- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02167737
The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (ED-STEADI)
"ED-STEADI:" The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (A Pilot Study)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This prospective, randomized controlled study will be conducted when there is a member of the research team available to consent patients at a Level I Trauma Center with approximately 90,000 annual ED visits across all age groups. Each potentially eligible patient will be identified by the research team and approached in the ED. Consented and enrolled patients will be assigned a study identification number and the enrollment documented by a member of the research team in the ED's electronic medical record after subjects are confirmed to meet inclusion and exclusion criteria. Subjects will be assigned randomly (by using a computer generated sequence) to either the control or intervention study arms.
Subjects in the control arm will have demographic data collected, a baseline Falls Efficacy Scale (FES) and Vulnerable Elders Survey (VES) screening completed and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). The FES and VES are validated surveys measuring fall concern and functional decline. The research team will advise them that they have a risk of falling as identified by inclusion criteria and that we are advising them to take action to prevent future falls. They will be given the brochure, "What YOU Can Do to Prevent Falls," that is standardized information recommended in the STEADI Tool Kit for Health Care Providers by the Centers for Disease Control (CDC).
Subjects in the active arm will also have demographic data collected, a baseline FES and VES screening completed, and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). Their risk of falling will be reviewed with them using a bedside decision aid indicating what they can do to decrease their risk. Particular attention will be given to personalizing their fall risk. The fall prevention management options will be presented in a value neutral fashion, along with the advantages and disadvantages of each option. They will have an opportunity to discuss what outcomes are the most important to them and choose the management options from the list provided that are the most valuable to them. Study and treatment team members will then work with this agreed upon selection to provide reliable intervention and outpatient follow up to improve the gains that can be realized in an integrated healthcare system. If the participant chooses to do their own home safety evaluation, they will be provided with a checklist to guide them in looking for hazards in their home and how to fix them. The patient will keep the original copy of their decision aid with their agreed-upon selected treatment options, and a copy of it will be placed in the subject's study file. All actions that are in response to the subject's selected plan (prescriptions, appointments, etc.) will also be documented in the study file.
Both groups will have phone follow-up at 6 weeks post ED visit, and then again at 3, 6, 9 and 12 months to collect self-reported data about goal completion and fall history. The last phone follow-up will include an exit FES and VES reassessment. All participants in both arms will have data collected about their inpatient and outpatient visits throughout the network during the study period to corroborate their self-report (e.g., occupational therapy, physical therapy visits, hospital admissions or ER visits for injuries related to a fall, etc.).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Estados Unidos, 18017
- Lehigh Valley Hospital, Emergency Medicine Research
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Patients must:
- Be 65 years of age or older
- Be discharged home from the ED
- Be able to speak English.
- Be competent and able to give consent (not in critical condition, intoxicated or otherwise incapacitated)
- Have a mechanical fall risk as defined by one of the following:
Reports to have fallen in the last year Reports worrying about falling Admits they feel unsteady when standing or walking
Exclusion Criteria:
Patients must not:
- Be younger than 65 years old
- Be discharged from the ED to anywhere, but home (i.e., must not be discharged to family member's home, personal care facility, nursing home, group home, etc.)
- Be unable to speak English
- Be incompetent and unable to give consent (in critical condition, intoxicated or otherwise incapacitated)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Bedside Decision Aid Group
This arm will include study participants who are randomized to the group utilizing the bedside decision aid, which has hospital staff arrange fall-risk reduction interventions (e.g., home safety checks, exercise programs, vision checks, etc.).
|
This group will have an initial FES and VES screening completed in the ED, the TUG test and Chair 30-Second Stand test, and the participant's risk of falling evaluated using our Bedside Decision worksheets. A study team member explains what subjects can do to decrease their risk of falling and discuss what mobility goals are the most important to them. Participants will receive a follow-up telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history. |
Comparador Ativo: Control Arm
Participants in the control/comparator arm will experience the same study procedures with the exception of not using the Bedside Decision Aid and instead being given the Centers for Disease Control (CDC) brochure, "What You Can Do to Prevent Falls," and arranging for their own fall prevention strategies.
|
This group will also have an initial FES and VES screening completed in the ED and the same two mobility tests (TUG and Chair 30-Second Stand). Study staff will advise subjects on how to take action to prevent falls and give them a brochure, "What YOU Can Do to Prevent Falls," from the CDC's "STEADI Tool Kit for Health Care Providers." Participants will receive a telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Efficacy of the bedside decision tool/worksheet
Prazo: 12 months
|
A single sheet bedside decision aid form/worksheet will be used to engage the patient in a discussion about fall prevention, the aim of which is to increase patient interest and participation in different management options that decrease fall risk.
Patients will be followed up via phone calls re: their management option choices and how thorough/successful they were in completing them.
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Gender differences in use of the decision tool
Prazo: 12 months
|
Responses from the bedside decision tool choices will be grouped by gender to determine if men and women select different management options and/or have different patterns in completing them.
|
12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Gender differences in fall management choices
Prazo: 12 months
|
Participants in *both* study arms will have phone follow-ups at the same time intervals to determine if men and women have different management option preferences and/or different patterns in completing them.
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marna R. Greenberg, DO, MPH, Lehigh Valley Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- #PRO-00001450
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Bedside Decision Aid
-
Unity Health TorontoAtivo, não recrutando
-
Christina Murphey, RN, PhDRescindidoDepressão | Insônia | Ansiedade | Qualidade do SonoEstados Unidos
-
Christina Murphey, RN, PhDSuspenso
-
Chinese University of Hong KongRecrutamentoColonoscopia de triagemHong Kong
-
Chinese University of Hong KongConcluído
-
University of Alabama at BirminghamNational Cancer Institute (NCI)RecrutamentoCâncer | Membros da famíliaEstados Unidos
-
University of Alabama at BirminghamConcluídoCâncer | Cuidadores familiaresEstados Unidos
-
Sakarya UniversityRecrutamentoGravidez relacionada | Náusea Grávida | Vômito da Gravidez | AcupressãoPeru
-
Fondazione Poliambulanza Istituto OspedalieroConcluídoAdenoma de cólon | Adenoma do cólonItália
-
University of PittsburghNational Institute on Minority Health and Health Disparities (NIMHD); University... e outros colaboradoresConcluídoContracepção | Comportamento contraceptivo | Saúde da mulher | Comportamento Reprodutivo | Esterilização TubáriaEstados Unidos