Advance DirectivesNCT01683097
Patient Understanding of End of Life Care
A study testing Standardized explanation in people with Advance Directives and Resuscitation Orders, run by Partners in Internal Medicine at 1 site in United States.
Trial summary
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Directives, Resuscitation Orders
- What is being tested?
- Standardized explanation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2010
- 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 years
- Admitted to regular nursing floor
Who cannot join
- altered mental status
- admitted in ICU
- positive screening for depression
- terminal illness defined as life expectancy< 100 days
- inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Vincent Hospital
Worcester, Massachusetts, 01608
About this study
Official title: Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire
- Conditions
- Advance Directives, Resuscitation Orders
- Being tested
- Standardized explanation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized explanationOther
Standardized explanation provided on code status, advance directives and end of life care
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Questionnaire |
| Intervention | Experimental | Standardized explanation followed by questionnaire Receives: Other: Standardized explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of correct responses
Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire
Measured: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Secondary outcomes (1)
Compare differences in demographic, medical, social and associated factors on patient choice of code status
Measured: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance DirectivesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Partners in Internal Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Abraham, MD, Principal investigator, Saint Vincent HospitalKriti Mittal, MD, Principal investigator, Saint Vincent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683097
- Sponsor's protocol ID
- SVH 1195
- Status last verified
- Sep 2012
- First submitted
- 25 Jul 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion
- ClinicalTrials.gov ID
- NCT01683097
- Acronym / sponsor ID
- SVH 1195
- Conditions
- Advance Directives, Resuscitation Orders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Partners in Internal MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Sep 2012 (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.
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Questionnaire |
| Intervention | Experimental | Other: Standardized explanationStandardized explanation followed by questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Admitted to regular nursing floor
Key exclusion criteria (5 listed)
- altered mental status
- admitted in ICU
- positive screening for depression
- terminal illness defined as life expectancy< 100 days
- inability to 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 |
|---|---|---|
| Standardized explanationStandardized explanation provided on code status, advance directives and end of life care | Other | Intervention |
Primary outcome
Composite score of correct responses
Time frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire
1 secondary outcome
Compare differences in demographic, medical, social and associated factors on patient choice of code status
Time frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
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 11 Sep 2012.
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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.
George Abraham, MD principal investigator
Saint Vincent Hospital
Kriti Mittal, MD principal investigator
Saint Vincent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized explanation in people with Advance Directives and Resuscitation Orders, run by Partners in Internal Medicine at 1 site 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 2 inclusion and 5 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Composite score of correct responses (time frame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2012.