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OpenTrials
Completed

NCT Number: NCT01878968

Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.

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Key information

Conditions

Congestive Heart Failure Acute Kidney Injury Acute Renal Failure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Infections Inflammation Kidney Diseases Male Urogenital Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Stroke Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Jewish Hospital

Cincinnati, Ohio, 45236, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients
  • ≥65 yrs
  • Admitted to the hospitalist Medicine Service

Exclusion criteria

  • Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
  • Patients already receiving critical care on admission will also be excluded

Treatment and study plan

Script and CPR/Mechanical ventilation video.

Other

Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.

Primary outcomes

  1. Number of patients opting out of routine care - no intubation

    Time frame: 48 hours

    Number of patients in each group who opt out of intubation 48 hours after admission.

  2. Number of patients opting out of routine care - no CPR

    Time frame: 48 hours

    Number of patients in each group who opt out of CPR within 48 hours of admission.

Secondary outcomes

  1. Hospital Mortality

    Time frame: Length of patient's hospital stay

    Number of deaths in each group in the hospital

  2. 30-day mortality

    Time frame: 30 days

    Number of deaths in each group after 30 days.

  3. 90 day mortality

    Time frame: 90 days

    Number of deaths in each group in 90 days.

  4. Number of patients undergoing CPR

    Time frame: Length of patient's hospital stay

    Number of patients in each group who undergo CPR during their hospitalization.

  5. Number of patients undergoing intubation

    Time frame: Length of patient's hospital stay

    Number of patients in each group who undergo intubation during their hospital stay.

Sponsors and collaborators

Lead sponsor

Jewish Hospital, Cincinnati, Ohio

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2013
Registry last updated
Jan 6, 2016

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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