Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-10-01
2018-10-22
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention - Decision Support
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.
Decision Support
A two-part intervention to help patients make better decisions about CPR
Control
Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them.
No interventions assigned to this group
Interventions
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Decision Support
A two-part intervention to help patients make better decisions about CPR
Eligibility Criteria
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Inclusion Criteria
2. Satisfying at least one of the following criteria groups
1. 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)
* 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).
2. 80 years of age or older and admitted to hospital from the community for an acute medical or surgical condition.
3. 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.
4. At least 55 years old and predicted risk of death in the next 12 months of \>=10% as calculated with the HOMR Now! Score
Exclusion Criteria
* Patients or SDMs who do not provide informed consent.
55 Years
ALL
No
Sponsors
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Canadian Frailty Network
OTHER
The Ottawa Hospital Academic Medical Association
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Daniel Kobewka
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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The Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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20170531
Identifier Type: -
Identifier Source: org_study_id