Dataset Information

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study.

ABSTRACT: Obtaining informed consent for commonly performed ICU procedures is often compromised by variability in communication styles and inadequate verbal descriptions of anatomic concepts. The objective of this study was to evaluate the efficacy of an audiovisual module in improving the baseline knowledge of ICU procedures among patients and their caregivers.

Design

Prospective, observational study.

Setting

Forty-eight-bed adult surgical ICU at a tertiary care center.

Subjects

Critically ill surgical patients and their legally authorized representatives.

Interventions

An audiovisual module describing eight commonly performed ICU procedures.

Measurements and main results

Fifty-nine subjects were enrolled and completed an 11-question pre- and postvideo test of knowledge regarding commonly performed ICU procedures and a brief satisfaction survey. Twenty-nine percent had a healthcare background. High school was the highest level of education for 37% percent of all subjects. Out of 11 questions on the ICU procedure knowledge test, subjects scored an average 8.0 ± 1.9 correct on the pretest and 8.4 ± 2.0 correct on the posttest (p = 0.055). On univariate logistic regression, having a healthcare background was a negative predictor of improved knowledge (odds ratio, 0.185; 95% CI, 0.045-0.765), indicating that those with a health background had a lower probability of improving their score on the posttest. Among subjects who did not have a healthcare background, scores increased from 7.7 ± 1.9 to 8.3 ± 2.1 (p = 0.019). Seventy-five percent of all subjects indicated that the video was easy to understand, and 70% believed that the video improved their understanding of ICU procedures.

Conclusions

Audiovisual modules may improve knowledge and comprehension of commonly performed ICU procedures among critically ill patients and caregivers who have no healthcare background.

SUBMITTER: Loftus TJ

PROVIDER: S-EPMC7685966 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study.

Loftus Tyler J TJ Alfaro Maria E ME Anderson Tiffany N TN Murphy Travis W TW Zayko Olga O Davis John P JP Hothem Zachary A ZA Darden Dijoia B DB Patel Rohit P RP Whittet Wanda W McGough Edward K EK Bihorac Azra A Croft Chasen A CA Rosenthal Martin D MD Smith R Stephen RS Vanzant Erin L EL Moore Fredrick A FA Brakenridge Scott C SC Ghita Gabriela L GL Brumback Babette A BA Mohr Alicia M AM Efron Philip A PA

Critical care explorations 20201123 12

Obtaining informed consent for commonly performed ICU procedures is often compromised by variability in communication styles and inadequate verbal descriptions of anatomic concepts. The objective of this study was to evaluate the efficacy of an audiovisual module in improving the baseline knowledge of ICU procedures among patients and their caregivers.<h4>Design</h4>Prospective, observational study.<h4>Setting</h4>Forty-eight-bed adult surgical ICU at a tertiary care center.<h4>Subjects</h4>Crit ...[more]

PMID: 33251517

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Project description:IntroductionDoctors have a legal requirement and duty of care to ensure patients are enabled to make an informed decision about their treatment, including discussion of the benefits, risks and alternatives to a procedure. A patient-centred approach to consent has been firmly established in Ireland, and fundamental to this is the ability to engage in a dialogue that offers comprehensible information to patients. Telemedicine has revolutionised the way we can deliver care to patients in the modern era of computers, tablets, and smartphones, and its use has been rapidly expanded. Novel digital strategies to improve the informed consent process for surgical procedures have been increasingly under investigation over the last 10-15 years and may offer a low cost, accessible and tailored solution to consent for surgical interventions. Within vascular surgery, superficial venous interventions have been associated with a high number medicolegal claims and also represents an area within the specialty with rapidly evolving technology and techniques. The ability to communicate comprehensible information to patients has never been greater. Thus, the author's aim is to explore whether it is feasible and acceptable to deliver a digital health education intervention to patients undergoing endovenous thermal ablation (EVTA) to supplement the consent process.MethodsThis is a prospective, single centre, randomised controlled, feasibility trial recruiting patients with chronic venous disease deemed suitable to undergo EVTA. Patients will be randomised to receive either standard consent (SC) or a newly developed digital health education tool (dHET). The primary outcome is feasibility; assessing the recruitment and retention rate of participants and assessing acceptability of the intervention. Secondary outcomes include knowledge retention, anxiety and satisfaction. This feasibility trial is designed to recruit 40 patients, which will allow for a moderate dropout rate. This pilot study will inform the authors of the appropriateness of an adequately powered multicentre trial.DiscussionTo examine the role of a digital consent solution for EVTA. This may improve and standardise the consent dialogue with patients and may have the potential to reduce claims related to poor consent processes and disclosure of risks.Ethical committee referenceEthical approval has been sought and received from both the Bon Secours Hospital and RCSI (202109017), on 14 May 2021 and 10 October 2021, respectively.Trial registrationClinicalTrials.gov Identifier: NCT05261412 , registered on 1 March 2022.

Project description:BackgroundWe sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC) in Greece.Methodology/principal findingsA prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman's rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC.ConclusionsDespite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant's comprehension of the right to IC and the provision of information regarding other possible therapeutic options.

Project description:PurposeWith the growing demand for shared decision-making and patient-centered care, optimal informed consent (IC) has gained relevance. Virtual reality (VR) has seen significant technological advancements, and its medical applications currently include surgical planning and medical education. This pilot study investigates the feasibility of VR-enhanced informed consent (VR-IC) in neurosurgery to improve preoperative IC and patient satisfaction.MethodsWe included patients aged 18 to 75 years who were scheduled for skull base meningioma or brain aneurysm surgery between May and December 2023. Exclusion criteria were visual/auditory impairments and severe cognitive/psychiatric disorders. Patients received standard IC followed by VR-IC using patient-specific VR models of their pathology. After an initial demonstration by the surgeon, the patients used the VR station independently. A questionnaire with 18 questions on a 5-point Likert scale assessed the subjective impression of VR-IC.ResultsTen patients participated in the study, with six (60%) undergoing aneurysm clipping and four (40%) undergoing skull base meningioma resection. The mean age of the participants was 58 years (± 15, range 27 to 75 years), with four female patients (40%). Patients overall rated the VR-informed consent (VR-IC) positively with a mean of 4.22 (± 0.84). There was a better understanding of their pathology (mean 4.30 ± 0.92) and the planned procedure (mean 3.95 ± 1.04). Trust in the surgeon was rated with a mean of 3.47 (± 0.94). Only minimal side effects from the VR experience including dizziness or discomfort were noted (mean 4.60 ± 0.22). None of the participants dropped out of the study.ConclusionVR-enhanced informed consent is feasible and improves patient understanding and satisfaction without significant side effects. These findings will guide the planning of a randomized controlled trial to validate the benefits of VR-IC in neurosurgery further.

Dataset Information

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study.

Design

Setting

Subjects

Interventions

Measurements and main results

Conclusions

Publications

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study.

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