- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07925710
Osteoarthritis Care Tools for Primary Care Providers in Family Medicine and Geriatrics Clinics
OACareTools PLUS (OACareTools Primary Care-Led Usability & Scalability Study): Aim 3 Implementation and Evaluation
The purpose of this study is to test the implementation of OACareTools+, a program designed to help healthcare providers connect adults with arthritis to physical activity programs. OACareTools+ includes provider training, patient resources, and tools to make referrals easier. The goal is to increase awareness of programs like Walk With Ease and help more people with arthritis participate in them.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Participants will be clinicians (n= 165) in geriatrics and family medicine clinics and a subset of patients (n=30). The study team will deliver education and resources to providers in a training session about Walk With Ease. After the provider training, providers will use the study resources to refer patients with arthritis to Walk With Ease. Healthcare provider participants will complete surveys after their first referral and at the end of the study (12-months). Patient participants who are referred to Walk With Ease through the OACareTools+ intervention will be invited to participate in interviews about their experience (6-weeks) with the referral process. Primary endpoints of the study will be 1) number of healthcare providers that referred patients to Walk With Ease 2) number of Walk With Ease patient participants 3) healthcare provider acceptability and feasibility 4) patient acceptability of the intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Katie Huffman
- Número de telefone: 919-962-5145
- E-mail: katie_huffman@med.unc.edu
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- UNC Thurston Arthritis Research Center
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Contato:
- Katie Huffman
- Número de telefone: 919-962-5145
- E-mail: katie_huffman@med.unc.edu
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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:
- Healthcare provider participants: currently a healthcare provider or staff person in the UNC study clinics (Geriatrics and Family Medicine)
- Patient participants: 18 years or older; received a referral to Walk With Ease from a provider at a UNC study clinic or used clinic flyers to register for Walk with Ease and agreed to participate in the phone interview on the post-Walk With Ease evaluation form
Exclusion Criteria:
- Both: non-English speaking
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Healthcare providers
Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
Outros nomes:
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Experimental: Patients
A subset of patients who are referred through OACareTools+ to Walk With Ease will provide feedback on their experience with the referral process to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Healthcare provider acceptability
Prazo: Measure collected up to 2 months after provider's first referral
|
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
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Healthcare provider feasibility
Prazo: Measure collected up to 2 months after provider's first referral
|
The Feasibility of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater feasibility; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
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Patient acceptability
Prazo: 6-weeks post- Walk With Ease registration
|
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via telephone interview. |
6-weeks post- Walk With Ease registration
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Patient usefulness: clinician referral to Walk With Ease
Prazo: 6-weeks post- Walk With Ease registration
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During a phone interview, patients will be asked, "How helpful was it to talk with healthcare provider about physical activity and Walk With Ease?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post- Walk With Ease registration
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Number of healthcare providers who referred patients
Prazo: 12 months
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Healthcare providers in the study clinics who refer patients to the Walk With Ease program using the study referral process and resources |
12 months
|
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Number of patients who registered for Walk with Ease
Prazo: 12 months
|
Patients from the study clinics who register in the Walk With Ease program |
12 months
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Patient usefulness: educational resources
Prazo: 6-weeks post-Walk with Ease registration
|
During a phone interview, patients will be asked, "How helpful were the education materials given to you by your healthcare provider?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post-Walk with Ease registration
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Leigh Callahan, PhD, UNC Thurston Arthritis Research Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
- 26-2715
- 1U48DP006837-01 (Concessão/Contrato do NIH dos EUA)
- 1 U48DP006837-01-03 (Número de outro subsídio/financiamento: Centers for Disease Control and Prevention)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Data collected include: pre/post walking program assessments, referral count, patient engagement metrics, arthritis outcomes, satisfaction (provider and patient). Qualitative data will be available in the form of a summary.
Prazo de Compartilhamento de IPD
Beginning 9 and continuing for 36 months following publication.
Critérios de acesso de compartilhamento IPD
Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
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