Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success.

Patients with chronic pain experience stigma within the healthcare system. This stigma is compounded for those taking long-term prescription opioids. Often, public messaging and organizational policies have telegraphed that opioid treatment is a problem to be solved by focusing only on medication reduction efforts. Lack of data has contributed to misperceptions and poor opioid policies. In part, data collection remains poor because patients feel fractured from systems of care and are often not interested in engaging with opioid reduction mandates and research. Similarly, clinicians may fail to engage with opioid stewardship and research due to complexities that exceed their training or capacities. The EMPOWER study applies a coproduction model that engages researchers, patients, clinicians, managers, and other health system users. Key stakeholders shaped the design of the study to best ensure acceptability and engagement of the "end users"-patients who enroll in the study and the clinicians who implement the opioid tapers. Targeting the needs of any stakeholder group in isolation is suboptimal. Accordingly, we detail the EMPOWER patient-centered opioid tapering clinical research framework and specific strategies to address stakeholder concerns. We also discuss how this framework may be applied to enhance engagement in healthcare research broadly.

Feasibility and acceptability of monitoring personal air pollution exposure with sensors for asthma self-management.

BACKGROUND: Exposure to fine particulate matter (PM2.5) increases the risk of asthma exacerbations, and thus, monitoring personal exposure to PM2.5 may aid in disease self-management. Low-cost, portable air pollution sensors offer a convenient way to measure personal pollution exposure directly and may improve personalized monitoring compared with traditional methods that rely on stationary monitoring stations. We aimed to understand whether adults with asthma would be willing to use personal sensors to monitor their exposure to air pollution and to assess the feasibility of using sensors to measure real-time PM2.5 exposure. METHODS: We conducted semi-structured interviews with 15 adults with asthma to understand their willingness to use a personal pollution sensor and their privacy preferences with regard to sensor data. Student research assistants used HabitatMap AirBeam devices to take PM2.5 measurements at 1-s intervals while walking in Philadelphia neighborhoods in May-August 2018. AirBeam PM2.5 measurements were compared to concurrent measurements taken by three nearby regulatory monitors. RESULTS: All interview participants stated that they would use a personal air pollution sensor, though the consensus was that devices should be small (watch- or palm-sized) and light. Patients were generally unconcerned about privacy or sharing their GPS location, with only two stating they would not share their GPS location under any circumstances. PM2.5 measurements were taken using AirBeam sensors on 34 walks that extended through five Philadelphia neighborhoods. The range of sensor PM2.5 measurements was 0.6-97.6 µg/mL (mean 6.8 µg/mL), compared to 0-22.6 µg/mL (mean 9.0 µg/mL) measured by nearby regulatory monitors. Compared to stationary measurements, which were only available as 1-h integrated averages at discrete monitoring sites, sensor measurements permitted characterization of fine-scale fluctuations in PM2.5 levels over time and space. CONCLUSIONS: Patients were generally interested in using sensors to monitor their personal exposure to PM2.5 and willing to share personal sensor data with health care providers and researchers. Compared to traditional methods of personal exposure assessment, sensors captured personalized air quality information at higher spatiotemporal resolution. Improvements to currently available sensors, including more reliable Bluetooth connectivity, increased portability, and longer battery life would facilitate their use in a general patient population.

Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial.

BACKGROUND: Few interventions have targeted low-income adults with moderate to severe asthma despite their high mortality. OBJECTIVE: To assess whether a patient advocate (PA) intervention improves asthma outcomes over usual care (UC). METHODS: This 2-armed randomized clinical trial recruited adults with moderate to severe asthma from primary care and asthma-specialty practices serving low-income neighborhoods. Patients were randomized to 6 months of a PA intervention or UC. PAs were recent college graduates anticipating health care careers, who coached, modeled, and assisted participants with preparations for asthma-related medical visits, attended visits, and confirmed participants' understanding of provider recommendations. Participants were followed for at least a year for patient-centered asthma outcomes: asthma control (primary outcome), quality of life, prednisone requirements, emergency department visits, and hospitalizations. RESULTS: There were 312 participants. Their mean age was 51 years (range, 19-93 years), 69% were women, 66% African American, 8% Hispanic/Latino, 62% reported hospitalization for asthma in the year before randomization, 21% had diabetes, and 61% had a body mass index of 30 or more. Asthma control improved over 12 months, more in the intervention group (-0.45 [95% CI, -0.67 to -0.21]) than in the UC group (-0.26 [95% CI, -0.53 to -0.01]), and was sustained at 24 months but with no statistical difference between groups. The 6-month rate of emergency department visits decreased in the intervention (-0.90 [95% CI, -1.56 to -0.42]) and UC (-0.42 [95% CI, -0.72 to -0.06]) groups over 12 months. The cost of the PA program was $1521 per patient. Only 64% of those assigned had a PA visit. CONCLUSIONS: A PA may be a promising intervention to improve and sustain outcomes in this high-risk population if expanded to address factors that make keeping appointments difficult.

Patient Portal Usage and Outcomes Among Adult Patients with Uncontrolled Asthma.

BACKGROUND: Patient-clinician communication, essential for favorable asthma outcomes, increasingly relies on information technology including the electronic heath record-based patient portal. For patients with chronic disease living in low-income neighborhoods, the benefits of portal communication remain unclear. OBJECTIVE: To describe portal activities and association with 12-month outcomes among low-income patients with asthma formally trained in portal use. METHODS: In a longitudinal observational study within a randomized controlled trial, 301 adults with uncontrolled asthma were taught 7 portal tasks: reviewing upcoming appointments, scheduling appointments, reviewing medications, locating laboratory results, locating immunization records, requesting refills, and messaging. Half the patients were randomized to receive up to 4 home visits by community health workers. Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life were assessed over time and estimated as of 12 months from randomization. RESULTS: Fewer than 60% of patients used the portal independently. Among users, more than half used less than 1 episode per calendar quarter. The most frequent activities were reading messages and viewing laboratory results and least sending messages and making appointments. Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12-month postintervention. CONCLUSIONS: Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training. Usage was not associated with regular appointments or with clinical outcomes. Patient portals need modification to accommodate low-income patients with uncontrolled asthma.

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

OBJECTIVE: Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS: EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION: The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

Home visits for uncontrolled asthma among low-income adults with patient portal access.

BACKGROUND: Asthma disproportionately affects low-income and minority adults. In an era of electronic records and Internet-based digital devices, it is unknown whether portals for patient-provider communication can improve asthma outcomes. OBJECTIVE: We sought to estimate the effect on asthma outcomes of an intervention using home visits (HVs) by community health workers (CHWs) plus training in patient portals compared with usual care and portal training only. METHODS: Three hundred one predominantly African American and Hispanic/Latino adults with uncontrolled asthma were recruited from primary care and asthma specialty practices serving low-income urban neighborhoods, directed to Internet access, and given portal training. Half were randomized to HVs over 6 months by CHWs to facilitate competency in portal use and promote care coordination. RESULTS: One hundred seventy (56%) patients used the portal independently. Rates of portal activity did not differ between randomized groups. Asthma control and asthma-related quality of life improved in both groups over 1 year. Differences in improvements over time were greater for the HV group for all outcomes but reached conventional levels of statistical significance only for the yearly hospitalization rate (-0.53; 95% CI, -1.08 to -0.024). Poor neighborhoods and living conditions plus limited Internet access were barriers for patients to complete the protocol and for CHWs to make HVs. CONCLUSION: For low-income adults with uncontrolled asthma, portal access and CHWs produced small incremental benefits. HVs with emphasis on self-management education might be necessary to facilitate patient-clinician communication and to improve asthma outcomes.

Inhaler Technique in Low-Income, Inner-City Adults with Uncontrolled Asthma.

BACKGROUND: Poor inhaler technique has been shown to be associated with less asthma control and increased health care utilization. Little is known about the impact of inhaler technique on the most vulnerable patients. OBJECTIVE: This study examined inhaler technique in low-income, inner-city adults with uncontrolled asthma. METHODS: Inhaler technique data and other patient characteristics were evaluated in adults drawn from 2 studies conducted at the University of Pennsylvania. Subjects were from low-income Philadelphia neighborhoods and had uncontrolled asthma. Baseline characteristics were collected. Inhaler technique was rated by research coordinators who were trained with written materials. RESULTS: In 584 adults, 56% of metered dose inhaler users and 64% of dry powder inhaler users had adequate visually assessed inhaler technique. Inhaler technique did not vary by reading comprehension or numeracy levels. CONCLUSIONS: In this group of patients with uncontrolled asthma, visually assessed inhaler technique was adequate in more than one-half. Although incorrect inhaler technique is generally common and must be routinely addressed, this study suggests that other factors that lead to poor control must be identified.

Filling the patient-provider knowledge gap: a patient advocate to address asthma care and self-management barriers.

Introduction: In an ongoing study, a new clinical role adapted from a patient navigator called the patient advocate (PA) met with patients before medical visits, attended appointments and afterwards reviewed provider instructions. This qualitative analysis examines the perspectives of PAs and providers regarding their experiences with patients to understand how a PA can help patients and providers achieve better asthma control. Methods: PAs recorded journal entries about their experiences with patients. Provider focus groups and interviews were conducted by researchers and transcribed. Analysis was based on the Grounded Theory approach for qualitative research, using open and then focused coding. Two researchers independently coded these sources until intercoder agreement was achieved. Results: Upon review of 31 journal entries on PA experiences with 24 patients and transcripts from 2 provider focus groups and 12 provider interviews, 5 themes emerged surrounding asthma care and self-management: medication adherence, follow-up, communication, social determinants of health and time. While patients shared with PAs specific socioeconomic barriers to medication adherence and follow-up, providers often did not know about these problems and cited barriers to communication. Time restrictions on medical visits further limited communication. Conclusions: Perspectives reported here illustrate a gap in knowledge and understanding between patients and providers. The PA's unique relationship with patients and presence inside and outside of medical visits allowed them to learn contextual patient information unknown to providers. PAs and providers cited numerous ways PAs can help to improve patient-provider mutual understanding.

Exploring Patient Engagement: A Qualitative Analysis of Low-Income Urban Participants in Asthma Research.

BACKGROUND: Uncontrolled asthma is a common highly morbid condition with worse outcomes in low-income and minority patients in part due to barriers accessing and engaging with health care. We developed a patient advocate to educate about and assist with navigating access to care and provider-patient communication. Participants completed an End of Study Questionnaire (ESQ) that was analyzed to assess experience and engagement with the protocol. OBJECTIVE: This study uses qualitative analysis to evaluate participant experience with the patient advocate and control group interventions. METHODS: The ESQ aimed to prompt an open-ended discussion of study experience. Questions were developed from patient focus groups about the patient advocate intervention (PAI), and were revised based on early responses. The questionnaire was administered after 12 months of study participation: 6 months of control or PAI, followed by 6 months of follow-up. Answers were evaluated using qualitative coding and a grounded theory analytical approach. RESULTS: A total of 102 low-income and minority adults with moderate or severe asthma who had completed the study protocol at the time of publication (approximately one-third of total participants) found PAI and control group activities acceptable. Four themes emerged from both groups: (1) appreciation of interpersonal and educational interaction, (2) perception of improved health care adherence, (3) preparedness for physician appointments, (4) improved patient-provider communication. Attention from study personnel and review of asthma-related information was unanimously well received and empowered patients' active health care participation. CONCLUSIONS: Patient engagement and empowerment were elicited by perceived education and personal attention. This study suggests a low-resource, feasible method to improve patient engagement.

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.

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.

Home visits are needed to address asthma health disparities in adults.

Research on asthma frequently recruits patients from clinics because the ready pool of patients leads to easy access to patients in office waiting areas, emergency departments, or hospital wards. Patients with other chronic conditions, and with mobility problems, face exposures at home that are not easily identified at the clinic. In this article, we describe the perspective of the community health workers and the challenges they encountered when making home visits while implementing a research intervention in a cohort of low-income, minority patients. From their observations, poor housing, often the result of poverty and lack of social resources, is the real elephant in the chronic asthma room. To achieve a goal of reduced asthma morbidity and mortality will require a first-hand understanding of the real-world social and economic barriers to optimal asthma management and the solutions to those barriers.

A health care navigation tool assesses asthma self-management and health literacy.

BACKGROUND: Self-management of moderate-to-severe asthma depends on the patient's ability to (1) navigate (access health care to obtain diagnoses and treatment), (2) use inhaled corticosteroids (ICSs) properly, and (3) understand ICS function. OBJECTIVE: We sought to test whether navigation skills (medication recall, knowledge of copay requirements, and ability to provide information needed for a medical visit about a persistent cough unresponsive to medication) are related to other self-management skills and health literacy. METHODS: A 21-item Navigating Ability (NAV2) questionnaire was developed, validated, and then read to adults with moderate-to-severe asthma. ICS technique was evaluated by using scales derived from instructions in national guidelines; knowledge of ICS function was evaluated by using a validated 10-item questionnaire. Spearman correlation was computed between NAV2 score and these questionnaires and with numeracy (Asthma Numeracy Questionnaire) and print literacy (Short Test of Functional Health Literacy in Adults). RESULTS: Two hundred fifty adults participated: age, 51 ± 13 years; 72% female; 65% African American; 10% Latino; 50% with household income of less than $30,000/y; 47% with no more than a 12th-grade education; and 29% experienced hospitalizations for asthma in the prior year. A higher NAV2 score was associated with correct ICS technique (ρ = 0.24, P = .0002), knowledge of ICSs (ρ = 0.35, P < .001), better print literacy (ρ = 0.44, P < .001), and numeracy (ρ = 0.41, P < .001). CONCLUSIONS: Patients with poor navigational ability are likely to have poor inhaler technique and limited understanding of ICS function, as well as limited numeracy and print literacy. Clinicians should consider these elements of self-management for their effect on asthma care and as a marker of more general health literacy deficits.