Project description:BackgroundA general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection).MethodsGPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings.ResultsFour GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data.ConclusionThe findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness.Trial registrationISRCTN18176245.
Project description:BackgroundPolypharmacy is frequently observed in hip fracture patients. Although it is associated with an increased risk of hip fracture, polypharmacy often continues after hip fracture recovery. This study aimed to evaluate the effectiveness of an intervention to improve appropriate polypharmacy for elderly patients admitted to the hospital for hip fractures.MethodsWe conducted a retrospective observational study to compare the outcomes of patients receiving the intervention (n?=?32) with those of patients who received usual care (n?=?132). All hip fracture patients aged 65 years or older and prescribed 5 or more medications at admission from January 2015 to December 2016 were included in the study. The intervention consisted of an assessment by internal medicine physicians of the appropriateness of polypharmacy and the de-prescription of any unnecessary medications during the patients' hospital stay. The primary composite outcome was death or the first occurrence of any new fracture. Comparisons between the intervention and usual care groups were analyzed using binary logistic regression.ResultsA total of 164 patients were included in the study. The mean patient age was 84.8 years, and the mean numbers of prescribed medications and potentially inappropriate medications at admission were 8.0 and 1.3, respectively. The mean follow-up period was 8.0 months. The primary composite outcome occurred in 35 (21.3%) patients. The total number of potentially inappropriate medications at discharge was significantly lower in the intervention group than in the usual care group (0.8?±?0.8 for the intervention group vs 1.1?±?1.0 for the usual care group; p?=?0.03). However, no significant differences in the primary composite outcome were found between the intervention and usual care groups (7 in the intervention group and 28 in the usual care group, odds ratio 1.04, 95% CI 0.41-2.65; p?=?1.00).ConclusionsThe intervention to improve appropriate polypharmacy was associated with a reduction in potentially inappropriate medications but not an improvement in clinical outcomes. This intervention, which focused only on polypharmacy, may not effectively improve outcomes for elderly patients with hip fractures.Trial registrationUMIN-CTR UMIN000025495 . Retrospectively registered 2 January 2017.
Project description:BackgroundFor older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI).MethodsThis external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT.ResultsTwelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two 'Go', three 'Amend').ConclusionDespite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions.Trial registrationISRCTN, ISRCTN41009897 . Registered 19 November 2019.Clinicaltrialsgov, NCT04181879 . Registered 02 December 2019.
Project description:BackgroundThe use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI).MethodsTwelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action.DiscussionThis pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT.Trial registrationISRCTN, ISRCTN41009897 . Registered 19 November 2019. ClinicalTrials.gov, NCT04181879 . Registered 02 December 2019.
Project description:BackgroundPrevious interventions have shown limited success in improving medication adherence in older adults, and this may be due to the lack of a theoretical underpinning.ObjectiveThis review sought to determine the effectiveness of theory-based interventions aimed at improving medication adherence in older adults prescribed polypharmacy and to explore the extent to which psychological theory informed their development.Data sourcesEight electronic databases were searched from inception to March 2015, and extensive hand-searching was conducted.Eligibility criteriaInterventions delivered to older adults (populations with a mean/median age of ≥65 years) prescribed polypharmacy (four or more regular oral/non-oral medicines) were eligible. Studies had to report an underpinning theory and measure at least one adherence and one clinical/humanistic outcome.Review methodsData were extracted independently by two reviewers and included details of intervention content, delivery, providers, participants, outcomes and theories used. The theory coding scheme (TCS) was used to assess the extent of theory use.ResultsFive studies cited theory as the basis for intervention development (social cognitive theory, health belief model, transtheoretical model, self-regulation model). The extent of theory use and intervention effectiveness in terms of adherence and clinical/humanistic outcomes varied across studies. No study made optimal use of theory as recommended in the TCS.ConclusionsThe heterogeneity observed and inclusion of pilot designs mean conclusions regarding effectiveness of theory-based interventions targeting older adults prescribed polypharmacy could not be drawn. Further primary research involving theory as a central component of intervention development is required. The review findings will help inform the design of future theory-based adherence interventions.
Project description:BackgroundThe PolyPrime intervention is a theory-based intervention aimed at improving appropriate polypharmacy in older people (aged ≥65 years) in primary care. The intervention consists of an online video which demonstrates how general practitioners (GPs) can prescribe appropriate polypharmacy during a consultation with an older patient and a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. The aim of the process evaluation is to further examine the implementation of the PolyPrime intervention in primary care. This will involve investigating whether the PolyPrime intervention can be delivered as intended across two healthcare systems, how acceptable the intervention is to GPs, practice staff and patients, and to identify the intervention's likely mechanisms of action.MethodsThe PolyPrime study is an external pilot cluster randomised controlled trial (cRCT) which aims to recruit 12 GP practices across Northern Ireland [NI] (n=6) and the six counties in the Republic of Ireland (ROI) that border NI (n=6). Practices have been randomised to intervention or usual care. An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention to GPs, practice staff and patients and potential mechanisms of action (i.e. what components of the intervention were perceived to be effective). Quantitative data will be collected from data collection forms completed by GPs and practice staff and a feedback questionnaire completed by patients from intervention arm practices, which will be analysed using descriptive statistics. Qualitative data will be collected through semi-structured interviews with GPs and practice staff and audio-recordings of medication review appointments from the intervention arm practices which will be transcribed and analysed using the framework method. Quantitative and qualitative data will be triangulated to provide an overall assessment of intervention fidelity, intervention acceptability, and mechanisms of action.DiscussionThis process evaluation will add to feasibility data from the pilot cRCT by providing evidence on the fidelity of implementing the intervention package across two healthcare systems, the acceptability of the intervention and potential mechanisms of action.Trial registrationClinicalTrials.gov ISRCTN41009897 . Registered on 19 November 2019. ClinicalTrials.gov NCT04181879 . Registered 02 December 2019.
Project description:Introduction:By the time an intervention is ready for evaluation in a definitive RCT the context of the evidence base may have evolved. To avoid research waste, it is imperative that intervention design and evaluation is an adaptive process incorporating emerging evidence and novel concepts. The aim of this study is to describe changes that were made to an evidence based intervention at the protocol stage of the definitive RCT to incorporate emerging evidence. Methods:The original evidence based intervention, a GP delivered web guided medication review, was modified in a five step process:Identification of core components of the original intervention.Literature review.Modification of the intervention.Pilot study.Final refinements. A framework, developed in public health research, was utilised to describe the modification process. Results:The population under investigation changed from older people with a potentially inappropriate prescription (PIP) to older people with significant polypharmacy, a proxy marker for complex multimorbidity. An assessment of treatment priorities and brown bag medication review, with a focus on deprescribing were incorporated into the original intervention. The number of repeat medicines was added as a primary outcome measure as were additional secondary patient reported outcome measures to assess treatment burden and attitudes towards deprescribing. Conclusions:A framework was used to systematically describe how and why the original intervention was modified, allowing the new intervention to build upon an effective and robustly developed intervention but also to be relevant in the context of the current evidence base.
Project description:BackgroundPolypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.ObjectiveTo test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.MethodsWe assessed the efficacy and safety of a 5-point checklist to be used by all physicians on the internal medicine wards of a Swiss hospital by comparing outcomes in 450 consecutive patients aged ≥65 years hospitalized after the introduction of the checklist, and in 450 consecutive patients ≥65 years hospitalized before the introduction of the checklist. The main measures were the proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to STOPP criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria.ResultsAt admission 59% of the 900 patients were taking > 5 drugs, 13% ≥ 10 drugs, 37% had ≥ 1 PIM and 25% ≥ 1 PPO. The introduction of the checklist was associated with a significant reduction by 22% of the risk of being prescribed ≥ 1 PIM at discharge (adjusted risk ratios [RR] 0.78; 95% CI: 0.68-0.94), but not with a reduction of at least 20% of the number of drugs prescribed at discharge, nor with a reduction of the risk of PPOs at discharge.ConclusionsThe introduction of an easy-to-use 5-point checklist aimed at supporting therapeutic reasoning of physicians on internal medicine wards significantly reduced the risk of prescriptions of inappropriate medications at discharge.
Project description:Background: Polypharmacy paves the way for non-adherence, adverse drug reactions, negative health outcomes, increased use of healthcare services and rising costs. Since it is most prevalent in the older adults, there is an urgent need for introducing effective strategies to prevent and manage the problem in this age group. Purpose: To perform a scoping review critically analysing the available literature referring to the issue of polypharmacy management in the older adults and provide narrative summary. Data sources: Articles published between January 2010-March 2018 indexed in CINHAL, EMBASE and PubMed addressing polypharmacy management in the older adults. Results: Our search identified 49 papers. Among the identified interventions, the most often recommended ones involved various types of drug reviews based on either implicit or explicit criteria. Implicit criteria-based approaches are used infrequently due to their subjectivity, and limited implementability. Most of the publications advocate the use of explicit criteria, such as e.g. STOPP/START, Beers and Medication Appropriateness Index (MAI). However, their applicability is also limited due to long lists of potentially inappropriate medications covered. To overcome this obstacle, such instruments are often embedded in computerised clinical decision support systems. Conclusion: Multiple approaches towards polypharmacy management are advised in current literature. They vary in terms of their complexity, applicability and usability, and no "gold standard" is identifiable. For practical reasons, explicit criteria-based drug reviews seem to be advisable. Having in mind that in general, polypharmacy management in the older adults is underused, both individual stakeholders, as well as policymakers should strengthen their efforts to promote these activities more strongly.
Project description:AimsFrailty is a complex geriatric syndrome resulting in decreased physiological reserves. Frailty and polypharmacy are common in older adults and the focus of extensive studies, although little is known about the impact they may have on each other. This is the first systematic review analysing the available evidence on the relationship between frailty and polypharmacy in older adults.MethodsSystematic review of quantitative studies. A comprehensive literature search for publications in English or Spanish was performed on MEDLINE, CINAHL, the Cochrane Database and PsycINFO in September 2017 without applying restrictions on the date of publication. Studies reporting any relationship between frailty and polypharmacy in older adults were considered.ResultsA total of 25 publications were included, all of them observational studies. Evaluation of Fried's frailty criteria was the most common approach, followed by the Edmonton Frail Scale and FRAIL scale. Sixteen of 18 cross-sectional analyses and five of seven longitudinal analyses demonstrated a significant association between an increased number of medications and frailty. The causal relationship is unclear and appears to be bidirectional. Our analysis of published data suggests that polypharmacy could be a major contributor to the development of frailty.ConclusionsA reduction of polypharmacy could be a cautious strategy to prevent and manage frailty. Further research is needed to confirm the possible benefits of reducing polypharmacy in the development, reversion or delay of frailty.