Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma
Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma
Asthma-related deaths are more numerous among low-income minority patients and older adults
 with chronic diseases. Guidelines for asthma management have not addressed the needs of these
 groups. The investigators recently demonstrated the feasibility, acceptability, and evidence
 of effectiveness of two interventions to improve access to care, patient-provider
 communication, and asthma outcomes: 1) CI: clinic intervention using a patient advocate to
 prepare for, attend, and confirm understanding of an office visit, and 2) HV: home visits for
 care coordination and informing clinicians of home barriers to managing asthma is associated
 with subsequent improvement in asthma outcomes. This project explores whether these
 interventions can be combined for greater effectiveness, delivery of guideline-based asthma
 care, and outcomes in low-income minority patients.

 In a randomized controlled factorial trial, 400 adults with uncontrolled asthma living in
 low-income urban neighborhoods are offered 18-months' participation: 12 months of clinical
 intervention and 6 months of evaluation to monitor sustainability of interventions and
 outcomes. Patients will be randomized to 1) a patient advocate and (2) an advocate and home
 visits, (3) an advocate and real-time feedback to the asthma provider (clinician) at each
 clinic visit of guidelines-relevant relevant information, and 4) (2), and (3). Interventions
 will be delivered by a community health worker. The study estimates Specific Aim 1:
 improvement over time of within-group (before-after in four groups) asthma outcomes (asthma
 control, quality of life, ED visits, hospitalizations, prednisone bursts) Specific Aim 2:
 across group differences in improvement over time in asthma outcomes; Specific Aim 3: the
 costs associated with each of the interventions. A cost-offset analysis will determine which
 intervention costs are offset by savings attributable to reductions in ED, hospitalization or
 other visits for asthma control and other outcomes.

 Exploratory Aim: changes in behavior from the interventions using interviews of clinicians
 and patients.

 Investigators hypothesize that improved outcomes in asthma patients will result from enhanced
 patient-clinician communication, clinician attention to home environmental exposures, and
 clinician consideration of the guidelines, at a program cost offset by lower patient health
 care utilization.
Asthma, a chronic but treatable disease, affects 18.7 million US adults. Asthma-related
 deaths, hospitalizations, and ED visits are more prevalent in low-income and minority
 patients, especially African Americans and particularly among older adults, many with
 co-morbidities.

 The Expert Panel Report 3 (EPR3) Guidelines for Asthma Diagnosis and Management, currently
 undergoing revision, is primarily directed at children and young adults. It overlooks older
 patients, many with comorbidities and many who live in poverty. Action plans are infrequently
 used and their benefits, strongly recommended by guidelines, have not been evaluated in older
 or low-income minority adults. Regular use of inhaled steroids, endorsed by the Guidelines
 for all but the mildest asthma is limited by social and economic barriers, e.g. cost and
 accessibility of medication. Failure of guidelines to address the barriers of poverty,
 limited education, poor housing and communication infrastructure, and suboptimal public
 transportation may promote non-adherence by clinicians.

 For these vulnerable adults, the investigators recently demonstrated the feasibility,
 acceptability, and evidence of effectiveness of two separate interventions to improve access
 to care, patient-provider communication, and asthma outcomes: 1) a patient advocate (PA)
 (HAP2 Study (R18 HL116285)) to prepare for, attend, and confirm understanding of an office
 visit, and 2) community health workers (CHWs) (ARC Study (PCORI AS 1307-05218)) to assess
 home barriers to asthma management and coordinate care between home and clinic. Both
 protocols, well-accepted by patients and clinicians, allow prompting, delivery, and testing
 of guideline recommendations in a tailored real-world setting. Although these studies were
 designed and initiated separately, patient advocates in the clinic-based study felt that
 understanding the home circumstances would be beneficial to clinicians making guideline-based
 recommendations, while the CHWs visiting homes in the second study wanted more communication
 with treating clinicians. The proposed project combines these interventions by offering all
 "PA activities", called the Clinic Intervention (CI) and randomizing half to Home Visits
 (HV). Additionally, in a factorial design half of patients will be randomized to have their
 clinician receive feedback on guideline-relevant domains recommended for discussion with
 patients at appointments. The proposed interventions facilitate communication between
 clinicians and patients, enriched by understanding of the home environment, the unique view
 of the patient-clinician interaction at appointments, and barriers to asthma management that
 patients encounter. While the communication focuses on asthma management, it extends to
 general care coordination of common co-morbidities such as diabetes, hypertension, obesity
 and patients will be recruited from both primary care and specialty practices. Community
 Health Navigators (CHNs), who are lay health workers, will deliver the CI in all patients and
 the HVs in those so randomized. CHNs with close ties to patients' neighborhoods and also
 embedded in the clinics, will ensure patients' voices are heard in the delivery of
 guideline-based care and support patients at risk for health disparities, e. g., older
 adults, those with comorbidities, low income or limited literacy.

 In a randomized controlled factorial trial, adults with uncontrolled asthma living in
 low-income urban neighborhoods will be offered 18-months participation in four groups of 100
 each (1) CI only, (2) CI plus Home Visits (HV), (3) CI and clinician feedback, and (4) CI +
 HV + clinician feedback. Patients will be evaluated quarterly for 12 months and then observed
 for 6 months to assess sustainability of the intervention. The investigators will estimate:

 Specific Aim 1: improvement over time of within-group (before-after in four groups) asthma
 outcomes (asthma control, quality of life, ED visits, hospitalizations, prednisone bursts)
 Specific Aim 2: across group differences in improvement over time in asthma outcomes;
 Specific Aim 3: the costs associated with each of the intervention, and the investigators
 will conduct a cost-offset analysis to determine which intervention costs are offset by
 savings attributable to reductions in ED, hospitalizations or other visits for asthma control
 and other outcomes.

 Exploratory Aim: changes in behavior from the interventions using interviews of clinicians
 and patients.

 Hypothesis and Impact: The investigators hypothesize improved outcomes in asthma patients
 through enhanced communication of patient and clinician, clinician attention to home
 environmental exposure, and clinician consideration of the guidelines, at a program cost
 offset by lower patient health care utilization.
Inclusion Criteria:

 -  Female or male > 18 years and living in a Philadelphia neighborhood in which at least
 20% of households have incomes below the federal poverty level (19104, 19120, 19121,
 19122, 19124, 19125, 19131, 19132, 19133, 19134, 19139, 19140, 19141, 19142, 19143,
 19144, 19145, 19146, 19153, 19151)

 -  A patient in a participating clinic

 -  Doctor's diagnosis of asthma

 -  Prescribed an inhaled corticosteroid for asthma

 -  Required prednisone or an Emergency Department (ED) visit or hospitalization for
 asthma within 12 months before enrollment.

 -  Some patients with a diagnosis of asthma and prescribed inhaled corticosteroid
 may also have mention of Chronic Obstructive Pulmonary Disease (COPD) in their
 record, particularly if they smoke. Asthma and COPD are both heterogeneous
 diseases, and may be impossible to distinguish by clinical characteristics.Both
 COPD and asthma can have evidence of reversible obstruction and also of
 irreversible obstruction. It is important not to exclude these patients,
 sometimes called overlap patients as they may benefit from these interventions.

 Exclusion Criteria:

 -  Severe psychiatric or cognitive problems making it impossible to understand or carry
 out the protocol;

 -  Excluded are those with other chronic lung diseases: lung cancer, cystic fibrosis,
 heart failure, chronic bronchitis, pulmonary hypertension, a candidate or recipient
 for lung transplant, a history of bronchial thermoplasty.

 Excluded are those with more than 20 pack year tobacco use.