E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Summary

The aim of this trial is to establish the position of online computer-based education as a tool for patient preparation prior to a colonoscopy. Computer based education is compared with the standard of care, nurse counseling, evaluating endoscopic quality measures and patient related outcome measures.

Abstract

Improving patient education focusing on bowel preparation before a colonoscopy leads to cleaner colons. Endoscopy units must obtain informed consent and perform a risk assessment for sedative use prior to a colonoscopy. The current practice in the Netherlands to achieve these goals is nurse counseling in an outpatient setting. This is costly and has disadvantages in terms of uniformity and time consumption for both the patient and the hospital. The hypothesis is that computer-based education with use of video and 3D animations may replace nurse counseling in most cases, without losing quality of bowel cleanliness during colonoscopy.

This multicenter, randomized, endoscopist blinded clinical trial evaluates a primary outcome measure (bowel preparation) during colonoscopy. Secondary outcome measures are sickness absence, patient anxiety after instruction and prior to colonoscopy, patient satisfaction and information re-call. The study will be performed in four endoscopy units of different levels (rural, urban, and tertiary). Inclusion criteria are adult age and referral for complete colonoscopy. Exclusion criteria are Dutch illiteracy, audiovisual handicaps or mental disabilities and no (peers with) internet access.

This trial aims to establish online computer-based education as tool for patient education prior to a colonoscopy. By choosing a direct comparison with the standard of care (nurse counseling), both endoscopic quality measures and patient related outcome measures can be evaluated.

Introduction

A complete colonoscopy is the procedure for detection of precancerous lesions in the colon¹. For adequate examination of the colon mucosa, optimal bowel cleanliness is crucial. A poorly prepared colon leads to insufficient adenoma detection rate and therefore the need for repeated procedures. In previous studies, better patient understanding of how to prepare clearly results in a higher quality of bowel preparation². To achieve a clean colon, patients have a restricted diet for 1-2 days and use purgatives to induce diarrhea. This elicits abdominal discomfort and interrupts daily routine. In view of these barriers, inadequate bowel preparation is not infrequent³. Optimal patient compliance to the protocol enhances effective bowel preparation and subsequent efficacy of colonoscopy.

There is appreciable variation in the way information for a colonoscopy is administered to patients⁴. Some patients receive information directly from their health care professional during consultation, or are informed by auxiliary personnel (nurses, technicians, or administrators), while other units provide information through printed leaflets⁵. The effect of any information transfer is compounded by patient dependent factors such as educational level, comprehensive capacities, and cultural aspects. This results in a mixed understanding of the information that can negatively affect compliance to instructions.

A pivotal element in patient preparation is that every patient is thoroughly informed about risks and benefits of the procedure including the bowel preparation steps for colonoscopy. In addition, the routine use of sedative and analgesics requires a risk assessment of the individual patient. Many centers rely on nurse counseling to obtain informed consent before the procedure. This results in patient improved adherence to the instructions for bowel preparation. However, while effective, it is time-consuming for the nurse, repetitive, and results in patient-to-patient variability of information. More importantly, it demands an extra hospital visit for the patient, implicating absence of the patient at work⁶. In summary, it is an economically challenging practice in cost-conscious healthcare environments. Previous studies show that focused e-learning paths enable good comprehension and learning and enhance patients satisfaction⁷. Web-based education is used successfully for increasing knowledge of patients and it has become an accepted mechanism for obtaining informed consent. This has led to the development of tailored instruction programs for bowel preparation that combines the advantages of flexibility in time and environment, yet maintains consistency in delivery of information. Previously, the authors developed a tool that allows computer assisted instruction (CAI) for colonoscopy⁸. This tool employs a computer animation that captures the viewers’ attention while adequately informing him/her of objectives for colonoscopy. Written in comprehensible language in logical order, the module educates patients on different aspects of colonoscopy. It provides basic anatomical teaching points and step-by-step instructs the patient how to perform bowel preparation. In our pilot study we showed that CAI for colonoscopy enhanced bowel preparation to the level that is comparable to nurse counseling.

The research group sought to enhance the efficacy of the developed CAI. Its limitation was that it was a unidirectional tool that delivered information but did not allow acquiring patient specific information concerning medical history and medication use. This is an important part of the nurse counseling visit, as it allows a pre-sedation risk assessment when judged by the nurse. Therefore, a dedicated questionnaire was developed, designed to collect data points for structured risk assessment. This questionnaire is completed by the patient at the end of the CAI. This eliminates the need for a face-to-face meeting with a nurse or physician at this point in time. The use of two-way communication (combining CAI with a questionnaire) is practical and provides high quality information to the patient whilst at the same time attending to the need of the endoscopist for information on sedation risks. This combined instruction and acquiring of information is known as computer based education (CBE)⁷.

The goal of this trial is to test the utility, practicality, and patient-perceived usefulness of CBE off-center, in comparison to conventional nurse counseling. The hypothesis is that CBE is non-inferior to nurse counseling in achieving high quality of bowel preparation during colonoscopy. This process is independent of time and space and therefore can be viewed in the comfort of the patients’ home. Accordingly, the chosen secondary outcomes are patient related outcome measures such as a short leave absence, anxiety, satisfaction and comprehension of information, as these might benefit from delivery through this digital channel. Included process measures are patient activation, health and e-health literacy to determine which patients benefit most from this tool.

Study design
The trial is set up as an endoscopist blinded multicenter randomized controlled trial design. Inclusion criteria are adult age and a referral for elective complete colonoscopy. Exclusion criteria are illiteracy in Dutch and significant audiovisual handicaps and mental disabilities that preclude delivery of CBE. Also, patients were excluded if there is no internet access or a relative with internet access (see Table 1). Patients will be recruited by back office staff at the outpatient’s clinic in 4 large volume endoscopy centers in the Netherlands. All patients receive a split dose laxative regime based on either polyethylene glycol or sodium picosulfate. After evaluation of in- and exclusion criteria by trained staff, patients are randomized in 1:1 distribution per trial site using a randomization tool (described in the protocol below). Reasons for declining to participate are recorded. The trial flowchart is presented in Figure 2.

Outcome measures
The primary outcome measure is the quality of bowel preparation during endoscopy. Endoscopists are trained to score the bowel preparation with the Boston Bowel Preparation Scale (BBPS). The BBPS is a cumulative score of three bowel segments, ranging from 0-1 “unsatisfactory”, 2-3 “poor”, 4-5 “fair”, 6-7 “good”, and 8-9 “excellent”. Scores of ≥6 are considered adequate^9,10. As secondary outcomes, the focus is on sickness absence, anxiety, satisfaction and information re-call. Information is also collected on patient activation and health literacy.

The cost minimization effect of the intervention is calculated in two ways. The comparison between groups with regard to endoscopy unit costs will be done using a cost-per-visit analysis. The macroeconomic effect of sickness absence is also evaluated, as patients in the intervention group will need less hospital visits. To do so, several items are assessed: socio-economic status, work status and duration of sickness absence, using an adapted iProductivity Cost Questionnaire¹¹.

Patients anticipating invasive medical procedures often experience anxiety that may exceed their coping mechanisms. Anxiety is assessed at T0 and T1 with the State-Trait Anxiety Inventory (STAI)¹². The STAI is a widely used 20-item self-report instrument with scores ranging from 20 (absence of anxiety) to 80 (high anxiety). Patient satisfaction is scored using two different measures. Patient experience impacts future behavior and therefore “willingness to return” is assessed at T3, ranging from 1 (extremely unwilling to return) to 10 (extremely willing to return). Furthermore, the Net Promoter Score (NPS) is utilized on the question “Would you recommend this endoscopy unit to your peers?”. Patient’s scores range from 1 (Not at all likely) to 10 (Extremely likely). The NPS will be assessed at T0 and T3 and is calculated as % Promoters (scores 9-10) - % Detractors (scores 1-6)¹³. To evaluate patient comprehension of the information in the CBE patients are asked to reproduce elements of the instruction. The patient information re-call is assessed at T1 (before colonoscopy) using a 10-item test, with questions to be answered with “yes” or “no”. The effect of patient education in colonoscopy is influenced by the patient ability to understand medical information. The 14-item Dutch validated Health Literacy Scale is used to assess this item, divided in 3 subscales, at T0¹⁴. A new 21-item questionnaire is added as a measure for e-Health Literacy¹⁵. This contains questions regarding the skill and experience of patients in handling medical information online. Patients are confronted with options every day that may have major implications for their health. Effectively managing their choices requires knowledge, skill, and confidence. To this end these elements were mapped at T0 13-item Patient Activation Measure Scale (PAM-13)¹⁶. The current health status of patients is evaluated with the Medical Outcomes Study 36-item health survey (RAND-36) at T0¹⁷.

Statistical analysis
To statistically compare both groups on the primary outcome, the relative risk for an inadequately prepared colon, defined as a BBPS <6, is used. In literature, a 90% success rate (for an adequately prepared colon) is common, with a 10% non-inferiority margin as the maximum clinically acceptable difference. The non-inferiority power calculation resulted in 180 patients per group, 360 patients in total. This is required to exclude a difference in favor of the standard group of more than 10%. With a margin of ± 60% loss of patients before completing the protocol, based on earlier research, the target number of patients to approach is set at 1,000. In addition to the non-inferiority analyses, superiority analyses will be conducted to investigate effects on secondary outcome measures.

Protocol

The study is authorized by the ethics review board of the Radboud University Medical Center (#2015-1742). Subsequent approval of the executive boards from each of the participating institutes is obtained (Trial registration: Dutch Trial Registry, NTR 5475).

1. Enrolling patients in the trial/randomization

1. Approach all referred patients by general practitioners, surgeons or internal medicine specialists for colonoscopy, to achieve a diverse sample.
2. Contact all eligible patients for inclusion by the outpatient’s clinic assistant by telephone call or face-to-face contact with the patient in a protocol led manner (described below).
   1. Say the following: Good morning/afternoon, you are speaking to the gastroenterology department of the trial center. You have been referred for colonoscopy, correct? We have to inform you prior to the examination. Do you have a computer/tablet/smart phone with internet access? (If not, do you have a peer who does?) We have the possibility to give you the information using an internet-based application. This is subject to our scientific research, comparing the novel method to a traditional visit of the outpatient’s clinic. If you cooperate in this trial, you will have to answer several questionnaires in the process. We also use information from your patient record. If you agree, we will randomize the method of education; either digital or nurse counseling. If no, reason for declining is noted. Negative answers are categorized in reasons to decline participation. If yes, can I have your e-mail address?
3. Randomize patients to the intervention or control group per center after obtaining permission.
   NOTE: This is linked to the invitation that is sent out; patients are asked for their e-mail addresses, linked to their patient identification number. The automated HTML script then randomly decides which invitation is being sent (nurse visit or computer-based education). The outcome is visible to the assistant.
4. Make sure that the patient reads the automatically sent email with instructions regarding more information on the trial. Here, digital informed consent for trial participation is obtained.

2. Baseline questionnaire

1. Subject the patient to the intervention or control group after randomization. Make sure that the patient completes the first questionnaire, containing baseline characteristics, several validated tools such as the RAND-36, PAM-13, e-Health Literacy Scale and the STAI.

3. Intervention arm: patient is prepared with computer-based education

1. Make sure that the patient receives the interactive CBE via e-mail.
   NOTE: Current best practices are implemented in the design, including the use of plain language, good accessibility and obligatory interaction to engage users⁷. The used CBE is a web-based platform, mimicking the patient journey with specific video guided by voiceover, supported by photos, three-dimensional animation and instructive texts.
2. Conduct a dedicated video and photo shoot specific for each separate endoscopy unit in the trial following a uniform script. (Figure 1, the CBE used in one of the trial sites is accessible via https://trials.medify.eu/cbe-colonoscopy). Divide the video in short clips, with a maximum duration of 45 seconds. Implement a mandatory mouse-click after each item to ascertain interaction in the CBE. Ensure that the tool contains all elements that are obligatory for informed consent such as risks, benefits and alternatives for colonoscopy.
3. Have the patient complete the CBE.
   NOTE: The following steps (under tab 3.3) are mandatory for the patient to follow in the CBE.
   1. Click on the link in the email: https://trials.medify.eu/cbe-colonoscopy.
   2. Enter the main menu of the CBE. First, read the pop-up with instructions how to use the CBE.
   3. Click on the tab Explanation of colonoscopy procedure.
   4. Read the text on slide (1/21): How do you prepare for the examination? After finishing, click Next.
   5. Play the video on slide (2/21): Just before the examination. The video voiceover will say: “Welcome to the hospital, where the examination of your large intestine will take place. It is important that you are here 30 minutes before the examination is due to start. You check in at the endoscopy center reception and take a seat in the waiting room. A department staff member will pick you up from the waiting room. The telephone number of your contact person is noted to let them know when you can be picked up again.” After finishing, click Next.
   6. Play the video on slide (3/21): Preparation for the examination. The video voiceover will say: “In the preparation room, you will have an intake discussion with a nurse with the help of the COW (computer on wheels). Your name and date of birth are verified and your medical information checked. You will receive a wrist band with your patient information on it. Then an IV needle is inserted into your arm. The pain killer and, if applicable, the sedative will be administered via this IV needle.” After finishing, click Next.
   7. Play the video on slide (4/21): Preparation for the examination. The video voiceover will say: “The nurse will ask you to take off your trousers/skirt/dress and underwear. You can place your belongings under the bed. You lay down on the bed. You are now ready to be taken to the endoscopy room.” After finishing, click Next.
   8. Play the video on slide (5/21): The endoscope. The video voiceover will say: “The tube with which we will perform the examination is called an endoscope. It is first thoroughly cleaned and kept in a special clean cupboard. The clean endoscope is fed into a box, the cover of which is closed with a cable tie. In accordance with requirements, the endoscope is always checked before the examination starts.”. After finishing, click Next.
   9. Play the video on slide (6/21): Meeting the doctor. The video voiceover will say: “In connection with the sedative, it is important to monitor your blood pressure, heart rate and the oxygen saturation in your blood. You will have a small clip on your finger and a blood pressure meter on your arm. Then you will meet the gastroenterologist or resident gastroenterologist who will perform the endoscopy.” After finishing, click Next.
   10. Play the video on slide (7/21): Time out procedure. The video voiceover will say: “Before the procedure actually starts, a time out procedure takes place. The doctor and nurse will run through a list of control questions with you. You can also ask questions at this time.” After finishing, click Next.
   11. Play the video on slide (8/21): Sedative. The video voiceover will say: “To alleviate the pain, you will receive a pain-relieving medicine, sometimes in combination with a sedative, administered via the IV needle. You will get a bit sleepy, which will help you relax and make the examination easier for you. This is not an anesthetic. It may cause you to be a bit forgetful for the rest of the day. Due to the medication administered, it is important that you do not drive a vehicle or drink alcohol for twenty four hours after the examination.” After finishing, click Next.
   12. Read the text on slide (9/21): Location of the intestines. After finishing, click Next.
   13. Look at the automated 3D animation in the background, centering the intestine. Drag to rotate the 3D image. Read the text on slide (10/21): Small intestine. After finishing, click Next.
   14. Drag to rotate the 3D image. Read the text on slide (11/21): Large intestine. After finishing, click Next.
   15. Drag to rotate the 3D image. Read the text on slide (12/21): Continuation of large intestine examination. After finishing, click Next.
   16. Look at the automated 3D animation in the background, centering the anus. Read the text on slide (13/21): Alternative examination. After finishing, click Next.
   17. Look at the automated 3D animation in the background, entering the colon. Play the video on slide (14/21): Air infusion. The video voiceover will say: “The examination usually takes half an hour. You lie on your left side and the lights are dimmed during the examination. The endoscope is inserted carefully. Then air, or actually carbon dioxide gas, is blown into the intestine. The endoscope is pushed forward to the end of the large intestine. During the withdrawal of the endoscope, the intestinal wall is thoroughly inspected. The doctor may remove small pieces of intestinal tissue or polyps. It may be necessary for you to change your position during the examination. The nurse may occasionally press on your stomach to prevent the endoscope from slipping out of place. In order to ensure that your intestine cramps as little as possible, a medication is often given to relax the intestine. This may cause you to have a dry mouth and your heart may beat faster. After the examination, we place the used endoscope back in the box and it is covered with a lid before the scope is taken away to disinfection..” After finishing, click Next.
   18. Read the text on slide (15/21): Examination technique. After finishing, click Next.
   19. Look at the automated 3D animation in the background, centering a polyp. Play the video on slide (16/21): Removing the polyp. The video voiceover will say: “Here you see the removal of a polyp from the large intestine. This is also called a polypectomy. The doctor will first inspect the polyp. A polyp is usually between 5 and 15 millimeters in diameter. Then the doctor will put a noose around the base of the polyp. This is pulled tight. Using the noose, the base of the polyp is continually heated, which cauterizes the base. The polyp is kept for further examination.” After finishing, click Next.
   20. Play the video on slide (17/21): After the examination. The video voiceover will say: “After the examination we will take you back to the recovery room. You will be reconnected to the monitoring equipment. The nurse will keep an eye on this and will regularly check on how you are doing. During this period, blood pressure, pain and possible blood loss are monitored. You may have some abdominal pain after the procedure, namely cramping, due to the carbon dioxide gas which was blown into your large intestine during the examination. It is important to release the gas you feel and not to keep it in. When you are awake enough, you will be given something to eat and drink. The IV needle will be removed.” After finishing, click Next.
   21. Play the video on slide (18/21): Examination report and follow-up appointment. The video voiceover will say: “When you have significantly recovered, your companion will be notified that you can be picked up. You can get dressed. When you leave, you will receive a letter from the doctor with the preliminary results of the examination and telephone numbers you can call if you experience any complications after the procedure. The referring physician or a nurse from your surgery will give you the definitive results of the examination and the results of the tissue biopsy.” After finishing, click Next.
   22. Read the text on slide (19/21): Have a nice journey. After finishing, click Next.
   23. Read the text on slide (20/21): Risks of the examination. After finishing, click Next.
   24. Fill out the questionnaire on medical history and medication use on slide (21/21): Questionnaire & Informed consent. After finishing, click Send.
       NOTE: This module serves as a pre-sedation risk assessment. It double-checks the informed consent. After final approval by the patient the information is sent via e-mail to the endoscopy unit.
   25. Click on the tab Preparation for the colonoscopy that is now made available. Follow the steps and read all information on the use of the laxatives in the same stepwise fashion.
   26. Click on the tab Route to the department for the routing to the endoscopy unit.
4. For the trained endoscopic nurse: assess the received information sent by the patient. Use the automated protocol whereby actions are related to the answers provided by the patients.
   NOTE: This system automatically labels responses with “green” (no action), “orange” (action might be necessary) and “red” (action is necessary). When in doubt, risk assessment will be performed by a consultant gastroenterologist.

4. Control arm: Patient is visiting the outpatient clinic

1. Schedule a visit for the patient at the outpatient clinic for instruction by a trained nurse. Follow the standard operating procedure during counseling.
   NOTE: This provides information on how to use the purgatives, dietary instructions, effects of sedation with benzodiazepines and relevant practical matters. Finally the nurse double-checks signed informed consent and files information on medical history.

5. Day of colonoscopy

1. Schedule the patient approximately 2-8 weeks from baseline for the colonoscopy. Ask the patient to complete the questionnaire, containing the 10-item knowledge test, the STAI and measures for patient satisfaction prior to colonoscopy (T1).
2. Score the bowel cleanliness during colonoscopy (T2) online and in the endoscopy report; also fill out the several relevant items regarding colonoscopy here (indication, type of sedation and analgesic, ASA classification).
3. Ask the patient to complete the post-colonoscopy questionnaire, containing measures for patient satisfaction (T3), just prior to discharge.

Results

The earlier mentioned pilot study compared nurse instruction to CAI using the same interactive tool as used in this protocol⁸. As the goals of this study were comparable to the outcomes used in this protocol, a short explanation of the results of the pilot are provided here in more detail. See also Table 2⁸.

In this pilot study 385 patients were enrolled. The CAI g...

Discussion

The E-Patient Counseling (E-PACO) trial aims to study the utility, practicality, and patient-perceived usefulness of computer-based education (CBE), in comparison to conventional nurse counseling. In this manuscript the CBE is demonstrated together with the methodology used to evaluate the hypotheses.

It is established that high quality colonoscopy is the golden standard for prevention of colorectal cancer. Inadequate bowel preparation is related to the missing of neoplasm’s and increase...

Materials

Name	Company	Catalog Number	Comments
Computer Based Education	Medify BV	n/a	Computer Based Education tool for patient instruction prior to colonoscopy
Computer / tablet	Any		A computer or tablet should be used to complete the e-learning and fill out the questionnaires
Medify Content Management System	Medify BV	n/a	A content management system to process the e-learning content