Dr Robert I. Fearn M.D.
Medical Director, 11 Health and Technologies
In October 2018 surgical teams from ten major hospital systems in New York, Cleveland, Massachusetts and California began to recruit patients into a multicentre service evaluation pilot analysing the impact of a novel remote monitoring and care pathway for new ostomy patients.
The intervention incorporated remote monitoring, peer support, telehealth nursing and home healthcare components. Remote monitoring was provided through a 'smart' stoma bag and base-plate system (11 Health and Technologies Inc.), an FDA approved product which utilizes capacitive and thermal data to map stoma output and saturation of the base-plate in real time. Alerts inform a patient of a full bag or of an impending leak. All patients were paired with a peer who is a current or previous stoma patient, trained as a health coach to provide education and support. Ongoing health concerns including dehydration or skin issues could be escalated to a telehealth nurse who has access to telemetry from the platform. Clinicians could use the platform to provide IV rehydration in the patient's own home. The impact of this pathway on readmissions and other complications was assessed.
The overall structure of the care model can be seen in figure 1. Patients were recruited prior to surgery and provided with an educational program and access to their peer mentor. A mobile application provided access to resources and a means to review daily stoma output and record fluid intake. Telehealth nursing can be accessed at the push of a button within the application. The platform was designed to facilitate discharge and reduce readmissions in an era of Enhanced Recovery After Surgery and quality improvement programs.
Recruitment began in October 2018. To date 43 patients (24 male) have been supported by this program. Three-month follow up data was available for 25 of these patients. Coaching interaction, smart stoma bag usage, detection of adverse events, nurse interventions and reports of significant quality of life benefits were analysed.
Figure 1:A novel model of care where patients are provided with educational resources delivered through a smartphone application and peer support preoperatively, a remote monitoring 'smart' stoma bag system in the early postoperative period and access to telehealth nursing and homecare following discharge.
Peer support coaching was found to be acceptable and durable to new ileostomy patients and 716 coaching interactions were recorded. Mean duration of coaching follow-up was 30 days (1-90). Coaching contact predominantly began in the perioperative week (174 interactions, 22.6%) and 86% of initial encounters were by telephone. The modality of ongoing contact was email in 25 encounters (3.5%), telephone call in 181 encounters (25.3%) and messenger application in 478 encounters (66.8%). The mean (SD) duration of phone calls was 13.8 (14.4) minutes, time spent on email exchange was 7.3 (3.8) minutes and text exchange was 4.8 (5.4) minutes.
Remote monitoring using a smart stoma bag was achieved with 21 patients. A total of 2077 bag-hours of data were monitored and over 55,000 individual observations. Mean (SD) hourly stoma output was 39.3 (163.9) ml/h. Stoma output exceeding 100ml/h was detected 164 times and affected 12 (57%) of the remote monitoring cohort at any time during monitoring. Figure 2 below demonstrates the hourly ileostomy output over time in 75 continual days of monitoring. Note the trend towards reduced output as the bowel adapts.
All 43 participants were eligible for nursing support and this could be triggered based on the remote monitoring system or self-initiated by the patient. Nursing interventions were provided to eight patients (38%) for management of skin issues (6) and concerns regarding risk of dehydration (2). No hospital admissions for IV fluid were recorded in this cohort. Three patients received home fluid infusions (6.9%), however one of these was a short gut patient on long term home parenteral nutrition. Two patients were readmitted due to surgical complications, but not due to dehydration or peristomal issues.
A qualitative analysis of records of the coaching encounters reported evidence of benefit likely to impact positively on quality of life in 28 cases (65%). Examples of comments that were deemed to be reflective of a positive impact are shown below in Box 1.
"I like this much better than those little bags I was given in the hospital."
"I am just really grateful for people like you that go out of their way just to help their patients. These days, it's rare to meet wonderful people like you."
"I love how you care & are always willing to help."
"Super helpful and comforting. Thank you."
"I'm so lucky to have you."
"I love the personalized care! Hydration is going well, and my pain is under control. The program is super helpful and comforting. Thank you!"
Complication rates for stoma patients exceed 55% (1) and in a review of all US healthcare data the all cause 30-day readmission rate for ileostomy patients matched kidney transplant at 29.1% (2). Commonly reported complications include acute kidney injury, skin complications and a reduced quality of life (3). Dehydration is the most common cause for readmission present in approximately 40% and high output stoma (HOS), defined as ostomy output >1500ml/d for two or more consecutive days occurs in up to 17%. Patients that develop postoperative HOS stay in hospital longer (18 vs 12 days in one study).
The cumulative impact of the complications listed above also imparts a significant burden on the quality of life (QOL) of stoma patients(4). A systematic review demonstrated that living with a stoma influenced the overall QOL negatively and the overall cost of care is greatly increased (5).
The results of this pilot suggest that an integrated platform involving remote monitoring, peer support and nursing is effective in providing durable benefit to new ileostomy patients. The reported rates of complication and adverse impact on quality of life appeared to be superior to the existing standard of care. These initial findings are extremely promising and support the ongoing use and further evaluation of such pathways.
1. Kwiatt M, Kawata M. Avoidance and management of stomal complications. Clin Colon Rectal Surg. 2013;26(2):112-21.
2. Justiniano CF, Temple LK, Swanger AA, Xu Z, Speranza JR, Cellini C, et al. Readmissions With Dehydration After Ileostomy Creation: Rethinking Risk Factors. Dis Colon Rectum. 2018;61(11):1297-305.
3. Arenas Villafranca JJ, López-Rodríguez C, Abilés J, Rivera R, Gándara Adán N, Utrilla Navarro P. Protocol for the detection and nutritional management of high-output stomas. Nutr J. 2015;14:45.
4. Liao C, Qin Y. Factors associated with stoma quality of life among stoma patients. International Journal of Nursing Sciences. 2014;1(2):196-201.
5. Vonk-Klaassen SM, de Vocht HM, den Ouden ME, Eddes EH, Schuurmans MJ. Ostomy-related problems and their impact on quality of life of colorectal cancer ostomates: a systematic review. Qual Life Res. 2016;25(1):125-33.