In aging populations, multimorbidity (two or more chronic diseases in the same person [1, 2] is very common [3-5]. Patients with multimorbidity have complex health and social needs, are at risk of being admitted to the hospital or residential care home and require a wide range of interventions [6]. To satisfy the needs of these patients and their families, new innovative integrated care models are needed. To be effective, they should have primary care as the cornerstone of care [7]; effective integration between care levels [8, 9]; empowered patient´ and carers/families' [8]; and it should be patient-centered. The use of information and communication technology (ICT) platforms could
BackgroundThis paper crystallises the experience developed by the pan-European PALANTE Consortium in dealing with the generation of relevant evidence from heterogeneous eHealth services for patient empowerment in nine European Regions. The European Commission (EC) recently funded a number of pan-European eHealth projects aimed at empowering European patients/citizens thus transforming the traditional patient/citizen role in the management of their health (e.g., PALANTE, SUSTAIN, CARRE, HeartCycle, Empower). However, the heterogeneity of the healthcare systems, of the implemented services and of the target patients, the use of ad-hoc definitions of the salient concepts and the development of small-size experiences have prevented the dissemination of “global” results and the development of cumulative knowledge. The main challenge has been the generation of large-scale evidence from heterogeneous small-size experiences.DiscussionThree lessons have been collectively learnt during the development of the PALANTE project, which involves 9 sites that have implemented different eHealth services for empowering different typologies of patients. These lessons have been refined progressively through project meetings, reviews with the EC Project Officer and Reviewers. The paper illustrates the ten steps followed to develop the three lessons.The first lesson learnt is about how EC-funded projects should develop cumulative knowledge by avoiding self-crafted measures of outcome and by adopting literature-grounded definitions and scales. The second lesson learnt is about how EC-funded projects should identify ambitious, cross-pilot policy and research questions that allow pooling of data from across heterogeneous experiences even if a multi-centre study design was not agreed before. The third lesson learnt is about how EC-funded projects should open their collections of data and make them freely-accessible to the scientific community shortly after the conclusion of the project in order to guarantee the replicability of results and conclusions.SummaryThe three lessons might provide original elements for fuelling the ongoing debate about the capability of the EC to develop evidence-based policies by pooling evidence from heterogeneous, local experiences.
IntroductionClinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy.Methods and analysisPlanned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter. Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients. Population: patients (≥18 years) with polypharmacy (≥5 prescriptions). Sample size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved. Intervention: complex intervention eMMa. Follow-up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa. Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse. Statistical analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints.Ethics and disseminationTrial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences.Trial registrationNCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).
Background To investigate patients’ perspectives on polypharmacy and the use of a digital decision support system to assist general practitioners (GPs) in performing medication reviews. Methods Qualitative interviews with patients or informal caregivers recruited from participants in a cluster-randomized controlled clinical trial (cRCT). The interviews were transcribed verbatim and analyzed using thematic analysis. Results We conducted 13 interviews and identified the following seven themes: the patients successfully integrated medication use in their everyday lives, used medication plans, had both good and bad personal experiences with their drugs, regarded their healthcare providers as the main source of medication-related information, discussed medication changes with their GPs, had trusting relationships with them, and viewed the use of digital decision support tools for medication reviews positively. No unwanted adverse effects were reported. Conclusions Despite drug-related problems, patients appeared to cope well with their medications. They also trusted their GPs, despite acknowledging polypharmacy to be a complex field for them. The use of a digital support system was appreciated and linked to the hope that reasons for selecting specific medication regimens would become more comprehensible. Further research with a more diverse sampling might add more patient perspectives. Trial registration ClinicalTrials.gov, NCT03430336. Registered on February 6, 2018.
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