- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02543190
System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program (SWIFT)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
At the start of the study, inpatient and outpatient nurses, physicians and physicians assistants will be oriented to the intervention in the study and will be suggested that the intervention is standard of care based on the following study:
Nagle D, Pare T, Keenen E, Marcet K, Tizio S, Poylin V*. Ileostomy Pathway Virtually Eliminates Readmissions for Dehydration in New Ostomates. Diseases of the Colon and Rectum 2012; 55: 1266-1272.
The intervention patients will be subject to a compliance surveillance and intervention strategy (CSIS) administered by study personnel to encourage the following and persist with telephone calls if the following have not been achieved.
- Prospective audits by study personnel to check and encourage teaching in the clinic, teaching on the wards, and telephone follow up occurred.
- A self-assessment tool for patients and families to confirm understanding of the education materials.
- Coaching of inpatient nurses taking care of ileostomy patients by WOCN and/or the inpatient nurse champion
- Call from the clinic nurse practitioner or physician's assistant within 7 days of discharge to review the educational materials and administer a screening questionnaire to identify patients at risk of dehydration. In patients randomized to CSIS, study personnel will ensure this phone call is made.
The usual care arm will include no such surveillance.
The randomized study will be powered to detect a decrease in hospital readmission rates (all-cause) from 25% to 5%. Secondary outcomes include readmission due to dehydration and patient satisfaction (Surgical-CAHPS survey)
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Medical Center -Fairview
-
Saint Paul, Minnesota, Estados Unidos, 55114
- Colon and Rectal Surgery Associates
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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:
- Patients who are scheduled or who undergo ileostomy alone or as part of a multiple procedure operation
- patients who have had an ileostomy in the past are eligible
- patients who have an ileostomy to address a recent surgical complication are eligible
Exclusion Criteria:
- Patients who have an ileostomy already in place immediately prior to the procedure (ie. revision, transposition, or parastomal hernia procedures
- patients on dialysis
- patients who require chronic TPN, IVF, or have short gut
- non-English speaking patients who do not have easy access to an appropriate interpreter.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: compliance surveillance
|
External monitor to ensure compliance with an educational protocol.
|
Sem intervenção: Usual Care
educational session at the start of the study
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Readmission to the hospital
Prazo: 30 days after hospital discharge
|
30 days after hospital discharge
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patient satisfaction
Prazo: 3-6 months after surgery
|
S-CAHPS
|
3-6 months after surgery
|
Index length-of-stay
Prazo: Index length-of-stay
|
Time from surgical date to hospital discharge
|
Index length-of-stay
|
Emergency room visit
Prazo: 30 days after hospital discharge
|
Emergency room visits for any reason 30 days after surgery
|
30 days after hospital discharge
|
Total hospital-length-of-stay
Prazo: 30 days after hospital discharge
|
Total hospital length of stay for any reason after surgery
|
30 days after hospital discharge
|
Readmission due to dehydration or acute renal failure
Prazo: 30 days after hospital discharge
|
Dehydration by clinician assessment, acute renal failure defined as elevation in creatinine to >2 mg/dl, or oliguria/anuria
|
30 days after hospital discharge
|
Post-discharge follow up phone call
Prazo: 30 days after hospital discharge
|
Nurse, physician, or physician-assistant documentation of phone call to the patient that describes monitoring of ileostomy output volume
|
30 days after hospital discharge
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mary R Kwaan, MD, University of Minnesota
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
Outros números de identificação do estudo
- 1408M52923
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