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.

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.

Study Overview

• Status: Completed
• Conditions: Benzodiazepine Dependence; Benzodiazepine Withdrawal; Benzodiazepine Dependent
• Intervention / Treatment: Behavioral: Usual care; Behavioral: Blended care

• Study Type: Interventional
• Enrollment (Actual): 924
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • De Sutter Inge
  • Alken, Belgium
    • Maenen Arjen
  • Ans, Belgium
    • Janssen Marie-Eve
  • Antwerpen, Belgium, 2000
    • Cramm Myrjam
  • Antwerpen, Belgium
    • Maus Katelijne
  • Barvaux, Belgium, 6940
    • Debanterlé Stéphane
  • Bastogne, Belgium
    • Bourcy Gaelle
  • Bastogne, Belgium
    • Deckers Clementine B
  • Berchem, Belgium, 9690
    • Vercruysse Klaas
  • Beringen, Belgium
    • Balligand Elie
  • Beveren, Belgium
    • De Wilde Kristien
  • Beverlo, Belgium
    • Maes Marc
  • Boechout, Belgium, 2530
    • Van De Plas Flip
  • Boortmeerbeek, Belgium
    • Haemels Maria-Magdalena
  • Brugge, Belgium
    • Cloetens Hanne
  • Brugge, Belgium
    • Maryssael Mia
  • Damme, Belgium
    • Freson Micheline
  • Gozée, Belgium
    • De Meulemeester Marc
  • Halle, Belgium
    • Van Rossem Inès
  • Hannut, Belgium
    • Compes Annick
  • Heers, Belgium
    • (Mingneau Jannick) Bourguignon Sofie
  • Herentals, Belgium
    • De Walsche Bram
  • Hove, Belgium
    • Van Immerseel Ilke
  • Kortrijk, Belgium
    • Devolder Tyrone
  • Kortrijk, Belgium
    • Maertens Katrien
  • Kortrijk, Belgium
    • Vanderbauwhede Stefanie
  • Lauwe, Belgium
    • Staelens Toon
  • Lauwe, Belgium
    • Van Der Auwera Jolien
  • Linkebeek, Belgium
    • Maury Olivier
  • Liège, Belgium, 4000
    • Marganne Anneline
  • Liège, Belgium
    • Lambert Fabienne
  • Marche-en-Famenne, Belgium
    • Saintmar Hélène
  • Mechelen, Belgium
    • Moeremans Paul
  • Merchtem, Belgium, 1785
    • Heyvaert Goedele
  • Merelbeke, Belgium, 9820
    • Muylaert Peter
  • Mol, Belgium
    • Peetermans Luc
  • Mol, Belgium
    • Wuyts Tinne
  • Monceau-sur-Sambre, Belgium
    • Pierard Virginie
  • Mont-sur-Marchienne, Belgium
    • Grosjean Joël
  • Mortsel, Belgium
    • Andries Laura
  • Oudenaarde, Belgium
    • De Groote Jaron
  • Putte, Belgium
    • Steeno Pieter
  • Roeselare, Belgium
    • Lemiengre Marieke
  • Sambreville, Belgium, 5060
    • Cardon Philippe
  • Spa, Belgium
    • Meuris Michel
  • Tienen, Belgium
    • De Neef Sara
  • Turnhout, Belgium, 2300
    • Op De Beeck Sabine
  • Wanze, Belgium
    • Froidcoeur Xavier
  • Wanze, Belgium
    • Tilquin Marlene
  • Watervliet, Belgium
    • Janssen Reinhilde
  • Weelde, Belgium
    • Bayens Kris
  • Weelde, Belgium
    • Klaasen Geert
  • Zottegem, Belgium
    • Hertegonne Nele
  • Antwerpen
    • Broechem, Antwerpen, Belgium, 2520
      • Leysen Bert
    • Hoboken, Antwerpen, Belgium, 2660
      • Asselman Valerie
    • Mechelen, Antwerpen, Belgium, 2800
      • Van Tongelen Sofie
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Thomas Pol
    • Saint-Gilles, Brussel, Belgium, 1060
      • Maquet Elisabeth
    • Schaerbeek, Brussel, Belgium, 1030
      • Fauquert Benjamin
    • Uccle, Brussel, Belgium, 1180
      • Uhry Franck
    • Vilvoorde, Brussel, Belgium, 1800
      • Vansintejan Johan
    • Woluwe St Pierre, Brussel, Belgium, 1150
      • Bedoret Virginie
  • Henegouwen
    • Chatelineau, Henegouwen, Belgium, 6200
      • Catinus Pierric
  • Kluisbergen
    • Berchem, Kluisbergen, Belgium
      • Vanderstraeten Katrien
  • Limburg
    • Beverst, Limburg, Belgium, 3740
      • Ceulemans Steven
    • Beverst, Limburg, Belgium, 3740
      • Coolen Antoon
    • Beverst, Limburg, Belgium, 3740
      • Geskens Valérie
    • Ham, Limburg, Belgium, 3945
      • Fransis Jan
    • Hasselt, Limburg, Belgium, 3500
      • Stulens Jan
    • Hasselt, Limburg, Belgium, 3500
      • Thys Eline
    • Hasselt, Limburg, Belgium, 3510
      • Vernyns Sander
    • Maaseik, Limburg, Belgium, 3680
      • Beenders Wim
    • Zolder, Limburg, Belgium, 3350
      • Vanleeuw Ben
  • Luik
    • Boncelles, Luik, Belgium, 4100
      • Kang Thida
    • Hodeige, Luik, Belgium, 4351
      • Deleu Gabriel
    • Liège, Luik, Belgium, 4000
      • Andre Jean-François
    • Liège, Luik, Belgium, 4020
      • Rousseau Cecile
    • Neupré, Luik, Belgium, 4120
      • Steyaert Elodie
    • Ougree, Luik, Belgium, 4102
      • Debry Jean-Yves
    • Tilff, Luik, Belgium, 4130
      • Evrard Antoine
    • Trois-Ponts, Luik, Belgium, 4980
      • Parada Alberto
    • Waimes, Luik, Belgium, 4950
      • Cohnen Ingrid
  • Luxemburg
    • Libin, Luxemburg, Belgium, 6890
      • Germay Arlette
    • Libin, Luxemburg, Belgium, 6890
      • Gueibe France
    • Saint-Hubert, Luxemburg, Belgium, 6870
      • De Vleeschouwer Oriane
    • Saint-Hubert, Luxemburg, Belgium, 6870
      • Vanschepdael Céline
  • Namen
    • Andenne, Namen, Belgium, 5300
      • Mattart Jacques
    • Namur, Namen, Belgium, 5000
      • Lafontaine Jean Baptiste
  • Oost-Vlaanderen
    • Aalter, Oost-Vlaanderen, Belgium, 9880
      • Kerckvoorde Lien
    • Asper, Oost-Vlaanderen, Belgium, 9890
      • Mahieu Inge
    • Assenede, Oost-Vlaanderen, Belgium, 9960
      • Cuelenaere Maarten
    • Borsbeke, Oost-Vlaanderen, Belgium, 9552
      • De Sadeleer Jo
    • Herzele, Oost-Vlaanderen, Belgium, 9550
      • Degrave Stijn
    • Kaprijke, Oost-Vlaanderen, Belgium, 9970
      • De Muynck Kim
    • Lebbeke, Oost-Vlaanderen, Belgium, 9280
      • Van Marcke Maarten
    • Nevele, Oost-Vlaanderen, Belgium, 9580
      • Joos Ellen
    • Nevele, Oost-Vlaanderen, Belgium, 9850
      • Everaert Leen
    • Sint-Martens-Latem, Oost-Vlaanderen, Belgium, 9830
      • Vermeulen Sofie
    • Zulte, Oost-Vlaanderen, Belgium, 9870
      • Heyerick Maaike
  • Vlaams-Brabant
    • Kessel-Lo, Vlaams-Brabant, Belgium, 3010
      • Lemlijn Nathalie
    • Linkebeek, Vlaams-Brabant, Belgium, 1630
      • Heijmans Stephane
  • Waals-Brabant
    • Nivelles, Waals-Brabant, Belgium, 1400
      • Pening Maud
    • Ottignies, Waals-Brabant, Belgium, 1340
      • Lens Marie
    • Wavre, Waals-Brabant, Belgium, 1300
      • Massaux Godelieve
  • West-Vlaanderen
    • Jabbeke, West-Vlaanderen, Belgium, 8490
      • De Vlieghere Marieke
    • Koksijde, West-Vlaanderen, Belgium, 8670
      • Caenepeel Laurens
    • Lissewege, West-Vlaanderen, Belgium, 8380
      • Delvaux Nicolas
    • Lissewege, West-Vlaanderen, Belgium, 8380
      • Knockaert Iris
    • Moorslede, West-Vlaanderen, Belgium, 8890
      • Demeyere Tijs
    • Sijsele, West-Vlaanderen, Belgium, 8340
      • Vandenameele Steffi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; Patients 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.	Behavioral: Usual care; 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.
Experimental: Blended care; Usual 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.	Behavioral: Blended care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening	Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD	6 months
EQ-5D-3L assessed at week 6, 12, 26 and 52	Effect of a blended care approach versus usual care on the quality of life. The EQ-5D-3L is the three-level version of the EuroQol five dimension scale measuring quality of life.	12 months
Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52	Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use	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	Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed	12 months

Collaborators and Investigators

• Sponsor: Kristien Coteur
• Collaborators: University Ghent; Belgium Health Care Knowledge Centre; Vrije Universiteit Brussel; Universiteit Antwerpen; Université Libre de Bruxelles; Université de Liège
• Investigators: Study Chair: Catharina Matheï, KU Leuven

Publications and helpful links

General Publications

• Coteur 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: benzodiazepines; blended care
• Other Study ID Numbers: S61194; KCE-17016 (Other Grant/Funding Number: KCE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: Reuse of the IPD set is only allowed for non-profit research, with correct reference to the original research and Sponsor.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No