Clinical trial NCT02187380: Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants
Official title: Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Antidepressant
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care patients with a new prescription for antidepressants in Flanders, Belgium.

Brief summary: The objective of the SIMCA study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants.

A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At the time of the start of the study, the Surplus Network included 97 pharmacies, in all five Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were informed about the SIMCA-study and instructed how to approach eligible patients.

Randomisation was obtained at the pharmacy level by a computerized random-number generator, following a permuted block design (1:1). The Surplus Network contains a number of local pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy chains.

Pharmacists in the intervention group were trained in communication skills related to depression treatment counselling in groups of no more than 10 participants over a single day. In total, 10 training days were scheduled between November and December, 2010.

Patients were eligible for inclusion in the study if they started using at least one antidepressant drug, if they were at least 18 years old, if they were able to understand and complete Dutch questionnaires and if they could be reached by telephone for follow-up. "Starting" was defined as not having been prescribed antidepressants over the last six months, which was checked in the pharmacy records. If the patient gave verbal consent to the pharmacist, to be contacted by the research team, the patient was provided with written and oral information about the SIMCA project and a consent form. At the same time an automatic e-mail was generated from the pharmacy software to inform the research team about the patient's willingness to be contacted about the study. The patient was contacted by the research team, as soon as possible to give more information about the study, to ask for informed consent and to schedule a first telephone survey interview. If the patient wished to participate, he/she completed the consent form, and sent it back with the included postage-paid envelope addressed to the research team. Upon receipt of the consent form, the recruited patient's prescribing doctor was contacted and asked to complete and return a brief questionnaire to provide the diagnosis and its severity related to prescribing antidepressants.

Telephone survey interviews based on validated scales were used to collect data at the start of treatment (as close as possible to the time of recruitment), after one month, three months and six months of treatment.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* able to understand and complete Dutch questionnaires
* could be reached by telephone for follow-up

Exclusion Criteria:

* used antidepressants over the last six months

Primary outcomes:
measure: Medication adherence
timeFrame: 1 month after start of antidepressants treatment
measure: Medication adherence
timeFrame: 3 months after start of antidepressants treatment
measure: Medication adherence
timeFrame: 6 months after start of antidepressants treatment
Secondary outcomes:
measure: Economic outcomes
timeFrame: at the start of antidepressants treatment
measure: Economic outcomes
timeFrame: 1 month after the start of antidepressants treatment
measure: Economic outcomes
timeFrame: 3 months after the start of antidepressants treatment
measure: Economic outcomes
timeFrame: 6 months after the start of antidepressants treatment
measure: Clinical outcomes
timeFrame: at the start of antidepressants treatment
measure: Clinical outcomes
timeFrame: 1 month after the start of antidepressants treatment
measure: Clinical outcomes
timeFrame: 3 months after the start of antidepressants treatment
measure: Clinical outcomes
timeFrame: 6 months after the start of antidepressants treatment
measure: Beliefs about medicines
timeFrame: At the start of antidepressants treatment
measure: Beliefs about medicines
timeFrame: 1 month after the start of antidepressants treatment
measure: Beliefs about medicines
timeFrame: 3 months after the start of antidepressants treatment
measure: Beliefs about medicines
timeFrame: 6 months after the start of antidepressants treatment
measure: Satisfaction with the pharmacist
timeFrame: At the start of antidepressants treatment
measure: Satisfaction with the pharmacist
timeFrame: 1 month after the start of antidepressants treatment
measure: Satisfaction with the pharmacist
timeFrame: 3 months after the start of antidepressants treatment
measure: Satisfaction with the pharmacist
timeFrame: 6 months after the start of antidepressants treatment
measure: Feelings about side effects
timeFrame: 1 month after the start of antidepressants treatment
measure: Feelings about side effects
timeFrame: 3 months after the start of antidepressants treatment
measure: Feelings about side effects
timeFrame: 6 months after the start of antidepressants treatment
measure: Satisfaction with treatment
timeFrame: 1 month after the start of antidepressants treatment
measure: Satisfaction with treatment
timeFrame: 3 months after the start of antidepressants treatment
measure: Satisfaction with treatment
timeFrame: 6 months after the start of antidepressants treatment
measure: Satisfaction with information regarding treatment
timeFrame: At the start of antidepressants treatment
measure: Satisfaction with information regarding treatment
timeFrame: 1 month after the start of antidepressants treatment
measure: Satisfaction with information regarding treatment
timeFrame: 3 months after the start of antidepressants treatment
measure: Satisfaction with information regarding treatment
timeFrame: 6 months after the start of antidepressants treatment
measure: Satisfaction with information regarding side effects
timeFrame: At the start of antidepressants treatment
measure: Satisfaction with information regarding side effects
timeFrame: 1 month after the start of antidepressants treatment
measure: Satisfaction with information regarding side effects
timeFrame: 3 months after the start of antidepressants treatment
measure: Satisfaction with information regarding side effects
timeFrame: 6 months after the start of antidepressants treatment
measure: Health-related quality of life
timeFrame: At the start of antidepressants treatment
measure: Health-related quality of life
timeFrame: 1 month after the start of antidepressants treatment
measure: Health-related quality of life
timeFrame: 3 months after the start of antidepressants treatment
measure: Health-related quality of life
timeFrame: 6 months after the start of antidepressants treatment
measure: Enjoyment and satisfaction
timeFrame: At the start of antidepressants treatment
measure: Enjoyment and satisfaction
timeFrame: 1 month after the start of antidepressants treatment
measure: Enjoyment and satisfaction
timeFrame: 3 months after the start of antidepressants treatment
measure: Enjoyment and satisfaction
timeFrame: 6 months after the start of antidepressants treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Sophie Liekens, M Psy
role: PRINCIPAL_INVESTIGATOR
References: