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Clinical Trials/NCT03287895
NCT03287895
Completed
Not Applicable

A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill

Ottawa Hospital Research Institute2 sites in 1 country200 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CPR Decision-Making
Sponsor
Ottawa Hospital Research Institute
Enrollment
200
Locations
2
Primary Endpoint
CPR Orders
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
October 22, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)
  • 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.

Exclusion Criteria

  • Patients or SDMs who do not speak English.
  • Patients or SDMs who do not provide informed consent.

Outcomes

Primary Outcomes

CPR Orders

Time Frame: 14 days post enrollment

The proportion of patients with an order for CPR in the medical record

Secondary Outcomes

  • Decisional Conflict(Immediately after intervention, or enrollment for control group)
  • Health Resource Usage(From enrolment to 1 year after enrollment.)
  • Number of emergency department visits(In the year following index admission)
  • Quality of documented goals of care conversations(Between study enrollment and up to 14 days post enrollment)
  • Number of hospital admissions(In the year following index admission)
  • Number of hospital days(In the year following index admission)
  • Number of documented goals of care conversations(Between study enrollment and up to 14 days post enrollment)
  • SDM Self-efficacy(Immediately after intervention, or enrollment for control group)
  • Number of participants with in-hospital mortality(In the year following index admission)
  • Number of ICU days(In the year following index admission)
  • Patient/Substitute Decision Maker (SDM) satisfaction with decision-making(Immediately after intervention, or enrollment for control group)
  • Discharge Disposition(End of index admission)

Study Sites (2)

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