Big Bird: Blended Care for the Discontinuation of Benzodiazepine Use

Sponsor

Kristien Coteur (Other)

Overall Status

Completed

CT.gov ID

NCT03937180

Collaborator

Belgium Health Care Knowledge Centre (Other), Universiteit Antwerpen (Other), University Ghent (Other), Vrije Universiteit Brussel (Other), Université Libre de Bruxelles (Other), Université de Liège (Other)

924

Enrollment

110

Locations

Arms

25.3

Actual Duration (Months)

8.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benzodiazepine Dependence Benzodiazepine Dependent Benzodiazepine Withdrawal	Behavioral: Blended care Behavioral: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

924 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

cluster randomized controlled trialcluster randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.

Actual Study Start Date :

Jun 24, 2019

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Aug 2, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening [12 months]
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD

Secondary Outcome Measures

Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening [6 months]
Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
EQ-5D-3L assessed at week 6, 12, 26 and 52 [12 months]
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.
Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52 [12 months]
Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use
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]
Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leysen Bert	Broechem	Antwerpen	Belgium	2520
2	Asselman Valerie	Hoboken	Antwerpen	Belgium	2660
3	Van Tongelen Sofie	Mechelen	Antwerpen	Belgium	2800
4	Thomas Pol	Jette	Brussel	Belgium	1090
5	Maquet Elisabeth	Saint-Gilles	Brussel	Belgium	1060
6	Fauquert Benjamin	Schaerbeek	Brussel	Belgium	1030
7	Uhry Franck	Uccle	Brussel	Belgium	1180
8	Vansintejan Johan	Vilvoorde	Brussel	Belgium	1800
9	Bedoret Virginie	Woluwe St Pierre	Brussel	Belgium	1150
10	Catinus Pierric	Chatelineau	Henegouwen	Belgium	6200
11	Vanderstraeten Katrien	Berchem	Kluisbergen	Belgium
12	Ceulemans Steven	Beverst	Limburg	Belgium	3740
13	Coolen Antoon	Beverst	Limburg	Belgium	3740
14	Geskens Valérie	Beverst	Limburg	Belgium	3740
15	Fransis Jan	Ham	Limburg	Belgium	3945
16	Stulens Jan	Hasselt	Limburg	Belgium	3500
17	Thys Eline	Hasselt	Limburg	Belgium	3500
18	Vernyns Sander	Hasselt	Limburg	Belgium	3510
19	Beenders Wim	Maaseik	Limburg	Belgium	3680
20	Vanleeuw Ben	Zolder	Limburg	Belgium	3350
21	Kang Thida	Boncelles	Luik	Belgium	4100
22	Deleu Gabriel	Hodeige	Luik	Belgium	4351
23	Andre Jean-François	Liège	Luik	Belgium	4000
24	Rousseau Cecile	Liège	Luik	Belgium	4020
25	Steyaert Elodie	Neupré	Luik	Belgium	4120
26	Debry Jean-Yves	Ougree	Luik	Belgium	4102
27	Evrard Antoine	Tilff	Luik	Belgium	4130
28	Parada Alberto	Trois-Ponts	Luik	Belgium	4980
29	Cohnen Ingrid	Waimes	Luik	Belgium	4950
30	Germay Arlette	Libin	Luxemburg	Belgium	6890
31	Gueibe France	Libin	Luxemburg	Belgium	6890
32	De Vleeschouwer Oriane	Saint-Hubert	Luxemburg	Belgium	6870
33	Vanschepdael Céline	Saint-Hubert	Luxemburg	Belgium	6870
34	Mattart Jacques	Andenne	Namen	Belgium	5300
35	Lafontaine Jean Baptiste	Namur	Namen	Belgium	5000
36	Kerckvoorde Lien	Aalter	Oost-Vlaanderen	Belgium	9880
37	Mahieu Inge	Asper	Oost-Vlaanderen	Belgium	9890
38	Cuelenaere Maarten	Assenede	Oost-Vlaanderen	Belgium	9960
39	De Sadeleer Jo	Borsbeke	Oost-Vlaanderen	Belgium	9552
40	Degrave Stijn	Herzele	Oost-Vlaanderen	Belgium	9550
41	De Muynck Kim	Kaprijke	Oost-Vlaanderen	Belgium	9970
42	Van Marcke Maarten	Lebbeke	Oost-Vlaanderen	Belgium	9280
43	Joos Ellen	Nevele	Oost-Vlaanderen	Belgium	9580
44	Everaert Leen	Nevele	Oost-Vlaanderen	Belgium	9850
45	Vermeulen Sofie	Sint-Martens-Latem	Oost-Vlaanderen	Belgium	9830
46	Heyerick Maaike	Zulte	Oost-Vlaanderen	Belgium	9870
47	Lemlijn Nathalie	Kessel-Lo	Vlaams-Brabant	Belgium	3010
48	Heijmans Stephane	Linkebeek	Vlaams-Brabant	Belgium	1630
49	Pening Maud	Nivelles	Waals-Brabant	Belgium	1400
50	Lens Marie	Ottignies	Waals-Brabant	Belgium	1340
51	Massaux Godelieve	Wavre	Waals-Brabant	Belgium	1300
52	De Vlieghere Marieke	Jabbeke	West-Vlaanderen	Belgium	8490
53	Caenepeel Laurens	Koksijde	West-Vlaanderen	Belgium	8670
54	Delvaux Nicolas	Lissewege	West-Vlaanderen	Belgium	8380
55	Knockaert Iris	Lissewege	West-Vlaanderen	Belgium	8380
56	Demeyere Tijs	Moorslede	West-Vlaanderen	Belgium	8890
57	Vandenameele Steffi	Sijsele	West-Vlaanderen	Belgium	8340
58	De Sutter Inge	Aalst		Belgium
59	Maenen Arjen	Alken		Belgium
60	Janssen Marie-Eve	Ans		Belgium
61	Cramm Myrjam	Antwerpen		Belgium	2000
62	Maus Katelijne	Antwerpen		Belgium
63	Debanterlé Stéphane	Barvaux		Belgium	6940
64	Bourcy Gaelle	Bastogne		Belgium
65	Deckers Clementine B	Bastogne		Belgium
66	Vercruysse Klaas	Berchem		Belgium	9690
67	Balligand Elie	Beringen		Belgium
68	De Wilde Kristien	Beveren		Belgium
69	Maes Marc	Beverlo		Belgium
70	Van De Plas Flip	Boechout		Belgium	2530
71	Haemels Maria-Magdalena	Boortmeerbeek		Belgium
72	Cloetens Hanne	Brugge		Belgium
73	Maryssael Mia	Brugge		Belgium
74	Freson Micheline	Damme		Belgium
75	De Meulemeester Marc	Gozée		Belgium
76	Van Rossem Inès	Halle		Belgium
77	Compes Annick	Hannut		Belgium
78	(Mingneau Jannick) Bourguignon Sofie	Heers		Belgium
79	De Walsche Bram	Herentals		Belgium
80	Van Immerseel Ilke	Hove		Belgium
81	Devolder Tyrone	Kortrijk		Belgium
82	Maertens Katrien	Kortrijk		Belgium
83	Vanderbauwhede Stefanie	Kortrijk		Belgium
84	Staelens Toon	Lauwe		Belgium
85	Van Der Auwera Jolien	Lauwe		Belgium
86	Maury Olivier	Linkebeek		Belgium
87	Marganne Anneline	Liège		Belgium	4000
88	Lambert Fabienne	Liège		Belgium
89	Saintmar Hélène	Marche-en-Famenne		Belgium
90	Moeremans Paul	Mechelen		Belgium
91	Heyvaert Goedele	Merchtem		Belgium	1785
92	Muylaert Peter	Merelbeke		Belgium	9820
93	Peetermans Luc	Mol		Belgium
94	Wuyts Tinne	Mol		Belgium
95	Pierard Virginie	Monceau-sur-Sambre		Belgium
96	Grosjean Joël	Mont-sur-Marchienne		Belgium
97	Andries Laura	Mortsel		Belgium
98	De Groote Jaron	Oudenaarde		Belgium
99	Steeno Pieter	Putte		Belgium
100	Lemiengre Marieke	Roeselare		Belgium
101	Cardon Philippe	Sambreville		Belgium	5060
102	Meuris Michel	Spa		Belgium
103	De Neef Sara	Tienen		Belgium
104	Op De Beeck Sabine	Turnhout		Belgium	2300
105	Froidcoeur Xavier	Wanze		Belgium
106	Tilquin Marlene	Wanze		Belgium
107	Janssen Reinhilde	Watervliet		Belgium
108	Bayens Kris	Weelde		Belgium
109	Klaasen Geert	Weelde		Belgium
110	Hertegonne Nele	Zottegem		Belgium

Sponsors and Collaborators

Kristien Coteur
Belgium Health Care Knowledge Centre
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Université Libre de Bruxelles
Université de Liège

Investigators

Study Chair: Catharina Matheï, KU Leuven

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Mar 20, 2020

More Information

Publications

None provided.

Responsible Party:

Kristien Coteur, Project manager - p.p. Chief investigator prof. dr. Catharina Matheï, KU Leuven

ClinicalTrials.gov Identifier:

NCT03937180

Other Study ID Numbers:

S61194
KCE-17016

First Posted:

May 3, 2019

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Kristien Coteur, Project manager - p.p. Chief investigator prof. dr. Catharina Matheï, KU Leuven

benzodiazepines

blended care

Study Results

No Results Posted as of Jul 15, 2022