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

23. August 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

312

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania Health System

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Asthma Control at One Year
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Andrea J Apter, MD, University of Pennsylvania

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Dezember 2013

Primärer Abschluss (Tatsächlich)

16. März 2017

Studienabschluss (Tatsächlich)

30. April 2022

Studienanmeldedaten

Zuerst eingereicht

16. Oktober 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Oktober 2013

Zuerst gepostet (Schätzen)

30. Oktober 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. September 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. August 2022

Zuletzt verifiziert

1. August 2022

Mehr Informationen

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