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
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.
Section snippets
Adapting the patient navigator
Patient Navigators have been widely used to assist uninsured, minority, elderly, and low-income patients in a number of different settings, particularly in screening or facilitating induction of therapy for cancer [18], [19], and for chronic diseases such as diabetes [20]. Patient Navigators have arranged transportation, scheduled appointments, ensured medical record availability, and provided social and financial support [21]. They have been nurses [22], social workers [23], [24], and
Results
We present baseline characteristics, challenges and solutions in recruitment, engagement, retention. As the trial is still in progress, investigators are blinded to study assignments and outcomes which are not presented.
Discussion
While low-income minority adults have the worst outcomes and highest death rates from asthma, research to develop interventions to improve outcomes for this group is relatively limited [4], [5], [6], [7]. Interventions to address access to health care and patient-provider communication have been advocated to eliminate these health disparities [9]. Research is needed to examine the feasibility, acceptability, adaptability, effectiveness, and sustainability of proposed interventions in different
Funding source
This work was supported by the National Institute of Health/National Heart, Lung, and Blood Institute R18 HL116285.
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Ensuring equitable access to guideline-based asthma care across the lifespan: Tips and future directions to the successful implementation of the new NAEPP 2020 guidelines, a Work Group Report of the AAAAI Asthma, Cough, Diagnosis, and Treatment Committee
2023, Journal of Allergy and Clinical ImmunologySocial Determinants of Health in Asthma Through the Life Course
2022, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :Tailoring asthma management plan: Studies have shown that effective communication and provider’s participation in shared decision making may improve outcomes in asthma and other chronic disease.34-40 One way to achieving closed-loop communication is to use patient advocates or CHWs, where their effectiveness has been demonstrated in both children and adult populations with asthma in controlled trials; but more real-world effectiveness studies must be conducted to further elucidate how this may translate to clinical outcomes.41,42 Discussion of resource in the context of asthma care: Linking the families to resources is a key step in the approach to addressing SDOH in asthma clinical visits.
Understanding Autonomy in Patients with Moderate to Severe Asthma
2022, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :We conducted a retrospective review of baseline characteristics of patients enrolled in the HAP2 (Helping Asthma Patients 2) trial, a cohort of patients with moderate to severe asthma recruited from low-income backgrounds.5,6 HAP2 compared the effect of a patient advocate intervention with usual care in the management of asthma.5,6 For this study, characteristics of patient autonomy were evaluated using a 21-question assessment.
Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial
2020, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :To ensure health equity, the Institute of Medicine advocated addressing access to health care and patient-provider communication by intervening at several levels: the provider-patient interaction, the culture of the practice, the encompassing health system, the community, and the local and national government.8 We report the evaluation of a patient advocate intervention (PAI) that operates at the first 2 levels of intervention.8,9 The PAI was adapted from the Patient Navigator program, which was conceived by Harold P. Freeman, MD, to overcome barriers to diagnosis and initial treatment of cancer for patients living in poverty in Harlem.10
New Directions in Pediatric Asthma
2019, Immunology and Allergy Clinics of North AmericaCitation Excerpt :Education content usually includes discussion of asthma, triggers, medications, peak flows, inhalation technique, and review of a written asthma action plan. Behavioral techniques include self-management strategies, feedback, and incentive plans.78 Health care system navigators or community health care works reinforce to families the importance of following their treatment plan resulting in improvements in adherence and asthma control.79–81