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Completed

NCT Number: NCT03287895

Improving Decisions About CPR

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Hospital Civic Campus, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Decision Support

Behavioral

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

Primary outcomes

  1. CPR Orders

    Time frame: 14 days post enrollment

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

Secondary outcomes

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

    Time frame: Immediately after intervention, or enrollment for control group

    Decision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire

  2. Decisional Conflict

    Time frame: Immediately after intervention, or enrollment for control group

    Measured using a modified version of the Decisional Conflict Scale

  3. Health Resource Usage

    Time frame: From enrolment to 1 year after enrollment.

    Case costing system at the Ottawa Hospital data warehouse used to measure total cost of hospital care for patients (direct and indirect)

  4. Number of documented goals of care conversations

    Time frame: Between study enrollment and up to 14 days post enrollment

    Count of documented goals of care conversations, defined as "a conversation that addressed at least one of the following domains: patient values and goals; prognosis or illness understanding; end-of-life care planning; or code status (that is, whether or not a patient has requested resuscitation in the event of a Code Blue) or desire for other life-sustaining treatments or procedures." (Lakin et al. Health Affairs 36, no.7 (2017):1258-1264). We will report the presence or absence of any goals of care conversation, as well as the mean number of conversations in each group.

  5. Quality of documented goals of care conversations

    Time frame: Between study enrollment and up to 14 days post enrollment

    Mean quality score for the first instance of a goals of care conversation following study enrollment. Quality assessed using the scale developed for Lakin et al. 2017. This scale has a maximum score of 17 and a minimum score of 1.

  6. SDM Self-efficacy

    Time frame: Immediately after intervention, or enrollment for control group

    For substitute decision-makers who participate, their confidence to make medical decisions on behalf of their loved will be measured using a 5-question questionnaire. The questionnaire asks SDMs to rate their knowledge and confidence about different aspects of decision-making, on a scale from 0 (not confident at all) to 4 (very confident). SDM self-efficacy will be calculated as the mean score among the 5 questions.

  7. Number of emergency department visits

    Time frame: In the year following index admission

    Count of presentations to emergency department

  8. Number of participants with in-hospital mortality

    Time frame: In the year following index admission

    Participants will contribute to this measure if they die while admitted to hospital

  9. Discharge Disposition

    Time frame: End of index admission

    Patient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).

  10. Number of hospital admissions

    Time frame: In the year following index admission

    Count of admissions to hospital

  11. Number of hospital days

    Time frame: In the year following index admission

    Count of days admitted to hospital

  12. Number of ICU days

    Time frame: In the year following index admission

    Count of days admitted to an intensive care unit

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Frailty Network
  • The Ottawa Hospital Academic Medical Association

Registry information

Official study title

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

Acronym: iCANACP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2017
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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