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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Antidepressant

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Pharmacists received no depression training, delivered usual care to patients starting a new treatment with depression. | |
| Intervention group<br>Pharmacists received a depression training day and provided structured medication counselling to patients starting a new treatment with antidepressants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Medication adherence measured by the MMAS-8 | 1 month after start of antidepressants treatment | 
| Medication adherence | Medication adherence measured by the MMAS-8 | 3 months after start of antidepressants treatment | 
| Medication adherence | Medication adherence measured by the MMAS-8 | 6 months after start of antidepressants treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic outcomes | Economic outcomes are measured by the WPAI | at the start of antidepressants treatment | 
| Economic outcomes | Economic outcomes are measured by the WPAI | 1 month after the start of antidepressants treatment | 
| Economic outcomes | Economic outcomes are measured by the WPAI | 3 months after the start of antidepressants treatment | 
| Economic outcomes | Economic outcomes are measured by the WPAI | 6 months after the start of antidepressants treatment | 
| Clinical outcomes | Clinical outcomes are measured by the HADS | at the start of antidepressants treatment | 
| Clinical outcomes | Clinical outcomes are measured by the HADS | 1 month after the start of antidepressants treatment | 
| Clinical outcomes | Clinical outcomes are measured by the HADS | 3 months after the start of antidepressants treatment | 
| Clinical outcomes | Clinical outcomes are measured by the HADS | 6 months after the start of antidepressants treatment | 
| Beliefs about medicines | Patients' beliefs about medicines are measured by the BMQ | At the start of antidepressants treatment | 
| Beliefs about medicines | Patients' beliefs about medicines are measured by the BMQ | 1 month after the start of antidepressants treatment | 
| Beliefs about medicines | Patients' beliefs about medicines are measured by the BMQ | 3 months after the start of antidepressants treatment | 
| Beliefs about medicines | Patients' beliefs about medicines are measured by the BMQ | 6 months after the start of antidepressants treatment | 
| Satisfaction with the pharmacist | Patients' satisfaction with the pharmacist is measured by the SWiP | At the start of antidepressants treatment | 
| Satisfaction with the pharmacist | Patients' satisfaction with the pharmacist is measured by the SWiP | 1 month after the start of antidepressants treatment | 
| Satisfaction with the pharmacist | Patients' satisfaction with the pharmacist is measured by the SWiP | 3 months after the start of antidepressants treatment | 
| Satisfaction with the pharmacist | Patients' satisfaction with the pharmacist is measured by the SWiP | 6 months after the start of antidepressants treatment | 
| Feelings about side effects | Patients' feelings about side effects of antidepressants are measured by the FSE | 1 month after the start of antidepressants treatment | 
| Feelings about side effects | Patients' feelings about side effects of antidepressants are measured by the FSE | 3 months after the start of antidepressants treatment | 
| Feelings about side effects | Patients' feelings about side effects of antidepressants are measured by the FSE | 6 months after the start of antidepressants treatment | 
| Satisfaction with treatment | Patients' satisfaction with antidepressants treatment is measured by the SWT | 1 month after the start of antidepressants treatment | 
| Satisfaction with treatment | Patients' satisfaction with antidepressants treatment is measured by the SWT | 3 months after the start of antidepressants treatment | 
| Satisfaction with treatment | Patients' satisfaction with antidepressants treatment is measured by the SWT | 6 months after the start of antidepressants treatment | 
| Satisfaction with information regarding treatment | Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE | At the start of antidepressants treatment | 
| Satisfaction with information regarding treatment | Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE | 1 month after the start of antidepressants treatment | 
| Satisfaction with information regarding treatment | Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE | 3 months after the start of antidepressants treatment | 
| Satisfaction with information regarding treatment | Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE | 6 months after the start of antidepressants treatment | 
| Satisfaction with information regarding side effects | Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE | At the start of antidepressants treatment | 
| Satisfaction with information regarding side effects | Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE | 1 month after the start of antidepressants treatment | 
| Satisfaction with information regarding side effects | Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE | 3 months after the start of antidepressants treatment | 
| Satisfaction with information regarding side effects | Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE | 6 months after the start of antidepressants treatment | 
| Health-related quality of life | Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D | At the start of antidepressants treatment | 
| Health-related quality of life | Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D | 1 month after the start of antidepressants treatment | 
| Health-related quality of life | Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D | 3 months after the start of antidepressants treatment | 
| Health-related quality of life | Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D | 6 months after the start of antidepressants treatment | 
| Enjoyment and satisfaction | Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q | At the start of antidepressants treatment | 
| Enjoyment and satisfaction | Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q | 1 month after the start of antidepressants treatment | 
| Enjoyment and satisfaction | Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q | 3 months after the start of antidepressants treatment | 
| Enjoyment and satisfaction | Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q | 6 months after the start of antidepressants treatment |