Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants

Completed

• Conditions: Depression; Antidepressant

• Registration Number: NCT02187380
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication adherence	6 months after start of antidepressants treatment	Medication adherence measured by the MMAS-8

Secondary Outcome Measures

Name	Time	Method
Feelings about side effects	6 months after the start of antidepressants treatment	Patients' feelings about side effects of antidepressants are measured by the FSE
Satisfaction with information regarding side effects	6 months after the start of antidepressants treatment	Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
Economic outcomes	6 months after the start of antidepressants treatment	Economic outcomes are measured by the WPAI
Beliefs about medicines	6 months after the start of antidepressants treatment	Patients' beliefs about medicines are measured by the BMQ
Satisfaction with treatment	6 months after the start of antidepressants treatment	Patients' satisfaction with antidepressants treatment is measured by the SWT
Clinical outcomes	6 months after the start of antidepressants treatment	Clinical outcomes are measured by the HADS
Satisfaction with the pharmacist	6 months after the start of antidepressants treatment	Patients' satisfaction with the pharmacist is measured by the SWiP
Health-related quality of life	6 months after the start of antidepressants treatment	Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
Enjoyment and satisfaction	6 months after the start of antidepressants treatment	Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
Satisfaction with information regarding treatment	6 months after the start of antidepressants treatment	Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium