Preventing Falls Through Enhanced Pharmaceutical Care
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States. Past research suggests that individuals taking four or more prescription medications are at increased risk for falls. CNS-active drugs (e.g., benzodiazepines), in particular, have been associated with increased risk. Research also suggests that interventions to reduce inappropriate medications can reduce the risk of falls. This finding comes primarily from multifaceted interventions, however, and the impact of medication modification, by itself, remains largely unknown.
This study is using a a randomized controlled clinical trial design to evaluate a falls prevention program targeting community-dwelling older adults through community pharmacies. The study focuses on individuals at high risk for future falls. Individuals in the intervention group receive an in-depth consultation concerning their current medications, conducted by a community pharmacist. The consultation is designed to elicit medication-related problems (e.g., orthostatic hypotension, daytime sedation). Problems identified during the consultation, and therapeutic recommendations designed to address these problems, are communicated to the prescribing physician. With physician approval, appropriate modifications are made to the patient's medication regimen. The primary study endpoints are: time to first fall and proportion of individuals who fall during the one-year follow-up period.
Two primary hypotheses will be tested.
- Compared to individuals in the control group, individuals in the intervention group will experience a 30% reduction in the hazard of falling (hazard ratio=0.70) for time to first fall following randomization.
- Compared to individuals in the control group, 25% fewer people in the intervention group will experience a fall during the one-year follow-up period.
If the intervention is effective in reducing falls, these effects should be mediated by improvements in the overall quality of medication use. Thus, we will also assess effects of the intervention on: change in the number of inappropriate medications prescribed and change in the number of CNS-active medications prescribed.
One secondary hypotheses will be tested.
1. Compared to individuals in the control group, individuals in the intervention group will experience a 40% reduction in the use of high-risk medications during the one-year follow-up period.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7505
- Injury Prevention Research Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Currently taking at least four prescription medications
- Currently taking at least one high risk medication
- At least one fall during 12 month period before study entry
- Able to speak and read English
Exclusion Criteria:
- Resident of a long-term care facility
- Cognitive impairment
- Housebound
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Pharmacist Care
Pharmacist Intervention
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Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen.
The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.
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Comparador Ativo: Control
Written information only group
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Participants receive written information about falls prevention.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Time to first fall
Prazo: One Year
|
One Year
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Proportion of participants who fall
Prazo: One Year
|
One Year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Use of high-risk medications
Prazo: One Year
|
One Year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 5-38047/0-401-4974
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