- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Health System
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Score of Asthma Control Questionnaire
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma-related Quality of Life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: bursts at baseline and at one year
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new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.
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bursts at baseline and at one year
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Andrea J Apter, MD, MSc, MA, University of Pennsylvania
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R-1307-05218
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