Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy

Adequate Colonoscopy Preparation for Inpatients Clinical Trial

Official title:

Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02887014
• Other study ID #: INPATIENTS_VERBAL-001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2016
• Last updated: September 11, 2016
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Attikon Hospital
• Contact: Konstantinos Triantafyllou, Ass. Prof.
• Phone: 00302105832087
• Email: ktriant[@]med.uoa.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Description:

Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.

It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.

Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.

Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.

300 patients will be randomized in 2 groups, in blocks of 10 with an analogy 1:1. They will also be stratified in a 60%-40% percentage depending on whether the patient is bedridden or not at the time of the examination

Statistical Analysis According to the literature similar interventions showed a gain of 20% in favor of the intervention. Statistical significance level α is defined 5% and the study is powered at the level of 80%. According to data from Hepatogastroenterology Unit of Attikon University General Hospital regarding the adequateness of bowel preparation of patients undergoing colonoscopy and with an expected 10% drop out, 300 patients are needed (including a 10% drop out) in order to succeed 18% improvement of the primary endpoint (from 66% for inpatients during 2015 to 84% for outpatients during the same period) favoring the intervention group. Interim analysis and sample size re-estimation will be undergone after data collection from 90 patients.

Both an intention to treat (ITT) and a per protocol (PP) analysis are planned. Data will be recorded in predefined CRFs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• assignment of informed consent

Exclusion Criteria:

• inability to provide informed consent

• history of colectomy

• indication for rectosigmoidoscopy

• lack of knowledge of the Greek language.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adequate Colonoscopy Preparation for Inpatients

Intervention

Procedure:
• SPECIFIC VERBAL INSTRUCTIONS
Participants will be randomized either to get detailed instructions verbally by the medico-paramedical staff of the participating centers (physicians or nurses) before starting bowel preparation (Group A) or to get ordinary instructions as usual in each of the participating centers (Group B). Instructions provided to Group A will include details about the procedure of bowel preparation, its potential side effects and the importance of the adequate preparation (Appendix)

Locations

Country	Name	City	State
Greece	Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital	Athens

Sponsors (4)

Lead Sponsor	Collaborator
Attikon Hospital	Larissa University Hospital, University Hospital of Patras, University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (8)

Dik VK, Moons LM, Hüyük M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fèvre DM, Stouten M, van der Galiën O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17. — View Citation

Ergen WF, Pasricha T, Hubbard FJ, Higginbotham T, Givens T, Slaughter JC, Obstein KL. Providing Hospitalized Patients With an Educational Booklet Increases the Quality of Colonoscopy Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Jun;14(6):858-64. doi: 10.1016/j.cgh.2015.11.015. Epub 2015 Dec 8. — View Citation

Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2016 May 14. pii: S0016-5107(16)30158-4. doi: 10.1016/j.gie.2016.05.012. [Epub ahead of print] Review. — View Citation

Kumar A, Lin L, Bernheim O, Bagiella E, Jandorf L, Itzkowitz SH, Shah BJ. Effect of Functional Status on the Quality of Bowel Preparation in Elderly Patients Undergoing Screening and Surveillance Colonoscopy. Gut Liver. 2016 Jul 15;10(4):569-73. doi: 10.5009/gnl15230. — View Citation

Lee YJ, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Education for Ward Nurses Influences the Quality of Inpatient's Bowel Preparation for Colonoscopy. Medicine (Baltimore). 2015 Aug;94(34):e1423. doi: 10.1097/MD.0000000000001423. — View Citation

Rotondano G, Rispo A, Bottiglieri ME, De Luca L, Lamanda R, Orsini L, Bruzzese D, Galloro G; SIED Campania PISCoPO study group investigators, Romano M, Miranda A, Loguercio C, Esposito P, Nardone G, Compare D, Magno L, Ruggiero S, Imperatore N, De Palma GD, Gennarelli N, Cuomo R, Passananti V, Cirillo M, Cattaneo D, Bozzi RM, D'Angelo V, Marone P, Riccio E, De Nucci C, Monastra S, Caravelli G, Verde C, Di Giorgio P, Giannattasio F, Capece G, Taranto D, De Seta M, Spinosa G, De Stefano S, Familiari V, Cipolletta L, Bianco MA, Sansone S, Galasso G, De Colibus P, Romano M, Borgheresi P, Ricco G, Martorano M, Gravina AG, Marmo R, Rea M, Maurano A, Labianca O, Colantuoni E, Iuliano D, Trovato C, Fontana A, Pasquale L, Morante A, Perugini B, Scaglione G, Mauro B. Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study. Dig Liver Dis. 2015 Aug;47(8):669-74. doi: 10.1016/j.dld.2015.04.013. Epub 2015 Apr 25. — View Citation

Srisarajivakul N, Chua D, Williams R, Leigh L, Ou A, Quarta G, Poles MA, Goodman A. How We Cleaned It Up: A Simple Method That Improved Our Practice's Bowel Prep. Am J Gastroenterol. 2016 Aug;111(8):1079-81. doi: 10.1038/ajg.2016.148. Epub 2016 Apr 26. — View Citation

Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in the number of examinations with adequate bowel preparation	Bowel preparation will be considered adequate if overall BBPS=6 and all segments achieving BBPS=2.	At colonoscopy completion	No
Secondary	Overall BBPS score change		At colonoscopy completion	No
Secondary	Segmental BBPS score changes		At colonoscopy completion	No
Secondary	Total examination time, cecal intubation time and time needed to washout during the colonoscopy		At colonoscopy completion	No
Secondary	Cecal intubation rate		At cecum intubation	No
Secondary	Percentage of patients who received the whole amount of liquid preparation		Before colonoscopy start	No
Secondary	Polyp and adenoma detection rate (overall and per segment)		Up to 4 weeks after patient's enrollment	No
Secondary	Side effects related either to the preparation or the examination	A questionnaire will be used as assessment method	Before colonoscopy start	No
Secondary	Identification of potential additional risk factors for inadequate preparation	Identification of potential additional risk factors for inadequate preparation (e.g. a bed status, performance status, autonomy level (measured by the Katz score) ?SA Score, diabetes, use of tricyclic antidepressants, history of inadequate bowel preparation, chronic constipation, history of abdominal surgery other than colectomy, use of opioids, proposed predictive score. A questionnaire will be used.	After colonoscopy completion	No
Secondary	Patient satisfaction from the bowel preparation using the visual analogue scale.		After colonoscopy completion	No