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A Patient Advocate and Literacy-Based Treatment of Asthma (HAP)

19 mars 2013 uppdaterad av: Andrea Apter, University of Pennsylvania
Half of US adults have no more than basic reading and numerical skills. A consequence is inadequate health literacy, which is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases, including asthma. We have adapted a patient navigator intervention to address asthma in high risk communities as a practical, immediate, and sustainable method of achieving effective health literacy in patients low health literacy. This intervention will lead to improved adherence and asthma control, attenuating health disparities so marked in asthma. It is compared for efficacy and cost-effectiveness with asthma education.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This application addresses broad Challenge Area (05), Comparative Effectiveness Research, and Specific Challenge Topic 05-MD105, Health Literacy. Half of US adults have no more than basic reading and numerical skills; inadequate health literacy is a consequence. It is associated with unsatisfactory patient-provider communication and poor health outcomes in chronic diseases including asthma. We found low numeracy to be associated with prior ED visits and hospitalizations for asthma and determined that numerical skill may attenuate the association of minority status with lower asthma-related quality of life. We propose a Patient Advocate Intervention (PAI) as the most practical immediate but sustainable method of achieving effective health literacy (EHL) (understanding of asthma management and the practice/health system). Adapted from the Patient Navigator of Harold P. Freeman, MD and informed by focus groups of asthma patients, the PAI addresses low literacy, facilitating patient-provider communication surrounding self-management and navigation of the practice and health system to ensure medical recommendations can be accomplished. The PA is a nonprofessional with guidance from a social worker who will assist with and model preparations for a visit with the asthma doctor, attend the visit, and afterwards confirm understanding as well as facilitate scheduling, obtaining insurance coverage, and overcoming other barriers to carrying out medical advice. The primary outcome is electronically-monitored use of inhaled corticosteroids (ICS), the treatment of choice for all but the mildest asthma. ICS use is a marker of successful patient-provider communication. Other outcomes are asthma-related: hospitalizations, ED visits, change in FEV1, and asthma-related quality of life. We hypothesize that the PAI will improve these outcomes by promoting EHL.

We will enroll 84 adults with a high prevalence of low numerical skills who are approximately 67% black and 10% Latino with moderate or severe asthma to carry out the following Specific Aims. Specific Aim 1: refine and evaluate the feasibility of PAI and Specific Aim 2: conduct a randomized comparison of PAI with standard asthma education to obtain effect size estimates for ICS adherence and asthma-related outcomes for a future R01 confirmatory randomized trial of the final version of PAI. Exploratory analyses will assess EHL as a mediator, various moderators, and estimate the incremental costs of PAI. This novel project fills several research gaps. It 1) compares and tests an intervention addressing literacy to improve health, one that can easily be incorporated into practice to better patient self-management and preventive care, 2) is a potentially long-lasting intervention which will benefit all patients, especially those with low health literacy, and 3) will potentially improve prevention of asthma exacerbations, reducing the need for ED use.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • physician's diagnosis of asthma
  • prescribed inhaled steroid
  • moderate or severe asthma according to NHLBI Guidelines
  • evidence of reversible airflow obstruction and improvement with bronchodilator
  • Did not participate in the experimental arm (problem-solving) of WIN Study, HL073932

Exclusion Criteria:

  • significant other current pulmonary or cardiac disease
  • severe psychiatric problems making it impossible to understand or carryout the protocol

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: patient advocate

Patient advocate works with patient before, during, and after a visit to asthma doctor.

Patient receives video of asthma education materials

patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
Aktiv komparator: asthma education
Patient receives video of asthma education materials
patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
adherence to prescribed inhaled corticosteroid regimen
Tidsram: 16 weeks
16 weeks

Sekundära resultatmått

Resultatmått
Tidsram
change in FEV1
Tidsram: 16 weeks
16 weeks
asthma-related quality of life
Tidsram: 16 weeks
16 weeks
asthma control
Tidsram: 16 weeks
16 weeks
emergency department visits for asthma
Tidsram: 16 weeks
16 weeks
hospitalizations for asthma
Tidsram: 16 weeks
16 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Andrea J Apter, MD, MSc, MA, University of Pennsylvania

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2009

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2011

Studieregistreringsdatum

Först inskickad

20 maj 2010

Först inskickad som uppfyllde QC-kriterierna

20 maj 2010

Första postat (Uppskatta)

21 maj 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 mars 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 mars 2013

Senast verifierad

1 mars 2013

Mer information

Termer relaterade till denna studie

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