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Understanding Patient Management of COPD Exacerbations

29 de março de 2019 atualizado por: Vincent S. Fan, VA Puget Sound Health Care System
This observational study will examine the care-seeking behaviors of Veterans with chronic obstructive pulmonary disease (COPD) to see whether patients' perceived need for care or lack of access to care leads to delays in getting care for COPD exacerbations. Participants complete a baseline in-person visit and receive calls every two weeks for one year to monitor for COPD exacerbations. Detailed information about each exacerbation and time to care are obtained. A sample of participants and their caregivers participate in in-depth interviews. Approximately half the participants will also use a remote inhaler monitor to record their albuterol inhaler use to see if this approach can identify early exacerbations. Results from this study will be used to develop an intervention that will assist Veterans in the early identification, evaluation, and treatment of exacerbations, and will be integrated with the VA primary care team.

Visão geral do estudo

Descrição detalhada

Prompt treatment of chronic obstructive pulmonary disease (COPD) exacerbations with oral steroids and/or antibiotics, ideally within 3 days of onset of symptoms, can decrease the severity and duration of exacerbations and may reduce the risk of COPD hospitalizations. This observational study will examine Veterans' care-seeking behaviors and will focus on patients' perceived need for care and perceived access to care and whether these factors delay seeking care for COPD exacerbations, increasing the risk for hospitalizations. This study will also evaluate one approach of identifying early exacerbations through the use of a remote inhaler monitoring system.

This observational cohort study enrolled 412 Veterans with COPD at high-risk for exacerbations. As of March 2019, 246 participants have completed the 1 year follow-up; 133 are in follow-up. The Specific Aims are: 1) Examine the barriers to seeking care for COPD exacerbations or worsening breathing; 2) Test the use of a real-time remote inhaler monitor to identify early exacerbations.

All participants attended one in-person baseline visit to complete spirometry and baseline questionnaires. Participants are contacted every 2 weeks for 1 year using an interactive voice response system that screens for COPD exacerbations with 4 yes/no questions. Participants with a positive screen are called back by research staff to obtain additional detailed information on the exacerbation and how it was treated. Data analysis will examine whether access to care and baseline factors are associated with a delay in treatment.

The participants enrolled at two sites: 252 participants at VA Puget Sound in Seattle, WA and 160 participants at the VA Eastern Colorado in Denver, CO. For Aim 1, 60 participants who reported a COPD exacerbation (either hospitalized, seen in the emergency department, treated as outpatients, or did not seek treatment) participated in in-depth semi-structured interviews by a trained research staff to understand how they responded to their worsening symptoms and decided whether to seek care. 24 caregivers for these Veterans were interviewed about their perspective on the exacerbation event.

In Aim 2, 145 participants from Aim 1 used an inhaler monitor with their albuterol inhaler during the 12-month follow-up period, which transmits real-time data about their daily inhaler use. Data analysis will measure whether a change in albuterol use can predict patient reported COPD exacerbations to determine the appropriate cut-offs that can be used in a future intervention trial.

These aims will provide detailed information on how best to intervene to ensure prompt identification and treatment of COPD exacerbations. New health care delivery approaches will assist Veterans in early identification of exacerbations and provide early access to care that can be integrated into the VA primary care, emergency medicine and pulmonary specialty care settings.

Tipo de estudo

Observacional

Inscrição (Real)

436

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with chronic obstructive pulmonary disease (COPD) who receive care at the VA Puget Sound Health Care System in Seattle, WA or the VA Eastern Colorado Health Care System in Denver, CO. Informal caregivers (ie. family member or friend) to the Veteran subject will also be included

Descrição

Veteran Cohort:

Inclusion Criteria:

  1. COPD diagnosis
  2. Spirometry showing FEV1/VC<0.70
  3. COPD exacerbation treated with prednisone and/or antibiotics, or that resulted in a visit to the emergency department or hospitalization in the previous 12 months
  4. English speaking
  5. Access to telephone

Exclusion Criteria:

  1. nursing home resident
  2. institutionalized, imprisoned
  3. life expectancy < 1 year

Informal Caregiver Cohort:

Inclusion Criteria:

  1. Identified by Veteran patient as informal caregiver
  2. English speaking
  3. Access to telephone
  4. >=18 years old

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
COPD patients
Veterans with COPD who are cared for at VA Puget Sound Health Care System (Seattle, WA) or VA Eastern Colorado (Denver, CO) who are at high risk for a COPD exacerbation based on an exacerbation treated with prednisone or antibiotics in the year preceding enrollment.
Not applicable. This is an observational study without an intervention.
Informal Caregiver for COPD patients
Informal caregiver (ie. family member, friend, etc.) for the patient with COPD who is participating in the COPD patients cohort.
Not applicable. This is an observational study without an intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Decision to seek care
Prazo: Determined for each exacerbation event during the 1-year follow-up period
All participants with at least one exacerbation will be included in this analysis. Individuals could have both treated or untreated exacerbations and the unit of analysis will be each patient-exacerbation event. The outcome will be whether the patient sought treatment (yes/no) for their COPD exacerbation.
Determined for each exacerbation event during the 1-year follow-up period

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Treatment delay
Prazo: Determined for each treated exacerbation event during the 1-year follow-up period
Only patients with ≥1 treated exacerbation during follow-up will be included in this analysis. A patient could have more than one exacerbation, and the unit of analysis will be each patient-exacerbation event
Determined for each treated exacerbation event during the 1-year follow-up period

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2016

Conclusão Primária (Antecipado)

1 de novembro de 2019

Conclusão do estudo (Antecipado)

1 de março de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

28 de março de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de março de 2016

Primeira postagem (Estimativa)

31 de março de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de março de 2019

Última verificação

1 de março de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 00874

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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 .

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