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A Single Consent for Serial Anesthetics in Burn Surgery

Fahy, Brenda G. MD; Vasilopoulos, Terrie PhD; Ford, Susan RN; Gravenstein, Dietrich MD; Enneking, F. Kayser MD

doi: 10.1213/ANE.0000000000000780
Economics, Education, and Policy: Brief Report

Obtaining anesthesia informed consent for a series of repetitive debridements in burn-injured patients requires a significant time investment for anesthesiologists and patient families. A single consent form was introduced that covered multiple related anesthetics in burn patients. The number of consents per patient before and after implementation was analyzed using Welch ANOVA; Tukey-Kramer post hoc test, with 99% confidence intervals for mean differences was used to examine pairwise comparisons. The mean number of consents per patient was 4.5 ± 2.8 and 1.6 ± 0.51 (P < 0.001) before (2010) and after implementation (2013), respectively. The Multiple Related Anesthetics Consent Form in this population resulted in less time spent by anesthesia providers in obtaining consent for patients undergoing multiple related procedures while providing patient- and family-centric care.

Published ahead of print April 28, 2015

From the Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida.

Dietrich Gravenstein, MD, is currently affiliated with the Department of Anesthesiology, Geisinger Medical Center, Danville, Pennsylvania.

Accepted for publication March 12, 2015.

Published ahead of print April 28, 2015

Funding: None.

The authors declare no conflicts of interest.

Reprints will not be available from the authors.

Address correspondence to Brenda G. Fahy, MD, Department of Anesthesiology, University of Florida College of Medicine, 1600 SW Archer Rd., P.O. Box 100254, Gainesville, FL 32610. Address e-mail to bfahy@anest.ufl.edu.

Obtaining informed consent for anesthesia should include a thoughtful discussion with the patient and/or his/her representative concerning the risks and benefits of the anesthetic. Although local requirements influence the decision for a separate and specific written consent for anesthesia, written separate consent is advocated around the world by anesthesiologists.1–3 Informed consent can be a challenge in the burn population, as the patient often lacks medical decision-making capacity because of the severity of his/her illness and/or the effect of medications administrated to alleviate pain and discomfort. When a patient is incapacitated, providers must contact the surrogate decision maker to obtain informed consent. However, patient family feedback given during our Anesthesia Department Quality Rounds indicated that the families were often confused about the need to give additional consent when they knew a series of procedures was going to be performed.4 Frequently, the requests for consent came in the form of a phone call from the intensive care unit, which added to their anxiety and frustration with what they viewed to be an uncoordinated system. To improve the process of obtaining informed consent when a series of operations is planned, we devised the Multiple Related Anesthetics Consent Form (MRACF). To begin implementation, the Chair of the Department of Anesthesiology (FKE) approached the legal department to ask for help in crafting an MRACF. The form was then approved by the institutional legal services. Multiple other approvals were obtained, as outlined in Figure 1. Thereafter, a single MRACF was used for the course of treatment only if the risks, benefits, and alternative treatment options remained unchanged, treatment proceeded as planned, and the patient’s condition did not alter the risk assessment as disclosed in the original consent. A new anesthesia consent was obtained for any operation different than the planned series (i.e., tracheostomy versus debridement and grafting). The risk with a tracheostomy of exsanguinating blood loss is low, whereas the risk for hypoxia and or a lost airway is high. A new consent form was obtained if anesthetic risks were altered by a change in the patient’s condition (e.g., acute myocardial infarction) where the overall risk of mortality changed.5 The form codifies for the patient and or family the expectation that multiple procedures would be done over the course of the proposed treatment.

Figure 1

Figure 1

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METHODS

The University of Florida Institutional Review Board exempted this retrospective study. Two months (January and February) from each year (2010–2013) were examined to demonstrate the impact of the MRACF, including the total number of patients treated for burns, their procedures, and anesthesia consents. Baseline data for 2010 reflected current institutional practice, with each surgical procedure being accompanied by separate, date-specific, informed anesthesia consent. In August 2010, the hospital legal department approved the use of the MRACF for related procedures performed during a 30-day period. The concept of the MRACF was also reviewed by The Joint Commission (TJC) during their usual hospital inspection during the fall of 2010. TJC applauded our efforts to respond to patient feedback but found several incidents where the form had been used for patients not undergoing a series of planned anesthetics. Based on the findings of TJC, an additional coversheet outlining the appropriate use of the MRACF was added in November of 2010. An audit of the appropriate use of the MRACF was completed during the first year of use. This 30-day consent change was reflected in the data for January and February of 2011 and 2012, respectively. In August 2012, the MRACF timeframe was expanded to 60 days, and this was reflected in the 2013 consent data. To assess the effects of the consent forms, the average number of consents per patient for the respective months of January and February from 2010 to 2013 was analyzed using the Welch ANOVA in JMP Pro 11 (SAS Institute, 2013), which is robust to heterogeneity of variances. Pairwise mean differences in consents per patient were compared with the Tukey-Kramer post hoc test, with 99% confidence intervals (CI) calculated around the mean differences. For these analyses, only patients with more than 1 procedure were analyzed because (1) these patients would always have only 1 consent and thus would not be affected by the implementation of MRACF and (2) the proportion of patients with only 1 consent was not consistent across years (Fig. 2). To understand the effect of the MRACF on the number of consents obtained from each patient, the MRACFs were fully analyzed for the year 2012 and compared with 2010 consents.

Figure 2

Figure 2

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RESULTS

The total number of patients remained stable over the 2 months for each year, 2010 (n = 51), 2011 (n = 50), 2012 (n = 46), and 2013 (n = 57), with overall procedures slightly increased in 2012 and 2013 compared to 2010 (Fig. 2). The proportion of patients with multiple procedures varied across each year: 15.4% in 2010, 21.35% in 2011, 30.4% in 2012, and 21.1% in 2013. In patients with only multiple procedures, the number of consents per patient was significantly associated with the introduction of the MRACF (F [3, 18] = 12.06, P < 0.0001; Fig. 3). The mean number of consents per patient decreased from 2010, before the implementation of the MRACF, to 2011, after the 30-day MRACF implementation, (mean difference = 1.60; 99%CI, 0.03–3.17), though this was not a statistically significant comparison (P = 0.055). There was a statistically significant decrease (P < 0.001) in mean number of consents from 2010 to 2012 (mean difference = 3.07; 99% CI, 1.60 to 4.54) and from 2010 to 2013 (mean difference = 2.97; 99% CI, 1.45 to 4.41). Although this decrease was statistically significant (P = 0.039) from 2011 to 2012 (mean difference = 1.47; 99% CI, 0.10 to 2.84), it was not statistically significant (P = 0.092) from 2011 to 2013 (mean difference = 1.32; 99% CI, −0.10 to 2.74). There was no significant difference number of consents per patient with the 60-day (2013) compared to the 30-day (2012) MRACF (mean difference = 0.15; 99% CI, −1.14 to 1.44).

Figure 3

Figure 3

In 2010, 8 patients received multiple procedures (2–10) for a total of 36 procedures and 36 consents obtained. In 2012, there were 3 patients, and in 2013, there were 4 patients who each had a consent other than the MRACF for procedures not specified on the MRACF. No MRACF was replaced because of worsening condition or risk assessment of the patients during the study periods. All anesthesia consents for patients receiving serial procedures could be located in the medical records for the 4 years studied.

Using a conservative estimate of 15 minutes per consent, the 14 patients that used the MRACF required 48 fewer consents than if one had been obtained for each surgery, amounting to a savings of 12 hours of provider time for the anesthesia consent process. Using the reduction in the mean consent forms from before (2010) and after (2013) the MRACF, the calculated time saved per patient obtaining consent before and after MRAC was approximately 44 minutes.

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DISCUSSION

Many institutions require physicians to obtain consent for any invasive procedure and for anesthesiologist physicians to obtain separate consent for the associated anesthetic for all nonemergent procedures. Obtaining informed consent in the burn population can be especially difficult because of the incapacitation of the critically ill patient and the low level of health literacy in this population. Our Anesthesia Quality Rounds identified obtaining consent from family members of incapacitated patients as a source of dissatisfaction. The family members found the consent process redundant and often frightening, as they received what they perceived to be an additional call from the ICU about their loved one. On the other side of the consent, anesthesiologists have frequently described time pressure when obtaining informed consent, reporting that the consent process is time-consuming and a waste of time.6 We developed an MRACF to improve this aspect of the care we provide.

This study outlines the steps needed to improve the consent process of burn patients. The reduction in the number of consents obtained in our burn population serves as a proxy for the efficacy of our efforts in implementing a more patient-centered process. However, the estimated time saved in finding the often off-site medical decision makers, gathering the witness, and obtaining the consent is real. In an era of reduced work hours for trainees, this process had potential benefits of a streamlined workflow to reduce redundant consents for a planned series of procedures. Reducing the time for the consent process can reduce both direct and intangible costs related to anesthesia providers working longer than 8 hours.7 The rest of the burn-care team benefits from having a lower risk of operating with no consent or with an out-of-date consent. One center8 tracked missing consent forms for 1 week, finding that 66% of patients had missing surgical consent forms in the preoperative area at the time of surgery. Missing surgical consents resulted in a delayed operative start in 14% of cases, in addition to increasing patient anxiety and frustrating providers.8

Perhaps most importantly, the use of the MRACF permitted the anesthesiologist to obtain consent for the initial operation and initiate a discussion of risks and complications within the context of the overall plan for multiple similar procedures. This study focuses on the use of MRACF in the burn population. The MRACF has the potential to be applicable to other patient populations where the treatment plan entails multiple related procedures; for example, in cases where a planned series of electroconvulsive therapy treatments is performed several times a week for a specified period. Patients undergoing electroconvulsive therapy treatments often lack capacity, thus requiring a family member or legal guardian to provide anesthesia consent. Although not studied, in low health literacy populations, like the burn population, this could potentially improve the overall understanding of the plan of care and emphasize a change in the plan if a new consent is needed.

The limitations of the study include its retrospective nature and the evolving process studied. Like many processes in health care, the obtaining of the MRACF was not static over the period of time studied. Clearly, more study is needed to elucidate the impact of MRACF on the patient’s and family’s understandings of the care plan. As we ask patients and families to more actively engage in their health care, listening to their feedback is essential. This project represents an attempt to do just that.

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DISCLOSURES

Name: Brenda G. Fahy, MD.

Contribution: This author made substantial contributions to include study design, conduct of the study, data collection, data analysis, and manuscript preparation.

Attestation: Brenda G. Fahy approved the final manuscript, attests to the integrity of the original data and the analysis reported in this manuscript, and is the archival author.

Name: Terrie Vasilopoulos, PhD.

Contribution: This author made substantial contributions to analysis and interpretation of data.

Attestation: Terrie Vasilopoulos approved the final manuscript.

Name: Susan Ford, RN.

Contribution: This author made substantial contributions to the acquisition of data.

Attestation: Susan Ford approved the final manuscript.

Name: Dietrich Gravenstein, MD.

Contribution: This author made substantial contributions to include study design, conduct of the study, data collection, data analysis, and manuscript preparation.

Attestation: Dietrich Gravenstein approved the final manuscript.

Name: F. Kayser Enneking, MD.

Contribution: This author made substantial contributions to include study design, conduct of the study, data collection, data analysis, and manuscript preparation.

Attestation: F. Kayser Enneking approved the final manuscript and attests to the integrity of the original data and the analysis reported in this manuscript.

This manuscript was handled by: Sorin J. Brull, MD, FCARCSI (Hon).

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