Effects telephone counselling intervention by pharmacist on beliefs about medicines for patients starting treatment: Results of an interim analysis of a cluster randomized controlled trial

Background and objective: Adherence to medication is often low. Goal of this study is to assess the effects of Telephone Counselling Intervention by Pharmacist (TelCIP) at the start of therapy on patient beliefs, satisfaction with information about medicines and refill adherence. Setting and method: A Cluster Randomized Controlled Trial with 26 Dutch pharmacies that were randomly assigned to 1 of the 2 intervention groups. Each group consisted of an intervention (TelCIP) arm and an usual care arm. The TelCIP arm in the first group was the usual care arm in the second group and vice versa. One group focuses on patients starting with antidepressants or bisphosponates and the other on antilipaemic drugs or renin angiotensin system (RAS)-inhibiters. TelCIP is a telephone call initiated by a pharmacist 2 or 3 weeks after the first prescription. A selection of pharmacies sent questionnaires 3 months after the first prescription which contained sociodemographic questions, a measure of beliefs about medicines (BMQ), satisfaction with information received (SIMS) and frequency of pharmacy counselling (Consumer Quality Index, CQI). Main outcome measures: Beliefs about medicines is expressed as the necessity-concerns differential. The SIMS and CQI result in a dichotomous outcome. Results: In this interim analysis, 69 patients in the TelCIP arm responded (Intention to treat, ITT) of which 52 actual received the telephone call (Per protocol, PP). In the usual care arm 306 patients responded. There were no differences at baseline in gender, age or firstrefill medication. In the ITT-analysis the necessity-concerns differential was 1.1 [95 %CI-0.2 to 2.4] higher in the TelCIP arm, compared to usual care in the PP analysis the differential was 1.5 [95 %CI 0.0 to 2.9] points higher. Of the patients in the TelCIP arm 50 % (ITT) and 51 % (PP) were satisfied about the information given about side-effects compared to 39 % in the usual care arm but this difference was not significant (p = 0.13 respectively 0.13). The difference on the other SIMS items was less than 10 %. In the TelCIP arm, patients were more frequently asked about their experiences and about the occurrence of side-effects and whether they manage to use medicine as prescribed (

Effects telephone counselling intervention by pharmacist on beliefs about medicines for patients starting treatment: Results of an interim analysis of a cluster randomized controlled trial

Background and objective: Adherence to medication is often low. Goal of this study is to assess the effects of Telephone Counselling Intervention by Pharmacist (TelCIP) at the start of therapy on patient beliefs, satisfaction with information about medicines and refill adherence. Setting and method: A Cluster Randomized Controlled Trial with 26 Dutch pharmacies that were randomly assigned to 1 of the 2 intervention groups. Each group consisted of an intervention (TelCIP) arm and an usual care arm. The TelCIP arm in the first group was the usual care arm in the second group and vice versa. One group focuses on patients starting with antidepressants or bisphosponates and the other on antilipaemic drugs or renin angiotensin system (RAS)-inhibiters. TelCIP is a telephone call initiated by a pharmacist 2 or 3 weeks after the first prescription. A selection of pharmacies sent questionnaires 3 months after the first prescription which contained sociodemographic questions, a measure of beliefs about medicines (BMQ), satisfaction with information received (SIMS) and frequency of pharmacy counselling (Consumer Quality Index, CQI). Main outcome measures: Beliefs about medicines is expressed as the necessity-concerns differential. The SIMS and CQI result in a dichotomous outcome. Results: In this interim analysis, 69 patients in the TelCIP arm responded (Intention to treat, ITT) of which 52 actual received the telephone call (Per protocol, PP). In the usual care arm 306 patients responded. There were no differences at baseline in gender, age or firstrefill medication. In the ITT-analysis the necessity-concerns differential was 1.1 [95 %CI-0.2 to 2.4] higher in the TelCIP arm, compared to usual care in the PP analysis the differential was 1.5 [95 %CI 0.0 to 2.9] points higher. Of the patients in the TelCIP arm 50 % (ITT) and 51 % (PP) were satisfied about the information given about side-effects compared to 39 % in the usual care arm but this difference was not significant (p = 0.13 respectively 0.13). The difference on the other SIMS items was less than 10 %. In the TelCIP arm, patients were more frequently asked about their experiences and about the occurrence of side-effects and whether they manage to use medicine as prescribed (

Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence : Results of a Cluster Randomized Trial

OBJECTIVES: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. DESIGN: Pragmatic cluster randomized controlled trial. SETTING: 53 Community pharmacies in The Netherlands. PARTICIPANTS: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. INTERVENTION: INTERVENTION consisted of a telephone counseling intervention 7-21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. MAIN OUTCOME MEASURE: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. RESULTS: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11-1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. CONCLUSIONS: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per protocol analysis indicated an improvement for lipid lowering drugs and bisphosphonates. No effect for on adherence in patients initiating antidepressants was found. The trial was registered at www.trialregister.nl under the identifier NTR3237

Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence: Results of a Cluster Randomized Trial

OBJECTIVES: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. DESIGN: Pragmatic cluster randomized controlled trial. SETTING: 53 Community pharmacies in The Netherlands. PARTICIPANTS: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. INTERVENTION: INTERVENTION consisted of a telephone counseling intervention 7-21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. MAIN OUTCOME MEASURE: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. RESULTS: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11-1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. CONCLUSIONS: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per protocol analysis indicated an improvement for lipid lowering drugs and bisphosphonates. No effect for on adherence in patients initiating antidepressants was found. The trial was registered at www.trialregister.nl under the identifier NTR3237