Blended Care for the Discontinuation of Benzodiazepine Use
Big Bird
The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
2 other identifiers
interventional
924
1 country
110
Brief Summary
This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Typical duration for not_applicable
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2021
CompletedJuly 15, 2022
July 1, 2022
2.1 years
May 2, 2019
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
12 months
Secondary Outcomes (4)
Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening
6 months
EQ-5D-3L assessed at week 6, 12, 26 and 52
12 months
Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52
12 months
The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52
12 months
Study Arms (2)
Usual care
OTHERPatients will receive 'usual care' left at the discretion of the treating general practitioner (GP). They are expected to follow the Belgian guidelines, which propose education of the patient about the harmful effects of chronic benzodiazepines and z-drugs ((z-)BZD) use, the alternatives, and the advice to discontinue (z-)BZD use. A stepped approach is recommended. First, a minimal intervention strategy such as a discontinuation letter or a short advice is applied. If unsuccessful, a brief intervention, which may span one or more consults, is recommended. During such an intervention, the GP will - based on the principles of motivational interviewing- assess the patient's readiness for change and match the appropriate intervention. A tapering scheme will be developed which typically consists of a 10-20% reduction in the daily dose of the (z-)BZD every 2-4 weeks.
Blended care
EXPERIMENTALUsual care is supported by the use of an interactive e-tool. The e-tool provides psycho-education about sleep and sleep medication, and exercises featuring cognitive behavioural techniques to enhance the self-management of the patient. It's purpose is to motivate patients to discontinue the use of (z-)BZD, to adapt alternative remedies and to support them in this process. The patient can grant the participating GP access to all his answers in the e-tool, making it possible to discuss their findings and experiences face-to-face. During consultations, the GP will also assess the patients' readiness for change and match the appropriate intervention. A tailored gradual taper of the (z-)BZD will be agreed upon, which typically consists of a 10-20% reduction in the daily dose every 2-4 weeks. Follow-up appointments are scheduled depending on the needs of the patient until the end of dose reduction.
Interventions
An interactive e-learning programme delivered through a secured web-based platform for patients and general practitioners (GPs), blended with face-to-face contacts between the involved GP and patient.
General practitioners offering usual care are expected to follow the Belgian guidelines as described in the most recent online version of "Anxiety, stress and sleeping problems A toolbox for general practitioners." or "Sleeping pills and sedatives. How to assist your patients in the search for other solutions?" which are both available in French and Dutch.
Eligibility Criteria
You may qualify if:
- Patients aged 18 and older capable of giving informed consent,
- Having his/her Global Medical File managed by one of the participating general practitioners
- Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
- Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems
You may not qualify if:
- Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
- Presence of terminal illness
- Any cases where stopping of (z-)BZDs might be harmful
- Unwillingness or inability to provide informed consent
- Not having e-literacy (being familiar with email and internet use)
- Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kristien Coteurlead
- Belgium Health Care Knowledge Centrecollaborator
- Universiteit Antwerpencollaborator
- University Ghentcollaborator
- Vrije Universiteit Brusselcollaborator
- Université Libre de Bruxellescollaborator
- Université de Liègecollaborator
Study Sites (110)
Leysen Bert
Broechem, Antwerpen, 2520, Belgium
Asselman Valerie
Hoboken, Antwerpen, 2660, Belgium
Van Tongelen Sofie
Mechelen, Antwerpen, 2800, Belgium
Thomas Pol
Jette, Brussels Capital, 1090, Belgium
Maquet Elisabeth
Saint-Gilles, Brussels Capital, 1060, Belgium
Fauquert Benjamin
Schaarbeek, Brussels Capital, 1030, Belgium
Uhry Franck
Uccle, Brussels Capital, 1180, Belgium
Vansintejan Johan
Vilvoorde, Brussels Capital, 1800, Belgium
Bedoret Virginie
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, 1150, Belgium
Catinus Pierric
Châtelineau, Henegouwen, 6200, Belgium
Vanderstraeten Katrien
Berchem, Kluisbergen, Belgium
Ceulemans Steven
Beverst, Limburg, 3740, Belgium
Coolen Antoon
Beverst, Limburg, 3740, Belgium
Geskens Valérie
Beverst, Limburg, 3740, Belgium
Fransis Jan
Ham, Limburg, 3945, Belgium
Stulens Jan
Hasselt, Limburg, 3500, Belgium
Thys Eline
Hasselt, Limburg, 3500, Belgium
Vernyns Sander
Hasselt, Limburg, 3510, Belgium
Beenders Wim
Maaseik, Limburg, 3680, Belgium
Vanleeuw Ben
Zolder, Limburg, 3350, Belgium
Kang Thida
Boncelles, Luik, 4100, Belgium
Deleu Gabriel
Hodeige, Luik, 4351, Belgium
Andre Jean-François
Liège, Luik, 4000, Belgium
Rousseau Cecile
Liège, Luik, 4020, Belgium
Steyaert Elodie
Neupré, Luik, 4120, Belgium
Debry Jean-Yves
Ougrée, Luik, 4102, Belgium
Evrard Antoine
Tilff, Luik, 4130, Belgium
Parada Alberto
Trois-Ponts, Luik, 4980, Belgium
Cohnen Ingrid
Waimes, Luik, 4950, Belgium
Germay Arlette
Libin, Luxemburg, 6890, Belgium
Gueibe France
Libin, Luxemburg, 6890, Belgium
De Vleeschouwer Oriane
Saint-Hubert, Luxemburg, 6870, Belgium
Vanschepdael Céline
Saint-Hubert, Luxemburg, 6870, Belgium
Mattart Jacques
Andenne, Namen, 5300, Belgium
Lafontaine Jean Baptiste
Namur, Namen, 5000, Belgium
Kerckvoorde Lien
Aalter, Oost-Vlaanderen, 9880, Belgium
Mahieu Inge
Asper, Oost-Vlaanderen, 9890, Belgium
Cuelenaere Maarten
Assenede, Oost-Vlaanderen, 9960, Belgium
De Sadeleer Jo
Borsbeke, Oost-Vlaanderen, 9552, Belgium
Degrave Stijn
Herzele, Oost-Vlaanderen, 9550, Belgium
De Muynck Kim
Kaprijke, Oost-Vlaanderen, 9970, Belgium
Van Marcke Maarten
Lebbeke, Oost-Vlaanderen, 9280, Belgium
Joos Ellen
Nevele, Oost-Vlaanderen, 9580, Belgium
Everaert Leen
Nevele, Oost-Vlaanderen, 9850, Belgium
Vermeulen Sofie
Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium
Heyerick Maaike
Zulte, Oost-Vlaanderen, 9870, Belgium
Lemlijn Nathalie
Kessel-Lo, Vlaams-Brabant, 3010, Belgium
Heijmans Stephane
Linkebeek, Vlaams-Brabant, 1630, Belgium
Pening Maud
Nivelles, Waals-Brabant, 1400, Belgium
Lens Marie
Ottignies, Waals-Brabant, 1340, Belgium
Massaux Godelieve
Wavre, Waals-Brabant, 1300, Belgium
De Vlieghere Marieke
Jabbeke, West-Vlaanderen, 8490, Belgium
Caenepeel Laurens
Koksijde, West-Vlaanderen, 8670, Belgium
Delvaux Nicolas
Lissewege, West-Vlaanderen, 8380, Belgium
Knockaert Iris
Lissewege, West-Vlaanderen, 8380, Belgium
Demeyere Tijs
Moorslede, West-Vlaanderen, 8890, Belgium
Vandenameele Steffi
Sijsele, West-Vlaanderen, 8340, Belgium
De Sutter Inge
Aalst, Belgium
Maenen Arjen
Alken, Belgium
Janssen Marie-Eve
Ans, Belgium
Cramm Myrjam
Antwerp, 2000, Belgium
Maus Katelijne
Antwerp, Belgium
Debanterlé Stéphane
Barvaux, 6940, Belgium
Bourcy Gaelle
Bastogne, Belgium
Deckers Clementine B
Bastogne, Belgium
Vercruysse Klaas
Berchem, 9690, Belgium
Balligand Elie
Beringen, Belgium
De Wilde Kristien
Beveren, Belgium
Maes Marc
Beverlo, Belgium
Van De Plas Flip
Boechout, 2530, Belgium
Haemels Maria-Magdalena
Boortmeerbeek, Belgium
Cloetens Hanne
Bruges, Belgium
Maryssael Mia
Bruges, Belgium
Freson Micheline
Damme, Belgium
De Meulemeester Marc
Gozée, Belgium
Van Rossem Inès
Halle, Belgium
Compes Annick
Hannut, Belgium
(Mingneau Jannick) Bourguignon Sofie
Heers, Belgium
De Walsche Bram
Herentals, Belgium
Van Immerseel Ilke
Hove, Belgium
Devolder Tyrone
Kortrijk, Belgium
Maertens Katrien
Kortrijk, Belgium
Vanderbauwhede Stefanie
Kortrijk, Belgium
Staelens Toon
Lauwe, Belgium
Van Der Auwera Jolien
Lauwe, Belgium
Marganne Anneline
Liège, 4000, Belgium
Lambert Fabienne
Liège, Belgium
Maury Olivier
Linkebeek, Belgium
Saintmar Hélène
Marche-en-Famenne, Belgium
Moeremans Paul
Mechelen, Belgium
Heyvaert Goedele
Merchtem, 1785, Belgium
Muylaert Peter
Merelbeke, 9820, Belgium
Peetermans Luc
Mol, Belgium
Wuyts Tinne
Mol, Belgium
Pierard Virginie
Monceau-sur-Sambre, Belgium
Grosjean Joël
Mont-sur-Marchienne, Belgium
Andries Laura
Mortsel, Belgium
De Groote Jaron
Oudenaarde, Belgium
Steeno Pieter
Putte, Belgium
Lemiengre Marieke
Roeselare, Belgium
Cardon Philippe
Sambreville, 5060, Belgium
Meuris Michel
Spa, Belgium
De Neef Sara
Tienen, Belgium
Op De Beeck Sabine
Turnhout, 2300, Belgium
Froidcoeur Xavier
Wanze, Belgium
Tilquin Marlene
Wanze, Belgium
Janssen Reinhilde
Watervliet, Belgium
Bayens Kris
Weelde, Belgium
Klaasen Geert
Weelde, Belgium
Hertegonne Nele
Zottegem, Belgium
Related Publications (3)
Coteur K, Van Nuland M, Schoenmakers B, Anthierens S, Van den Broeck K. Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Apr 7;7:e43738. doi: 10.2196/43738.
PMID: 37027198DERIVEDCoteur K, Henrard G, Schoenmakers B, Laenen A, Van den Broeck K, De Sutter A, Anthierens S, Devroey D, Kacenelenbogen N, Offermans AM, Van Nuland M. Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care. Sleep. 2023 Apr 12;46(4):zsac278. doi: 10.1093/sleep/zsac278.
PMID: 36413221DERIVEDCoteur K, Van Nuland M, Vanmeerbeek M, Henrard G, Anthierens S, Van den Broeck K, De Sutter A, Creupelandt H, Devroey D, Van Overmeire R, Offermans AM, Kacenelenbogen N, Laenen A, Mathei C. Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial. BMJ Open. 2020 Feb 18;10(2):e033688. doi: 10.1136/bmjopen-2019-033688.
PMID: 32075832DERIVED
Study Officials
- STUDY CHAIR
Catharina Matheï
KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project manager - p.p. Chief investigator prof. dr. Catharina Matheï
Study Record Dates
First Submitted
May 2, 2019
First Posted
May 3, 2019
Study Start
June 24, 2019
Primary Completion
July 30, 2021
Study Completion
August 2, 2021
Last Updated
July 15, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- All IPD will be available upon request, after publication of the results concerning the primary outcome, starting six months after publication. The IPD set can be requested until September 2023. For any request later than this date, follow-up by the Sponsor cannot be guaranteed.
- Access Criteria
- Reuse of the IPD set is only allowed for non-profit research, with correct reference to the original research and Sponsor.
All individual participant data (IPD) that underlie the results in our publications will be made available upon request. The IPD set will consist of deidentified participant data. It can be obtained by contacting the research team at KU Leuven: PI, catharina.mathei@kuleuven.be; trial coordinator, marc.vannuland@kuleuven.be; project manager, kristien.coteur@kuleuven.be. Each request before September 2023 will be reviewed by the Sponsor. In addition to the IPD set, we will also make the study protocol available through an open access publication, and have registered the trial on clinicaltrials.gov (NCT03937180). The informed consent forms are also publicly available through the trial website (www.bigbirdtrial.com), where the clinical study report will also be disseminated at the end of the trial, after approval of the funder KCE.