A Universal Consent Form for 8 Common ICU Procedures
September 1, 2003
A Universal Consent Form for 8 Common ICU Procedures
Abstract & Commentary
Synopsis: Providing a universal consent form to patients, proxies, and staff increased the frequency with which consent was obtained without compromising understanding of the process.
Source: Davis N, et al. Improving the process of informed consent in the critically ill. JAMA. 2003;289: 1963-1968.
In this study, the research team first documented all invasive procedures performed within the first 21 days of a patient’s stay in a medical ICU, how often informed consent was obtained, and, if it was not obtained, the reason for this, by contacting the clinician. When invasive procedures were performed without consent, the most common reasons given were emergency, consent not deemed necessary, and no proxy present. Patients and proxies who gave consent were given a multiple-choice test to assess knowledge of the procedure, what it entailed, their right to refuse, and potential complications. The researchers then developed a universal consent for 8 common ICU procedures, eg, arterial, central venous, pulmonary artery, or peripheral catheter insertion; lumbar puncture; thoracentesis; paracentesis; and intubation/mechanical ventilation with accompanying forms that described each procedure and common complications.
The universal consent form was introduced into the MICU and comparisons were made for 2 months before and after its use. Before use, 53% (155/292) of procedures in 125 patients were performed with consent, as compared to 90% (308/340) of procedures in 145 patients after introduction or the form (P < .001). There was no change in patient/proxy knowledge of indications for the procedure, what it entailed, and the option to refuse; scores on the comprehension test were 81.7% before and 89.8% after use of the universal consent (P = 0.75).
Comment by Leslie A. Hoffman, PhD, RN
This investigation is one of only a few to examine ways to improve the process of obtaining informed consent in a critical care setting. While many invasive procedures are performed in ICUs, some are more commonly required than others. Based on this observation, Davis and associates developed a universal informed consent form that applied to 8 commonly performed invasive ICU procedures, along with corresponding handouts that described each procedure, its indications, and common complications. Each patient/proxy was then asked to sign the universal consent at the time of ICU admission.
Before the universal consent was adopted, several procedures had almost universal written consent, eg, blood transfusion (98%), gastrointestinal track endoscopy (95%), and bronchoscopy (100%). However these procedures accounted for only a minority (27%) of the procedures performed. Procedures most commonly performed without consent included insertion of an arterial, central venous, or pulmonary artery catheter, with the rationale that the procedure was emergent, that consent was not deemed necessary, or that the patient was unable to consent and no proxy was present. Patient/proxy understanding of the indications for the procedure was assessed before and after use of the universal consent. Importantly, use of the form was not associated with change in understanding. Once constructed, the form was viewed as simple to use and well received by patients and/or proxies. There was only one refusal during the study period.
Findings of this study support a relatively simple method of improving the consent process in critical care areas. By providing clinicians with a standard consent form and accompanying literature, and by encouraging routine completion by patients and/or proxies at the time of admission to the ICU, Davis et al were able to significantly increase the frequency with which informed consent was obtained without any change in patient/proxy understanding of the procedures involved.
Dr. Hoffman is Professor Medical-Surgical Nursing Chair, Department of Acute/Tertiary Care University of Pittsburgh School of Nursing.
Providing a universal consent form to patients, proxies, and staff increased the frequency with which consent was obtained without compromising understanding of the process.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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