Implementation of a medicine management plan (MMP) to reduce medication-related harm (MRH) in older people post-hospital discharge: a randomised controlled trial.

BACKGROUND: Medication-related harm (MRH) is an escalating global challenge especially among older adults. The period following hospital discharge carries high-risk for MRH due to medication discrepancies, limited patient/carer education and support, and poor communication between hospital and community professionals. Discharge Medical Service (DMS), a newly introduced NHS scheme, aims to reduce post-discharge MRH through an electronic communication between hospital and community pharmacists. Our study team has previously developed a risk-prediction tool (RPT) for MRH in the 8-weeks period post discharge from a UK hospital cohort of 1280 patients. In this study, we aim to find out if a Medicines Management Plan (MMP) linked to the DMS is more effective than the DMS alone in reducing rates of MRH. METHOD: Using a randomized control trial design, 682 older adults ≥ 65 years due to be discharged from hospital will be recruited from 4 sites. Participants will be randomized to an intervention arm (individualised medicine management plan (MMP) plus DMS) or a control arm (DMS only) using a 1:1 ratio stratification. Baseline data will include patients' clinical and social demographics, and admission and discharge medications. At 8-weeks post-discharge, a telephone interview and review of GP records by the study pharmacist will verify MRH in both arms. An economic and process evaluation will assess the cost and acceptability of the study methods. DATA ANALYSIS: Univariate analysis will be done for baseline variables comparing the intervention and control arms. A multivariate logistic regression will be done incorporating these variables. Economic evaluation will compare the cost-of-service use among the study arms and modelled to provide national estimates. Qualitative data from focus-group interviews will explore practitioners' understanding, and acceptance of the MMP, DMS and the RPT. CONCLUSION: This study will inform the use of an objective, validated RPT for MRH among older adults after hospital discharge, and provide a clinical, economic, and service evaluation of a specific medicines management plan alongside the DMS in the National Health Service (UK).

Incidence and cost of medication harm in older adults following hospital discharge: a multicentre prospective study in the UK.

AIMS: Polypharmacy is increasingly common in older adults, placing them at risk of medication-related harm (MRH). Patients are particularly vulnerable to problems with their medications in the period following hospital discharge due to medication changes and poor information transfer between hospital and primary care. The aim of the present study was to investigate the incidence, severity, preventability and cost of MRH in older adults in England postdischarge. METHODS: An observational, multicentre, prospective cohort study recruited 1280 older adults (median age 82 years) from five teaching hospitals in Southern England, UK. Participants were followed up for 8 weeks by senior pharmacists, using three data sources (hospital readmission review, participant telephone interview and primary care records), to identify MRH and associated health service utilization. RESULTS: Overall, 413 participants (37%) experienced MRH (556 MRH events per 1000 discharges), of which 336 (81%) cases were serious and 214 (52%) potentially preventable. Four participants experienced fatal MRH. The most common MRH events were gastrointestinal (n = 158, 25%) or neurological (n = 111, 18%). The medicine classes associated with the highest risk of MRH were opiates, antibiotics and benzodiazepines. A total of 328 (79%) participants with MRH sought healthcare over the 8-week follow-up. The incidence of MRH-associated hospital readmission was 78 per 1000 discharges. Postdischarge MRH in older adults is estimated to cost the National Health Service £396 million annually, of which £243 million is potentially preventable. CONCLUSIONS: MRH is common in older adults following hospital discharge, and results in substantial use of healthcare resources.

Effectiveness of medication withdrawal in older fallers: results from the Improving Medication Prescribing to reduce Risk Of FALLs (IMPROveFALL) trial.

Objectives: To investigate the effect of withdrawal of fall-risk-increasing-drugs (FRIDs) versus 'care as usual' on reducing falls in community-dwelling older fallers. Design: Randomised multicentre trial Participants: Six hundred and twelve older adults who visited an Emergency Department (ED) because of a fall. Interventions: Withdrawal of FRIDs. Main Outcomes and Measures: Primary outcome was time to the first self-reported fall. Secondary outcomes were time to the second self-reported fall and to falls requiring a general practitioner (GP)-consultation or ED-visit. Intention-to-treat (primary) and a per-protocol (secondary) analysis were conducted. The hazard ratios (HRs) for time-to-fall were calculated using a Cox-regression model. Differences in cumulative incidence of falls were analysed using Poisson regression. Results: During 12 months follow-up, 91 (34%) control and 115 (37%) intervention participants experienced a fall; 35% of all attempted interventions were unsuccessful, either due to recurrence of the initial indication for prescribing, additional medication for newly diagnosed conditions or non-compliance. Compared to baseline, the overall percentage of users of ≥3 FRIDs at 12 months did not change in either the intervention or the control group. Our intervention did not have a significant effect on time to first fall (HR 1.17; 95% confidence interval 0.89­1.54), time to second fall (1.19; 0.78­1.82), time to first fall-related GP-consultation (0.66; 0.42­1.06) or time to first fall-related ED-visit (0.85; 0.43­1.68). Conclusion: In this population of complex multimorbid patients visiting an ED because of a fall, our single intervention of FRIDs-withdrawal was not effective in reducing falls. Trial Registration: Netherlands Trial Register NTR1593.

Cost-utility of medication withdrawal in older fallers: results from the improving medication prescribing to reduce risk of FALLs (IMPROveFALL) trial.

BACKGROUND: The use of Fall-Risk-Increasing-Drugs (FRIDs) has been associated with increased risk of falls and associated injuries. This study investigates the effect of withdrawal of FRIDs versus 'care as usual' on health-related quality of life (HRQoL), costs, and cost-utility in community-dwelling older fallers. METHODS: In a prospective multicenter randomized controlled trial FRIDs assessment combined with FRIDs-withdrawal or modification was compared with 'care as usual' in older persons, who visited the emergency department after experiencing a fall. For the calculation of costs the direct medical costs (intramural and extramural) and indirect costs (travel costs) were collected for a 12 month period. HRQoL was measured at baseline and at 12 months follow-up using the EuroQol-5D and Short Form-12 version 2. The change in EuroQol-5D and Short Form-12 scores over 12 months follow-up within the control and intervention groups was compared using the Wilcoxon Signed Rank test for continuous variables and the McNemar test for dichotomous variables. The change in scores between the control and intervention groups were compared using a two-way analysis of variance. RESULTS: We included 612 older persons who visited an emergency department because of a fall. The mean cost of the FRIDs intervention was €120 per patient. The total fall-related healthcare costs (without the intervention costs) did not differ significantly between the intervention group and the control group (€2204 versus €2285). However, the withdrawal of FRIDs reduced medication costs with a mean of €38 per participant. Furthermore, the control group had a greater decline in EuroQol-5D utility score during the 12-months follow-up than the intervention group (p = 0.02). The change in the Short Form-12 Physical Component Summary and Mental Component Summary scores did not differ significantly between the two groups. CONCLUSIONS: Withdrawal of FRID's in older persons who visited an emergency department due to a fall, did not lead to reduction of total health-care costs. However, the withdrawal of FRIDs reduced medication costs with a mean of €38 per participant in combination with less decline in HRQoL is an important result. TRIAL REGISTRATION: The trial is registered in the Netherlands Trial Register ( NTR1593 - October 1st 2008).

Protocol for a Prospective (P) study to develop a model to stratify the risk (RI) of medication (M) related harm in hospitalized elderly (E) patients in the UK (The PRIME study).

BACKGROUND: Medication related harm (MRH) is a common cause of morbidity and hospital admission in the elderly, and has significant cost implications for both primary and secondary healthcare resources. The development of risk prediction models has become an increasingly common phenomenon in medicine and can be useful to guide objective clinical decision making, resource allocation and intervention. There are no risk prediction models that are widely used in clinical practice to identify elderly patients at high risk of MRH following hospital discharge. The aim of this study is to develop a risk prediction model (RPM) to identify elderly patients at high risk of MRH upon discharge from hospital, and to compare this with routine clinical judgment. METHODS/DESIGN: This is a multi-centre, prospective observational study following a cohort of patients for 8 weeks after hospital discharge. Data collection including patient characteristics, medication use, social factors and frailty will take place prior to patient discharge and then the patient will be followed up in the community over the next 8 weeks to determine if they have experienced MRH. Research pharmacists will determine whether patients have experienced MRH by prospectively reviewing records for unplanned emergency department attendance, hospital readmission and GP consultation related to MRH. Research pharmacists will also telephone patients directly to determine self-reported MRH, which patients may not have sought further medical attention for. The data collected will inform the development of a RPM which will be externally validated in a follow-up study. DISCUSSION: There are no RPMs that are used in clinical practice to help stratify elderly patients at high risk of MRH in the community following hospital discharge, despite this being a significant public health problem. This study plans to develop a clinically useful RPM that is better than routine clinical judgment. As this is a multi-centre study involving clinical settings that serve elderly people of heterogeneous sociodemographic background, it is anticipated that this RPM will be generalizable.

Do lifestyle, health and social participation mediate educational inequalities in frailty worsening?

BACKGROUND: Lower educated older persons are at increased risk of becoming frail as compared with higher educated older persons. To reduce educational inequalities in the development of frailty, we investigated whether lifestyle, health and social participation mediate this relationship. METHODS: Longitudinal data of 14 082 European community-dwelling persons aged 55 years and older participating in the Survey on Health, Ageing, and Retirement in Europe (SHARE) in 2004 and 2006, were used. Associations of lifestyle (smoking behaviour and alcohol consumption), health (depression, memory function, chronic diseases) and social participation, with educational level and frailty worsening were investigated using regression models. In multinomial logistic regression analysis, mediators were added to models in which educational level was associated with worsening in frailty over 2 years follow-up. RESULTS: In all countries, frailty worsening was more prevalent among lower as compared with higher educated persons, although odds ratios were only statistically significant in five of the 11 countries included [ORs varying from 1.40 (95% CI: 1.06-1.84) to 1.61 (95% CI: 1.21-2.14)]. Except for smoking behaviour and memory function, the factors under study all showed associations with educational level and frailty worsening that met the conditions for mediation. After inclusion of the four relevant mediators, attenuation of odds ratios varied between 4.9 and 31.5%. CONCLUSION: While lifestyle, health and social participation were associated with frailty worsening over 2 years among European community-dwelling older persons, only small to moderate parts of educational inequalities in frailty worsening were explained by these factors.

Costs of falls in an ageing population: a nationwide study from the Netherlands (2007-2009).

BACKGROUND: Falls are a common mechanism of injury in the older population, putting an increasing demand on scarce healthcare resources. The objective of this study was to determine healthcare costs due to falls in the older population. METHODS: An incidence-based cost model was used to estimate the annual healthcare costs and costs per case spent on fall-related injuries in patients ≥ 65 years, The Netherlands (2007-2009). Costs were subdivided by age, gender, nature of injury, and type of resource use. RESULTS: In the period 2007-2009, each year 3% of all persons aged ≥ 65 years visited the Emergency Department due to a fall incident. Related medical costs were estimated at €675.4 million annually. Fractures led to 80% (€540 million) of the fall-related healthcare costs. The mean costs per fall were €9370, and were higher for women (€9990) than men (€7510) and increased with age (from €3900 at ages 65-69 years to €14,600 at ages ≥ 85 year). Persons ≥ 80 years accounted for 47% of all fall-related Emergency Department visits, and 66% of total costs. The costs of long-term care at home and in nursing homes showed the largest age-related increases and accounted together for 54% of the fall-related costs in older people. DISCUSSION: Fall-related injuries are leading to a high healthcare consumption and related healthcare costs, which increases with age. Programmes to prevent falls and fractures should be further implemented in order to reduce costs due to falls in the older population and to avoid that healthcare systems become overburdened.

Socio-demographic determinants of worsening in frailty among community-dwelling older people in 11 European countries.

BACKGROUND: The rapid increase of frail older people worldwide will have a substantial impact on healthcare systems. The frailty process may be delayed or even reversed, which makes it attractive for early interventions. However, little is known about the determinants of frailty state changes. The aim of this study is to compare socio-demographic determinants of worsening in frailty state in 11 European countries. METHODS: Data of 14,424 community-dwelling persons aged ≥55 years, enrolled in 2004 in the Survey of Health, Ageing and Retirement in Europe, were analysed. Three frailty states were identified (non-frail, pre-frail and frail) using Fried's criteria, and frailty state changes over a 2-year period were determined. Multinomial regression analyses adjusted for baseline frailty state were conducted to investigate whether sex, age, marital status and level of education determined a worsening in frailty state in the total and country-specific European population. RESULTS: Of all individuals, 22.1% worsened, 61.8% showed no change and 16.1% improved in frailty state. Women, those aged ≥65 years, and lower educated persons showed an increased risk of worsening in frailty state. In Southern European countries, there was an earlier and larger increase in risk of worsening in frailty state in life, which was more pronounced in women compared with men. CONCLUSIONS: In Europe, persons aged ≥65 years, women and lower educated persons are at increased risk of worsening in frailty state. Differences between countries indicate that interventions aimed at delaying the frailty process in Southern European countries should start earlier with more attention towards women.

Assessment and treatment of malnutrition in Dutch geriatric practice: consensus through a modified Delphi study.

OBJECTIVE: scientific evidence regarding the optimal management of malnutrition in geriatric patients is scarce. Our aim was to develop a consensus statement for geriatric hospital practice concerning six elements: (i) definition of malnutrition, (ii) screening and assessment, (iii) treatment and monitoring, (iv) roles and responsibilities of involved health care professionals, (v) communication and coordination of care between hospital and community health care professionals, (vi) quality indicators for malnutrition management. DESIGN: a modified Delphi study. METHODS: eleven geriatricians with special interest in malnutrition participated. In four rounds the experts rated the relevance of 204 statements, which were based on a literature review, on a five-point Likert scale. From the responses, means and 95% CIs were calculated. Consensus was defined as a lower 95% confidence limit ≥4.0. RESULTS: the panel reached consensus that malnutrition should be considered a geriatric syndrome. The nutritional status should be assessed using the Mini Nutritional Assessment combined with comprehensive geriatric assessment. Nutritional interventions should be combined with interventions targeting underlying factors. Specific goals for nutritional therapy and ways to achieve them were agreed upon. According to the experts, malnutrition is best managed by a multidisciplinary team for whom roles and responsibilities were specified. At discharge written information about the nutritional problem, treatment plan and goals should be provided to the patient, caregiver and community health care professionals. CONCLUSION: this study shows that a qualitative study based on a modified Delphi technique can result in national consensus on essential ingredients for a practical malnutrition guideline for geriatric patients.

[Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

BACKGROUND: Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. METHODS/DESIGN: A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. TRIAL REGISTRATION: The trial is registered in the Netherlands Trial Register (NTR1593).

Societal consequences of falls in the older population: injuries, healthcare costs, and long-term reduced quality of life.

BACKGROUND: Fall incidents are a major cause of morbidity and mortality in older adults. The aim of this cohort study was to determine the incidence, costs, and quality of life for fall-related injuries in the older Dutch population presenting at the emergency department. METHODS: Data on fall-related injuries in persons aged 65 years or older were retrieved from the Dutch Injury Surveillance System, which records injuries treated at the emergency department, and a patient follow-up survey conducted between 2003 and 2007. Injury incidence, discharge rates, healthcare costs, and quality of life measures were calculated. RESULTS: Fall-related injuries were to the upper or lower limb in 70% of cases and consisted mainly of fractures (60%), superficial injuries (21%), and open wounds (8%). Falls led to a total healthcare cost of €474.4 million, which represents 21% of total healthcare expenses due to injuries. Both admitted and nonadmitted patients reported a reduced quality of life up to 9 months after the injury. CONCLUSIONS: Fall-related injuries in older adults are age and gender related, leading to high healthcare consumption, costs, and long-term reduced quality of life. Further implementation of falls prevention strategies is needed to control the burden of fall-related injuries in the aging population.

Is the Tinetti Performance Oriented Mobility Assessment (POMA) a feasible and valid predictor of short-term fall risk in nursing home residents with dementia?

BACKGROUND: The feasibility and predictive validity of balance and gait measures in more severe stages of dementia have been understudied. We evaluated the clinimetric properties of the Tinetti Performance Oriented Mobility Assessment (POMA) in nursing home residents with dementia with a specific objective of predicting falls in the short term. METHODS: Seventy-five ambulatory nursing home residents with dementia, mean age 81 +/- 8 years, participated in a prospective cohort study. All participants underwent the full POMA-test. Fall statistics were retrieved from incident reports during a three-months follow-up period. The predictive validity was expressed in terms of sensitivity and specificity. Loglinear regression analysis was used to examine the relationship between POMA scores and the occurrence of a fall. RESULTS: The POMA showed several feasibility problems, with 41% of patients having problems in understanding one or more instructions. The inter-rater reliability of the instrument was good. The predictive validity was acceptable, with a sensitivity of 70-85% and a specificity of 51-61% for the POMA and its subtests, and an area under the curve (AUC) of 0.70 for POMA-Total (95% CI: 0.53-0.81), 0.67 for POMA-Balance (95% CI: 0.52-0.81), and 0.67 for POMA-Gait (95% CI: 0.53-0.81). After loglinear regression analysis, only POMA-T was significant in predicting a fall (adjusted HR = 1.08 per point lower; 95% CI 1.00-1.17). CONCLUSIONS: Application of the POMA in populations with moderate to severe dementia is hampered by feasibility problems. Its implementation in clinical practice cannot therefore be recommended, despite an acceptable predictive validity. To refine our findings, large prospective studies on the predictive validity of the POMA in populations with mild, moderate and severe dementia are needed. In addition, the performance of mobility assessment methods that are less dependent on cognition should be evaluated.

Cost effectiveness of withdrawal of fall-risk-increasing drugs in geriatric outpatients.

BACKGROUND: Withdrawal of fall-risk-increasing drugs has been proven to be effective in older persons. However, given the enormous rise in healthcare costs in recent decades, the effect of such withdrawals on healthcare costs also needs to be considered. METHOD: Within a common geriatric outpatient population, patients with a history of falls were assessed for falls risk (n = 139). Fall-risk-increasing drugs were withdrawn when appropriate (n = 75). All participants had a 2-month follow-up for fall incidents. The number of prevented falls was calculated using a loglinear regression model. The savings on health expenditures as a result of prevented injuries (estimated from a literature review) and reduced consumption of pharmaceuticals were compared with the intervention costs. RESULTS: After adjustment for confounders, drug withdrawal resulted in a falls risk reduction of 0.89 (95% CI 0.33, 0.98) per patient compared with the non-withdrawal group. Net cost savings were euro1691 (95% CI 662, 2181) per patient in the cohort. This resulted in a cost saving of euro491 (95% CI 465, 497) per prevented fall. CONCLUSION: Withdrawal of fall-risk-increasing drugs generates significant cost savings. Extrapolation of these findings to a national scale results in an estimated reduction of euro60 million in healthcare expenditures, that is, 15% of fall-related health costs.

Comprehensive Geriatric Assessment (CGA) in general practice: results from a pilot study in Vorarlberg, Austria.

BACKGROUND: Most comprehensive geriatric assessment (CGA) programs refer to hospital-based settings. However the body of geriatric healthcare is provided by general practitioners in their office. Structured geriatric problem detection by means of assessment instruments is crucial for efficient geriatric care giving in the community. METHODS: We developed and pilot tested a German language geriatric assessment instrument adapted for general practice. Nine general practices in a rural region of Austria participated in this cross-sectional study and consecutively enrolled 115 persons aged over 75 years. The prevalence of specific geriatric problems was assessed, as well as the frequency of initiated procedures following positive and negative tests. Whether findings were new to the physician was studied exemplarily for the items visual and hearing impairment and depression. The acceptability was recorded by means of self-administered questionnaires. RESULTS: On average, each patient reported 6.4 of 14 possible geriatric problems and further consequences resulted in 43.7% (27.5% to 59.8%) of each problem. The items with either the highest prevalence and/or the highest number of initiated actions by the GPs were osteoporosis risk, urinary incontinence, decreased hearing acuity, missing pneumococcal vaccination and fall risk. Visual impairment was newly detected in only 18% whereas hearing impairment and depression was new to the physician in 74.1% and 76.5%, respectively.A substantial number of interventions were initiated not only following positive tests (43.7% per item; 95% CI 27.5% to 59.8%), but also as a consequence of negative test results (11.3% per item; 95% CI 1.7% to 20.9%). The mean time expenditure to accomplish the assessment was 31 minutes (SD 10 min). Patients (89%) and all physicians confirmed the CGA to provide new information in general on the patient's health status. All physicians judged the CGA to be feasible in everyday practice. CONCLUSION: This adapted CGA was feasible and well accepted in the general practice sample. High frequencies of geriatric problems were detected prompting high numbers of problem-solving initiatives. But a substantial number of actions of the physicians following negative tests point to the risks of too aggressive treatment of elderly patients with possibly subsequent negative effects.