- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05986214
Desenvolvendo uma intervenção para otimizar a adoção de cuidados virtuais para o gerenciamento da DPOC (VC-OPTIONS)
Desenvolvendo uma intervenção para otimizar a adoção de cuidados virtuais para o gerenciamento da DPOC (CDA 21-187)
VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This single-arm pilot will assess the feasibility and acceptability of VC-OPTIONS, as well as engagement and preliminary effectiveness specific to VC adoption, such as change in patient awareness of VC services. The investigators hypothesize that developing educational content about VC that can be delivered via text messaging will be an effective way to empower Veterans with knowledge and support them in their decision to adopt VC if they are interested.
Setting and design.
This feasibility pilot will be conducted at the VA Bedford and/or Boston Healthcare Systems. This pilot study will use quantitative data to assess patient and team perceptions of feasibility and acceptability, and preliminary effectiveness of the intervention. VC-OPTIONS will include patient- and team-facing strategies. The core component will be the delivery of educational content about VC for COPD via Annie text messaging. Other patient- and healthcare team-facing strategies will be refined in prior, preparatory aims.
Patient level. 40 eligible and interested Veterans will be assigned to the core patient-facing implementation strategy, the Annie texting protocol. Preparatory work will shape final length of protocol, content, and frequency of messages. The texting protocol as currently envisioned will span 12 weeks (1 module [Appendix 5] with up to 5 messages per week, and 2 messages every 4 weeks that ask about behavioral intention). Participants will receive compensation for initial baseline assessments and additional compensation after completion of the follow-up assessments.
Team-level. Pre-implementation meetings with local clinical team stakeholders (e.g., leadership, clinical team members, local telehealth/connected care coordinators) will be held to discuss site-level needs and contextual factors. Potential team-facing strategy components, developed during preparatory aims, will be presented and discussed to reach consensus and finalize the team-facing strategy components that are tailored to the site-level needs and resources.
Data collection. Patient-level. Recruitment procedures will be evaluated to inform a subsequent larger trial by examining how many potential participants agreed to participate in the intervention (feasibility and acceptability), and documenting reasons Veterans declined to participate. Participants will complete a baseline survey in person or over the phone to gather participant characteristics, VC awareness, current use of VC, and intent to use VC. Using Annie's two-way texting feature and dashboard, objective data will be collected on participant engagement during the protocol (i.e., how frequently participants respond to the texts, which patients received which modules, and completion rates). Engagement will also be assessed via survey at the post-evaluation. After completion of the texting protocol and clinical visit, data will be obtained via survey on the feasibility and acceptability of the core implementation component using the Feasibility of Intervention, Acceptability of Intervention, and Intervention Appropriateness measures. Preliminary effectiveness data will be gathered via surveys and clinical chart review on participants' awareness of VC, intention to adopt one or more VC options, intention to discuss VC with their clinical team, occurrence of patient-team communication about VC, and impact on COPD management.
Team-level. Clinical team perceptions of feasibility and acceptability will be measured quantitatively, such as through a brief survey to clinical team members who were exposed to the implementation components (e.g., those who attended the educational meetings, those who participated in clinical visits with participants who were enrolled in the texting protocol). Engagement will be measured by examining attendance of educational meetings. Preliminary effectiveness outcomes data will also be collected, including survey and chart-review to identify occurrence of conversations with patients about VC services (anticipated primary outcome of future IIR) and referrals to the Virtual Health Resource Centers or telehealth services and surveys to evaluate awareness of VC services before/after strategy deployment.
Data analysis. Summary statistics will be used to examine measurements and assess for perceptions of feasibility, acceptability, and preliminary effectiveness of the implementation strategy. The strategy components (the texting protocol, recruitment, and data collection procedures) will further be refined based on what is learned. Inferential analyses (paired t-tests or Wilcoxon signed rank tests) will be used to estimate effect sizes of changes between pre/post timepoints within individual participant. This feasibility pilot is not intended or powered to detect statistically significant changes in outcomes. Additionally, this pilot with no prospective control arm cannot definitively ascertain whether VC-OPTIONS causes leads to changes in effectiveness. These preliminary analyses seek to inform the design and generate effect size estimates.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Stephanie Robinson, PhD
- Número de telefone: (781) 687-4766
- E-mail: stephanie.robinson5@va.gov
Estude backup de contato
- Nome: Saige M Calkins, MA BA
- Número de telefone: 4414 (781) 687-4414
- E-mail: saige.calkins@va.gov
Locais de estudo
-
-
Massachusetts
-
Bedford, Massachusetts, Estados Unidos, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
-
Contato:
- Stephanie Robinson, PhD
- Número de telefone: (781) 687-4766
- E-mail: stephanie.robinson5@va.gov
-
Contato:
- Saige M Calkins, MA BA
- Número de telefone: 4414 (781) 687-4414
- E-mail: saige.calkins@va.gov
-
Investigador principal:
- Stephanie Robinson, PhD
-
Boston, Massachusetts, Estados Unidos, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
Contato:
- Marilyn Moy, MD
- E-mail: Marilyn.Moy@va.gov
-
Contato:
- Renda Wiener, MD
- E-mail: renda.wiener@va.gov
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- VHA user
- US Veteran
- Chronic obstructive pulmonary disease (COPD) diagnosis
- The ability to speak and understand English
- Own a text-enabled phone
Exclusion Criteria:
- Prior participation in preparatory research for the development of the intervention
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: VC-OPTIONS
Participants will be enrolled in the Annie texting VC-OPTIONS protocol |
Participants will be enrolled in the Annie texting VC-OPTIONS protocol
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility
Prazo: 12 Weeks
|
The feasibility of the core implementation component will be assessed with the Feasibility of Intervention Measure (FIM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): I can see other Veterans receiving these messages; I was able to respond to the text messages; texting with Annie was easy; the amount of messages I received from Annie was just right. |
12 Weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Acceptability
Prazo: 12 Weeks
|
The acceptability of the core implementation component will be assessed with the Acceptability of Intervention Measure (AIM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): I approved of the text messages I received; the text messages I received were appealing to me; I liked receiving and responding to the text messages I received; I welcomed the text messages I received. |
12 Weeks
|
|
Appropriateness
Prazo: 12 Weeks
|
The appropriateness of the core implementation component will be assessed with the Intervention Appropriateness Measure (IAM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): the text messages were fitting; the text messages were suitable, the text messages were applicable to me; the text messages were a good match with my COPD management needs. |
12 Weeks
|
|
Awareness of Virtual Care
Prazo: 12 Weeks
|
Change between baseline and 12 weeks in awareness of Virtual Care services will be assessed via survey, pre and post intervention, through the following question: which of the following VA services are you aware of? |
12 Weeks
|
|
Intention to Adopt Virtual Care
Prazo: Baseline and 12 weeks
|
Change between baseline and 12 weeks in awareness of Virtual Care services will be assessed via survey through the following question: which of the following VA services are you interested in trying out? |
Baseline and 12 weeks
|
|
Intent to Communicate about Virtual Care
Prazo: Baseline and 12 weeks
|
Change between baseline and 12 weeks will assess intent to communicate about Virtual Care from baseline to post-intervention (12 weeks) through the following questions: how interested are you in discussing these different services with your healthcare team; and how prepared do you feel to discuss these different services with your healthcare team? Participants will indicate on a 4-point scale from "not very" to "very." |
Baseline and 12 weeks
|
|
Impact of Chronic Obstructive Pulmonary Disease (COPD) Management
Prazo: 12 weeks
|
Participants will be asked to describe via free text any impacts participation in this study has had on how they use technology to manage their COPD. This will be qualitative data. |
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephanie Robinson, PhD, VA Bedford HealthCare System, Bedford, MA
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
- CDX 23-001
- CDA 21-187 (Número de outro subsídio/financiamento: VA HSR&D)
- 1IK2HX003532-01A2 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
There is not a plan to make IPD available. Data will be used by the research team only to inform manuscripts and future grant submissions.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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 .