Guidance 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 rate80%). between Latanoprostene bunod 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 1.11C1.99). 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. 0.05 to be statistically significant. For the descriptive and effect analyses we used R software version 3.1.2. (Austria, www.R-project.org). For multilevel analysis, library lme4 was used with lmer function for continuous outcomes, glmer function for dichotomous outcomes and survival function for Cox regression. In a secondary, exploratory analysis we tested several factors as potential modifying factors: age, gender, Chronic Disease Score (CDS), and the status score at baseline. The CDS uses medication dispensed, as a surrogate marker for chronic illness (Von Korff et al., 1992). The status score (SS) is used as a marker for the individual socioeconomic status (SES). The SS is based on the patient’s postal code and uses the average income, income, education and employment of persons living in that area (The statusscore presented by The Netherlands Institute for Social Research, 2014). Ethics and confidentiality The Medical Ethics Review Committee (METC) of the University Medical Centre Utrecht has considered our research proposal in a meeting on 13 July 2010 and concluded that the Dutch Medical Research Involving Human Subjects Act (WMO) was not applicable. Consequently the protocol was submitted to the departmental Institutional Review Board (IRB) which approved the study protocol. The trial was registered at www.trialregister.nl under the identifier NTR3237. Patients received an information letter and gave informed consent before participating. All patient data were anonymised at the pharmacies. Results Of 62 pharmacies that included patients in the study, dispensing data were available from 53 pharmacies (25 arm A and 28 arm B) (see Figure ?Figure1).1). In total 6731 patients were eligible (3627 control patients and 3094 intervention patients). A telephone call was registered for 1054 (34%) of the 3094 patients in the intervention arm. For 545 (18%) patients it was registered that the patient did not receive the intervention and for 1495 (48%) patients no registration was found. Overall, patients in the intervention arm were younger and more often female (Table ?(Table1).1). However this was mainly due to the slight unequal distribution of medication classes over both arms. In the appendix additional information is provided: health characteristics are presented in Table ?TableA1,A1, information at cluster level in Table ?TableA2A2 and on eligible patients without counseling in Table ?TableA3A3. Table 1 Baseline socio-demographic and health characteristics for each group at individual level. = 3637= 3094= 1054Mean age, years59.0 (15.1)56.9 (15.9)58.6 (15.8)Female, (%)1987 (54.6)1785 (57.7)644 (61.1)Mean status score?0.44 (1.29)?0.31 (1.20)?0.43 (1.27)Mean CDS3.3 (3.1)3.1 (3.1)3.4 (3.2)Patients starting with RAS-inhibitor= 1317= 850= 257Mean age, years61.1 (13.7)62.2 (13.0)63.8 (12.2)Female, (%)710 (53.9)439 (51.6)145 (56.4)Mean status score?0.62 (1.32)?0.01 (1.06)?0.08 (1.18)Mean CDS3.3 (3.1)3.3 (3.0)3.5 (2.9)Patients starting with statin= 1345= 839= 268Mean age, years60.6 (12.6)61.6 (11.5)62.5 (11.3)Female, (%)660 (49.1)414 (49.3)139 (51.9)Mean status score?0.60 (1.29)?0.02 (0.97)?0.01 (0.98)Mean CDS3.4 (2.9)3.4 (2.8)3.6 (2.8)Patients starting with bisphosphonate= 252= 319= 137Mean age, years66.5 (13.4)66.2 (13.5)67.8 (12.1)Female, (%)186 (73.8)251 (78.7)111 (81.0)Mean status score0.14 (1.12)?0.54 (1.25)?0.64 (1.23)Mean CDS4.8 (3.9)5.1 (3.7)5.4 (3.7)Patients starting with antidepressant= 723= 1086= 392Mean age, years49.4 (17.9)46.5 (16.1)49.3 (17.0)Female431 (59.6)681 (62.7)249 (63.5)Mean status score?0.03 (1.15)?0.70 (1.33)?0.89 (1.34)Mean CDS2.3 (2.9)2.2 (2.9)2.4 (3.1) Open in a separate window Values are numbers (percentages) unless stated otherwise. In a secondary analysis we compared baseline characteristics for patients with counseling (PP) to patients in the usual care arm. Patients with counseling starting with RAS-inhibitors (= 0.049) or statins (= 0.04) where slightly older compared to patients with usual care. Other characteristics were not significantly different. The most important reasons for not delivering the intervention were: no telephone number available (186,.For 545 (18%) patients it was registered that the patient did not receive the intervention and for 1495 (48%) patients no registration was found. Overall, patients in the intervention arm were younger and more often female (Table ?(Table1).1). 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 1.11C1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically Latanoprostene bunod 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 LRP8 antibody adherence in patients initiating RAS-inhibitors. The per protocol analysis indicated an improvement for lipid lowering drugs and bisphosphonates. Latanoprostene bunod No effect for on adherence in patients initiating antidepressants was found. The trial was registered at www.trialregister.nl under the identifier NTR3237. 0.05 to be statistically significant. For the descriptive and effect analyses we used R software version 3.1.2. (Austria, www.R-project.org). For multilevel analysis, library lme4 was used with lmer function for continuous outcomes, glmer function for dichotomous outcomes and survival function for Cox regression. In a secondary, exploratory analysis we tested several factors as potential modifying factors: age, gender, Chronic Disease Score (CDS), and the status score at baseline. The CDS uses medication dispensed, as a surrogate marker for chronic illness (Von Korff et al., 1992). The status score (SS) is used as a marker for the individual socioeconomic status (SES). The SS is based on the patient’s postal code and uses the average income, income, education and employment of persons living in that area (The statusscore presented by The Netherlands Institute for Social Study, 2014). Ethics and confidentiality The Medical Ethics Review Committee (METC) of the University or college Medical Centre Utrecht has regarded as our study proposal in a meeting on 13 July 2010 and concluded that the Dutch Medical Study Involving Human Subjects Act (WMO) was not applicable. As a result the protocol was submitted to the departmental Institutional Review Table (IRB) which authorized the study protocol. The trial was authorized at www.trialregister.nl under the identifier NTR3237. Individuals received an info letter and offered educated consent before participating. All individual data were anonymised Latanoprostene bunod in the pharmacies. Results Of 62 pharmacies that included individuals in the study, dispensing data were available from 53 pharmacies (25 arm A and 28 arm B) (observe Figure ?Number1).1). In total 6731 individuals were eligible (3627 control individuals and 3094 treatment individuals). A telephone call was authorized for 1054 (34%) of the 3094 individuals in the treatment arm. For 545 (18%) individuals it was authorized that the patient did not receive the treatment and for 1495 (48%) individuals no sign up was found. Overall, individuals in the treatment arm were more youthful and more often female (Table ?(Table1).1). However this was mainly due to the minor unequal distribution of medication classes over both arms. In the appendix additional information is definitely provided: health characteristics are offered in Table ?TableA1,A1, info at cluster level in Table ?TableA2A2 and about eligible individuals without counseling in Table ?TableA3A3. Table 1 Baseline socio-demographic and health characteristics for each group at individual level. = 3637= 3094= 1054Mean age, years59.0 (15.1)56.9 (15.9)58.6 (15.8)Female, (%)1987 (54.6)1785 (57.7)644 (61.1)Mean status score?0.44 (1.29)?0.31 (1.20)?0.43 (1.27)Mean CDS3.3 (3.1)3.1 (3.1)3.4 (3.2)Individuals starting with RAS-inhibitor= 1317= 850= 257Mean age, years61.1 (13.7)62.2 (13.0)63.8 (12.2)Woman, (%)710 (53.9)439 (51.6)145 (56.4)Mean status score?0.62 (1.32)?0.01 (1.06)?0.08 (1.18)Mean CDS3.3 (3.1)3.3 (3.0)3.5 (2.9)Individuals starting with statin= 1345= 839= 268Mean age, years60.6 (12.6)61.6 (11.5)62.5 (11.3)Female, (%)660 (49.1)414 (49.3)139 (51.9)Mean status score?0.60 (1.29)?0.02 (0.97)?0.01 (0.98)Mean CDS3.4 (2.9)3.4 (2.8)3.6 (2.8)Individuals starting with bisphosphonate= 252= 319= 137Mean age, years66.5 (13.4)66.2 (13.5)67.8 (12.1)Woman, (%)186 (73.8)251 (78.7)111 (81.0)Mean status score0.14 (1.12)?0.54 (1.25)?0.64 (1.23)Mean CDS4.8 (3.9)5.1 (3.7)5.4 (3.7)Individuals starting with antidepressant= 723= 1086= 392Mean age, years49.4 (17.9)46.5 (16.1)49.3 (17.0)Female431 (59.6)681 (62.7)249 (63.5)Mean status score?0.03 (1.15)?0.70 (1.33)?0.89 (1.34)Mean CDS2.3 (2.9)2.2 (2.9)2.4 (3.1) Open in a separate window Ideals are figures (percentages) unless stated otherwise. In a secondary analysis we compared baseline characteristics for individuals.