnaire at 3 months
Measured: baseline and 3 months
Satisfaction with Decision Scale
satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
Measured: baseline
Decisional Conflict Scale
Decisional Conflict Scale measured immediately after completion of an advance directive
Measured: up to 4 weeks
no life-sustaining therapy preference specified
among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott D Halpern, MD, PhD, Principal investigator, University of PennsylvaniaKatherine R Courtright, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209038
- Sponsor's protocol ID
- 820002
- Status last verified
- Jan 2016
- First submitted
- 16 Jul 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Courtright KR, Madden V, Gabler NB, Cooney E, Kim J, Herbst N, Burgoon L, Whealdon J, Dember LM, Halpern SD. A Randomized Trial of Expanding Choice Sets to Motivate Advance Directive Completion. Med Decis Making. 2017 Jul;37(5):544-554. doi: 10.1177/0272989X16663709. Epub 2016 Aug 10.
PubMed 27510741
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
- ClinicalTrials.gov ID
- NCT02209038
- Acronym / sponsor ID
- 820002
- Conditions
- End Stage Renal Disease
- Keywords
- end stage renal disease, hemodialysis, dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Aug 2014 (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.
There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.
Detailed description
This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expanded AD Choice | Experimental | Behavioral: Expanded AD Choice"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 4 answer choices: * Yes, I would like to complete a comprehensive version of an advance directive. * Yes, I would like to complete an expanded version of an advance directive. * Yes, I would like to complete a brief version of an advance directive. * No, I do not wish to complete an advance directive. |
| Standard AD Choice | No intervention | –"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices: * Yes, I would like to complete an AD. * No, I do not wish to complete an advance directive. |
| Expanded Life-sustaining therapy Choice | Experimental | Behavioral: Expanded Life-sustaining Therapy ChoiceFor each hypothetical illness state described in the living will: 4 answer choices: * No, I would not want life support. * Yes, I would want life support. * I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death. * I do not wish to specify a preference at this time. |
| Standard Life-sustaining Therapy Choice | No intervention | –For each hypothetical illness state described in the living will: 3 answer choices: * No, I would not want life support. * Yes, I would want life support. * I do not wish to specify a preference at this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Proficient in English
- Chronic hemodialysis for minimum 90 days
- Does not currently have a living will
Key exclusion criteria (2 listed)
- Blindness
- Cognitive impairment that prohibits subject's provision of informed consent
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 |
|---|---|---|
| Expanded AD Choice | Behavioural | Expanded AD Choice |
| Expanded Life-sustaining Therapy Choice | Behavioural | Expanded Life-sustaining therapy Choice |
Primary outcome
advance directive
Time frame: up to 4 weeks
return of a completed and signed advance directive
5 secondary outcomes
Medical Outcomes Study Short Form-12v2
Time frame: baseline and 3 months
McGill Quality of Life Questionnaire
Time frame: baseline and 3 months
Satisfaction with Decision Scale
Time frame: baseline
Decisional Conflict Scale
Time frame: up to 4 weeks
no life-sustaining therapy preference specified
Time frame: up to 4 weeks
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 7 Jan 2016.
- Derived from this study: PubMed 27510741Courtright KR, Madden V, Gabler NB, Cooney E, Kim J, Herbst N, Burgoon L, Whealdon J, Dember LM, Halpern SD. A Randomized Trial of Expanding Choice Sets to Motivate Advance Directive Completion. Med Decis Making. 2017 Jul;37(5):544-554. doi: 10.1177/0272989X16663709. Epub 2016 Aug 10.
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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
Katherine R Courtright, MD study director
University of Pennsylvania
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded AD Choice and Expanded Life-sustaining Therapy Choice in people with End Stage Renal Disease, run by University of Pennsylvania at 15 sites in United States.
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 4 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
advance directive (time frame: up to 4 weeks). 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 NCT02209038, which also lists 1 linked publication.
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 7 Jan 2016.