AnxietyNCT04925596
Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program
A study testing ePrimaPrescribe online educational program and ComunicaSaudeMental online educational program in people with Anxiety and Prescription Drug Abuse and Dependency, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Portugal has the highest benzodiazepine utilization compared to other European countries. The high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Prescription Drug Abuse and Dependency
- What is being tested?
- ePrimaPrescribe online educational program and ComunicaSaudeMental online educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2017to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary care units using the Portuguese online prescription tool (created by the Portuguese Shared Services of the Ministry of Health and Finance - SPMS)
Who cannot join
- Primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School
Lisbon
About this study
Portugal has the highest benzodiazepine utilization compared to other European countries. The high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. Also, these data demonstrate that doctors are possibly choosing an inadequate treatment to manage anxious and depressive syndromes.
This research aims to develop and implement in primary health care units an online educational program, following a cluster randomized study design; to study the impact of this educational program for changing general practitioner's benzodiazepine prescription pattern; to analyze of barriers and facilitators to the implementation of the e-PrimaPrescribe program.
Read the detailed description
BZD excessive prescription has long been considered a serious mental health concern in many countries. A large number of interventions using different methodologies have been implemented to change BZD prescription pattern at primary health care settings, with limited positive results.
The investigators propose the implementation of an effectiveness-implementation hybrid type 1 intervention. In the study it was developed an online platform, named ePrimaPrescribe, which was delivered using a Digital Behavior Change Intervention(DBCI).
The investigators included all primary health care units from one region in Portugal which were randomly allocated to receive a Digital Behavior Change Intervention (DBCI) in the format of an online platform to reduce BZD prescription (ePrimaPrescribe) or an online platform concerning communication techniques (control).
The investigators primarily aimed to evaluate the effectiveness of the Digital Behavior Change Intervention (DBCI) using as outcome measure the frequency of BZD prescriptions issued per month. Secondarily the investigators aimed to analyze the effect of ePrimaprescribe on antidepressant prescriptions, to study the effect of ePrimaprescribe on diagnosis definition associated with BZD and antidepressant prescription; to perform a cost analysis considering the monthly National Health Service spending with BZD co-payment. The investigators finally aim to analyze the implementation process using quantitative and qualitative methods.
- Conditions
- Anxiety, Prescription Drug Abuse and Dependency
- Being tested
- ePrimaPrescribe online educational program, ComunicaSaudeMental online educational program
- Keywords
- Prescribing Patterns, Benzodiazepines, General Practitioners
- Medical subject headings
- Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePrimaPrescribe online educational programBehavioural
online training program aiming to change general practitioners' benzodiazepine prescription
ComunicaSaudeMental online educational programBehavioural
online training program aiming to improve general practitioners' communication with mentally ill patients
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | general practitioners randomized to intervention group will be given access to ePrimaPrescribe online program Receives: Behavioral: ePrimaPrescribe online educational program |
| Control | Active comparator | general practitioners randomized to control group will be given access to an online program concerning doctor-patient communication Receives: Behavioral: ComunicaSaudeMental online educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of BZD prescriptions issued per month
Each prescription data was coded using an individual GP and patient numerical identification, in a secured and validated electronic database, directly extracted by the central Shared Services of the Portuguese Ministry of Health.
Measured: Change from baseline prescription to 6 months after intervention
Secondary outcomes (3)
Change in the frequency of antidepressant prescriptions issued per month
Each prescription data was coded using an individual GP and patient numerical identification, in a secured and validated electronic database, directly extracted by the central Shared Services of the Portuguese Ministry of Health.
Measured: Change from baseline prescription to 6 months after intervention
Change in the diagnosis registration frequency
Monthly registration distribution of psychological symptoms, complaints, and diagnoses coded at the same month as BZD and antidepressant prescriptions. The GP's diagnosis registration used the International Classification of Primary Care, second edition (ICPC-2) developed and updated by the World Organization of Family Doctors' (WONCA) International Classification Committee (WICC).
Measured: Change from baseline prescription to 6 months after intervention
Change in the costs with BZD co-payment
Cost analysis considering the monthly National Health Service spending with BZD co-payment. This cost was compared with the amount that would need to be spent to comply with needs and solutions suggested when evaluating GP's perceptions of the feasibility and implementation.
Measured: Change from baseline prescription to 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Mar 2017
- Primary completion15 May 2017
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Reis, Md, Principal investigator, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925596
- Sponsor's protocol ID
- 47/2016/CEFCM
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reis T, Faria I, Serra H, Xavier M. Barriers and facilitators to implementing a continuing medical education intervention in a primary health care setting. BMC Health Serv Res. 2022 May 13;22(1):638. doi: 10.1186/s12913-022-08019-w.
PubMed 35562695
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program
- ClinicalTrials.gov ID
- NCT04925596
- Acronym / sponsor ID
- 47/2016/CEFCM
- Conditions
- Anxiety, Prescription Drug Abuse and Dependency
- Keywords
- Prescribing Patterns, Benzodiazepines, General Practitioners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Portugal has the highest benzodiazepine utilization compared to other European countries. The high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. Also, these data demonstrate that doctors are possibly choosing an inadequate treatment to manage anxious and depressive syndromes.
This research aims to develop and implement in primary health care units an online educational program, following a cluster randomized study design; to study the impact of this educational program for changing general practitioner's benzodiazepine prescription pattern; to analyze of barriers and facilitators to the implementation of the e-PrimaPrescribe program.
Detailed description
BZD excessive prescription has long been considered a serious mental health concern in many countries. A large number of interventions using different methodologies have been implemented to change BZD prescription pattern at primary health care settings, with limited positive results.
The investigators propose the implementation of an effectiveness-implementation hybrid type 1 intervention. In the study it was developed an online platform, named ePrimaPrescribe, which was delivered using a Digital Behavior Change Intervention(DBCI).
The investigators included all primary health care units from one region in Portugal which were randomly allocated to receive a Digital Behavior Change Intervention (DBCI) in the format of an online platform to reduce BZD prescription (ePrimaPrescribe) or an online platform concerning communication techniques (control).
The investigators primarily aimed to evaluate the effectiveness of the Digital Behavior Change Intervention (DBCI) using as outcome measure the frequency of BZD prescriptions issued per month. Secondarily the investigators aimed to analyze the effect of ePrimaprescribe on antidepressant prescriptions, to study the effect of ePrimaprescribe on diagnosis definition associated with BZD and antidepressant prescription; to perform a cost analysis considering the monthly National Health Service spending with BZD co-payment. The investigators finally aim to analyze the implementation process using quantitative and qualitative methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ePrimaPrescribe online educational programgeneral practitioners randomized to intervention group will be given access to ePrimaPrescribe online program |
| Control | Active comparator | Behavioral: ComunicaSaudeMental online educational programgeneral practitioners randomized to control group will be given access to an online program concerning doctor-patient communication |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care units using the Portuguese online prescription tool (created by the Portuguese Shared Services of the Ministry of Health and Finance - SPMS)
Key exclusion criteria (1 listed)
- Primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePrimaPrescribe online educational programonline training program aiming to change general practitioners' benzodiazepine prescription | Behavioural | Intervention |
| ComunicaSaudeMental online educational programonline training program aiming to improve general practitioners' communication with mentally ill patients | Behavioural | Control |
Primary outcome
Change in the frequency of BZD prescriptions issued per month
Time frame: Change from baseline prescription to 6 months after intervention
Each prescription data was coded using an individual GP and patient numerical identification, in a secured and validated electronic database, directly extracted by the central Shared Services of the Portuguese Ministry of Health.
3 secondary outcomes
Change in the frequency of antidepressant prescriptions issued per month
Time frame: Change from baseline prescription to 6 months after intervention
Change in the diagnosis registration frequency
Time frame: Change from baseline prescription to 6 months after intervention
Change in the costs with BZD co-payment
Time frame: Change from baseline prescription to 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 35562695Reis T, Faria I, Serra H, Xavier M. Barriers and facilitators to implementing a continuing medical education intervention in a primary health care setting. BMC Health Serv Res. 2022 May 13;22(1):638. doi: 10.1186/s12913-022-08019-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Reis, Md principal investigator
Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePrimaPrescribe online educational program and ComunicaSaudeMental online educational program in people with Anxiety and Prescription Drug Abuse and Dependency, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the frequency of BZD prescriptions issued per month (time frame: Change from baseline prescription to 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.