Exploring the Challenges of Implementing a Web-Based Telemonitoring Strategy for Teenagers With Inflammatory Bowel Disease: Empirical Case Study.

BACKGROUND: We designed a telemonitoring strategy for teenagers with inflammatory bowel disease to prevent an anticipated disease flare and avert unplanned office visits and day care procedures. The strategy was evaluated in a randomized controlled trial that involved 11 Dutch pediatric gastroenterology centers, each using repeated symptom scores and stool calprotectin measurements. In the telemonitoring arm of the trial, teenagers (n=84) as well as their health providers were alerted to out-of-range results, and suggestions for change in therapy were offered. We demonstrated that the technology was a safe and cost saving alternative to health checks by the specialist at fixed intervals. OBJECTIVE: The aim of this study was to evaluate whether we could move our telemonitoring strategy from a demonstration project to one that is sustained within existing sites. METHODS: In this empirical case study, we used the nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework to explore the challenges to implementing our strategy. The framework distinguishes 7 domains: (1) the illness, (2) the technology, (3) the value proposition, (4) the adopter system, (5) the organization, (6) the societal system, and (7) the time dimension. We summarized the challenges across all 7 domains and classified them as simple (+++), complicated (++), or complex (+). Technologies in which multiple domains are complicated have proven difficult to implement, whereas those with multiple complex domains may not even become mainstreamed. RESULTS: The technology that we used and the linked program (IBD-live) allowed us to select and target the teenagers who were most likely to benefit from a face-to-face encounter with their specialist (+++). The value proposition of the technology was clear, with a distinct benefit for patients and an affordable service model, but health providers had plausible personal reasons to resist (double data entry, ++). The organization was not yet ready for the innovation, as it requires a shift to new ways of working (+). We had no concerns about reimbursement, as Dutch health insurers agreed that screen-to-screen consultations will be reimbursed at a rate equivalent to face-to-face consultations (+++). Finally, the technology was considered easy to adapt and evolve over time to meet the needs of its users (+++). CONCLUSIONS: The challenges to be addressed are merely complicated (++) rather than complex (+), which means that our program may be difficult but not impossible to sustain within existing sites. After integrating the technology and its use with local workflows first, we believe that our telemonitoring strategy will be ready for sustained adoption. In contrast with what we did ourselves, we recommend others to use the NASSS framework prospectively and in real time to predict and explore the challenges to implementing new technologies.

Simple Urine Test to Evaluate Adherence to Oral 5-ASA in Teenagers With Ulcerative Colitis: Proof of Concept.

OBJECTIVES: 5-Aminosalicylic acid (5-ASA) is an important maintenance drug for patients with ulcerative colitis. A proportion of the ingested dose is excreted in the urine. Measuring 5-ASA and its metabolites in urine requires mass spectrometry, which is not widely available for this purpose. Urinary 5-ASA can be measured by colorimetry using the serum salicylic acid assay and is a surrogate marker of recent 5-ASA ingestion. We evaluated whether measuring 5-ASA in first morning voids or in random spot urine samples correctly identifies teenagers with poor adherence to oral 5-ASA. METHODS: Teenagers who were prescribed a current regimen including >40 mg ·â€Škg ·â€Šday of 5-ASA were invited to collect their spot urine with various time lapses since their last presumed 5-ASA ingestion. Classification of adherence was based on a composite method that included a patient-reported adherence scale and 6-thioguanine levels in erythrocytes. RESULTS: Teenagers who were classified as "good adherers" had 66 of 69 (96%; 95% confidence interval 87%-99%) spot urine samples with detectable 5-ASA levels. "Poor adherers" had 30 of 45 (67%; 95% confidence interval 52%-79%) spot urine samples with undetectable 5-ASA levels. The "good adherers" with false-negative urine tests were on a once daily dosing regimen and had collected a spot urine sample shortly before the next dosage. Their first morning voids had detectable 5-ASA levels. CONCLUSIONS: Undetectable 5-ASA levels in the first morning void confirms short-term nonadherence to oral 5-ASA.

Efficacy of Home Telemonitoring versus Conventional Follow-up: A Randomized Controlled Trial among Teenagers with Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Conventional follow-up of teenagers with inflammatory bowel diseases [IBD] is done during scheduled outpatient visits regardless of how well the patient feels. We designed a telemonitoring strategy for early recognition of flares and compared its efficacy with conventional follow-up. METHODS: We used a multicentre randomized trial in patients aged 10-19 years with IBD in clinical remission at baseline. Participants assigned to telemonitoring received automated alerts to complete a symptom score and send a stool sample for measurement of calprotectin. This resulted in an individual prediction for flare with associated treatment advice and test interval. In conventional follow-up the health check interval was left to the physician's discretion. The primary endpoint was cumulative incidence of disease flares. Secondary endpoints were percentage of participants with a positive change in quality-of-life and cost-effectiveness of the intervention. RESULTS: We included 170 participants [84 telemonitoring; 86 conventional follow-up]. At 52 weeks the mean number of face-to-face visits was significantly lower in the telemonitoring group compared to conventional follow-up [3.6 vs 4.3, p < 0.001]. The incidence of flares [33 vs 34%, p = 0.93] and the proportion of participants reporting positive change in quality-of-life [54 vs 44%, p = 0.27] were similar. Mean annual cost-saving was €89 and increased to €360 in those compliant to the protocol. CONCLUSIONS: Telemonitoring is as safe as conventional follow-up, and reduces outpatient visits and societal costs. The positive impact on quality-of-life was similar in the two groups. This strategy is attractive for teenagers and families, and health professionals may be interested in using it to keep teenagers who are well out of hospital and ease pressure on overstretched outpatient services. TRIAL REGISTRATION: NTR3759 [Netherlands Trial Registry].

A Cross-Sectional Study on the Perceptions and Practices of Teenagers With Inflammatory Bowel Disease About Repeated Stool Sampling.

PURPOSE: Repeated stool sampling to monitor disease activity is increasingly used in teenagers with inflammatory bowel disease (IBD). Knowledge about their perceptions and practices regarding collection of feces will increase the success rate of this monitoring strategy. METHODS: We sent a survey to teenagers with IBD treated in an academic center. RESULTS: Seventy-two of 122 invited teenagers completed the survey (response rate 59%; median age 15 years (interquartile range, 13-17). Eighty-five percent reported that stool sampling is normally initiated with help of their parents or caretakers. Seventy-eight percent of respondents say that their parents assist with the placement of stool in the container. CONCLUSIONS: Teenagers do not feel embarrassed by the idea of stool sampling, but an active role of the parents or caretakers is an important prerequisite for maintaining a stool-based disease monitoring system. Autonomy in stool sampling is an essential skill required for a successful transition to adult-centered IBD care.

Comparing the efficacy of a web-assisted calprotectin-based treatment algorithm (IBD-live) with usual practices in teenagers with inflammatory bowel disease: study protocol for a randomized controlled trial.

BACKGROUND: To prevent clinical relapse in teenagers with inflammatory bowel disease (IBD) there is a need to monitor disease activity continuously. Timely optimisation of medical treatment may nip a preclinical relapse in the bud and change the natural course of IBD. Traditionally, disease monitoring is done during scheduled visits, but this is when most teenagers report full control. IBD care could be more efficient if patients were seen at times of clinical need. This study aims to examine the effectiveness of a web-assisted calprotectin-based treatment algorithm (IBD-live) compared with usual practices in teenagers with IBD. METHODS/DESIGN: A randomized trial of web-based disease monitoring versus usual care is conducted at 10 Dutch IBD care centers. We plan to recruit 180 patients between 10- and 19-years old with quiescent IBD at baseline. Teenagers assigned to IBD-live will use the flarometer--an automatic cumulation of disease activity and fecal calprotectin measurements- to estimate probability of relapse. In case the flarometer indicates high risk the patient requires treatment intensification in accordance with national guidelines; low risk means that maintenance therapy is unchanged; and intermediate risk requires optimisation of drug adherence. Patients assigned to usual practice get the best accepted medical care with regular health checks. Primary outcome is the frequency of relapse at 52 weeks of follow-up. The diagnosis of relapse is based on a clinical activity index score >10 points necessitating remission induction therapy. Secondary outcomes include quality of life and cost-effectiveness. DISCUSSION: Web-assisted monitoring of disease activity with rapid access for those with acute relapse may allow teenagers to develop skills that are required of adult patients (including communication and self-determination). Similar monitoring systems have been introduced for teenagers with asthma and diabetes, with a positive effect on disease control, but the intervention has not been evaluated in teenagers with IBD. A randomized trial in adult patients with ulcerative colitis showed that a web-assisted treatment algorithm is feasible, safe and cost-effective. Results of the current trial are expected to have important implications for teenagers with IBD that incurs substantial health burdens and economic costs. TRIAL REGISTRATION: Dutch Trial Register identifier: NTR3759 (registered 29 December 2012).