An interventional study of ePrimaPrescribe online educational program and ComunicaSaudeMental online educational program in Anxiety and Prescription Drug Abuse and Dependency, sponsored by Universidade Nova de Lisboa. Completed at 1 site in Portugal. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Universidade Nova de Lisboa · Not applicable, Interventional, and Health services research
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 110 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Universidade Nova de Lisboa is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
general practitioners randomized to intervention group will be given access to ePrimaPrescribe online program
Behavioral: ePrimaPrescribe online educational program
general practitioners randomized to control group will be given access to an online program concerning doctor-patient communication
Behavioral: ComunicaSaudeMental online educational program
online training program aiming to change general practitioners' benzodiazepine prescription
online training program aiming to improve general practitioners' communication with mentally ill patients
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.
Time frame: Change from baseline prescription to 6 months after intervention
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.
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline prescription to 6 months after intervention
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Universidade Nova de Lisboa