Improving Decisions About CPR

NCT03287895 | Completed

• 1 other identifier: 20170531
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

CPR Decision-Making

Keywords

Cardio-pulmonary resuscitation; CPR; Decision-making; Advance Care Planning; End of life; Code Status; Goals of Care; Communication

Outcome Measures

Primary Outcomes (1)

• CPR Orders

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

  14 days post enrollment

Secondary Outcomes (12)

• Patient/Substitute Decision Maker (SDM) satisfaction with decision-making

  Immediately after intervention, or enrollment for control group

• Decisional Conflict

  Immediately after intervention, or enrollment for control group

• Health Resource Usage

  From enrolment to 1 year after enrollment.

• Number of documented goals of care conversations

  Between study enrollment and up to 14 days post enrollment

• Quality of documented goals of care conversations

  Between study enrollment and up to 14 days post enrollment

Study Arms (2)

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.

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.

Interventions

Decision Support BEHAVIORAL

A two-part intervention to help patients make better decisions about CPR

Intervention - Decision Support

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible to receive CPR
• Satisfying at least one of the following criteria groups
• 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).
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Frailty Network: collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (2)

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Death; Communication

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Daniel Kobewka

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 19, 2017
• Study Start: October 1, 2017
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)