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临床试验/NCT01972308
NCT01972308已完成不适用

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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2013年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
2
主要终点
Change in Asthma Control at One Year

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in Asthma Control at One Year

时间窗: 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.

次要结局

  • Change in Hospitalizations(one year)
  • Risk of Prednisone Bursts(baseline and one year)
  • Change in Emergency Department(ED) Visits at One Year(one year)
  • Change in Asthma-related Quality of Life(baseline to one year)
  • Change in Urgent Office Visit(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Apter

Professor

University of Pennsylvania

研究点 (2)

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