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

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

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