Timing of interventions and outcome measures for patients undergoing the comprehensive perioperative total laryngectomy (TL) education program. SLP indicates speech-language pathology; TEP, tracheoesophageal puncture.
Percentage of patients with 30-day unplanned readmission and 30-day unplanned readmission due to stoma or tracheoesophageal puncture (TEP) complications for historical cohort at our institution who did not undergo perioperative TL education (n = 155) and for pilot cohort who underwent comprehensive perioperative TL education (n = 50). The rate of unplanned readmissions due to stomal or TEP complications was 8% in the historical cohort and 2% in patients undergoing the TL education program.
A, Score on test of TL knowledge (out of 12) before and after perioperative TL education program. B, Self-rated TL preparedness (out of 10) before and after perioperative TL education program. The horizontal line in each box indicates the median, and the top and bottom borders of each box indicate the 25th and 75th percentiles, respectively. The whiskers above and below each box indicate the minimum and maximum, respectively. The circles beyond the whisker represent outliers that are 1.5 more than the upper quartile or 1.5 less than the lower quartile.
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Graboyes EM, Kallogjeri D, Zerega J, et al. Association of a Perioperative Education Program With Unplanned Readmission Following Total Laryngectomy. JAMA Otolaryngol Head Neck Surg. 2017;143(12):1200–1206. doi:10.1001/jamaoto.2017.1460
Can a perioperative education program decrease the rate of 30-day unplanned readmission in patients undergoing total laryngectomy?
This pilot study of 50 patients undergoing total laryngectomy found a 30-day unplanned readmission rate of 20% and a readmission rate of 2% for stomal or tracheoesophageal puncture complications.
This study provides preliminary data that a total laryngectomy education program is feasible, may decrease readmission due to stomal or tracheoesophageal puncture complications, and may increase patient knowledge and preparedness.
Patients undergoing total laryngectomy (TL) are at high risk for 30-day hospital readmission. Strategies to decrease the readmission rate remain unknown.
To assess the association of a comprehensive perioperative TL education program with unplanned readmissions; to determine the program’s association with the rate of readmissions for stomal or tracheoesophageal puncture (TEP) complications and patient and caregiver knowledge of and preparedness for TL.
Design, Setting, and Participants
This single-institution prospective pilot study was conducted between December 1, 2014, and November 30, 2016, among 50 patients undergoing a perioperative TL education program at a tertiary care academic medical center.
The perioperative TL education program consisted of speech-language pathology counseling, a hands-on class with an otolaryngology nurse educator, a TL “Journal Guide” booklet, and a prehospital discharge competency assessment. A family member or friend acting as a laryngectomy coach accompanied patients throughout.
Main Outcomes and Measures
The primary outcome was the rate of 30-day unplanned readmission. Secondary measures included the rate of readmission for stomal or TEP complications and change in knowledge of and preparedness for TL.
Of the 50 patients (12 women and 38 men; median age, 61 years [range, 47-86 years]) who underwent the TL education program, the 30-day unplanned readmission rate was 20% (n=10). Only 1 patient (2%) had a readmission for a stomal or TEP complication. Patients increased their TL knowledge (median improvement in TL knowledge test score, 3.5 [95% CI, 2.8-4.2] of 12) and preparedness (median improvement in TL preparedness score, 3.1 [95% CI, 2.4-3.8] of 10) after undergoing the intervention.
Conclusions and Relevance
This prospective pilot study evaluated an intervention to decrease unplanned readmission in head and neck oncology patients. It provides data indicating that a comprehensive perioperative TL education program is feasible. This program has the potential to decrease 30-day readmission for stomal or TEP complications and merits further study in a larger, multicenter clinical trial.
Patients undergoing total laryngectomy (TL) are at high risk for unplanned 30-day hospital readmission.1-6 The rate of 30-day unplanned readmission following TL ranges from 14% to 27%.2,3 Although some risk factors for unplanned readmission in patients undergoing TL are not modifiable (eg, salvage TL),2,4 other factors such as postoperative complications2-4 are potentially modifiable. A high percentage of patients experience postdischarge stomal or tracheoesophageal puncture (TEP)–related complications, which accounted for more than 25% of unplanned readmissions in 1 series.2 Postdischarge stomal and TEP-related complications appear to be due to inadequate patient and caregiver knowledge and familiarity with post-TL care and thus are potentially preventable through a more thorough perioperative education program.
Perioperative education programs have been described and evaluated in the orthopedic joint replacement surgical literature, and implementation has generally been associated with favorable outcomes.7-12 There has been limited study about formal perioperative education programs in head and neck oncology, however. A single retrospective medical record review analyzing the effect of a quality care program, of which perioperative patient education was 1 component, identified a decrease in the rate of unplanned 30-day hospital readmission among otolaryngology patients.13
To our knowledge, prospective data are lacking that evaluate the outcome of implementing a perioperative education program for patients undergoing TL, a group of patients with a high rate of unplanned hospital readmission. We therefore designed a prospective pilot study to determine the feasibility of the perioperative education program and its association with unplanned readmission and patient and caregiver knowledge and preparedness. We hypothesize that implementation of a standardized comprehensive perioperative education program for patients and caregivers prior to TL will decrease the rate of 30-day unplanned readmission, decrease the rate of stomal or TEP complication–associated readmission, and improve patient and caregiver knowledge of and preparedness for TL.
This study was designed as a nonblinded, prospective, single-arm pilot study. The intervention group was assigned to a comprehensive perioperative education program for patients and their caregivers prior to undergoing TL. The study was approved by the Washington University School of Medicine institutional review board. Patients were enrolled in the study after providing written informed consent.
Patients were eligible for the prospective TL education program if they were 18 years of age or older, spoke English, and were undergoing TL with or without flap reconstruction, in the primary, salvage, or dysfunctional larynx setting. Sixty-three consecutive patients were assessed for study eligibility. Of these, 13 were excluded owing to failure to meet inclusion criteria (n = 5) or refusal to participate owing to scheduling conflicts or information fatigue (n = 8). Fifty patients were assigned to the study intervention and included in analysis.
The comprehensive perioperative TL education program consisted of the following 5 interventions: (1) preoperative speech-language pathology (SLP) evaluation and counseling session on TL physiology, stomal education, and alaryngeal voice rehabilitation; (2) preoperative hands-on interactive class with an otolaryngology nurse educator covering stomal care and expected hospital course; (3) a TL “Journey Guide” booklet detailing the preoperative, in-hospital, and postdischarge longitudinal journey; (4) a predischarge competency written and hands-on assessment; and (5) a patient-designated TL coach who accompanied the patient through the longitudinal journey. The schedule of the interventions and timetable of outcome measure collection are shown in Figure 1. Further details about each of the components of the comprehensive perioperative educational materials are in the eAppendix in the Supplement.
The primary outcome measure was the rate of 30-day unplanned hospital readmission. Secondary outcome measures included the rate of 30-day unplanned readmission due to stomal or TEP complications and change in patient and caregiver knowledge of and preparedness for TL. A stomal complication was defined as mucus plugging, stomal bleeding, stomal crusting, stomal cellulitis, or patient uncertainty or discomfort with stomal care, prompting unscheduled medical attention. A TEP complication was defined as an enteral feeding tube or TEP prosthesis that became unintentionally dislodged, requiring medical attention. All other complications were categorized as nonstomal or non-TEP complications. Knowledge about TL was assessed using a nonvalidated questionnaire designed by the study authors (eAppendix in the Supplement). Patient and caregiver preparedness for TL was measured using a 10-point Likert scale (where 1 indicated not prepared and 10 indicated maximally prepared).
Prospective data were collected by the study coordinator and by the authors. After enrollment, patients filled out a questionnaire detailing sociodemographic and comorbidity information; a baseline, preintervention questionnaire about TL knowledge; and an assessment of preparedness for TL on a 10-point Likert scale. At the time of hospital discharge, the patients were administered the same TL knowledge questionnaire and TL preparedness assessment to determine changes in knowledge and preparedness. At the time of discharge, patients and caregivers completed a hands-on predischarge practical assessment of readiness. Thirty days after discharge, the study participants completed an exit survey. Information about complications and hospital readmission was specifically queried and prospectively collected to ensure that emergency department visits and hospital readmission outside of our institution were captured.14 Information regarding oncologic characteristics, surgical details, and the hospital course were prospectively collected from the medical record.
Standard descriptive statistics were used to describe the sample of the 50 patients included in the study. For assessment of change in TL knowledge, we used the nonparametric Wilcoxon signed rank test to compare preintervention and postintervention scores. Correlations between TL knowledge, preparedness, postoperative complications, and postdischarge stomal or TEP complications were explored using the Spearman correlation analysis. All statistical tests were 2-sided. Alpha level for all analysis was set at .05. Median differences and 95% CIs around them were calculated using the student version of MINITAB, release 14.11.1 (Minitab Inc). Data analysis was performed using SPSS, version 24.0 (IBM SPSS Inc).
The demographic, comorbidity, and oncologic characteristics of the cohort is shown in Table 1. Patients were predominantly male (38 [76%]) and white (41 [82%]), with significant comorbidity (28 [56%] with a Charlson Comorbidity Index of ≥2). Thirteen patients (26%) underwent salvage TL after prior nonsurgical management, 40 of 43 patients (93%) had an American Joint Committee on Cancer classification of pT3-4, 30 patients [60%] required flap reconstruction (20 with pectoralis major pedicled flap [40%] and 10 with free flap [20%]), and 15 patients (30%) had a primary TEP.
The hospital course following TL is demonstrated in Table 2. Overall, 29 patients (58%) experienced at least 1 complication during the hospital stay (range, 0-6), of which 10 patients (20%) had either a wound dehiscence or pharyngocutaneous fistula and 9 (18%) had an unplanned return to the operating room for management of a complication. The median postoperative length of stay was 8 days (range, 5-35 days), and 18 patients (36%) were discharged to a skilled nursing facility.
After discharge, 22 patients (44%) experienced a new adverse event: pharyngocutaneous fistula (n = 5), peristomal dehiscence (n = 4), bleeding (n = 4), mucus plugging (n = 3), surgical site infection (n = 2), failure of free flap (n = 1), seroma (n = 1), gastrostomy tube complication (n = 1), and pneumonia (n = 1). One patient died within 30 days of discharge after being readmitted to an outside hospital with pneumonia and septic shock.
The association of the perioperative education program with unplanned readmission and stoma- or TEP complication–associated readmission is in Figure 2. Ten patients undergoing the TL education intervention had 30-day unplanned readmission (20%; 95% CI, 9%-31%). This lower boundary of the 95% CI shows that the TL education intervention could decrease unplanned readmission rates to as low as 9% or as high as 31%. Only 1 patient (2%) experienced stomal- or TEP complication–associated readmission. The reasons for unplanned readmission were pharyngocutaneous fistula (n = 4), pharyngeal bleeding (n = 2), delayed failure of free flap (n = 1), mucus plugging (n = 1), pneumonia (n = 1), and exacerbation of chronic obstructive pulmonary disease (n = 1). The median time to unplanned readmission was 3.5 days after discharge (range, 1-26 days). Most patients were admitted via the emergency department (n = 7). The median length of stay following readmission was 6.5 days (range, 1-47 days).
Overall, 17 patients (34%) had an emergency department visit within 30 days of surgery. Of these 17 patients, 7 were readmitted from the emergency department and 10 were discharged home. The 7 patients who were admitted had diagnoses of pharyngocutaneous fistula (n = 2), pharyngeal bleed (n = 2), mucus plugging (n = 1), pneumonia (n = 1), and exacerbation of chronic obstructive pulmonary disease (n = 1). The 10 patients who were discharged from the emergency department had diagnoses of mucus plugging (n = 2), stomal site bleeding (n = 2), neck pain (n = 2), shortness of breath (n = 1), dislodgement of nasogastric tube (n = 1), lower extremity swelling (n = 1), and exacerbation of chronic obstructive pulmonary disease (n = 1).
Patients undergoing TL exhibited improvements in both knowledge and preparedness (Figure 3). Patients showed an increase in their TL knowledge (median improvement in TL knowledge test score, 3.5 [95% CI, 2.8-4.2] of 12) and preparedness (median improvement in TL preparedness score, 3.1 [95% CI, 2.4-3.8] of 10) after undergoing the intervention. Only 4 of 47 patients (9%) did not report any improvement in knowledge and 9 of 46 patients (20%) did not report any improvement in preparedness.
Associations between TL knowledge, preparedness, postoperative complications, and postdischarge stomal or TEP complications were explored. There was no correlation between change in TL knowledge and change in TL preparedness. There was a weak to moderate level of correlation between change in knowledge and preparedness at discharge (Spearman ρ = –0.332). This finding suggests that patients may have knowledge about TL care and physiology, but still not feel prepared (or vice versa). We then performed a stratified analysis by postoperative complication (yes or no) to further explore the above association. In the group of patients who experienced a postoperative complication, there was no significant correlation between change in knowledge and change in preparedness. In the group of patients who did not experience a postoperative complication, there was a moderate correlation between change in knowledge and change in readiness (Spearman ρ = –0.557). There was no significant difference in the change in knowledge, change in preparedness, knowledge at the time of discharge, or preparedness at the time of discharge between patients with and without postoperative complications. The same findings held for patients with and without postdischarge stomal or TEP complications.
Within head and neck oncology, many studies document the incidence of, and risk factors for, unplanned hospital readmission.1-4,6,15-17 Few studies, however, analyze the effect of strategies to decrease the rate of unplanned readmission, and all have been retrospective.4,13 Our pilot study is a novel investigation that prospectively studied an intervention to decrease unplanned readmission in head and neck oncology patients, demonstrating its feasibility and potential for reduction in overall unplanned 30-day readmission and stomal or TEP complication–associated readmission.
One of the objectives of the study was to demonstrate the feasibility of the comprehensive perioperative education program. Overall, 50 of the 58 patients (86%) eligible for the study voluntarily enrolled in and completed the perioperative education program, showing its feasibility. The timing of the different components of the preoperative program were coordinated, as best as possible, with patient schedules to minimize additional trips to the hospital, which we believe facilitated its success. In addition to logistical considerations, the feasibility of the program was enhanced by the perception of effectiveness. Patients and caregivers alike found the education intervention to be beneficial and suggested that it be continued for other patients, even after the completion of the study.
Although this prospective pilot study did not contain a control group, these preliminary data indicate that the comprehensive TL education program has the potential to decrease unplanned hospital readmission via decreased stoma or TEP complication–associated readmission. The hypothesis that led to the pilot study was based on the observation that, for patients undergoing TL at our institution, postdischarge stomal- or TEP-related complications were common, likely owing to inadequate patient and caregiver knowledge and familiarity with post-TL care, and thus potentially preventable through a more thorough perioperative education program. The current pilot study demonstrated a 20% rate of unplanned readmission for patients undergoing the TL education program, with the lower bound of the 95% CI showing that the readmission rate could be as low as 9% and the upper bound showing that it could be as high as 31%. For comparison, a historical cohort of patients undergoing TL at our institution without the TL educational intervention had a 26.5% rate of unplanned readmission.2 Furthermore, only 1 patient (2%) in the pilot study of the TL education program had a readmission associated with a stomal or TEP complication, which compares favorably with the historical readmission rate of 7.7% associated with stomal or TEP complications.2
One component of the current multidimensional perioperative education program, preoperative SLP consultation, has been previously studied to determine its association with unplanned readmission following TL.4 In that retrospective analysis, patients undergoing preoperative SLP consultation did not have a lower rate of unplanned hospital readmission. An explanation for this finding may be that a more comprehensive and robust education program than solely SLP counseling is necessary to address the numerous physiologic, anatomical, lifestyle, and wound healing needs faced by patients undergoing TL that can lead to unplanned hospital readmission. It may also be that the study was underpowered to find a difference in hospital readmission. Despite its uncertain association with unplanned readmission as a solitary intervention, the role of preoperative SLP consultation for patients undergoing TL is well established. Numerous studies have nevertheless documented low use of appropriate preoperative SLP counseling among patients undergoing TL.4,18-20
The association of a perioperative education intervention with unplanned readmission in otolaryngology patients has also been studied. In 1 retrospective study, a multifaceted quality care plan that included perioperative patient education was associated with a significant decrease in the rate of unplanned readmission after introduction of the care plan.13 The findings in our prospective pilot study are in accord with those findings and highlight the multifaceted approach that will be required for decreasing unplanned readmission in head and neck oncology patients and those undergoing TL.
This study has many methodological strengths relative to prior studies of unplanned readmission in head and neck oncology patients.1-6,13,15,16 The data collection for the study intervention was prospective. It also specifically tracked 30-day readmission outside of the single academic institution, something that occurs in more than one-third of readmissions following head and neck cancer surgery14 and has not been accounted for in prior single-institution retrospective studies.1-4
Despite its methodological strengths, this pilot study does possess limitations. First, the study was conducted at a single academic medical center and therefore the results may not be generalizable to other head and neck oncology practices. Second, the outcome measures for change in knowledge about TL were designed by us but have not been validated for content or construct validity. Third, this pilot study did not involve a control group, so the causal effect of the intervention with readmission, stomal complication readmission, and patient and caregiver knowledge of and preparedness for TL remains unknown and requires further study. The comparison group included a historical cohort of patients who underwent TL at our institution who did not go through the perioperative education protocol. Although one might have considered directly comparing the current prospective pilot group and the historical retrospective cohort with inferential statistical analysis to evaluate the effectiveness of the comprehensive TL education, a comparison was not performed because of differences in study design between the 2 groups (eg, retrospective vs prospective). Fourth, we hypothesized that the education program would facilitate early recognition of impending or minor complications by patients or caregivers and thus lead to early management by a head and neck clinician in the clinic instead of later management in an emergency department. Whether this early recognition occurred remains uncertain, however, as data about patient-initiated phone calls prompting unscheduled visits to the head and neck clinic were not collected.
This study provides data that a comprehensive perioperative TL education program is feasible. Relative to historical rates at our institution, this program may decrease readmission for stomal or TEP complications. The perioperative TL education program is associated with improved knowledge and preparedness for patients and caregivers. The interventions in this pilot study merit further evaluation in a prospective multicenter clinical trial.
Corresponding Author: Brian Nussenbaum, MD, Department of Otolaryngology–Head and Neck Surgery, Washington University School of Medicine, 660 S Euclid Ave, Campus Box 8115, St Louis, MO 63110 (firstname.lastname@example.org).
Accepted for Publication: June 22, 2017.
Published Online: September 7, 2017. doi:10.1001/jamaoto.2017.1460
Author Contributions: Drs Graboyes and Nussenbaum had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Graboyes, Zerega, Kukuljan, Neal, Rosenquist, Nussenbaum.
Acquisition, analysis, or interpretation of data: Graboyes, Kallogjeri, Zerega, Nussenbaum.
Drafting of the manuscript: Graboyes, Kallogjeri, Nussenbaum.
Critical revision of the manuscript for important intellectual content: Graboyes, Kallogjeri, Zerega, Kukuljan, Neal, Rosenquist.
Statistical analysis: Graboyes, Kallogjeri.
Obtained funding: Graboyes.
Administrative, technical, or material support: Zerega, Kukuljan, Nussenbaum.
Study supervision: Zerega, Nussenbaum.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This research was supported by grant 7919-77 from the Barnes Jewish Hospital Foundation.
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Meeting Presentation: This paper was presented at the AHNS 2017 Annual Meeting; April 27, 2017; San Diego, California.
Additional Contributions: We thank all the head and neck cancer surgeons, radiation oncologists, and medical oncologists who cared for the patients; the clinical staff in the Center for Advanced Medicine and Center for Outpatient Health; and our nurse educators Diane Dischinger, RN, Andrea Vaughan, MS, CCC-SLP, and Lisa Shoemaker, RN. They were not compensated for their contributions.
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