[Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).
BMC Geriatr
; 11: 48, 2011 Aug 21.
Article
en En
| MEDLINE
| ID: mdl-21854643
ABSTRACT
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).
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Accidentes por Caídas
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Preparaciones Farmacéuticas
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Health_economic_evaluation
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Observational_studies
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Prognostic_studies
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Qualitative_research
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Risk_factors_studies
Límite:
Aged
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Aged80
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Female
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Humans
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Male
Idioma:
En
Revista:
BMC Geriatr
Asunto de la revista:
GERIATRIA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Países Bajos