An interventional study of Decision Support in CPR Decision-Making, sponsored by Ottawa Hospital Research Institute. Completed at 2 sites in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Supportive care
Objective
The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision support intervention aimed at improving the quality of decisions about Cardio Pulmonary Resuscitation (CPR) for seriously ill, elderly patients in hospital.
The hypothesis is that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
Methodological Approach
The study will be a randomized controlled trial comparing a multi-faceted decision support intervention to usual care for hospitalized patients. The primary objective of this study is to determine if our multifaceted intervention changes decisions about CPR. The components of the multifaceted intervention have already been evaluated for feasibility and acceptability in the hospital setting. The intervention has two parts: the first is a values clarification exercise, and the second part is a CPR video decision aid that explains the risks and benefits of CPR as well as the reasons a patient may choose to receive CPR or not. From previous research it is known that many hospitalized patients have prescribed orders for CPR despite expressing a preference not to have CPR when asked. Furthermore patients often have expressed values that are not concordant with their expressed wishes regarding resuscitation. Therefore it is hypothesized that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
We will conduct sensitivity analyses to investigate whether the intervention is more effective among patients who remain in hospital longer after enrollment. We will measure the intervention effect among patients who remained in hospital for fewer than three days after enrollment, among patients who were in hospital for 3-7 days after enrollment, and among patients who remained in hospital for longer than 7 days post-enrollment.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's enrollment of 200 is above the median of 163 across 210 interventional studies indexed under Death.
Browse Death studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Satisfying at least one of the following criteria groups
55 years of age or older with one or more of the following diagnoses:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to the regular conversation about CPR that a patient's physician may have with them, participants will be given a two-part intervention. First, the participant will receive a values clarification tool which helps them rate and understand which relevant values are most important to them. There are two forms of this tool, a full and simplified version. All participants in this arm will receive both, in randomized order. The second aspect of the intervention is an educational video about the potential risks and benefits of CPR, which all participants in this arm will receive.
Behavioral: Decision Support
Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them.
A two-part intervention to help patients make better decisions about CPR
CPR Orders
The proportion of patients with an order for CPR in the medical record
Time frame: 14 days post enrollment
Patient/Substitute Decision Maker (SDM) satisfaction with decision-making
Decision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire
Time frame: Immediately after intervention, or enrollment for control group
Decisional Conflict
Measured using a modified version of the Decisional Conflict Scale
Time frame: Immediately after intervention, or enrollment for control group
Health Resource Usage
Case costing system at the Ottawa Hospital data warehouse used to measure total cost of hospital care for patients (direct and indirect)
Time frame: From enrolment to 1 year after enrollment.
Number of documented goals of care conversations
Count of documented goals of care conversations, defined as "a conversation that addressed at least one of the following domains: patient values and goals; prognosis or illness understanding; end-of-life care planning; or code status (that is, whether or not a patient has requested resuscitation in the event of a Code Blue) or desire for other life-sustaining treatments or procedures." (Lakin et al. Health Affairs 36, no.7 (2017):1258-1264). We will report the presence or absence of any goals of care conversation, as well as the mean number of conversations in each group.
Time frame: Between study enrollment and up to 14 days post enrollment
Quality of documented goals of care conversations
Mean quality score for the first instance of a goals of care conversation following study enrollment. Quality assessed using the scale developed for Lakin et al. 2017. This scale has a maximum score of 17 and a minimum score of 1.
Time frame: Between study enrollment and up to 14 days post enrollment
SDM Self-efficacy
For substitute decision-makers who participate, their confidence to make medical decisions on behalf of their loved will be measured using a 5-question questionnaire. The questionnaire asks SDMs to rate their knowledge and confidence about different aspects of decision-making, on a scale from 0 (not confident at all) to 4 (very confident). SDM self-efficacy will be calculated as the mean score among the 5 questions.
Time frame: Immediately after intervention, or enrollment for control group
Number of emergency department visits
Count of presentations to emergency department
Time frame: In the year following index admission
Number of participants with in-hospital mortality
Participants will contribute to this measure if they die while admitted to hospital
Time frame: In the year following index admission
Discharge Disposition
Patient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).
Time frame: End of index admission
Number of hospital admissions
Count of admissions to hospital
Time frame: In the year following index admission
Number of hospital days
Count of days admitted to hospital
Time frame: In the year following index admission
Number of ICU days
Count of days admitted to an intensive care unit
Time frame: In the year following index admission
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Oct 2018, 12 months.
Of 105 non-industry interventional studies with no phase under Death, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 12 months is below that.
Counting every sponsor, half of 109 studies reached it within 24 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ottawa Hospital Research Institute →