Effectiveness of a medication adherence management intervention in a community pharmacy setting: a cluster randomised controlled trial.

BACKGROUND: Non-adherence to medications continues to be a burden worldwide, with significant negative consequences. Community pharmacist interventions seem to be effective at improving medication adherence. However, more evidence is needed regarding their impact on disease-specific outcomes. The aim was to evaluate the impact of a community pharmacist-led adherence management intervention on adherence and clinical outcomes in patients with hypertension, asthma and chronic obstructive pulmonary disease (COPD). METHODS: A 6-month cluster randomised controlled trial was conducted in Spanish community pharmacies. Patients suffering from hypertension, asthma and COPD were recruited. Patients in the intervention group received a medication adherence management intervention and the control group received usual care. The intervention was based on theoretical frameworks for changing patient behaviour. Medication adherence, disease-specific outcomes (Asthma Control Questionnaire (ACQ) scores, Clinical COPD Questionnaire (CCQ) scores and blood pressure levels) and disease control were evaluated. A multilevel regression model was used to analyse the data. RESULTS: Ninety-eight pharmacies and 1186 patients were recruited, with 1038 patients completing the study. Patients receiving the intervention had an OR of 5.12 (95% CI 3.20 to 8.20, p<0.05) of being adherent after the 6 months. At the end of the study, patients in the intervention group had lower diastolic blood pressure levels (mean difference (MD) -2.88, 95% CI -5.33 to -0.43, p=0.02), lower CCQ scores (MD -0.50, 95% CI -0.82 to -0.18, p<0.05) and lower ACQ scores (MD -0.28, 95% CI -0.56 to 0.00, p<0.05) when compared with the control group. CONCLUSIONS: A community pharmacist-led medication adherence intervention was effective at improving medication adherence and clinical outcomes in patients suffering from hypertension, asthma and COPD. Future research should explore the implementation of these interventions in routine practice. TRIAL REGISTRATION NUMBER: ACTRN12618000410257.

Using network analysis to explore factors moderating the implementation of a medication review service in community pharmacy.

BACKGROUND: Implementation factors are hypothesised to moderate the implementation of innovations. Although individual barriers and facilitators have been identified for the implementation of different evidence-based services in pharmacy, relationships between implementation factors are usually not considered. OBJECTIVES: To examine how a network of implementation factors and the position of each factor within this network structure influences the implementation of a medication review service in community pharmacy. METHODS: A mixed methods approach was used. Medication review with follow-up service was the innovation to be implemented over 12 months in community pharmacies. A network analysis to model relationships between implementation factors was undertaken. Two networks were created. RESULTS: Implementation factors hindering the service implementation with the highest centrality measures were time, motivation, recruitment, individual identification with the organization and personal characteristics of the pharmacists. Three hundred and sixty-nine different interrelationships between implementation factors were identified. Important causal relationships between implementation factors included: workflow-time; characteristics of the pharmacy-time; personal characteristics of the pharmacists-motivation. Implementation factors facilitating the implementation of the service with highest centrality scores were motivation, individual identification with the organization, beliefs, adaptability, recruitment, external support and leadership. Four hundred and fifty-six different interrelationships were identified. The important causal relationships included: motivation-external support; structure-characteristics of the pharmacy; demographics-location of the pharmacy. CONCLUSION: Network analysis has proven to be a useful technique to explore networks of factors moderating the implementation of a pharmacy service. Relationships were complex with most implementation factors being interrelated. Motivation and individual identification with the organisation seemed critical factors in both hindering and facilitating the service implementation. The results can inform the design of implementation programs and tailored strategies to promote faster implementation of innovations in pharmacy.

Cost-Utility Analysis of a Medication Adherence Management Service Alongside a Cluster Randomized Control Trial in Community Pharmacy.

BACKGROUND: It is necessary to determine the cost utility of adherence interventions in chronic diseases due to humanistic and economic burden of non-adherence. PURPOSE: To evaluate, alongside a cluster-randomized controlled trial, the cost-utility of a pharmacist-led medication adherence management service (MAMS) compared with usual care in community pharmacies. MATERIALS AND METHODS: The trial was conducted over six months. Patients with treatments for hypertension, asthma or chronic obstructive pulmonary disease (COPD) were included. Patients in the intervention group (IG) received a MAMS based on a brief complex intervention, whilst patients in the control group (CG) received usual care. The cost-utility analysis adopted a health system perspective. Costs related to medications, healthcare resources and adherence intervention were included. The effectiveness was estimated as quality-adjusted life years (QALYs), using a multiple imputation missing data model. The incremental cost-utility ratio (ICUR) was calculated on the total sample of patients. RESULTS: A total of 1186 patients were enrolled (IG: 633; CG: 553). The total intervention cost was estimated to be €27.33 ± 0.43 per patient for six months. There was no statistically significant difference in total cost of medications and healthcare resources per patient between IG and CG. The values of EQ-5D-5L at 6 months were significantly higher in the IG [IG: 0.881 ± 0.005 vs CG: 0.833 ± 0.006; p = 0.000]. In the base case, the service was more expensive and more effective than usual care, resulting in an ICUR of €1,494.82/QALY. In the complete case, the service resulted in an ICUR of €2,086.30/QALY, positioned between the north-east and south-east quadrants of the cost-utility plane. Using a threshold value of €20,000/QALY gained, there is a 99% probability that the intervention is cost-effective. CONCLUSION: The medication adherence management service resulted in an improvement in the quality of life of the population with chronic disease, with similar costs compared to usual care. The service is cost-effective.

Clinical impact of a pharmacist-led medication review with follow up for aged polypharmacy patients: a cluster randomized controlled trial

BACKGROUND: Medication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE. OBJECTIVE: The main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision. METHODS: An open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care. RESULTS: 178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95%CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%). CONCLUSIONS: This study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines

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Clinical impact of a pharmacist-led medication review with follow up for aged polypharmacy patients: A cluster randomized controlled trial.

BACKGROUND: Medication review with follow-up (MRF) is a service where community pharmacists undertake a medication review with monthly follow-up to provide continuing care. The ConSIGUE Program assessed the impact and implementation of MRF for aged polypharmacy patients in Spanish Community Pharmacies. The present paper reports on the clinical impact evaluation phase of ConSIGUE. OBJECTIVE: The main objective of the study was to measure the effect of MRF on the primary outcome of the number of uncontrolled health problems. Secondary objectives were to analyze the drug-related problems (DRPs) identified as potential causes of ineffective or unsafe medications and the pharmacists' interventions implemented during MRF provision. METHODS: An open-label multi-centered cluster randomized study with comparison group (CG) was carried out in community pharmacies from 4 provinces in Spain during 6 months. The main inclusion criteria were patients over 64 years old, using 5 or more medicines. The intervention group (IG) received the MRF service (advanced medication review-type 3 MR) whereas patients in the CG received usual care. RESULTS: 178 pharmacies recruited 1403 patients (IG= 688 patients; CG= 715 patients). During the 6 months of the study 72 patients were lost to follow up. The adjusted multi-level random effects models showed a significant reduction in the number of uncontrolled health problems over the periods in the IG (-0.72, 95% CI: -0.80, -0.65) and no change in the CG (-0.03, 95% CI: -0.10, 0.04). Main DRPs identified as potential causes of failures of uncontrolled health problems' treatment were undertreated condition (559 DRPs; 35.81%), lack of treatment adherence (261 DRP; 16.67%) and risk of adverse effects (207 DRPs; 13.53%). Interventions performed by pharmacist to solve DRP mainly included the addition (246 interventions; 14.67%) and change (330 interventions; 19.68%) of a medicine and educational interventions on medicine adherence (231 interventions; 13.78%) and non-pharmacological interventions (369 interventions; 22.01%). CONCLUSIONS: This study provides evidence of the impact of community pharmacist on clinical outcomes for aged patients. It suggests that the provision of an MRF in collaboration with general medical practitioners and patients contributes to the improvement of aged polypharmacy patients' health status and reduces their problems related with the use of medicines.

Evaluating an implementation programme for medication review with follow-up in community pharmacy using a hybrid effectiveness study design: translating evidence into practice.

OBJECTIVES: To evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT). SETTING: Community pharmacies in Spain. PARTICIPANTS: 135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over. INTERVENTION: The intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT. RESULTS: 55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed. CONCLUSIONS: The implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete. TRIAL REGISTRATION NUMBER: CGFTRA-2017-01.