Clinical trial NCT03287895: Improving Decisions About CPR
Official title: A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CPR Decision-Making
Keywords: Cardio-pulmonary resuscitation
CPR
Decision-making
Advance Care Planning
End of life
Code Status
Goals of Care
Communication
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
name: The Ottawa Hospital Academic Medical Association
First posted: 2017-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Eligible to receive CPR
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 speak English.
* Patients or SDMs who do not provide informed consent.

Primary outcomes:
measure: CPR Orders
timeFrame: 14 days post enrollment
Secondary outcomes:
measure: Patient/Substitute Decision Maker (SDM) satisfaction with decision-making
timeFrame: Immediately after intervention, or enrollment for control group
measure: Decisional Conflict
timeFrame: Immediately after intervention, or enrollment for control group
measure: Health Resource Usage
timeFrame: From enrolment to 1 year after enrollment.
measure: Number of documented goals of care conversations
timeFrame: Between study enrollment and up to 14 days post enrollment
measure: Quality of documented goals of care conversations
timeFrame: Between study enrollment and up to 14 days post enrollment
measure: SDM Self-efficacy
timeFrame: Immediately after intervention, or enrollment for control group
measure: Number of emergency department visits
timeFrame: In the year following index admission
measure: Number of participants with in-hospital mortality
timeFrame: In the year following index admission
measure: Discharge Disposition
timeFrame: End of index admission
measure: Number of hospital admissions
timeFrame: In the year following index admission
measure: Number of hospital days
timeFrame: In the year following index admission
measure: Number of ICU days
timeFrame: In the year following index admission
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Daniel Kobewka
role: PRINCIPAL_INVESTIGATOR
References: