In February 2003, at the Eye Care Centre (ECC), a physically. Nurse anaesthetic care during cataract surgery: a comparative quality assurance study

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1 Nurse anaesthetic care during cataract surgery: a comparative quality assurance study Ken Bassett,* MD, PhD; Stuart W. Smith, MD, FRCSC; Karen Cardiff,* RN, MHSc; Kathy Bergman, RN; Jaafar Aghajanian,* MHSc; Eva Somogyi, RN ABSTRACT RÉSUMÉ Background: We studied whether a new model of nurse-provision of conscious sedation for cataract surgery maintained patient satisfaction and safety. Methods: We prospectively and non-randomly studied 106 patients who had outpatient cataract surgery on a day when an anaesthetist was present at the UBC,Vancouver Hospital Eye Care Centre, and 105 patients with no anaesthetist, but instead a surgical suite nurse trained to give conscious sedation was present. Questionnaires determined patient perception of well-being, pain, and anxiety before surgery, before discharge, at 48 hours and at 6 weeks postoperative. Hospital records and a surgeon questionnaire were used to determine complications. Ophthalmology records were used to determine visual acuity (preoperative and at 6 weeks). Results: No anaesthetic complications were reported in either group and there were no significant differences in surgical complications. Patient responses to assessments of discomfort, well-being, and anxiety, preoperatively and postoperatively, were very similar on the nurse days and anaesthetist days. Interpretation: Conscious sedation of cataract surgery patients can be safely and effectively provided by a trained nurse for selected patients. This nursing role is likely replicable in similar operating room settings. Contexte : Étude d un nouveau modèle d administration de sédation consciente par une infirmière pour la chirurgie de la cataracte, évaluant le mainten de la satisfaction et la sécurité du patient. Méthodes : Nous avons fait une étude prospective et non randomisée de 106 patients externes qui avaient subi une chirurgie d un jour pour la cataracte avec la présence d un anesthésiste, au centre de soins oculaires de l Hôpital de Vancouver de l UBC, et 105 patients opérés sans anesthésiste mais avec la présence d une infirmière formée pour administrer la sédation consciente. Le questionnaire établissait la perception par le patient du bien-être, de la douleur et de l anxiété avant l opération, avant le renvoi, ainsi que 48 heures et 6 semaines après l opération. Les dossiers d hôpital et un questionnaire adressé au chirurgien ont servi à connaître les complications. Les dossiers ophtalmologiques ont servi à établir l acuité visuelle (après l opération et six semaines plus tard). Résultats : Aucune complication anesthésique n a été signalée dans les deux groupes et il n y a pas eu de différence en ce qui a trait aux complications chirurgicales. Les réponses des patients quant à l évaluation, au malaise, au bien-être et à l anxiété, avant et après l opération, étaient fort semblables qu ils aient été confiés à l infirmière ou à l anesthésiste. Interprétation : Une infirmière formée à cet effet peut administrer la sédation consciente pour la chirurgie de cataracte de façon sécuritaire et efficace à certains patients. Les soins infirmiers peuvent vraisemblablement s appliquer dans des cadres opératoires semblables. In February 2003, at the Eye Care Centre (ECC), a physically separate building within the Vancouver Hospital and Health Sciences Centre, operating room nurses began taking more responsibility for sedation and anaesthesia. The change was prompted by a severe shortage of anaesthetists, which forced them to withdraw services from the ECC 1 day a week. On these nonanaesthetist days certain senior ophthalmologists agreed to operate on carefully selected low-risk patients, and nursing staff were asked to expand their scope of practice responsibilities to include anaesthetic care. From *the British Columbia Centre for Epidemiologic and International Ophthalmology, Vancouver, B.C.; the University of British Columbia/Vancouver General Hospital Eye Care Centre, Vancouver, B.C.; and the Vancouver Coastal Health Authority, Department of Quality and Patient Safety, Vancouver, B.C. Originally received Apr. 1, Revised May 1, 2007 Accepted for publication June 8, 2007 Published online Sep. 13, 2007 Correspondence to: Ken Bassett, MD, PhD, British Columbia Centre for Epidemiologic and International Ophthalmology, Department of Ophthalmology, University of British Columbia, St. Paul s Hospital, 1081 Burrard St., Vancouver BC V6Z 1Y6; bassett@chspr.ubc.ca This article has been peer-reviewed. Cet article a été évalué par les pairs. Can J Ophthalmol 2007;42: doi: /can j ophthalmol.i Nurse anaesthetic care Bassett et al. 689

2 A group of nurses at the ECC agreed to take on the new responsibilities and were provided with additional training. Full consultation was conducted with the College of Physicians and Surgeons, the Registered Nurses Association of British Columbia, and the Professional Practice Department of the hospital. After about a year, all the ECC nurses had received training for and were expected to work, at times, within the new model of anaesthetic care. The ECC protocols for anaesthetic care are described in supplementary Appendix A (available on the CJO Web site at In 2004, with pressure to increase the nurse-anaesthetist days to 2 and 3 days per week, ophthalmologists, anaesthetists, and ECC nursing staff sought reassurance that the new practice model, at a minimum, retained the level of surgical outcome, patient satisfaction, and safety found on anaesthesiologist days. The local anaesthetists concerns fit within their specialty s long-standing focus on patient safety. 1 BACKGROUND On both nurse-anaesthetic days and anaesthesiologist days, a designated nurse works in the preoperative area admitting and assessing patients. The nurse administers topical ophthalmic anaesthesia (tetracaine 0.5%) to all patients and oral sedation (sublingual lorazepam mg) if required. When sedation is needed in the operating room, on nurse-anaesthetic days the newly designated conscious sedation nurse (as opposed to the anaesthetist on anaesthesiologist days) assesses the patient, administers sedation, and provides ongoing monitoring. On both days, an additional circulating nurse provides general assistance to the surgical team. In the operating room, either the conscious sedation or the circulating nurse administers xylocaine 2% gel immediately preoperatively if requested by the surgeon. Ophthalmologists provide intracameral xylocaine 1% to a proportion of patients. In the operating room, nonanaesthetic eye drops are provided routinely, including mydriatic agents (cyclopentolate, tropicamide, at times with phenylephrine), as well as an antibiotic (most often ofloxacin) and occasionally a nonsteroidal anti-inflammatory drug (usually diclofenac). This project looks at the shift in discretionary, intraoperative anaesthetic activities and examines the relative impact on patient satisfaction and safety, operating room function, and visual outcome. We hypothesized that patient satisfaction, safety, and visual outcome would be at least as good on nurse-anaesthetic days as on anaesthesiologist days because nurses are well-trained, patients selected for nurse-anaesthetic days are in the lowest risk category, and the surgery is performed by senior ophthalmologists. Therefore, the research question was: in a comparison of nurse-anaesthetic days and anaesthesiologist days are there measurable differences in patient satisfaction or visual outcome, and are the differences clinically significant? METHODS Consent Ethical approval was obtained from the University of British Columbia. Individual patient consent was obtained at the time of surgery. Population and sample The ECC performs cataract surgery on 3500 patients each year, approximately 60% (n = 2100) of the patients being cared for on anaesthesiologist days and 40% (n = 1400) on nurse-anaesthetic days. We prospectively studied alternate patients having first or second eye cataract surgery at the ECC over a period of approximately 4 months (November 2004 to February 2005), during which a total of 1800 patients underwent cataract surgery. The study was conducted during a subset of 1 or 2 days per week with additional study personnel present. We excluded patients with cognitive impairment. Patients unable to adequately understand English were included as long as an interpreter was available. Data collection instrument Previously validated patient satisfaction instruments were found unsuitable to assess anaesthetic care in an operating room setting. 2 Instead, a short and simple study-specific patient satisfaction questionnaire was adapted from hospital quality assurance programs. 3 The best alternative followed the model of the 10-point visual analogue pain scale, adapted to examine patient perception of comfort (i.e., degree of pain), well-being, and anxiety (supplementary Appendix B [available on the CJO Web site at Data collection After pilot testing for reliability and feasibility the questionnaire was applied 4 times: preoperatively by the admitting nurse; postoperatively, just prior to discharge, by the recovery room nurse; at 48 hours and 6 weeks postoperatively by the research assistant, by telephone. In addition to the questionnaire, open-ended questions were asked regarding patient satisfaction, comfort, and visual function. All patients reporting significant dissatisfaction or discomfort were asked for further details about their experience. The research assistant recorded preoperative visual 690 CAN J OPHTHALMOL VOL. 42, NO. 5, 2007

3 acuity (VA) from patient records. Information on postoperative VA and postoperative complications was collected from the surgeon s clinical records. In addition, a questionnaire distributed to the surgeons asked them how they selected their patients for anaesthesiologist days and nurse-anaesthetic days, respectively. We relied on routinely collected administrative and clinical data to obtain demographic and clinical characteristics of the patient population. We sought information on ocular and systemic comorbidity, drug therapy, and surgical history, as well as surgical complications and anaesthetic incident rate. We planned detailed case studies of all actual and suspected anaesthetic incident cases identified by the nursing or medical staff. When someone refused to participate, the next patient who was having cataract surgery was selected. There were 115 patients who refused to participate in the study. In addition to the exclusion criteria noted earlier (i.e., cognitive impairment or language barrier at the time of surgery) we excluded an additional 116 patients (51 from anaesthesiologist days and 65 from nurse-anaesthetic days) for various reasons: no English speaking person living with them (n = 58); no contact after discharge because the patients either did not return the telephone messages (n = 36) or the telephone number was incorrect (n = 9); there was no postoperative questionnaire (n = 10); or other reasons (n = 3). Analysis We sought a minimum sample of 100 patients on nurseanaesthetic days and anaesthesiologist days over the study period. This sample size was considered adequate for the analysis of covariance. The priori assumption was that a 1- point difference was the minimum meaningful clinical difference in any of the 3 questions administered to the patients in the study (range: 1 10). We examined the mean values for the sample on nurse-anaesthetic days vs. anaesthesiologist days. We also separately examined all patients who reported a >1-point mean difference from baseline, reported as patient outliers. Repeated measures analysis of covariance was used for the data. 4 The responses to the 3 questions were not normally distributed, and hence we chose a γ distribution for the generalized estimating equation procedures. Response variables were responses to postoperative questions (1, 2, and 3), ranging from 1 (good) to 10 (worst). Although the responses were ordinal, we fit the following model with necessary assumptions: 5 question i = intercept + b 1 day type + b 2 age + b 3 pre qi i = 1,2,3 Age and preoperative questions were used as covariates. The analysis was carried out using SAS-PROC GENMOD (SAS Institute Inc.). RESULTS Demographic and clinical characteristics There were 1800 patients in the population from which the sample was drawn. One or 2 days/week were selected for the study, according to staffing levels. On this subset of days, the sample consisted of 211 patients, 105 on nurse-anaesthetic days and 106 on anaesthesiologist days, representing 12% of the population of interest. The proportions of patients undergoing first eye cataract surgery were 68% and 65% on the nurse-anaesthetic days and anaesthesiologist days, respectively. Table 1 presents the demographic characteristics, cataract surgical history, and clinical characteristics of the study sample. The mean age of patients in the population was 71 years; 61% (n = 1098) were female and 39% (n = 702) male. The study sample, as a whole, represented the population of interest with respect to age. The nurseanaesthetic day sample represented the population of interest for both age and sex; however, the anaesthesiologist day sample had roughly equal numbers of men and women. In terms of age, the anaesthesiologist day sample was similar to the population. Patient selection Twelve out of 14 ophthalmologists performing cataract surgery at the ECC contributed patients to the study. The Table 1 Study sample: demographic and clinical characteristics Nurse-anaesthetic days (n = 105), n (%) Anaesthesiologist days (n = 106), n (%) Total (n = 211), n (%) Characteristic Details Sex Male 40 (45) 54 (51) 94 (45) Female 65 (55) 52 (49) 117 (55) Age, year Mean Range Previous surgery First eye 68 (65) 65 (61) 133 (63) Second eye 37 (35) 41 (39) 78 (37) Ocular comorbidity Macular degeneration 5 (3) 4 (2) 9 (4) Glaucoma 8 (8) 10 (12) 18 (8) Diabetic retinopathy 2 (2) 7 (7) 9 (4) Systemic comorbidity Diabetes 3 (3) 15 (14) 18 (8) Cardiovascular disease 5 (5) 10 (9) 15 (7) Hypertension 48 (46) 69 (65) 117 (55) Respiratory disease 5 (5) 10 (9) 15 (7) Parkinson s disease 0 3 (3) 3 (1) CAN J OPHTHALMOL VOL. 42, NO

4 2 ophthalmologists who did not participate performed about 30 cataract surgical operations during the study period. Of the 12 contributing ophthalmologists, 5 had 23 or more patients, 2 had patients, and 5 had 10 or fewer patients. Ten of the 12 ophthalmologists had patients on both nurse-anaesthetic days and anaesthesiologist days. Two of the more senior doctors who were asked to initiate the change in anaesthetic practice agreed to conduct most of their cataract surgery on nurse-anaesthetic days, and therefore had most of their study patients on these days. Of the 12 ophthalmologists who had patients in the study, 8 responded to a questionnaire regarding patient selection for anaesthesiologist days vs. nurse-anaesthetic days. The respondents indicated that, as requested, they selected more difficult patients for anaesthesiologist days, particularly those with increased cardiovascular risk or cognitive impairment, or patients whom they considered very anxious. Anaesthesia, sedation, and analgesia Anaesthetists started more intravenous infusions and provided more analgesics and sedatives than nurses (Table 2). Nurses and anaesthetists provided only 1 patient each with oral lorazepam (0.5 mg, and 1 mg, respectively). Nurses provided intravenous midazolam less often, 11 vs. 28 patients, and at a lower dose, than anaesthetists (Table 2). Complications Anaesthetic complications No anaesthetic complications were reported in any clinical or hospital record, nor were any problems alluded to by patients during the postoperative telephone interviews. One patient seen on a nurse-anaesthetic day required 0.2 mg atropine intravenously for bradycardia and dizziness, and the surgery proceeded without complications. On an anaesthesiologist day, one patient was reported to have moved suddenly. This patient had received the usual dose of midazolam. No further intervention was noted in the doctor or nursing chart, and no surgical complications occurred. Surgical complications Surgical complications occurred on both nurseanaesthetic days and anaesthesiologist days with no pattern emerging. None was associated with the presence or absence of adequate anaesthesia or analgesia. Patient questionnaire We examined patient-reported comfort, well-being, and anxiety at 4 times, once immediately preoperatively and 3 times postoperatively (before discharge, at 48 hours, and after 6 weeks [Figs. 1 3]). The 6-week, postoperative data are not shown. With respect to the scale used in Figs. 1 3, we report only the lower level of the scale, as the number of patients in the higher categories was too few for representation on bar graphs. In these questionnaires, 1 refers to the highest level of comfort and well-being and the lowest level of anxiety, and 5 refers to the lowest level of comfort and wellbeing and the highest level of anxiety. Compared with patients seen on nurse-anaesthetic days, patients on anaesthesiologist days reported higher scores of comfort (i.e., less comfort; p = 0.08) and well- Fig. 1 Preoperative assessment of comfort, well-being, and anxiety. ( 1 refers to the highest level of comfort and well-being and the lowest level of anxiety, and 5 refers to the lowest level of comfort and well-being and the highest level of anxiety. The scale is from 1 to 10, but only the lower levels are presented [too few in higher categories].) Table 2 Summary of anaesthesia and sedation methods Intervention Nurse-anaesthetic days (n = 105) Anaesthesiologist days (n = 106) Tetracaine All All Preoperative xylocaine 2% jelly All All Intracameral 1% xylocaine Intravenous (IV) tubes inserted No analgesic or sedative Sedative (oral and IV) Sedative and analgesic 2 4 Peribulbar blocks* 0 3 Fentanyl 25 mg IV 2 1 Fentanyl 37.5 mg IV 0 1 Fentanyl 50 mg 0 1 Fentanyl 100 mg IV 0 1 *No retrobulbar but 3 peribulbar blocks (a safer alternative to retrobulbar blocks) were used on anaesthesiologist days and none on nurse-anaesthetic days. Fig. 2 Immediate postoperative assessment of comfort, well-being, and anxiety. (See Fig. 1 for definition of levels.) 692 CAN J OPHTHALMOL VOL. 42, NO. 5, 2007

5 being (i.e., poorer well-being; p < 0.05), and greater anxiety (p = 0.10) preoperatively (Fig. 1). Patients on both anaesthesiologist days and nurseanaesthetic days reported less anxiety and greater wellbeing right after the surgery than before (Fig. 2), and a substantial number of patients reported improvement 48 hours after the surgery (Fig. 3). Nurse-anaesthetic-day patients reported significantly more comfort (p < 0.05) 48 hours after surgery than immediately after it, whereas patients on anaesthesiologist day did not (p = 0.58) (Fig. 3). Patients on both day types reported significant improvement after 6 weeks on all 3 questions with no day-type difference (p = 0.46 between days, data not shown). The rate of the recovery was more rapid on all 3 questions among the patients cared for on the nurse-anaesthetic days. As with the baseline differences noted earlier, these differences, while measurable, are considered to be of minimal clinical significance. Visual outcome VA remained the same or improved in all but 1 patient. Patients with poor preoperative VA (6/24 or worse) were evenly distributed between nurse-anaesthetic days and anaesthesiologist days, with 25 and 24 patients, respectively. Ocular comorbidity was also evenly distributed between nurse-anaesthetic days and anaesthesiologist days without any detectable pattern. More of the patients with comorbid eye conditions had predictably poorer VA outcome, although in all instances their VA improved with surgery. INTERPRETATION The patients seen on the nurse-anaesthetic days had lower cardiovascular risk and less anxiety than on anaesthesiologist days. This reflected the ECC innovation plan, which asked interested ophthalmologists to select low-risk patients for the nurse-anaesthetic days. Anaesthetists started more intravenous infusions and administered more sedatives (oral or intravenous) than nurses, perhaps as a reflection of the higher-risk patients Fig. 3 Forty-eight hour postoperative assessment of comfort, well-being, and anxiety. (See Fig. 1 for definition of levels.) seen on anaesthesiologist days. Anaesthetists are likely more comfortable with administration of intravenous sedative medication. According to the results from the patient questionnaires regarding comfort, well-being, and anxiety, the differences in the anaesthesiologist day vs. nurse-anaesthetic day samples, while measurable, are considered to have little clinical significance. VA improved in all but 1 patient. VA levels were distributed evenly between nurse-anaesthetic days and anaesthesiologist days. When we considered the 29 patients who reported some worsening on questionnaire answers, we found no correlation with preoperative VA, complications, or surgery on nurse-anaesthetic days vs. anaesthesiologist days. Twelve of the ECC s 14 ophthalmologists conducting cataract surgery participated in the study. None of the ophthalmologists expressed any concerns regarding anaesthetic care on nurse-anaesthetic days or felt that nurse-anaesthetic days increased patient risk or compromise of surgical care. No anaesthetic complications were reported on either day in clinical or hospital records, nor did patients allude to any problems during the postoperative telephone interviews. We did not enrol a sufficiently large sample to measure complication rates associated with topical anaesthetics, benzodiazepines, or narcotics. 6 This study did not examine the institutional process that led to the expanded nursing role at the ECC. The nurses and physicians involved admitted that, rather than a carefully planned change, the expanded nursing role grew out of unexpected necessity resulting from a sudden shortage of anaesthetists. In short, nurses needed to supply necessary anaesthetic care, or the operating room closure would have occurred one or more days a week. In time, concerns about meeting demands for operating room time were replaced with concerns about the impact of the changes on patient satisfaction, safety, and visual outcomes. Examining these concerns was the focus of our study. Finding similar efficacy and safety on anaesthesiologist days and nurse-anaesthetic days fits with established systems theory concepts of safe practices. 7 In this instance, nurses and anaesthetists are seen as equivalent actors within a carefully defined and standardized system. Equivalent actors provide actions that do not vary a great deal, leading to high reliability and low risk. A number of ECC nurses expressed concern that, in the absence of an anaesthetist on site, they were inadequately prepared to deal with a medical emergency. Issues related to risk management and emergency preparedness deserve some dedicated discussion and planning of emergency protocols. Additional training and practice in handling emergency situations may be required. Different ophthalmologists performed different numbers of surgical procedures on the nurse-anaesthetic days vs. CAN J OPHTHALMOL VOL. 42, NO

6 anaesthesiologist days. This could act as a significant bias, as ophthalmologists may increase or decrease patient anxiety and (or) comfort as a result of operating technique and personal style. Difference in nonanaesthetic drops (antibiotics and antiinflammatory drugs) are unlikely to result in bias, as virtually all patients received tetracaine first, negating virtually all irritant effects of other eye drops administered subsequently. CONCLUSIONS The model of care introduced at the ECC involving nurses in a full anaesthetic role provides a suitable and acceptable alternative for delivering care to low-risk patients and supports improved access to cataract surgery in this institution. There is no evidence that the model increases the risk of adverse events. The new practice of care is a potentially useful model in other similar operating room settings. The authors recognize the support of Linda Dempster in initiating and supporting this project. We are grateful to the UBC Eye Care Centre staff for administering questionnaires both before and immediately following surgery. Supplementary data for this paper can be found on the CJO Web site at REFERENCES 1. Gaba DM. Anaesthesiology as a model for patient safety in health care. BMJ 2000;320: Hadorn DC, Uebersax J. Large-scale health outcomes evaluation: how should quality of life be measured? Part I calibration of a brief questionnaire and a search for preference subgroups. J Clin Epidemiol 1995;48(5): Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989;27:S178 S Liang KY, Zeger SL. Longitudinal data analysis using general linear models. Biometrika 1986;73: McCullagh P, Nelder JA. Generalized Linear Models. 2nd ed. London: Chapman and Hall; Hardman JG, Limbird LE, eds. Goodman and Gilman s the pharmacological basis of therapeutics. 9 th ed. McGraw Hill; 2005: Amalberti R, Auroy Y, Berwick D, Barach P. Five system barriers to achieving ultrasafe health care. Ann Intern Med 2005;142: Key words: anaesthesia, nursing care, cataract surgery 694 CAN J OPHTHALMOL VOL. 42, NO. 5, 2007