- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01972308
A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults (HAP2)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This 5 year project tests the effectiveness, sustainability, and budget impact of a patient navigator intervention to facilitate and maintain patient-provider communication and access to chronic care of moderate or severe asthma in low income minority adults with other chronic morbidities. We will recruit from a variety of clinic practices including those of an urban academic health center, a VA, and a federally qualified health center and in both English-speaking and Spanish-speaking patients. The intervention is tailored to patients and their clinics, and informed by focus groups of patients and providers.
The Patient Advocate (PA), works with patients by coaching and modeling preparation for a visit with the asthma doctor, attending the visit with the permission of participant and provider, and confirming understanding of issues discussed. The PA also facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and exchange of information between providers and patients. The PAs are recent college graduates interested in health-related or education careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential subjects.
This dissemination and implementation project refines the intervention of RC1 HL099612 for real-world practice by 1) conducting a randomized controlled trial that compares the Patient Advocate Intervention (PAI) to currently practiced guideline-based usual care; 2) carrying out the intervention in a variety of primary care and asthma specialty practices; 3) extending the observation time to a year to test its sustainability; 4) assessing patient-centered outcomes including asthma control, quality of life, ED visits, and hospitalizations; 5) assessing mediators/moderators of the PAI-asthma outcome relationship; and 6) evaluating its cost-effectiveness.
We will recruit 300 adults, each to be followed for at least 1 year with moderate or severe persistent asthma from clinics serving low-income, urban, primarily minority patients and conduct a randomized controlled trial (RCT) to: 1) assess whether 6 months of the PAI improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion, 2) Assess whether the PAI improves other asthma outcomes (need for prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline compared with UC at 6 months and is sustained in the 6 months following the intervention's completion, 3) examine mediators and moderators of the relationship between the intervention and outcome, 4) assess the incremental direct and indirect costs of the PAI compared to usual care and the cost-effectiveness of the PAI relative to UC for the outcomes, and 5) in post-study focus groups of providers to explore awareness of the intervention and response to the PA
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Health System
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- > 18 years of age,
- physician's diagnosis of asthma,
- prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),
- moderate or severe persistent asthma according to the NHLBI Guidelines,
- evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) < 80% predicted at the time of screening or within the 3 years prior to this screening, and (b) improvement with bronchodilator: either (i) an increase of >15% and 200ml in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC >12% and 200 ml in FEV1 within 30 minutes,
- at least one appointment scheduled with the asthma physician during the 1st 6 months of participation
Exclusion Criteria:
- Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.
- Unable to understand and provide informed consent,
- Unable to communicate in English or Spanish.
- Participants of the pilot study for this project are excluded
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Patient advocate
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding.
The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.
|
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding.
The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient.
|
Outro: usual care
Patient receives asthma care as usual from their asthma provider
|
Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Asthma Control at One Year
Prazo: baseline and 1 year
|
Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control. |
baseline and 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Emergency Department(ED) Visits at One Year
Prazo: one year
|
Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint
|
one year
|
Change in Asthma-related Quality of Life
Prazo: baseline to one year
|
Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ).
This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score.
A 0.5-unit change is considered clinically meaningful.
the range is 1 - 7 with higher score better quality of life.
|
baseline to one year
|
Change in Hospitalizations
Prazo: one year
|
Participants will report hospitalizations verified if possible in participating health systems.
We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.
|
one year
|
Risk of Prednisone Bursts
Prazo: baseline and one year
|
a new dose or an increase in already prescribed prednisone dose
|
baseline and one year
|
Change in Urgent Office Visit
Prazo: one year
|
Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year.
An urgent office visit is one scheduled within 24 hours of the visit.
|
one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrea J Apter, MD, University of Pennsylvania
Publicações e links úteis
Publicações Gerais
- Apter AJ, Wan F, Reisine S, Bogen DK, Rand C, Bender B, Bennett IM, Gonzalez R, Priolo C, Sonnad SS, Bryant-Stephens T, Ferguson M, Boyd RC, Ten Have T, Roy J. Feasibility, acceptability and preliminary effectiveness of patient advocates for improving asthma outcomes in adults. J Asthma. 2013 Oct;50(8):850-60. doi: 10.3109/02770903.2013.812655. Epub 2013 Jul 17.
- Apter AJ, Wan F, Reisine S, Bender B, Rand C, Bogen DK, Bennett IM, Bryant-Stephens T, Roy J, Gonzalez R, Priolo C, Have TT, Morales KH. The association of health literacy with adherence and outcomes in moderate-severe asthma. J Allergy Clin Immunol. 2013 Aug;132(2):321-7. doi: 10.1016/j.jaci.2013.02.014. Epub 2013 Apr 13.
- Apter AJ, Bryant-Stephens T, Morales KH, Wan F, Hardy S, Reed-Wells S, Dominguez M, Gonzalez R, Mak N, Nardi A, Park H, Howell JT, Localio R. Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial. Contemp Clin Trials. 2015 Sep;44:119-128. doi: 10.1016/j.cct.2015.08.001. Epub 2015 Aug 8.
- Bryant-Stephens T, Reed-Wells S, Canales M, Perez L, Rogers M, Localio AR, Apter AJ. Home visits are needed to address asthma health disparities in adults. J Allergy Clin Immunol. 2016 Dec;138(6):1526-1530. doi: 10.1016/j.jaci.2016.10.006. Epub 2016 Oct 21.
- Kramer CB, LeRoy L, Donahue S, Apter AJ, Bryant-Stephens T, Elder JP, Hamilton WJ, Krishnan JA, Shelef DQ, Stout JW, Sumino K, Teach SJ, Federman AD. Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies. J Allergy Clin Immunol. 2016 Dec;138(6):1600-1607. doi: 10.1016/j.jaci.2016.10.011. Epub 2016 Oct 24.
- Apter AJ, Perez L, Han X, Ndicu G, Localio A, Park H, Mullen AN, Klusaritz H, Rogers M, Cidav Z, Bryant-Stephens T, Bender BG, Reisine ST, Morales KH. Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Nov - Dec;8(10):3466-3473.e11. doi: 10.1016/j.jaip.2020.06.058. Epub 2020 Jul 14.
- Korwin A, Black H, Perez L, Morales KH, Klusaritz H, Han X, Huang J, Rogers M, Ndicu G, Apter AJ. Exploring Patient Engagement: A Qualitative Analysis of Low-Income Urban Participants in Asthma Research. J Allergy Clin Immunol Pract. 2017 Nov - Dec;5(6):1625-1631.e2. doi: 10.1016/j.jaip.2017.03.022. Epub 2017 May 10.
- Buckey TM, Morales KH, Apter AJ. Understanding Autonomy in Patients with Moderate to Severe Asthma. J Allergy Clin Immunol Pract. 2022 Feb;10(2):525-533. doi: 10.1016/j.jaip.2021.10.068. Epub 2021 Nov 14.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R18HL116285-01 (Concessão/Contrato do NIH 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 .
Ensaios clínicos em Patient Advocate
-
Brigham and Women's HospitalNational Institutes of Health (NIH); National Library of Medicine (NLM)DesconhecidoCâncer | Perda de audição | Cardiomiopatia hipertróficaEstados Unidos, Canadá
-
University of SaskatchewanRecrutamentoImagiologia Abdominal Adulto | Imagem abdominal pediátrica | Imagem obstétricaCanadá
-
The Christie NHS Foundation TrustManchester University NHS Foundation Trust; Aptus Clinical Ltd.; Zenzium Ltd.Concluído
-
Imperial College Healthcare NHS TrustConcluído
-
Columbia UniversityNational Institute on Drug Abuse (NIDA); Johns Hopkins University; University... e outros colaboradoresConcluídoHIV | Abuso de substâncias | Paciente internado | AUXILIAEstados Unidos
-
Ankara City Hospital BilkentConcluídoDisfunção sexual | Vaginite | Síndrome Primária de Sjögren | Vaginite CandidaPeru
-
Abbott Medical DevicesConcluídoInsuficiência Cardíaca SistólicaAustrália, Hong Kong, Japão