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Improving Decisions About CPR

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03287895
Acronym
iCANACP
Enrollment
200
Registered
2017-09-19
Start date
2017-10-01
Completion date
2018-10-22
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CPR Decision-Making

Keywords

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

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.

Interventions

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

Sponsors

Canadian Frailty Network
CollaboratorOTHER
The Ottawa Hospital Academic Medical Association
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CPR Orders14 days post enrollmentThe proportion of patients with an order for CPR in the medical record

Secondary

MeasureTime frameDescription
Decisional ConflictImmediately after intervention, or enrollment for control groupMeasured using a modified version of the Decisional Conflict Scale
Health Resource UsageFrom 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)
Number of documented goals of care conversationsBetween study enrollment and up to 14 days post enrollmentCount 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.
Quality of documented goals of care conversationsBetween study enrollment and up to 14 days post enrollmentMean 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.
SDM Self-efficacyImmediately after intervention, or enrollment for control groupFor 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.
Patient/Substitute Decision Maker (SDM) satisfaction with decision-makingImmediately after intervention, or enrollment for control groupDecision-making domain of the Canadian Health Care Evaluation Project (CANHELP) questionnaire
Number of participants with in-hospital mortalityIn the year following index admissionParticipants will contribute to this measure if they die while admitted to hospital
Discharge DispositionEnd of index admissionPatient destination on discharge from index admission (home, home with support, rehabilitation, long-term care, etc).
Number of hospital admissionsIn the year following index admissionCount of admissions to hospital
Number of hospital daysIn the year following index admissionCount of days admitted to hospital
Number of ICU daysIn the year following index admissionCount of days admitted to an intensive care unit
Number of emergency department visitsIn the year following index admissionCount of presentations to emergency department

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026