CPR Decision-MakingiCANACPNCT03287895
Improving Decisions About CPR
A study testing Decision Support in people with CPR Decision-Making, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- CPR Decision-Making
- What is being tested?
- Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2017to 22 Oct 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible to receive CPR
- Satisfying at least one of the following criteria groups
- 55 years of age or older with one or more of the following diagnoses:
- Chronic obstructive lung disease (2 of the 3 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L)
- Congestive heart failure (New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%)
- Cirrhosis (confirmed by imaging studies or documentation of esophageal varices and one of three conditions; hepatic coma, child's class C liver disease, or child's class B liver disease with gastrointestinal bleeding)
Show all 11Show fewer
- Cancer (metastatic cancer or stage IV lymphoma)
- End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness).
- 80 years of age or older and admitted to hospital from the community for an acute medical or surgical condition.
- If none of the above criteria are met, any patient whose death within the next 6 months would not surprise any member of their care team.
- At least 55 years old and predicted risk of death in the next 12 months of >=10% as calculated with the HOMR Now! Score
Who cannot join
- Patients or SDMs who do not speak English.
- Patients or SDMs who do not provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9
About this study
Official title: A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill
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.
Read the detailed description
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.
- Conditions
- CPR Decision-Making
- Being tested
- Decision Support
- Keywords
- Cardio-pulmonary resuscitation, CPR, Decision-making, Advance Care Planning, End of life, Code Status, Goals of Care, Communication
- Medical subject headings
- Death, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision SupportBehavioural
A two-part intervention to help patients make better decisions about CPR
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Decision Support | Experimental | 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. Receives: Behavioral: Decision Support |
| Control | No intervention | Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Orders
The proportion of patients with an order for CPR in the medical record
Measured: 14 days post enrollment
Secondary outcomes (12)
Patient/Substitute Decision Maker (SDM) satisfaction with decision-making
Decision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire
Measured: Immediately after intervention, or enrollment for control group
Decisional Conflict
Measured using a modified version of the Decisional Conflict Scale
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after intervention, or enrollment for control group
Number of emergency department visits
Count of presentations to emergency department
Measured: 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
Measured: In the year following index admission
Discharge Disposition
Patient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).
Measured: End of index admission
Number of hospital admissions
Count of admissions to hospital
Measured: In the year following index admission
Number of hospital days
Count of days admitted to hospital
Measured: In the year following index admission
Number of ICU days
Count of days admitted to an intensive care unit
Measured: In the year following index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Oct 2017
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPR Decision-MakingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network, The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Daniel Kobewka, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287895
- Sponsor's protocol ID
- 20170531
- Acronym
- iCANACP
- Status last verified
- Dec 2018
- First submitted
- 28 Aug 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill
- ClinicalTrials.gov ID
- NCT03287895
- Acronym / sponsor ID
- iCANACP / 20170531
- Conditions
- CPR Decision-Making
- Keywords
- Cardio-pulmonary resuscitation, CPR, Decision-making, Advance Care Planning, End of life, Code Status, Goals of Care, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Frailty Network, The Ottawa Hospital Academic Medical Association
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Decision Support | Experimental | Behavioral: Decision SupportIn 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. |
| Control | No intervention | –Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Eligible to receive CPR
- Satisfying at least one of the following criteria groups
Key exclusion criteria (2 listed)
- Patients or SDMs who do not speak English.
- Patients or SDMs who do not provide 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 |
|---|---|---|
| Decision SupportA two-part intervention to help patients make better decisions about CPR | Behavioural | Intervention - Decision Support |
Primary outcome
CPR Orders
Time frame: 14 days post enrollment
The proportion of patients with an order for CPR in the medical record
12 secondary outcomes
Patient/Substitute Decision Maker (SDM) satisfaction with decision-making
Time frame: Immediately after intervention, or enrollment for control group
Decisional Conflict
Time frame: Immediately after intervention, or enrollment for control group
Health Resource Usage
Time frame: From enrolment to 1 year after enrollment.
Number of documented goals of care conversations
Time frame: Between study enrollment and up to 14 days post enrollment
Quality of documented goals of care conversations
Time frame: Between study enrollment and up to 14 days post enrollment
SDM Self-efficacy
Time frame: Immediately after intervention, or enrollment for control group
Number of emergency department visits
Time frame: In the year following index admission
Number of participants with in-hospital mortality
Time frame: In the year following index admission
Discharge Disposition
Time frame: End of index admission
Number of hospital admissions
Time frame: In the year following index admission
Number of hospital days
Time frame: In the year following index admission
Number of ICU days
Time frame: In the year following index admission
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 26 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for CPR Decision-Making
Not yet recruiting
The Effect of Escape Room Simulation on Nursing Students' Clinical Decision-Making and Teamwork Attitudes Regarding Cardiopulmonary Resuscitation
Cardiopulmonary Resuscitation (CPR), ESCAPE ROOM
Not yet recruiting
Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness
Cardiopulmonary Arrest, Pediatric ALL
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.
Daniel Kobewka principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support in people with CPR Decision-Making, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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 11 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
CPR Orders (time frame: 14 days post enrollment). 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 26 Dec 2018.