A patient advocate to facilitate access and improve communication, care, and outcomes in adults with moderate or severe asthma: Rationale, design, and methods of a randomized controlled trial

Abstract

Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices.

The PA coaches, models, and assists participants with preparations for a visit with the asthma clinician; attends the visit with permission of participant and provider; and confirms participants' understanding of what transpired at the visit. 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. PA activities are individualized, take account of comorbidities, and are generalizable to other chronic diseases. PAs are recent college graduates interested in health-related careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential participants.

We test whether the PA intervention, compared to usual care, is associated with improved and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with the intervention's cost-effectiveness.

Introduction

Asthma affects 18.7 million US adults [1]. Despite efficacious medications and national guidelines for management [2], asthma has a disproportionate impact on low income and minority adults, particularly African Americans and Puerto Ricans. In 2010, Blacks had more than 3 times the emergency department (ED) visits and 2 times the hospitalizations and death rate from asthma compared to whites [1]. Puerto Ricans were 3.4 times as likely to die from asthma compared to all Hispanic/Latino groups [3]. Overall Hispanic/Latino adults are 60% more likely to be hospitalized for asthma than non-Hispanic whites [3]. Compared to children, adults are more likely to die from asthma [1]. However, few interventions to improve asthma outcomes have targeted low-income minority adults [4], [5], [6], [7]; 65% are women [1], [8].

To reduce health outcome inequities the Institute of Medicine advocates addressing access to healthcare and patient-provider communication [9]. This report found racial and ethnic inequities in health care at two levels: 1) the operation of the practice/health system where administrative tasks are completed; and 2) the individual patient-provider interaction [9]. Asthma provides an excellent setting for addressing both levels. At the practice/health system level, features impeding asthma care in vulnerable patients may include general and urgent appointment availability, lack of evening hours; complicated insurance and health forms; and absence of policies that consider cultural or language differences between patients and staff [10], [11], [12]. At the patient-provider level, physicians have been found to underestimate asthma severity in black patients [13]. Comorbidities including hypertension, diabetes, and obesity, frequent in low-income adults, increase the likelihood of adverse asthma-related outcomes and make access to care and patient-provider communication more complex. We describe a Patient Advocate (PA), an intervention that addresses both levels.

The PA is based on the Patient Navigator, proposed by Harold P. Freeman, MD to overcome barriers to early diagnosis and treatment of cancer of patients living in poverty in Harlem [14], [15], [16]. With input from patient and physician focus groups, we adapted the Patient Navigator as a PA, a term preferred by patients, to facilitate and maintain access to chronic care for adults with uncontrolled asthma and prevalent chronic morbidities recruited from clinics serving low-income urban neighborhoods [17]. Our PA, designed to promote self-management of a chronic disease, compared to usual care, coaches, models, and assists with preparations for a visit with the asthma provider; attends the visit with permission of patient and provider; and confirms understanding of decisions and recommendations made at the visit. The PA 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. PA activities are individualized and are generalizable to other chronic diseases.

We describe the planning, design, methodology, challenges, and baseline results of this ongoing randomized controlled trial [“Helping Asthma Patients 2 (HAP2)] of 312 adults, implemented in a variety of practices. HAP2 tests whether the PA intervention, compared to usual care, is associated with better and sustained asthma control and other asthma outcomes (prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline. Mediators and moderators of the PA-asthma outcome relationship are examined along with cost-effectiveness.