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Objectives: Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice., Design: Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation., Setting: 72 general practices in Hesse, Germany., Participants: 505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study., Interventions: Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care., Outcome Measures: The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months' follow-up: quality of life, functioning, medication adherence, and so on., Results: At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence)., Conclusions: The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement., Trial Registration Number: ISRCTN99526053. NCT01171339; Results., Competing Interests: Competing interests: CM, FMG, CG, MB, SH, WEH, JR and LU report receiving grants from the German Federal Ministry of Education and Research, BMBF, grant number 01GK0702, during the course of the study. WEH reports other grants from Dosing, Heidelberg, during the course of the study; he received personal fees, non-financial support and other from Aqua Institute Göttingen; personal fees, non-financial support and other from Aspen Europe; personal fees and other from Diaplan; grants, personal fees, non-financial support and other from Actelion; personal fees and other from GSK GER/UK/Slovakia/France; personal fees from Thieme Verlag; personal fees and other from Daiichi Sankyo; personal fees and other from Bristol-Myers Squibb; personal fees and other from MSD Sharp & Dohme; personal fees and other from AstraZenica; personal fees and other from Boehringer; personal fees and other from Grünenthal; personal fees and other from KWHC; personal fees and other from Novartis; personal fees and other from Berlin-Chemie; grants, personal fees and other from Landesapothekerkammer BW; grants and other from BMBF (DZIF, ESTHER); grants, personal fees, non-financial support and other from BayerPharma; grants from CHIESI; personal fees and other from Doctrina Med; personal fees and other from GSK France, UK, Germany, Slovakai; personal fees, non-financial support and other from Pfizer; grants from Smooth ClinicalTrials; grants from Sumaya Biotec; grants from Klaus Tschira Stiftung; other from University Frankfurt; grants from Vaximm, outside the submitted work. FO, MvdA, JMV, RP and JAK have nothing to disclose., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To improve medication appropriateness and adherence in elderly patients with multimorbidity, we developed a complex intervention involving general practitioners (GPs) and their healthcare assistants (HCA). In accordance with the Medical Research Council guidance on developing and evaluating complex interventions, we prepared for the main study by testing the feasibility of the intervention and study design in a cluster randomised pilot study., Setting: 20 general practices in Hesse, Germany., Participants: 100 cognitively intact patients ≥65 years with ≥3 chronic conditions, ≥5 chronic prescriptions and capable of participating in telephone interviews; 94 patients completed the study., Intervention: The HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision-support system (CDSS), the GPs discussed medication intake with patients and adjusted their medication regimens. The control group continued with usual care., Outcome Measures: Feasibility of the intervention and required time were assessed for GPs, HCAs and patients using mixed methods (questionnaires, interviews and case vignettes after completion of the study). The feasibility of the study was assessed concerning success of achieving recruitment targets, balancing cluster sizes and minimising drop-out rates. Exploratory outcomes included the medication appropriateness index (MAI), quality of life, functional status and adherence-related measures. MAI was evaluated blinded to group assignment, and intra-rater/inter-rater reliability was assessed for a subsample of prescriptions., Results: 10 practices were randomised and analysed per group. GPs/HCAs were satisfied with the interventions despite the time required (35/45 min/patient). In case vignettes, GPs/HCAs needed help using the CDSS. The study made no patients feel uneasy. Intra-rater/inter-rater reliability for MAI was excellent. Inclusion criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results., Conclusions: Intervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions., Trial Registration Number: ISRCTN99691973; Results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)