This is a prospective, RCT designed to assess the impact of an educational telephone intervention performed by digestive endoscopy nurses on colonoscopy attendance outside colorectal cancer screening programmes. This study was conducted in a tertiary centre at Hospital del Mar of Barcelona. The study was approved by the ethics committee of our centre (7739/I) in accordance with the Declaration of Helsinki, and the trial was registered at ClinicalTrials.gov (ID: NCT03458377).

All consecutive outpatients referred for colonoscopy from November 2017 to May 2018 from the primary care centres in our health area were included. The exclusion criteria were unwillingness to participate, inability to obtain the signed informed consent form, hospital admission during the study period, simultaneous participation in another clinical trial and/or impossibility to carry out the educational intervention (colonoscopy cancellation or not having a telephone). Patients routinely excluded in endoscopic studies for presenting pathologies that condition the colon preparation regimen or the sedation plan (history of subtotal colectomy, active inflammatory bowel disease, or high comorbidity), were not excluded in our study according to the main objective of evaluating the attendance rate.

An intervention group (IG) and a control group (CG) were designed. We performed a prerandomization method (Zelen’s method) with a complete-double-consent-design to eliminate selection bias created by contact with the patient prior to randomization in a study where assessing the applicability of contact is crucial, and to avoid the risk of non-participation and drop out of the study, given the attractiveness of the designed intervention.

Patients were randomized to the CG and the IG 10 d before the colonoscopy appointment using a computer-generated randomization list with a 1:1 allocation rate. In the IG, verbal consent was obtained in all patients after receiving a detailed explanation of the nature, aims, and consequences of the study, coinciding with the telephone call for intervention 7 d before the colonoscopy appointment. We obtained the signed informed consent form for both groups on the day of the colonoscopy. For those who did not attend the colonoscopy appointment, the signed informed consent form was obtained after later contact.

Patient preparedness protocols included bowel cleansing, antithrombotic management and sedation scheduling. We recommended a low fibre diet 48 h before the colonoscopy and laxative intake in a split dose regimen, with an interval of less than 4 h between the last laxative dose and the colonoscopy, according to the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines[25]. In the case of antithrombotic drug intake, we followed the withdrawal ESGE guideline algorithm[26]. Sedation was administered by an anaesthesiologist if the patient had a high comorbidity burden; otherwise, a nurse directed by a gastroenterologist administered the sedation[27]. A high comorbidity burden was defined in cases of serious COPD, tracheostomy, severe ventricular function, Mobitz II-III atrioventricular block, implantable cardioverter defibrillator, severe mitral or aortic valvular stenosis, severe sleep apnoea or body mass index > 40, which were verified by the nurse after reviewing medical history and interviewing the patient.

All of the patients received information about patient preparedness protocols for colonoscopy in the primary care centres at the time of the colonoscopy referral. Additionally, the patients received a certified letter including the appointment time and a copy of bowel cleansing instructions.

Patients assigned to the IG received an educational telephone call 7 d before the colonoscopy appointment. The intervention was carried out by two nurses with deep endoscopic knowledge who were previously trained for a telephone educational intervention for colonoscopy[22,28,29] and instructed to evaluate the need for anaesthesia.

Special emphasis was placed on the attempt to eliminate socioeconomic, psychological and clinical barriers that could affect attendance. Rescheduling was performed in case of work conflict, and language translation help was requested when needed. After reviewing the clinical history, the nurses focused on explaining the importance of getting tested and the possibility of important conditions not being diagnosed in case of non-attendance. Efforts were made to eliminate fears and misconceptions related to first colonoscopies and previous negative experiences. Clinical aspects were approached by giving the patients instructions and tricks to help them successfully complete the preparedness protocols. Finally, other possible questions were addressed, and the intervention ended after confirmation of a complete understanding and willingness of the patient to attend the appointment. In the case of a disabled patient, the intervention was performed with the patient’s caretaker. Three attempts were made to locate the patient. Both mobile and landline telephones were considered for the intervention.

The primary outcome was the rate of non-attendance. Non-attendance was defined in case the patient did not show up to the colonoscopy appointment or in case of rescheduling or cancellation in the 3 d prior to the appointment, given the impossibility of preparing another patient in the remaining time and being able to fill the gap with another colonoscopy.

The secondary outcomes included compliance with patient preparedness protocols, bowel cleansing adequacy, patient satisfaction, and cost analysis derived from the nurse educational intervention.

To evaluate compliance with the cleansing protocols we asked the patient about the correct diet, taking the last dose of the laxative between 2 and 4 h, total intake of the cleansing agent, and split-dose regimen. According to the predominant social-economic low class of our patients, we preferred to measure the compliance with the bowel preparation protocol with a short face-to-face interview conducted by an endoscopy nurse before the colonoscopy, instead of a survey. Cleansing compliance was defined as an aggregate of the 4 previous cleansing variables.

Skilled endoscopists (> 1000 colonoscopies each) blinded to the randomization evaluated the adequacy according to the Boston Bowel Preparation Scale (BBPS). Cleansing adequacy was defined as all the colon segments scoring 2 or 3 points.

Compliance with the management of antithrombotic drugs was assessed according to ESGE guidelines. In the IG, patients with high comorbidity were referred to an endoscopy programme under anaesthesia. The appropriate scheduling according to the sedation administration was evaluated according to the presence of a high comorbidity burden. Disabled patients included any patient with physical or intellectual disability who needed help with colonoscopy preparedness.

Cost analysis was performed from the supplier’s perspective. We calculated the direct costs of the intervention compared with the cost of a colonoscopy that could not be billed. A colonoscopy service is invoiced based on its performance, which means it will not be charged if the patient does not show or there is a rescheduling need because of non-compliance with patient preparedness protocols. The cost of the colonoscopy was based on our hospital charges. The cost of the intervention was based on the nurse salary, according to our hospital’s collective agreement.

Patient satisfaction was quantified with the GHAA 9-me questionnaire from the ASGE[30] previously translated and validated into Spanish[31], including 7 items (waiting time until the appointment, waiting time on the day of examination, personal manner of staff, personal manner of the physician, adequacy of explanations given after the procedure, discomfort during examination and an overall rating of the visit). A specific item related to information given before the procedure was added (item 8). Each item was rated in an ordinal way (0-4), with 4 being the maximum satisfaction score, and satisfaction was assessed according to the score of the new item (0-4), the global score (0-32), and the percentage of patients who rated the information given before colonoscopy as excellent.

Demographic, clinical and endoscopic variables known to potentially impact attendance were recorded from the hospital electronic database and the telephone interview. The study nurses registered all relevant information regarding non-compliance with preparedness protocols in the endoscopy room before the colonoscopy. Endoscopists registered the BBPS in the endoscopy report. Patient satisfaction was assessed with a nurse-led telephone interview 30 d after the colonoscopy.

The statistical methods of the study were reviewed by Duran X from Consulting service on methodology for Biomedical Research. Hospital del Mar Medical Research Institute (IMIM). Barcelona. Spain.

The sample size was estimated to demonstrate the superiority of the educational intervention. We retrospectively obtained a non-attendance rate of 13.9% from November 2016 to May 2017, the same period of the study the year before. We use this figure to calculate the sample size because scarce published data on non-attendance in non-screening colonoscopies are available. Expecting a non-attendance rate of 13.9% in the CG and 8.9% in the IG to detect a 5% reduction as clinically significant and applying a significance level of 5%, a power of 80% for the comparison of two independent proportions and a 20% loss ratio, a sample size of 764 patients per group was calculated.

The intention-to-treat (ITT) analysis included all randomized patients. The per-protocol (PP) analysis included the participants who were finally contacted by telephone. Categorical variables were described through frequencies table (number and percentage). Quantitative variables were described through mean and standard deviation. The categorical variables were compared between groups by the Pearson chi-squared test or Fisher’s exact test if applicable and continuous variables by using Student’s t-test. Multivariate logistic regression was used to identify factors associated with non-attendance. The backward stepwise criterion was used for variable selection. A P value of > 0.1 as removal criteria and < 0.05 for inclusion criteria. The results are expressed as odds ratios (ORs). Stata software version 15.1 was used by our research statistician to perform the analysis.

A total of 1485 patients (738 in the IG and 746 in the CG) were finally enrolled (Figure 1). Telephone contact was achieved in 613 (83%) patients in the IG. At baseline, the two groups did not differ in any of the variables analysed. Demographic, clinical and endoscopy data are shown in Table 1. The mean telephone time for the educational intervention was 12 min.

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Figure 1 Patient flow chart. ITT: Intention-to-treat; PP: Per-protocol.

According to the ITT analysis, the non-attendance rate was higher in the CG than in the IG (14.3% vs 8.4%, P ≤ 0.001). The absolute risk reduction (ARR) was 5.9% (95%CI: 2.7% to 9.2%). In the PP analysis, there was a greater reduction in non-attendance (14.3% vs 4.4%, P ≤ 0.001), with an ARR of 9.9% (95%CI: 6.9% to 13%).

The study of variables related to non-attendance was assessed with a bivariable (Table 2) and a multivariable analysis (Table 3), in which 12 variables were found to be independent predictors, with the treatment group being an independent factor for non-attendance, both in the ITT analysis (OR 1.81, 95%CI: 1.27 to 2.58, P = 0.001) and the PP analysis (OR 3.56, 95%CI: 2.25 to 5.64, P ≤ 0.001).

In the IG, there was an improvement in all compliance-related variables (Table 4). It is important to highlight that there was a modest benefit in compliance with cleansing items. The benefit was much greater in regard to the management of antithrombotics and sedation scheduling.

Our hospital invoices €240.71 for a performed colonoscopy. The calculated nurse cost of the telephone intervention was €5.12 per patient. With a non-attendance rate of 14.3% and a non-compliance rescheduling rate of 2.3% (Table 4) the net income in the CG per 100 patients was €20075 (the result of subtracting €3442 for non-attendance and €554 for non-compliance to the total amount of €24071). According to the non-attendance and non-compliance figures in the IG of 8.4% and 0.3% respectively (Table 4), the net income in the IG per 100 patients was €21465 (the result of subtracting €2022 for non-attendance, €72 for non-compliance, and €512 for the nurse intervention to the total amount of €24071).

Therefore, the intervention was a cost-saving measure, as the benefit was greater in the IG, resulting in a net balance of €1390 (€21465-€20075) per 100 patients, €13.9 per patient. Since our centre performs approximately 4000 colonoscopies in a year, the implementation of the intervention would represent a benefit of €55600.

A total of 627 and 673 colonoscopies (584 in patients contacted) were finally performed in the CG and IG, respectively. The difference in cleansing adequacy did not reach statistical significance (CG 90.4% and IG 92.4%, P = 0.1); it also did not reach significance in the PP analysis (CG 90.4% and IG 93.2%, P = 0.08).

A total of 755 patients were contacted (50.8%). According to the total score and specific information item score, patient satisfaction improved with the intervention. The information was rated as excellent in 49.4% (IG) and 26% (CG) of patients, P ≤ 0.001 (Table 4).

Educative interventions with bidirectional contact to the patient have shown to improve colonoscopy attendance in colorectal cancer population screening programmes and because of its huge clinical and economic impact, they have been widely implemented. However, outside of this population programmes, educative measures to improve colonoscopy attendance have been poorly studied and no navigation interventions are usually performed.

We thought this lack of research needed attention, so we designed a randomized controlled trial to conduct an educational telephone nurse intervention with bidirectional contact directed to increase colonoscopy attendance, similar to the patient navigation carried out in the population screening setting.

The aim of the study was to determine the clinical and economic impact of this educational intervention.

We included all consecutive outpatients referred for colonoscopy from primary care centres in our health area. Patients randomized to the intervention group received a telephone call 7 d before colonoscopy appointment to eliminate socioeconomic, psychological and clinical barriers that could affect attendance. Baseline characteristics including demographics, clinical and endoscopic factors previously reported to be related to non-attendance were collected. The primary outcome was the attendance rate. The secondary outcomes included the economic impact and the potential benefit of the intervention in regard to compliance with patient preparedness protocols, cleansing adequacy, and patient satisfaction. We performed an intention-to-treat (ITT) and per-protocol (PP) analysis to measure the applicability of the telephone intervention.

A total of 738 and 746 patients were finally included in the intervention and control group (CG) respectively. Six hundred thirteen (83%) patients were contacted in the intervention group (IG). The non-attendance rate was lower in the IG, both in the ITT analysis (IG 8.4% vs CG 14.3%, P < 0.001) and in the PP analysis (4.4% vs 14.3%, P < 0.001). In a multivariable analysis, belonging to the CG increased the risk of non-attendance in both, the ITT analysis (OR 1.81, 95%CI: 1.27 to 2.58, P = 0.001) and the PP analysis (OR 3.56, 95%CI: 2.25 to 5.64, P < 0.001). There was also a significant difference in compliance with preparedness protocols [bowel cleansing: IG 61.7% vs CG 52.6% (P = 0.001), antithrombotic management: IG 92.5% vs CG 62.8% (P = 0.001), and sedation scheduling: IG 78.8% vs CG 0% (P ≤ 0.001)]. We observed a net benefit of €55600/year after the intervention. The information given before the procedure was rated as excellent by 26% (CG) and 51% (IG) of patients, P ≤ 0.001.

According to our results, non-attendance has a significant clinical and economic impact outside the population screening setting. This study proposes the necessity to routinely incorporate attendance measures into endoscopy units, not only in the population screening programmes but also in all colonoscopies. A telephone educative intervention by an endoscopy nurse seems to be a valid method.

Further multicentric studies on attendance outside colorectal cancer population screening programmes are needed. The type and percentage of undiagnosed pathology and the prognostic and therapeutic implications of the diagnostic delay in these patients have to be studied. We also do not know the effect that the intervention could have on attending future colonoscopies although the satisfaction results observed in our study are promising in this regard.