Congestive Heart FailureNCT01878968
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
A study testing Script and CPR/Mechanical ventilation video. in people with Congestive Heart Failure and Infections, run by Jewish Hospital, Cincinnati, Ohio at 1 site in United States.
Trial summary
There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Congestive Heart Failure, Infections, Sepsis
- What is being tested?
- Script and CPR/Mechanical ventilation video.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients
- ≥65 yrs
- Admitted to the hospitalist Medicine Service
Who cannot join
- Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
- Patients already receiving critical care on admission will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.
- Conditions
- Congestive Heart Failure, Infections, Sepsis, Acute Renal Failure, Stroke
- Being tested
- Script and CPR/Mechanical ventilation video.
- Medical subject headings
- Heart Failure, Infections, Sepsis, Acute Kidney Injury, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Script and CPR/Mechanical ventilation video.Other
Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.
| Study group | Role | What they receive |
|---|---|---|
| Script and Video | Experimental | Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video. Receives: Other: Script and CPR/Mechanical ventilation video. |
| Script only | Experimental | Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only. Receives: Other: Script and CPR/Mechanical ventilation video. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients opting out of routine care - no intubation
Number of patients in each group who opt out of intubation 48 hours after admission.
Measured: 48 hours
Number of patients opting out of routine care - no CPR
Number of patients in each group who opt out of CPR within 48 hours of admission.
Measured: 48 hours
Secondary outcomes (5)
Hospital Mortality
Number of deaths in each group in the hospital
Measured: Length of patient's hospital stay
30-day mortality
Number of deaths in each group after 30 days.
Measured: 30 days
90 day mortality
Number of deaths in each group in 90 days.
Measured: 90 days
Number of patients undergoing CPR
Number of patients in each group who undergo CPR during their hospitalization.
Measured: Length of patient's hospital stay
Number of patients undergoing intubation
Number of patients in each group who undergo intubation during their hospital stay.
Measured: Length of patient's hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish Hospital, Cincinnati, Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
- Investigators
- Imran Naqvi, MD, Principal investigator, Jewish Hospital of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878968
- Sponsor's protocol ID
- 13-06
- Status last verified
- Jan 2016
- First submitted
- 7 May 2013
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
- ClinicalTrials.gov ID
- NCT01878968
- Acronym / sponsor ID
- 13-06
- Conditions
- Congestive Heart Failure, Infections, Sepsis, Acute Renal Failure, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jewish Hospital, Cincinnati, OhioUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jun 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.
There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Script and Video | Experimental | Other: Script and CPR/Mechanical ventilation video.Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video. |
| Script only | Experimental | Other: Script and CPR/Mechanical ventilation video.Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- All patients
- ≥65 yrs
- Admitted to the hospitalist Medicine Service
Key exclusion criteria (2 listed)
- Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
- Patients already receiving critical care on admission will also be excluded
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 |
|---|---|---|
| Script and CPR/Mechanical ventilation video.Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators. | Other | Script and Video, Script only |
Primary outcome
Number of patients opting out of routine care - no intubation
Time frame: 48 hours
Number of patients in each group who opt out of intubation 48 hours after admission.
Number of patients opting out of routine care - no CPR
Time frame: 48 hours
Number of patients in each group who opt out of CPR within 48 hours of admission.
5 secondary outcomes
Hospital Mortality
Time frame: Length of patient's hospital stay
30-day mortality
Time frame: 30 days
90 day mortality
Time frame: 90 days
Number of patients undergoing CPR
Time frame: Length of patient's hospital stay
Number of patients undergoing intubation
Time frame: Length of patient's hospital stay
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 6 Jan 2016.
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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.
Imran Naqvi, MD principal investigator
Jewish Hospital of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Script and CPR/Mechanical ventilation video. in people with Congestive Heart Failure and Infections, run by Jewish Hospital, Cincinnati, Ohio 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 3 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 6 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 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?
Number of patients opting out of routine care - no intubation (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 6 Jan 2016.