Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

Study Overview
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Brief Summary
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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.

Official Title
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Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

Conditions
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Congestive Heart Failure, Infections, Sepsis, Acute Renal Failure, Stroke

Intervention / Treatment
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* Other: Script and CPR/Mechanical ventilation video.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients ≥65 yrs Admitted to the hospitalist Medicine Service Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Script and Video<br>Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video. | Other: Script and CPR/Mechanical ventilation video.<br>* Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.<br>|
| Experimental: Script only<br>Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only. | Other: Script and CPR/Mechanical ventilation video.<br>* Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | Number of deaths in each group in the hospital | Length of patient's hospital stay | 
| 30-day mortality | Number of deaths in each group after 30 days. | 30 days | 
| 90 day mortality | Number of deaths in each group in 90 days. | 90 days | 
| Number of patients undergoing CPR | Number of patients in each group who undergo CPR during their hospitalization. | Length of patient's hospital stay | 
| Number of patients undergoing intubation | Number of patients in each group who undergo intubation during their hospital stay. | Length of patient's hospital stay |