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A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults (HAP2)

23. august 2022 opdateret af: Andrea Apter, University of Pennsylvania
Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

312

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Health System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. > 18 years of age,
  2. physician's diagnosis of asthma,
  3. prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),
  4. moderate or severe persistent asthma according to the NHLBI Guidelines,
  5. 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,
  6. at least one appointment scheduled with the asthma physician during the 1st 6 months of participation

Exclusion Criteria:

  1. Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.
  2. Unable to understand and provide informed consent,
  3. Unable to communicate in English or Spanish.
  4. Participants of the pilot study for this project are excluded

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Asthma Control at One Year
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Emergency Department(ED) Visits at One Year
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline and one year
a new dose or an increase in already prescribed prednisone dose
baseline and one year
Change in Urgent Office Visit
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Andrea J Apter, MD, University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2013

Primær færdiggørelse (Faktiske)

16. marts 2017

Studieafslutning (Faktiske)

30. april 2022

Datoer for studieregistrering

Først indsendt

16. oktober 2013

Først indsendt, der opfyldte QC-kriterier

29. oktober 2013

Først opslået (Skøn)

30. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Patient Advocate

Abonner