Assessment of Ileostomy Output Using Telemedicine: A Feasibility Trial

Abstract

Background:

Ileostomies are a routine part of the care of rectal cancer patients, but are associated with significant risk for dehydration, readmission, and acute kidney injury. Telemedicine has proven beneficial in decreasing readmission in chronic medical illnesses, but its utility in ileostomy patients is not well studied.

Objective:

The purpose of this study was to evaluate the feasibility of televideoconferencing in the assessment of ileostomy output.

Design:

An institutional review board-approved, prospective clinical trial was conducted at a single institution from November, 2014-December, 2015.

Settings:

The study was conducted in a single, large academic medical center.

Patients:

Patients >18 years of age undergoing surgery with plans for ileostomy were eligible.

Interventions:

Televideoconference assessments of ileostomy output and the need for medical intervention were conducted during the postoperative stay and compared to in-person assessment.

Main Outcome Measures:

The primary endpoint of the trial was feasibility of using teleconferencing to assess the need for medical intervention, defined as 90% agreement between telemedicine and in-person assessments. Secondary endpoints included patient/provider satisfaction and correlative studies examined dehydration events and readmission.

Results:

Twenty-seven patients underwent 44 teleconferencing assessments of ileostomy output. Compared to in-person treatment decisions, there was a 95% match (95% CI: 85%, 99%). The readmission rate for the study participants was 31% and 18% experienced dehydration events. Both patients and faculty responded favorably to surveys regarding the use of telemedicine in the perioperative period.

Limitations:

The study is limited by its in-hospital use of technology and small sample size.

Conclusions:

Televideoconference evaluation is a feasible, reliable means of assessing ileostomy output with high patient and physician acceptance. Our pilot study provides rationale for further study in the post-discharge setting for patients with ileostomies. The incorporation of televideoconference assessment within a teledischarge program may enable early intervention to improve patient outcomes.

Introduction

Ileostomies are commonly used in the surgical management of patients with rectal cancer particularly for patients with low anastomoses and treatment with chemoradiation. Ileostomies result in increased salvage of low anastomoses and decreased septic events.^{1, 2} However, the creation of ileostomies is not without risk itself. Specifically, patients are at high risk for readmission (~20%).^3-7 The majority of those readmissions are due to dehydration (~50%).^{3, 6, 7} Moreover, studies have further demonstrated that patients suffering from these complications are at higher risk for not receiving adjuvant chemotherapy, which can impact long-term oncologic outcomes⁷. Unfortunately, objective clinical factors, such as volume of ileostomy output, do not consistently predict patients at risk for readmission.^{3, 6-8}

In the setting of such high readmission rates, the opportunity exists to leverage telemedicine technology to improve clinical outcomes for new ostomates. For example, telemedicine has been utilized to improve outcomes in medical patients with heart failure.^{9, 10} However, in surgical patients, telemedicine has not been well studied in the post-discharge setting. A recent meta-analysis by Gunter et al (2016) revealed that the use of telemedicine to date in the postoperative setting for surgical patients has been focused on individuals undergoing low risk surgery.¹¹ Models used were designed to implement telemedicine as a replacement for normal clinic follow up, to provide routine monitoring, or to address problems that arose. The findings demonstrate that there remains a need to evaluate the role of telemedicine in a higher risk surgical population.

Patients with new ileostomies are at significant risk for complications in the early post-operative period and utilize health care resources frequently post-discharge.¹² Educational programs have demonstrated benefit in this patient group in regards to readmission rates.^{4, 13} Given the potential value added in these patients by decreasing post-operative complications, they may benefit from the incorporation of telemedicine technology to assess ileostomy outputs and the need for antidiarrheal medication, which in turn could improve clinical outcomes. In this study, we report the results of a feasibility study examining the ability of surgeons to use teleconferencing technology to assess ileostomy output and the need for medical intervention.

Methods

An IRB-approved prospective trial was conducted at a single academic institution. The primary objective of the trial was to determine the feasibility of utilizing telemedicine technology to assess the need for medical intervention. Secondary objectives included the assessment of patient and physician satisfaction with the telemedicine technology, and correlative study was conducted to determine baseline rates of perioperative ostomy-related complications, including rate of readmission and dehydration. Patients ≥18 years of age undergoing colorectal surgery with the possibility of ileostomy creation were eligible for the study. The study was conducted from November 2014 through September 2015. Five surgeons enrolled patients and participated in the assessments.

Telemedicine Visits:

Postoperatively the patients underwent a telemedicine assessment of their ileostomy output once they had return of bowel function. The study allowed for patients to potentially undergo multiple assessments during the same hospitalization. IPad2 (Apple, Cuppertino, CA) tablets and FaceTime © were utilized within a secure wireless network to conduct the televideoconference visits. The visits were conducted during routine daily rounds, ranging from 0730 to 1530. The patient and the physician used tablets stored on the floor for the purpose of the study. This allowed the devices to communicate without disclosing personal email addresses.

The FaceTime © call was initiated by the patient’s attending surgeon. A brief introduction occurred between the patient and the attending surgeon. The visit then focused on visual assessment of the ileostomy output. The patient utilized the tablet to show the ostomy appliance and its contents to the attending surgeon. Once the surgeon had sufficiently evaluated the output, the teleconference was terminated. At the conclusion of the telemedicine encounter, the attending surgeon completed an assessment of the ileostomy output (Supplement 1). Volume of output was recorded in the chart by the nurses/staff. That information was then entered in the assessment by the attending surgeon. Two five-point Likert rating scales of consistency were utilized. The first was based on food consistency comparing ostomy output to Water (1), Milkshake (3) and Pudding (5). The second was rated from thin (1) to thick (5). Finally, the attending surgeon recorded their impression regarding the patient’s need for anti-motility agents (fiber, Imodium, lomotil). There were no guidelines for the initiation of medical therapy. The surgeons were permitted to use their own judgment regarding the need for antidiarrheal therapy based on their assessment of the ileostomy output.

Immediately following the telemedicine encounter, the same attending surgeon evaluated the patient in person and completed the same assessment form. The agreement of telemedicine and in person assessments of the need for medical intervention in the form of anti-motility agents was used to determine feasibility. The results of the assessments were recorded electronically using QUALTRICS, LLC (Provo, Utah) survey software. Additionally, satisfaction surveys were conducted to evaluate the patient and physician experience with telemedicine (Supplement 2).

Clinical and Pathologic Data

Medical charts were reviewed retrospectively to obtain clinical data including age, sex, diagnosis, pathology, oncologic treatment, and postoperative morbidity including dehydration events and readmission within 60 days of discharge. Dehydration events were defined as patients having to receive intravenous fluids as an outpatient or a readmission to the hospital for intravenous fluid resuscitation. Additionally, for patients who had telemedicine evaluations performed but were lacking in-person assessments, data regarding treatment decisions (primary endpoint) were obtained from review of the medical record.

Statistics

The primary endpoint was concordance of the ileostomy evaluation and treatment decision by telemedicine to in-person assessment. For the assessment of ileostomy output, patients needed to have responses to both the physician telerounding ileostomy survey and the in-person ileostomy survey as collected using QUALTRICS, LLC (Provo, Utah). Matching within the QUALTRICS data was performed by matching the date and patient id and confirming that the in-person information happened after the telerounding information. For patients with a telerounding survey but the in-person results were missing, the medical record was used to gather the treatment recommendation at the matching time of the telerounding survey. Only patients with matching survey and/or medical record information could be included to assess the primary endpoint of matching physician decisions about the need for pharmacologic intervention and type of intervention in both settings. Only patients with surveys in QUALTRICS could be used to compare the telerounding vs. in-person ileostomy assessments. If a patient had two surveys on the same date several minutes apart but data entry indicated that both were from the same type of rounding, the earlier one was determined to be telerounding and the later one was determined to be in-person. The percentage and 95% Blythe-Still-Casella confidence interval (CI) of identical medical decisions made between telerounding and in-person rounding are reported. We determined before the trial that this technology would be feasible for further study if at least 90% of rounding experiences provide the same treatment decision. A secondary analysis examined whether ileostomy characteristics could be used to predict hospital readmissions was implemented with univariate logistic regression. All analyses were performed in SAS9.3 [The SAS Institute Inc, Cary, NC] and figures were created in Stata 13 [StatCorp, College Station, TX].

Results

Patient Characteristics

Sixty patients were enrolled in the study. Eleven patients were removed from the study as a result of voluntary withdrawal (n=1), lack of an ileostomy at the conclusion of surgery (n=6), or the patient’s decision to defer surgery (n=4). These 49 patients (Group 1) were used for evaluation of secondary clinical outcome measures. Additionally, 22 patients were ineligible for evaluation secondary to delayed bowel function, weekend discharges, and faculty academic and personal obligations impacting assessment opportunities. The remaining 27 patients (Group2) underwent a total of 44 telemedicine evaluations of their ileostomy output and the data was used to evaluate the feasibility of televideoconference assessment of ileostomy output and satisfaction with telemedicine. The median age of the evaluable patients was 50.9 (22.3-75.1) years and the majority was male (70%) and white (74%). Almost all patients had rectal cancer (93%) and were treated with neoadjuvant chemoradiation (89%) and adjuvant chemotherapy (81%) (Table 1). There were no statistical differences between patients included in Group 2 and those that were not, but there was a trend for more male patients to have complete information (Table 1).

Table 1.

Patient Characteristics

	All Patients	Patients with Matched Data
Patient Characteristics	N (%)	N (%)
All	49 (100%)	27 (100%)
Age-median(min,max)
N=27	51.1 (22.3, 75.1)	50.9 (22.3, 75.1)
Gender
Female	19 (39%)	8 (30%)
Male	30 (61%)	19 (70%)
Race/Etdnicity
White	42 (86%)	20 (74%)
Asian	3 (6%)	3 (11%)
Black	3 (6%)	3 (11%)
Hispanic	1 (2%)	1 (4%)
Type of Cancer
RECTAL	46 (94%)	25 (93%)
COLON	3 (6%)	2 (7%)
Path Stage
0	10 (20%)	5 (19%)
I	12 (24%)	7 (26%)
II	6 (12%)	4 (15%)
III	18 (37%)	10 (37%)
IV	3 (6%)	1 (4%)
Neoadjuvant Therapy
N	6 (12%)	3 (11%)
Y	43 (88%)	24 (89%)
Adjuvant Therapy
N	11 (22%)	5 (19%)
Y	38 (78%)	22 (81%)
Tumor Type
Adeno	48 (98%)	27 (100%)
NeuroEndocrine	1 (2%)

Telemedicine Assessment of Ileostomy Output

Thirty-one encounters had matched telemedicine evaluations and in person assessments in Group 2. For the other 13 encounters, the medical record was reviewed to determine treatment decisions made by the medical team. The result was 44 comparative evaluations to determine the feasibility of utilizing telemedicine to determine the need for anti-motility agents in patients with ileostomies. In 43 of 44 encounters, the attending surgeon’s decision to initiate anti-motility agents was the same between the telemedicine assessment and the in person assessment. Similarly, 42 of 44 patient encounters had identical treatment recommendations resulting in 95% match (95% CI: 85%, 99%) (Table 2) demonstrating the feasibility of using telemedicine technology to evaluate ileostomy output and determine the need for medical intervention.

Table 2.

Ileostomy Output by Telerounding Status –Multiple Rounds for some Patients (N=27 Patients)

	Matched Round Information
	iPad	In-Person
Patient Characteristics	N (%)	N (%)
All Recorded Rounding Visits *	44 (100%)	44 (100%)
Intervention Needed
No	34 (77%)	35 (80%)
Yes	10 (23%)	9 (20%)
Specific Intervention
Fiber	6 (60%)	4 (44%)
Fiber and Imodium	4 (40%)	5 (56%)
Rounding Visits with Electronic Surveys **	31 (100%)	31 (100%)
Total Output
<1 Liter	18 (58%)	18 (58%)
1-1.5 Liters	6 (19%)	6 (19%)
>1.5 Liters	7 (23%)	7 (23%)
Consistency 1
1-Water	12 (39%)	11 (35%)
2	13 (42%)	12 (39%)
3-Milshake	5 (16%)	7 (23%)
4	1 (3%)	1 (3%)
Consistency 2
1-Thin	11 (35%)	11 (35%)
2	13 (42%)	12 (39%)
3	6 (19%)	7 (23%)
4	1 (3%)	1 (3%)

^*This includes supplemental information gathered from the medical record when in-person rounding information was missing in QUALTRICS.

^**This includes the electronically collected ileostomy assessment survey data only

Additionally, the attending surgeon was asked to evaluate the consistency of the stool using two five-point Likert scales. The first was based on food consistency comparing ostomy output to Water (1), Milkshake (3) and Pudding (5). The second was rated from thin (1) to thick (5). There was no apparent difference in assessment of stool consistency with either scale when comparing telemedicine assessment and in-person assessment for patients in Group 2 (Table 2).

Readmission and Dehydration

Retrospective evaluation of the outpatient post-operative course of the 49 patients (Group 1) enrolled in the study demonstrated that 9 patients (18%) experienced a dehydration event. Five patients required readmission with a component of dehydration, 3 were managed with outpatient infusion, and one patient received an outpatient infusion and subsequently was admitted. Nearly a third of patients (N=15, 31%) were readmitted, with dehydration and infection representing the majority of diagnoses (60%). There were no statistical differences in readmission rates or dehydration events in the subset that participated in the televideoconference assessments compared to all patients enrolled in the study (Table 3). The results demonstrate the high risk of readmission for patients with new ileostomies and the high prevalence of dehydration following discharge. The small sample size did not allow for evaluation of factors predicting readmission or dehydration events.

Table 3.

Post-Discharge Outcomes Overall and by Telerounding Status

	All Patients	Patients with Telerounding Information
Patient Characteristics	N (%)	N (%)
All Patients	49 (100%)	27 (100%)
Dehydration
N	40 (82%)	21 (78%)
Y	9 (18%)	6 (22%)
IV Fluid Support at Ambulatory Care
N	45 (92%)	25 (93%)
Y	4 (8%)	2 (7%)
Readmitted
N	34 (69%)	17 (63%)
Y	15 (31%)	10 (37%)
Reason Admitted
Anastomotic Leak	2 (13%)	1 (10%)
Dehydration	4 (27%)	3 (30%)
Ileus/pSBO	2 (13%)	2 (20%)
Infection	3 (20%)	1 (10%)
Multifactorial	2 (13%)	1 (10%)
Other	2 (13%)	2 (20%)

Satisfaction with Telemedicine Technology

A total of 31 patients responded to the satisfaction survey at least once and all matched patients responded. When patients had >1 telemedicine encounter with multiple survey responses, the worst overall survey response was incorporated in the analysis. Figure 1 presents the satisfaction results for Group 2. Using the lowest favorability score, most patients still responded with “excellent” or “very good” for all questions regarding the equipment including video and sound quality, comfort with using it, and the ease of accessing the internet, as well as the question regarding their pre-discharge ostomy training. Attending surgeons responded even more favorably, with only one fair response for getting online and only one fair response for ease of conferencing. The surgeons were more likely to respond that they were worried about loss or damage to the equipment (Figure 1).

Figure 1: Patient and Staff Satisfaction with the Telerounding Experience.

The bar graphs demonstrate the high rate of satisfaction for both patients (A) and physicians (B). Physicians were more likely to report some concern regarding the safety of the equipment compared to patients (C and D). Similarly, both patients and physicians responded favorably when asked about the use of telemedicine in routine post-operative care (E and F).

For the postoperative care portion of the questionnaire, almost all patients responded favorably with only 3 patients indicating that they would not like to use the telerounding as a regular part of their care and only 2 patients would not be comfortable using the technology in the outpatient setting (Figure 1).

Discussion

Utilization of a teleconferencing encounter in patients with ileostomies is a feasible mechanism for assessing the quality of ileostomy output for medical treatment decision-making. Concordance regarding the need for medical intervention was very high, as demonstrated by a 95% match (95% CI: 85%, 99%) between teleconferencing and in-person assessments. To the authors knowledge this is the first study assessing the reliability of telemedicine technology to assess ileostomy output consistency and its potential for treatment decision-making. Importantly, in this initial feasibility study, both the patients and the surgeons highly rated the experience with telemedicine and were in favor of the utilization of telemedicine following discharge.

Additionally, this study confirms previous reports demonstrating a high readmission rate of 31% with a high frequency of dehydration events despite the heightened attention given to the importance of ileostomy monitoring to the patients enrolled in the study (18%).^{3, 7, 12} The results highlight the need for novel interventions to improve the clinical outcomes among patients with ileostomies. Review of the literature demonstrates that there exists the potential for interventions targeting patient education and formal pathways to result in improvements in readmissions and in the incidence of dehydration.^{4, 13} Other reported approaches include more intensive monitoring post discharge for potentially high-risk patients.⁸ However, the ability to monitor the quality of ostomy output remotely through telemedicine may provide an early window of opportunity for preventive intervention.

Telemedicine could offer the ability to incorporate both education and a more intensive post-operative follow up program while simultaneously decreasing hospital resource utilization. Having a reliable means of communication, monitoring and evaluation in the outpatient setting without requiring a formal brick and mortar clinic visit is appealing in the ever evolving healthcare landscape. The opportunity exists to utilize telemedicine to achieve these goals. For example, Liu et al. demonstrated the benefit of a telemedicine program in the management of burn patients. The implementation of a comprehensive telemedicine program to evaluate burn patients during rehabilitation at a separate facility had a significant financial impact saving over $100,000 on transportation, and increasing clinic and rehabilitation center efficiency.¹⁴

Additional studies have shown some feasibility in implementation of teledischarge programs across the spectrum of complex and ambulatory surgical procedures.^15-18 These studies have examined resource utilization and have looked at implementation to aid in decreasing travel and simplifying follow up for patients. However, studies examining the benefits of telemedicine in the post-operative setting have been limited. To reach the full potential of telemedicine, future studies in this area need to examine the role of telemedicine and its ability to improve post surgical care through expedited discharge, improve the postoperative follow up experience and positively impact postoperative complications.

The study has several limitations. Specifically, as a feasibility study, there was a high number of patients who failed to complete the study. For those that completed the study, the use of technology had a high degree of agreement with in person evaluation. However, the challenges of implementation of a telemedicine program are reflected in the high number of patients who failed to complete the study. The lack of a formal infrastructure for telemedicine within our hospital directly influences the participation of both patients and attending surgeons. During the study, the assessments only occurred after bowel function had occurred but before discharge. This is frequently a short window, although this would not be an issue during post-discharge monitoring. Without dedicated staffing and resources, the impact of weekends, surgeon personal and academic obligations, timing of return of bowel function, and availability of the technology, decreased the number of participants completing the study. This study shows that telemedicine can be performed to adequately assess ostomy output compared to a face-to-face visit, as such, telemedicine could potentially be used in a post-discharge setting to continue ileostomy monitoring. However, successful implementation of a telemedicine program for ileostomy patients may require the ability for more frequent encounters in the post-discharge setting including on weekends given the potential to rapidly develop dehydration.

An additional limitation is that the study was conducted in-hospital only. However, this was done purposefully in this study of feasibility that required simultaneous both video-based and in person assessments in order to assess the reliability of the video assessments and test the safety of video-based assessments in the context of more complete clinical information such as vital signs and laboratory evaluations. Moreover, the inpatient setting ensured high-speed wireless internet for video streaming within a secured network. This study demonstrated that telemedicine evaluations of ileostomy outputs correlate with face-to-face assessments, and therefore may be a useful tool in the post-discharge setting as part of a formal teledischarge program aimed at decreasing readmission rates for patients with new ileostomies.

Conclusions

Technology and telemedicine enable greater connectivity between patients and their providers. Leveraging this technology in high-risk postoperative patient populations, including patients with ileostomies, in combination with programmatic institutional support could lead to marked improvements in clinical outcomes.