- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02086565
Using IT to Improve Access, Communication and Asthma in African American and Hispanic/Latino Adults
Background: Asthma morbidity is high in inner-city minority adults, despite the existence of efficacious therapy. Tailored, patient-centered interventions are needed to improve access to care and patient-provider communication. Access and communication increasingly rely on information technology (IT) as new incentives arise to use the Electronic Health Record (EHR). The EHR patient portal (PP) gives patients web-based communication with providers and practices. How the poor and those with limited educational opportunities can take advantage of these is unclear. In contrast, the investigators have found that home visits (HVs) by community health workers (CHWs) can improve access to care for children and promote caretaker-clinician communication. The investigators also found many inner-city adults have internet access and are willing to learn to use the PP.
Objective: to examine the benefits for adults of using the PP with and without HVs by CHWs who will encourage/facilitate PP use, understand patients' social context, and enhance communication with the medical team. The investigator hypothesize all patients will benefit from PPs, and that the addition of HVs will be particularly helpful for those with low literacy or language barriers. Specific Aims test if the 1-year interventions result in 1) better within-group asthma outcomes, 2) better outcomes in one group over the other, 3) more communication (use of PP) and access (appointments made and kept) which mediate the interventions' effects on asthma outcomes, and 4) effect modification by literacy level, primary language, and convenience of internet access.
Methods: In a randomized controlled trial, 301 adults, predominantly African American and Hispanic/Latino, with uncontrolled asthma recruited from low income urban neighborhoods will be assured internet access and taught to use the PP, with and without HVs from a CHW. CHWs will 1) train patients to competency in PP use, 2) enhance care coordination, 3) transmit a view of the complex social circumstances of patients' lives to providers, and 4) make up for differences in patients' health literacy skills.
Patient Outcomes are asthma control, asthma-related quality of life, emergency department (ED) visits, and hospitalizations for asthma or any cause. Together asthma and other health conditions affect patients' ability to perform their daily tasks and care for their families. Potential benefits of the intervention are enhanced patient-clinician communication, access to care, improved health, and ability to use IT.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania Health System
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- adults predominantly African American and Hispanic/Latino with uncontrolled asthma recruited from low income urban neighborhoods
Exclusion Criteria:
- severe psychiatric or cognitive problems that would make it impossible to understand and complete the protocol.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Portal training and home visits
Portal training and home visits from a community health worker to promote care coordination and use of the patient portal
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patient portal training and home visits by CHW to coordinate care
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|
Comparatore attivo: portal training
Participants are assured internet access and taught to use the patient portal
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training in use of patient portal
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Score of Asthma Control Questionnaire
Lasso di tempo: baseline and over a year
|
This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week.
Lower score is a better outcome.
We measured change in Asthma Control Questionnaire score from baseline to at least 12 months.
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baseline and over a year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Asthma-related Quality of Life
Lasso di tempo: baseline and over a year
|
Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life.
We measured the change from baseline and over a year.
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baseline and over a year
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Emergency Department Visits
Lasso di tempo: one year before baseline to one year after baseline
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Emergency department visits for asthma from one year before baseline to one year after baseline.
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one year before baseline to one year after baseline
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Hospitalizations
Lasso di tempo: Hospitalizations for asthma in the year before baseline to one year after baseline
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Hospitalizations for asthma in the year before baseline to one year after baseline.
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Hospitalizations for asthma in the year before baseline to one year after baseline
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|
Prednisone Bursts
Lasso di tempo: bursts at baseline and at one year
|
new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.
|
bursts at baseline and at one year
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Andrea J Apter, MD, MSc, MA, University of Pennsylvania
Pubblicazioni e link utili
Pubblicazioni generali
- Localio AM, Klusaritz H, Morales KH, Ruggieri DG, Han X, Apter AJ. Primary language and the electronic health record patient portal: Barriers to use among Spanish-speaking adults with asthma. J Asthma. 2022 Oct;59(10):2081-2090. doi: 10.1080/02770903.2021.1989462. Epub 2021 Oct 20.
- Apter AJ, Localio AR, Morales KH, Han X, Perez L, Mullen AN, Rogers M, Klusaritz H, Howell JT, Canales MN, Bryant-Stephens T. Home visits for uncontrolled asthma among low-income adults with patient portal access. J Allergy Clin Immunol. 2019 Sep;144(3):846-853.e11. doi: 10.1016/j.jaci.2019.05.030. Epub 2019 Jun 7.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R-1307-05218
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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