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Blended Care for the Discontinuation of Benzodiazepine Use (Big Bird)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937180
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Belgium Health Care Knowledge Centre
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Université Libre de Bruxelles
Université de Liège
Information provided by (Responsible Party):
Cathy Matheï, KU Leuven

Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening [ Time Frame: 12 months ]
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD [ Time Frame: 12 months ]
Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD [ Time Frame: 6 months ]
    Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening
  • Effect of a blended care approach versus usual care on the quality of life [ Time Frame: 12 months ]
    EQ-5D-3L 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 [ Time Frame: 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 the number of defined daily doses (DDD) of benzodiazepines prescribed [ Time Frame: 12 months ]
    The number of DDD of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blended Care for the Discontinuation of Benzodiazepine Use
Official Title  ICMJE The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Benzodiazepine Dependence
  • Benzodiazepine Dependent
  • Benzodiazepine Withdrawal
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Usual care
  • 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.
    Intervention: Behavioral: Blended care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 13, 2020)
924
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
1200
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937180
Other Study ID Numbers  ICMJE S61194
KCE-17016 ( Other Grant/Funding Number: KCE )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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 December 2022 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.

Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (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 December 2022. 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.
Responsible Party Cathy Matheï, KU Leuven
Study Sponsor  ICMJE Cathy Matheï
Collaborators  ICMJE
  • Belgium Health Care Knowledge Centre
  • Universiteit Antwerpen
  • University Ghent
  • Vrije Universiteit Brussel
  • Université Libre de Bruxelles
  • Université de Liège
Investigators  ICMJE Not Provided
PRS Account KU Leuven
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP