2.1 Patient Population. After approval from the institutional IRB, a single institution retrospective review from April 2016 to December 2020 was performed of AMBS patients (ranging from 14 to 18 years old) before and after full implementation of TERAS protocol in October 2019. Every patient underwent institutionally established preoperative workup and education by a multidisciplinary team. All patients had laparoscopic vertical sleeve gastrectomy (LVSG) performed by two board certified pediatric surgeons at our Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program® Comprehensive Center with Adolescent Qualifications. There were no intraoperative complications in any of the patients. The patients who had LVSG between December 2018 and March 2019 were included as the transition group as the feasibility of one of the critical components of TERAS (initiation of clear liquid diet (CLD) on postoperative day 0) was assessed during this time. The control group consisted of patients who had surgery before December 2018 in which TERAS was not implemented. The study group consisted of patients who had surgery after October 2019 and received the telemedicine device for postoperative follow up.
2.2 Implementation. The adolescent bariatric protocol before December 2018 consisted of minimization of in-dwelling postoperative catheters (no foley or nasogastric tubes), postoperative narcotic patient-controlled analgesia (PCA), scheduled non-narcotic analgesia such as non-steroidal anti-inflammatory drug (NSAID) and hyoscyamine, postoperative mobilization every 2 hours when awake, initiation of CLD starting postoperative day 1 and minimally invasive surgery, if possible.
After December 2018, the transition to TERAS program began. Limiting inpatient narcotic use was emphasized though this was not formalized as a protocol. In addition, patients were started on immediate postoperative CLD. All the other components of the protocol previously described were applied.
After October 2019, the TERAS protocol, formulated by the AMBS team, was fully implemented. Each patient and family were educated regarding the TERAS protocol. They were specifically asked to follow the preoperative CLD protocol (described in Section 2.3) and taught how to use the telemedicine device while inpatient. They were deemed proficient with the device once they could demonstrate how to use the device to the research team member. The research team educated the perioperative and inpatient nursing staff on the TERAS protocol and they were given an instructional sheet to be referred to on the inpatient floor. The operating surgeon coordinated with the pediatric anesthesia staff to implement this protocol and this was discussed for every case.
2.3 Description of the TERAS Protocol. The TERAS protocol consisted of preoperative, intraoperative, and postoperative stages, Figure 1.
The preoperative stage included: CLD consisting of carbohydrate rich electrolyte drink (or water if diabetic patient) up to 2 hours before surgery and preoperative dose of gabapentin (300mg, PO) at least 1 hour before surgery. The intraoperative stage included: emphasis on non-narcotic analgesia (acetaminophen, ketorolac, and magnesium sulfate) in coordination with the anesthesia provider. The postoperative stage included: maximization of non-narcotic analgesia (scheduled acetaminophen, ketorolac and gabapentin 300mg every 8 hours PO), minimization of narcotic analgesia (oxycodone as needed for breakthrough pain), initiation of CLD starting postoperative day 0, telemedicine follow up with the operating surgeon within 1 week after discharge, minimization of in-dwelling postoperative catheters (no foley or nasogastric tubes) and postoperative mobilization every 2 hours when awake.
All patients received routine postoperative care and the rounding pediatric surgery team decided the rest of their medical care as necessary. The rounding team was aware that the patients in the TERAS protocol were going to have close interval telemedicine follow up. The criteria to discharge regardless of the patient’s enrollment in the TERAS protocol were: 1) Tolerating 4 ounces of liquid every hour without nausea or vomiting, 2) Sufficient pain control as deemed by the patient, family, and the rounding team, 3) Medically stable for discharge per rounding team and 4) Agreement of patient, family, and the rounding team to be discharged with appropriate interval follow up.
2.4 Outpatient Follow Up. Telemedicine outpatient follow up visit was performed using the eVER-HOME (Dictum Health, Oakland, California, USA) device loaned to the patient family for two to four weeks depending on patient’s needs. This device is an FDA Class I cleared tablet that utilizes cloud platform (Care Central) to facilitate a virtual clinic visit over Wi-Fi or mobile cellular data. It includes FDA Class II cleared Bluetooth enabled attachments that enable patients and their families to measure the temperature, blood pressure, heart rate and oxygen saturation and transmit the data to the clinician. Using a desktop or laptop with a camera, the clinician can video conference with the patient while checking their vital signs.
Each telemedicine outpatient visit (done within 1 week of discharge) consisted of virtual clinical examination and a vital sign check (temperature, blood pressure, heart rate and oxygen saturation) by the operating surgeon. The patients were also given the option of checking their vital signs as necessary and contacting the outpatient clinic or the surgeon to set up another virtual or in-person visit. After the first visit, the surgeon determined the time of the next follow up visit and whether it would be virtual or in-person, depending on his clinical acumen. Due to the COVID-19 pandemic and outpatient restrictions, all the postoperative outpatient visits after March 2020 were virtual.
2.5 Outcome. The demographic and patient characteristics consisted of age, sex, BMI at the time of surgery, co-morbidities at the time of surgery and distance from residence to the hospital. The implementation of the TERAS protocol was measured by the number of included components out of total of 10 components as described in Section 2.3. The perioperative outcomes were measured by the LOS, intra- and postoperative narcotic use, pain control and surgical complications. The LOS was defined as the hours out of the OR to the time of discharge. The narcotic use was measured by the morphine milligram equivalent per hour of inpatient stay (MME/hour). Pain control was measured by averaging the 1 to 10 pain severity rating on only postoperative day 1. Surgical complications were defined by those diagnosed by the operating surgeon postoperatively in- or outpatient within 1 month after surgery. The follow up outcomes were measured by the postoperative virtual visits (within 3 months of surgery), postoperative traditional outpatient visits (within 3 months of surgery), time to first outpatient follow up visit after discharge, postoperative emergency department (ED) visits (within 1 month of surgery, any facilities), postoperative readmissions (within 1 month of surgery, any facilities), patient and caregiver satisfaction with the virtual outpatient visits and travel distance saved. Patient and caregiver satisfaction was measured by an anonymous survey consisting of nine questions after completion of the virtual visits, Table 1.
Table 1. Caregiver Survey. The caregiver survey was done anonymously to assess the patient’s satisfaction with the telemedicine follow up.
- How satisfied are you with the telemedicine device and it use during your child’s evaluation? 5-Very satisfied, 4-Satisfied, 3-Neutral, 2-Dissatisfied, 1-Very dissatisfied
- How satisfied are you with the ability of the medical provider to provide appropriate care to your child through the telemedicine evaluation? 5-Very satisfied, 4-Satisfied, 3-Neutral, 2-Dissatisfied, 1-Very dissatisfied
- What is your overall satisfaction with your child’s telemedicine evaluation? 5-Very satisfied, 4-Satisfied, 3-Neutral, 2-Dissatisfied, 1-Very dissatisfied
- If your child needs to be seen by a medical provider in the future for a postoperative visit, would you be comfortable with being evaluated with a telemedicine device with an option of in-person visit, if needed? 1-Yes, 2-No
- Would you be comfortable with a telemedicine evaluation for an initial evaluation with an option of in-person visit, if needed? 1-Yes, 2-No
- Would you recommend a telemedicine evaluation to a friend or family member for their child? 1-Yes, 2-No
Comment #1: If answered no to any of the above questions, why?
Comment #2: If you marked dissatisfied for any of the above questions please explain why:
Comment #3: General comments about telemedicine and its use in your child’s care:
Total distance saved was calculated by doubling the distance from primary residence to the hospital and then multiplying it by the total number of virtual visits.
2.6 Statistical Analysis. Statistical analysis was done using chi-square test and Mann-Whitney U test to compare the control group (the patients who had surgery before December 2018) and the study group (the patients who had surgery after October 2019). Transition group was excluded from statistical analysis due to small sample size (n=6). Statistical significance was determined based on the alpha cutoff of 0.05. This analysis was performed using the SPSS (IBM, Armonk, New York, USA) and Prism (GraphPad, San Diego, California, USA) software program.