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A Randomized Controlled Trial of TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD)

Cross, Raymond K., MD, MS1; Langenberg, Patricia, PhD2; Regueiro, Miguel, MD3; Schwartz, David A., MD4; Tracy, J. Kathleen, PhD2; Collins, Joseph F., PhD2,5; Katz, Jonathan6; Ghazi, Leyla, MD1; Patil, Seema A., MD1; Quezada, Sandra M., MD, MS1; Beaulieu, Dawn, MD4; Horst, Sara N., MD, MPH4; Russman, Katharine1; Riaz, Mahrukh, MPH1; Jambaulikar, Guruprasad, MBBS, MPH1; Sivasailam, Barathi, MD1; Quinn, Charlene C., RN, PhD2

American Journal of Gastroenterology: March 2019 - Volume 114 - Issue 3 - p 472–482
doi: 10.1038/s41395-018-0272-8
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INTRODUCTION: Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care.

METHODS: Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim.

RESULTS: 348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn’s disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control −5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls.

DISCUSSION: Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.

1University of Maryland School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology, Baltimore, MD, USA;

2University of Maryland School of Medicine, Department of Epidemiology and Public Health, Baltimore, MD, USA;

3University of Pittsburgh, Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Pittsburgh, PA, USA;

4Vanderbilt University, Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Nashville, TN, USA;

5Veterans Affairs Cooperative Studies Program, Perry Point, MD, USA;

6CircleLink Health LLC, Norwalk, CT, USA.

Correspondence: Raymond K. Cross, MD, MS. E-mail: rcross@som.umaryland.edu.

Received November 13, 2017

Accepted August 14, 2018

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INTRODUCTION

Inflammatory bowel diseases (IBD), comprising Crohn’s disease (CD) and ulcerative colitis (UC), affect nearly 1.6 million people in the United States (1). IBD are chronic diseases characterized by abdominal pain, diarrhea, bloody stools, fatigue, and extra-intestinal manifestations (EIM) (2). The symptoms have a negative impact on quality of life (QoL) (3) and result in increased utilization of healthcare resources (4–6). Effective treatments exist for patients with IBD; however, a significant number have suboptimal outcomes. Ineffective treatment is responsible for poor outcomes in some patients (7); other barriers exist including non-adherence (8,9), delays in initiating treatment, inadequate monitoring, side effects (10,11), poor education (12), discordance between patients and providers (9), and insufficient access to IBD care (13).

Traditional monitoring and management of IBD patients occur at the time of office visits. Given the unpredictable nature of IBD, flares can occur at times other than regular office visits. Urgent visits are scheduled when symptoms develop; however, limited availability can result in significant delays in treatment (14,15). Patients often have limited freedom to institute treatment for flares; however, prior studies have shown that UC patients are capable of initiating treatment with results equivalent or superior to those of traditional care (14,16). Telemedicine is increasingly being evaluated by healthcare systems and payers as an alternative service to address deficiencies in healthcare delivery.

In previous studies, we demonstrated that telemedicine was well accepted and easily implemented in IBD (17–20). Additionally, we determined that disease activity and QoL improved when patients use telemedicine (18,20). A large European study demonstrated that telemedicine results in more rapid initiation of treatment, shorter relapses and improved QoL compared to standard care (15). These studies used home monitoring systems requiring installation by staff or web-based technology with associated high dropout rates (15,20).

We hypothesized that a new telemedicine system, utilizing cellular telephones, would result in greater adherence and decreased attrition rates. Furthermore, we hypothesized that use of an improved telemedicine system would result in decreased disease activity, improved QoL, and decreased healthcare utilization compared to standard care. The primary objective of our study was to compare changes from baseline in disease activity and QoL between participants receiving telemedicine and standard of care. Decrease in healthcare utilization was a stated a priori secondary outcome.

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METHODS

Trial Design and Study Overview

The TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) study was a multicenter, randomized, controlled, clinical trial conducted over 12 months, previously described in detail (21). Participants in the intervention arms completed selftesting with TELE-IBD on either a weekly (W) or every other week (EOW) basis whereas participants randomized to the control group received standard care. All participants underwent study visits at baseline, 6 and 12 months in addition to routine clinic visits. Disease activity and QoL were measured at each study visit. Healthcare utilization was measured via extraction of data from the electronic medical record (EMR) during one year before and after randomization.

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Sites and Recruitment

Patients were recruited from the University of Maryland (UM), University of Pittsburgh Medical Center (UPMC) and Vanderbilt University (VU). Adults with CD, UC, and indeterminate colitis were eligible to participate. Patients were identified at the time of routine visits at each site. Additionally, potentially eligible participants at UM were sent a letter, and an email was sent to members of the Maryland and Southern Delaware Chapter of the Crohn’s and Colitis Foundation informing them of the study.

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Inclusion and Exclusion Criteria

Patients were eligible to be included in the study if they had:

  1. Documented IBD on the basis of usual diagnostic criteria (22)
  2. Experienced at least one flare of IBD in the 2 years prior to the baseline visit (an increase in IBD symptoms sufficient to warrant a change in medication dose or addition of a medication)
  3. ≥18 years of age

Patients in remission secondary to oral steroid use were included.

Patients were excluded if they met any of the following criteria: inability to speak and/or read English; inability to comply with the study protocol; presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis; imminent surgery; history of short bowel syndrome; uncontrolled medical or psychiatric disease; and/or pregnancy.

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Randomization and Group Assignment

Eligible patients were randomized after enrollment in a 1:1:1 ratio. Randomization was stratified by disease type (CD vs. UC/indeterminate colitis) and disease activity (remission vs. active disease) at the time of randomization. An electronic permuted block randomization procedure with randomly varied block sizes was used; randomization was carried out by the Cooperative Studies Program Coordinator Center (US Dept. Veterans Affairs, Perry Point, MD). Withdrawal based on group assignment was not permitted. Investigators and staff were blinded to the randomization order, but patients, staff, and providers were not masked to group assignment.

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Description of the TELE-IBD System

TELE-IBD was designed using a mobile phone for participants and a decision support server and website for staff and providers. CircleLink Health, LLC developed the secure web-portal for staff and providers and provided ongoing support. CircleLink Health sent texts to participants W or EOW depending on group assignment. The website provided an interface for staff and providers for participant profiles and collected data from each testing session. The provider could individualize alerts and action plans for each participant. If pre-determined criteria were met after testing, simultaneous action plans and email alerts were sent to the participant and nurse respectively. The nurse reviewed the information and if necessary consulted the provider for management changes. Medication changes were updated in the participant profile and communicated to the participant.

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Tele-IBD Self-Testing

Participants in the intervention groups were prompted to respond to a series of texts grading their IBD symptoms. To assess bowel symptoms and EIMs, abbreviated disease activity forms were used. For CD, participants completed a modified Harvey Bradshaw Index (HBI). Overall well-being, abdominal pain and diarrhea were core questions. For UC and indeterminate colitis, participants completed the Simple Clinical Colitis Activity Index (SCCAI). Overall well-being, number of bowel movements during the day, and presence of blood in the stool were core questions.

After answering questions about their symptoms, participants received a list of medication(s), dose(s) and direction(s). Participants were asked if they experienced any drug side effects. Participants were asked to describe and grade the severity (mild, moderate or severe) of side effects; moderate to severe side effects generated an alert. Participants used a scale provided by staff to assess weight.

Alerts and action plans were customized for participants and generated based on responses to the core questions in the activity indices for CD and UC/indeterminate colitis respectively. Depending on the response, they were assigned to a disease activity zone: the Green zone represented the participant was in remission or had mild disease activity; the Yellow zone represented the participant had moderate disease activity; the Red zone represented the participant had severe disease activity. The proportion of participants in each disease activity zone was tracked throughout the course of the study. Depending on the severity zone, the provider could select an action for the participant to begin following testing. For example, a participant with UC in the Yellow Zone could be instructed to start mesalamine enemas nightly.

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TELE-IBD Educational Curriculum

An educational curriculum was developed for participants in the intervention groups. TELE-IBD participants received an educational tip twice weekly (if in the W group) or every week (if in the EOW group). TELE-IBD participants also received periodic “pragmatic” educational messages at the discretion of the provider. Pragmatic messages were sent to TELE-IBD participants twice monthly. Two examples of pragmatic messages are listed below.

  • It is flu season. Remember to get a flu shot, especially if you are on immune suppressants or anti-TNF drugs, you are 50 years or older, or if you smoke.
  • If you are on immune suppressants or anti-TNF drugs, you should use sunscreen to prevent skin cancer. It is a good idea to see a dermatologist yearly for a skin examination.
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Description of Control Group

Standard of care was based on current evidence-based professional guidelines (23–25) including a comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed visits, scheduled and as needed calls, and administration of fact sheets about disease-specific topics. Administration of educational materials for control participants was not standardized and was at the discretion of the treating provider.

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Outcome Measures

Assessment of Disease Activity.

To assess disease activity for participants with CD, the HBI was used (26). The HBI is an activity index that rates overall well-being, abdominal pain, number of liquid stools per day and EIMs. Scores <5 are indicative of remission; scores ≥5 indicate active disease (26,27). The SCCAI was used to assess disease activity for patients with UC/indeterminate colitis (28). The SCCAI is a subjective activity index that rates overall well-being, daytime and nocturnal bowel movements, urgency, rectal bleeding and EIMs. Scores <3 are indicative of remission; scores ≥3 indicate active disease (29). Laboratories were measured at each visit if possible including a complete blood count, comprehensive metabolic profile, sedimentation rate, and c reactive protein.

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Assessment of Quality of Life.

Disease-specific QoL was assessed with the IBD Questionnaire (IBDQ). The IBDQ has been validated previously for IBD and correlates with disease activity indices (30–32). A score >168 correlates with remission in patients with CD (31). Changes from baseline of 16 to 32 are clinically meaningful (33).

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Assessment of Utilization of Healthcare Resources.

All three sites utilized an EMR. Hospitalizations, surgery, emergency department and office visits, procedures, intravenous therapeutics, and telephone and electronic encounters were extracted from the EMR during one year before and after randomization. We also compared medication use at the final study visit to those at baseline.

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Statistical Analyses

All analyses were done under the intention to treat principle. Initial analyses tabulated demographic and baseline characteristics by group and disease type. Because of randomization it was assumed that any differences among the groups on baseline characteristics were chance results; thus no baseline statistical comparisons were made. Mean disease scores and standard deviations were calculated within disease type (HBI or SCCAI) at each visit. Change from baseline were also compared within and between groups at each visit. Identical analyses were used for QoL scores by disease type and for all participants.

Comparisons were made of groups on change from baseline at each visit for disease activity and QoL using a mixed model repeated measures approach, to account for within person correlation. Clinical site was included as a random effect; models included race and tobacco use that were identified as potential confounders. In order to detect potential bias by analysis of only the collected data, we compared participants with and without data at a given time point to determine whether baseline characteristics of those who did not provide complete data differed.

All analyses were carried out with SAS, version 9.3 or later (SAS Institute, Inc., Cary, NC).

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Sample Size Calculations

Calculations were based on the assumption that we would recruit 375 patients at the sites, with 20% loss to follow up over 12 months. We anticipated that of the 300 participants with complete data, 60 and 40% would have CD and UC respectively. Power calculations were based on estimates of standard deviation for primary outcome measures from a prior trial in UC (20). We assumed α = 0.05 and power = 0.80 for two-sided tests comparing groups. Our only planned sub-group analyses were for CD and UC/indeterminate colitis, which was necessary because disease activity measures differ for the diseases. We estimated minimum detectable differences in disease activity and QoL (21). All calculations were based on pair-wise group comparisons, and implemented with the software PS: Power and Sample Size Program.

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Human Subjects Research Protection

The Human Subjects Research Protection Office at all 3 sites approved the study, and a Data Safety and Monitoring Board (DSMB) was established to review study procedures, enrollment, quality of data, adverse events, and safety. The trial was registered with ClinicalTrial.gov (NCT01692743).

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RESULTS

Enrollment, Attrition, and Completion of Study Visits

348 participants were enrolled in the study (UMB = 214, UPMC = 90, VU = 44). 116 were randomized to TELE-IBD W, 115 to TELE-IBD EOW and 117 to control group. 48 (13.8%) participants withdrew. Reasons for withdrawal included: patient request (n = 13), left the practice (n = 10), surgery (n = 11), lost to follow up (n = 6), pregnancy (n = 5), cancer (n = 2), and human immunodeficiency virus (n = 1). The attrition rates were 8.5, 13.9, and 19.0% in the control, TELE-IBD EOW, and TELE-IBD W groups respectively. 260 (75.0%) and 259 (74.4%) completed the 6-month and the 12-month visit respectively. 90 (76.9%), 88 (76.5%), and 81 (69.8%) of control, TELE-IBD EOW and TELE-IBD W participants completed the final visit (Fig. 1).

Fig. 1

Fig. 1

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Characteristics of Participants

Mean age was 38.9 ± 12.3 years and duration of disease was 11.6 ± 9.3 years. 56.6% were women and 91.9% were Caucasian. 67.9% had CD and 148 (42.5%) had active disease. CD participants had a high rate of ileocolonic disease (57.7%), upper GI tract involvement (12.4%), complicated disease behavior (56.5%) and perianal involvement (31.0%). 69.9% of UC participants had extensive colonic involvement. 32.2 and 60.1% were on an immune suppressant or biologic respectively. Baseline Crohn’s and Colitis Knowledge (CCKNOW) scores were low in all participants and not different between groups (Table 1) (12).

Table 1-a

Table 1-a

Table 1-b

Table 1-b

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Change in Disease Activity Scores and Remission Rates in Participants with Crohn’s Disease

Baseline HBI scores were 5.2 ± 5.0, 4.7 ± 4.1, and 4.2 ± 4.2 in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.44). HBI scores decreased to 3.7 ± 3.6, 4.2 ± 3.9, and 3.2 ± 3.4 at the final study visit in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.16) (Fig. 2a). The decreases in HBI scores over time were significant in all groups (p < 0.0001 for all groups). The differences in change in HBI scores from baseline were not different between groups (p = 0.18). After adjustment for race and smoking, there were no differences in change in HBI scores over time between groups (TELE-IBD W vs. control, p = 0.33, TELE-IBD EOW vs. control, p = 0.12). Per-protocol analyses demonstrated that all three arms improved without significant differences between them (data not shown). Additionally, there were no difference in change in disease activity scores between arms when comparing sub-groups of participants in remission or with active disease at baseline and when comparing patients on steroids and not on steroids at baseline (data not shown).

Fig. 2

Fig. 2

Likewise, remission rates were similar between groups at baseline. 53.4, 54.4 and 64.1% were in remission in the control, TELE-IBD EOW, and TELE-IBD W at baseline. The proportion in remission increased at the final visit to 63.5% in the control, 60.9% in the TELE-IBD EOW and 70.4% in the TELE-IBD W group respectively (Tele-IBD W vs. control, p = 0.39, TELE-IBD EOW vs. control, p = 0.99).

Additionally, the proportion of participants (TELE-IBD EOW and W only) in the Green, Yellow and Red Zone at each self-assessment were tracked from baseline to the end of the study (Fig. 3).

Fig. 3

Fig. 3

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Change in Disease Activity Scores and Remission Rates in Participants with Ulcerative Colitis/Indeterminate Colitis

Baseline SCCAI scores were 2.9 ± 3.1, 2.7 ± 3.1 and 2.5 ± 2.5 in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.80). SCCAI scores decreased to 1.4 ± 1.4, 1.7 ± 1.9 and 2.0 ± 1.8 at the final study visit in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.41) (Fig. 2b). The decrease in SCCAI scores over time was significant only in controls (control, p = 0.01, TELE-IBD EOW, p = 0.35, and TELE-IBD W, p = 0.31). The differences in change in SCCAI scores from baseline were not different between groups (p = 0.25). After adjustment for race and tobacco use, there were no differences in change in SCCAI scores over time between groups (TELE-IBD W vs. control, p = 0.09, TELE-IBD EOW vs. control, p = 0.11). Per-protocol analyses demonstrated that all three arms improved without significant differences between them (data not shown). Additionally, there were no difference in change in disease activity scores between arms when comparing sub-groups of participants in remission or with active disease at baseline and when comparing patients on steroids and not on steroids at baseline (data not shown).

Likewise, rates of remission were similar among groups at baseline. 54.1, 60.0 and 60.5% were in remission in the control, TELE-IBD EOW, and TELE-IBD W at baseline. The proportion of patients in remission increased at the final visit to 81.5% in the control, 78.3% in the TELE-IBD EOW, and 66.7% in the TELEIBD W respectively (Tele-IBD W vs. control, p = 0.37, TELE-IBD EOW vs. control, p = 0.50).

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Change in Disease-Specific Quality of Life Scores in Participants

Baseline IBDQ scores were 168.1 ± 34.0, 172.3 ± 33.1 and 172.3 ± 34.5 in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.58). IBDQ scores increased to 179.3 ± 28.2, 181.5 ± 28.2 and 179.2 ± 32.8 at the final study visit in the control, TELE-IBD EOW, and TELE-IBD W respectively (p = 0.42) [Fig. 2c]. The increase in IBDQ scores over time was significant only in the TELE-IBD EOW (control, p = 0.06, TELE-IBD EOW, p = 0.03, and TELE-IBD W, p = 0.10). The differences in change in IBDQ scores from baseline were not different between groups (p = 0.95). After adjustment for race and smoking, there were no differences in change in IBDQ scores over time between groups (TELE-IBD W vs. control, p = 0.63, TELE-IBD EOW vs. control, p = 0.66). Per-protocol analyses demonstrated that all three arms improved without significant differences between them (data not shown). Additionally, there were no difference in change in IBDQ scores between arms when comparing sub-groups of participants in remission or with active disease at baseline and when comparing patients on steroids and not on steroids at baseline (data not shown).

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Change in Healthcare Utilization in Participants from 1 Year Prior and After Enrollment

Total encounters are reported as rates, adjusted for 100 participants per year. The rate of total encounters for the year prior to enrollment were 1543, 1441, and 1267 in Controls, TELE-IBD EOW, and TELE-IBD Weekly respectively. Total encounters increased in all groups after enrollment; there were no significant differences between the TELE-IBD and control groups (2099 control, 2235 TELE-IBD EOW, 1935 TELE-IBD Weekly) [Table 2]. IBD-related hospitalizations increased in the control group from 14.7 to 16.4; however in the TELE-IBD EOW and TELE-IBD W, IBD-related hospitalizations decreased from 24.3 to 14.4 and 24.1 to 9.8 respectively. The difference in IBD-related hospitalization was significant for the TELE-IBD W group only (p = 0.04). Similarly, Non-IBD related hospitalizations increased from 3.4 to 11.2 in controls and decreased from 5.5 to 0.9 and 5.4 to 2.7 in the TELE-IBD EOW and W groups respectively (p = 0.02 in TELE-IBD EOW and p = 0.04 in TELE-IBD W). Conversely, non-invasive diagnostic tests (TELE-IBD W 39.3 to 86.6 vs. 80.2 to 112.9 controls, p = 0.04) and electronic encounters (144.6 to 238.4 TELE-IBD W vs. 197.4 to 250.9 controls, p = 0.05) were increased in the TELE-IBD W group compared to controls. Telephone encounters were increased in both TELE-IBD groups compared to controls (670.0 to 900.9 controls, 606.3 to 988.3 TELE-IBD EOW, and 571.4 to 953.6, p = 0.05 TELE-IBD EOW vs. controls, p = 0.002 TELE-IBD W vs. controls). Baseline medication use is reported in Table 1. At the final study visit, 31.7, 13.4, 31.6, and 61.1% of participants were on aminosalicylates, steroids, immune suppressants, and anti-TNFs respectively. The proportion of participants on these medications was not significantly different from baseline.

Table 2

Table 2

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DISCUSSION

Participants from this large, multicenter, randomized, controlled trial experienced a decrease in disease activity and improvement in QoL over 1 year; adjunctive monitoring with telemedicine (TELE-IBD) did not improve outcomes. However, recruitment of a large number of participants (n = 348) demonstrated that patients are receptive to telemedicine. The decreased withdrawal rates in this trial (13.9–19.0%) compared to prior studies (44– 59%) confirm that improvement in the delivery of telemedicine system resulted in better participant engagement; however, attrition rates were highest in the group which received the most frequent interactions with the TELE-IBD system (15,20). Although healthcare utilization increased in all groups during the study, TELE-IBD W participants had a significant decrease in IBD-related hospitalizations and both TELE-IBD groups had a significant decrease on non-IBD related hospitalizatons compared to baseline. Conversely, non-invasive diagnostic tests and electronic encounters were increased in the TELE-IBD W group and telephone encounters were increased in both TELE-IBD groups compared to baseline.

Previous studies have demonstrated that telemedicine improves control of disease and enhances QoL (15,18,20). Why are the results of this study disparate from previous studies? Our prior pilot studies were uncontrolled and our randomized controlled trial was of limited sample size. It is plausible that the improvements seen in these studies were related to IBD-specialty care received instead of telemedicine. The differences in outcomes between this study and the large trial in Europe are difficult to explain. It is possible that differences in outcomes between trials relate to the telemedicine systems used (web-based vs. text messaging). Further, The European study included patients with mild to moderate UC, primarily undergoing treatment with aminosalicylates (15). Participants in our trial had UC and CD and were recruited from referral centers. The disease characteristics and high proportion of participants on immune suppressants and biologics at baseline are consistent with patients with more severe CD and UC.

Although we excluded patients in remission for ≥2 years, more than half of participants had disease activity scores consistent with clinical remission at baseline. By inclusion of patients with inactive disease, it is possible that any potential benefit of adjunctive monitoring was attenuated. However, sub-group analyses based on disease activity at baseline, did not detect significant differences between groups. It is possible that use of telemedicine as an adjunct to care is not necessary in experienced IBD centers. All three centers enlist IBD-focused providers, colorectal surgeons, nurses, dieticians, and other ancillary personnel. UPMC and VU also have behavioral health teams to provide psychosocial care. It is possible that telemedicine would be more effective in primary care or community GI settings where providers have fewer resources and time to manage IBD patients.

Our study did not replace standard care visits with remote telemonitoring. The study from Europe demonstrated equal to superior outcomes when telemonitoring was used to replace routine visits in patients with UC. Investigators also demonstrated decreased office and acute care visits but increased emails and phone calls in the telemedicine group (15). A recent large Netherlands randomized controlled trial (n = 909) evaluated the efficacy of telemedicine (MyIBDcoach) compared to standard care over one year. Telemedicine patients were seen annually and as needed; these patients had fewer office visits and hospitalizations and equivalent QoL scores compared to controls. There were no differences in flares, steroid use, emergency room (ER) visits or surgeries between groups (34). We confirmed increased telephone calls and electronic messages in TELE-IBD participants compared to controls and demonstrated a decrease in hospitalizations. We also found an increase in noninvasive diagnostic tests in the TELE-IBD W group but could not confirm a decrease in ED visits.

To the best of our knowledge, the reported study is the largest US multi-site, randomized controlled trial of IBD telehealth. Our study has several strengths and weaknesses. The strengths of the study include the large sample size and randomized controlled trial design. We also used validated clinical indices to assess disease activity and QoL. We also evaluated healthcare utilization 1 year before and after enrollment and conducted multivariable analyses to reduce residual confounding.

Because of the lower than anticipated proportion of participants with UC enrolled in the trial, we did not have sufficient power to detect small to moderate differences in disease activity scores for participants with UC; however, the study had adequate power to detect moderate differences in disease activity in participants with CD and small to moderate QoL differences in all participants, the latter of which has been shown to correlate well with disease activity (32). It was not possible to blind providers to participant group assignment. It is plausible that providers knowingly or unknowingly gave more attention to the control group attenuating the effect of telemedicine. Healthcare utilization “events” could have been missed as participants could have received healthcare outside of the health systems at all three sites. If this were true, it is likely that non-differential bias would occur with an attenuation of effect across groups.

In summary, no differences were found in disease activity or QoL between participants with IBD receiving telemedicine compared to controls. The study demonstrated that use of a telemedicine system with text-message technology is associated with a lower rate of attrition than prior telephonic and web-based interventions (15,20). The study also found that use of telemedicine was associated with a significant decrease in hospitalizations and an increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Further evaluations are underway to determine if TELE-IBD improves secondary outcomes such as locus of control, patient activation, self-efficacy, and satisfaction with healthcare services. Ongoing research is also being done to determine if an improved telemedicine system with greater patient engagement can be used to improve outcomes. Future studies are needed to determine if telemedicine improves outcomes in patients with IBD treated in the community and to confirm if telemedicine can be used to decrease utilization of healthcare resources.

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CONFLICTS OF INTEREST

Guarantor of the article: Raymond K. Cross, MD, MS.

Specific author contributions: Raymond K. Cross: planning and/or conducting the study, collecting and/or interpreting data and/or drafting the manuscript. Patricia Langenberg: planning and/or conducting the study, collecting and/or interpreting data and/or drafting the manuscript. Miguel Regueiro: planning and/or conducting the study, collecting and/or interpreting data. David A. Schwartz: planning and/or conducting the study, collecting and/or interpreting data, J. Kathleen Tracy: planning and/or conducting the study, collecting and/or interpreting data. Joseph F. Collins: planning and/or conducting the study, collecting and/or interpreting data. Jonathan Katz: planning and/or conducting the study, collecting and/or interpreting data. Leyla Ghazi: planning and/or conducting the study, collecting and/or interpreting data. Seema A. Patil: planning and/or conducting the study, collecting and/or interpreting data. Sandra M. Quezada: Planning and/or conducting the study, collecting and/or interpreting data. Katharine Russman: planning and/or conducting the study, collecting and/or interpreting data. Mahrukh Riaz: planning and/or conducting the study, collecting and/or interpreting data. Guruprasad Jambaulikar: planning and/ or conducting the study, collecting and/or interpreting data. Barathi Sivasailam: planning and/or conducting the study, collecting and/or interpreting data. Charlene C. Quinn: planning and/or conducting the study, collecting and/or interpreting data. All authors approved the final draft submitted.

Financial support: This research was supported by the Agency for Healthcare Research and Quality (1R01HS018975-01A1) and the University of Maryland General Clinical Research Centers Program. The University of Maryland General Clinical Research Centers Program participated in data collection.

Potential competing interests: None.

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Study Highlights

WHAT IS KNOWN

  • ✓ Outcomes in patients with inflammatory bowel disease (IBD) are suboptimal for a variety of reasons including but not limited to nonadherence, limited access to IBD-specialty care, poor patient education, concurrent psychosocial conditions, inadequate monitoring and discordance between providers and patients.
  • ✓ Telemedicine has been used to improve outcomes in patients with IBD; most studies have demonstrated a high rate of early acceptance of the technology but subsequent attrition over time.
  • ✓ Several studies have demonstrated that telemedicine im-proves quality of life, disease state knowledge, adherence to treatment and decreases utilization of healthcare resources.
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WHAT IS NEW HERE

  • ✓ A telemedicine for patients with IBD (TELE-IBD) that utilizes text messaging for patient assessments is associated with lower rates of attrition over 1 year.
  • ✓ Use of a TELE-IBD system weekly or every other week as an adjunct to standard care is not associated with a decrease in disease activity or improvement in quality of life at tertiary referral centers.
  • ✓ Use of TELE-IBD is associated with decreased hospitalizations and increased non-invasive diagnostic tests, telephone calls and electronic encounters compared to standard care.
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