Identifying the Needs of Primary Care Providers Caring for Breast and Colon Cancer Survivors in the Safety-Net: a Qualitative Study.

As the number of cancer survivors continues to increase and given the shortage of oncology clinicians in safety net health care settings, primary care providers (PCPs) in these settings will increasingly provide cancer survivorship care. In order to ensure equitable care for low-income and underserved breast and colon cancer survivors, it is essential to understand the safety-net PCPs' perspective. We conducted semi-structured, in-depth qualitative interviews with 11 PCPs working in a safety-net health care system to identify their needs in caring for cancer survivors. Interviews were audio-recorded and professionally transcribed. Two coders independently coded the interviews and conducted regular meetings until we reached consensus on the results. Analysis was based in grounded theory and performed using the constant comparative method. Thematic analysis identified six themes as follows: (1) Cancer survivorship care can be integrated with the whole person and chronic disease care management that occurs in primary care; (2) PCPs' perceptions regarding patients' survivorship care needs and their confidence in meeting those needs; (3) preference for a shared care model; (4) coordination of care; (5) PCPs' need for survivorship care education and training; and (6) unique issues involved in the care of older cancer survivors. PCPs in the safety-net believe that providing comprehensive survivorship care requires coordination of care through the cancer continuum. Tools like checklists, electronic health records-based communication, and convenient electronic consultations with cancer specialists would enhance the quality of survivorship care. Respondents advocate the inclusion of survivorship care education in medical education. The continuity of care with PCPs means that they play a particularly important role in the care of older cancer survivors.

Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial.

PURPOSE: Poor adherence to medications is more prevalent for chronic obstructive pulmonary disease (COPD) than for other chronic conditions and is associated with unfavorable health outcomes. Few interventions have successfully improved adherence for COPD medications; none of these use unlicensed health care personnel. We explored the efficacy of lay health coaches to improve inhaler adherence and technique. METHODS: Within a randomized controlled trial, we recruited English- and Spanish-speaking patients with moderate to severe COPD from urban, public primary care clinics serving a low-income, predominantly African American population. Participants were randomized to receive 9 months of health coaching or usual care. Outcome measures included self-reported adherence to inhaled controller medications in the past 7 days and observed technique for all inhalers. We used generalized linear models, controlling for baseline values and clustering by site. RESULTS: Baseline adherence and inhaler technique were uniformly poor and did not differ by study arm. At 9 months, health-coached patients reported a greater number of days of adherence compared with usual care patients (6.4 vs 5.5 days; adjusted P = .02) and were more likely to have used their controller inhalers as prescribed for 5 of the last 7 days (90% vs 69%; adjusted P = .008). They were more than 3 times as likely to demonstrate perfect technique for all inhaler devices (24% vs 7%; adjusted P = .01) and mastery of essential steps (40% vs 11%; adjusted P <.001). CONCLUSIONS: Health coaching may provide a scalable model that can improve care for people living with COPD.

A Qualitative Study of How Health Coaches Support Patients in Making Health-Related Decisions and Behavioral Changes.

PURPOSE: Although health coaches are a growing resource for supporting patients in making health decisions, we know very little about the experience of health. We undertook a qualitative study of how health coaches support patients in making decisions and implementing changes to improve their health. METHODS: We conducted 6 focus groups (3 in Spanish and 3 in English) with 25 patients and 5 friends or family members, followed by individual interviews with 42 patients, 17 family members, 17 health coaches, and 20 clinicians. Audio recordings were transcribed and analyzed by at least 2 members of the study team in ATLAS.ti using principles of grounded theory to identify themes and the relationship between them. RESULTS: We identified 7 major themes that were related to each other in the final conceptual model. Similarities between health coaches and patients and the time health coaches spent with patients helped establish the health coach-patient relationship. The coach-patient relationship allowed for, and was further strengthened by, 4 themes of key coaching activities: education, personal support, practical support, and acting as a bridge between patients and clinicians. CONCLUSIONS: We identified a conceptual model that supports the development of a strong relationship, which in turn provides the basis for effective coaching. These results can be used to design health coach training curricula and to support health coaches in practice.

Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial.

PURPOSE: Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. METHODS: We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ(2) tests and linear regression models. RESULTS: Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. CONCLUSIONS: Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients' clinical conditions, interventions, and the contextual features of implementation.

Role of complement activation in obliterative bronchiolitis post-lung transplantation.

Obliterative bronchiolitis (OB) post-lung transplantation involves IL-17-regulated autoimmunity to type V collagen and alloimmunity, which could be enhanced by complement activation. However, the specific role of complement activation in lung allograft pathology, IL-17 production, and OB is unknown. The current study examines the role of complement activation in OB. Complement-regulatory protein (CRP) (CD55, CD46, complement receptor 1-related protein y/CD46) expression was downregulated in human and murine OB; and C3a, a marker of complement activation, was upregulated locally. IL-17 differentially suppressed complement receptor 1-related protein y expression in airway epithelial cells in vitro. Neutralizing IL-17 recovered CRP expression in murine lung allografts and decreased local C3a production. Exogenous C3a enhanced IL-17 production from alloantigen- or autoantigen (type V collagen)-reactive lymphocytes. Systemically neutralizing C5 abrogated the development of OB, reduced acute rejection severity, lowered systemic and local levels of C3a and C5a, recovered CRP expression, and diminished systemic IL-17 and IL-6 levels. These data indicated that OB induction is in part complement dependent due to IL-17-mediated downregulation of CRPs on airway epithelium. C3a and IL-17 are part of a feed-forward loop that may enhance CRP downregulation, suggesting that complement blockade could be a therapeutic strategy for OB.

Characterization of the bispecific VHH antibody tarperprumig (ALXN1820) specific for properdin and designed for low-volume administration.

The bispecific antibody tarperprumig (ALXN1820) was developed as a treatment option for diseases involving dysregulated complement alternative pathway (AP) activity that could be administered in small volumes, either subcutaneously or intravenously. Tarperprumig incorporates a C-terminal variable domain of a heavy chain only antibody (VHH) that binds properdin (FP) connected via a flexible linker to an N-terminal VHH that binds human serum albumin (HSA). The purified bispecific VHH antibody exhibits an experimental molecular weight average of 27.4 kDa and can be formulated at > 100 mg/mL. Tarperprumig binds tightly to FP and HSA with sub-nanomolar affinity at pH 7.4 and can associate simultaneously with FP and HSA to form a ternary complex. Tarperprumig potently and dose-dependently inhibits to completion in vitro AP-dependent complement C5b-9 formation, AP-dependent hemolysis, and the AP deposition of C3, FP and C9. X-ray crystallography revealed that the isolated FP-binding VHH recognizes the thrombospondin repeat 5 domain of FP, thereby preventing FP from binding to the AP convertase owing to severe steric hindrance. Tarperprumig cross-reacts with cynomolgus monkey FP and serum albumin. In summary, tarperprumig exhibits properties tailored for subcutaneous administration and is currently in clinical development for the treatment of complement AP-related disorders.

The effectiveness of medical assistant health coaching for low-income patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and baseline characteristics of the study population.

BACKGROUND: Many patients with chronic disease do not reach goals for management of their conditions. Self-management support provided by medical assistant health coaches within the clinical setting may help to improve clinical outcomes, but most studies to date lack statistical power or methodological rigor. Barriers to large scale implementation of the medical assistant coach model include lack of clinician buy-in and the absence of a business model that will make medical assistant health coaching sustainable. This study will add to the evidence base by determining the effectiveness of health coaching by medical assistants on clinical outcomes and patient self-management, by assessing the impact of health coaching on the clinician experience, and by examining the costs and potential savings of health coaching. METHODS/DESIGN: This randomized controlled trial will evaluate the effectiveness of clinic-based medical assistant health coaches to improve clinical outcomes and self-management skills among low-income patients with uncontrolled type 2 diabetes, hypertension, or hyperlipidemia. A total of 441 patients from two San Francisco primary care clinics have been enrolled and randomized to receive a health coach (n = 224) or usual care (n = 217). Patients participating in the health coaching group will receive coaching for 12 months from medical assistants trained as health coaches. The primary outcome is a change in hemoglobin A1c, systolic blood pressure, or LDL cholesterol among patients with uncontrolled diabetes, hypertension and hyperlipidemia, respectively. Self-management behaviors, perceptions of the health care team and clinician, BMI, and chronic disease self-efficacy will be measured at baseline and after 12 months. Clinician experience is being assessed through surveys and qualitative interviews. Cost and utilization data will be analyzed through cost-predictive models. DISCUSSION: Medical assistants are an untapped resource to provide self-management support for patients with uncontrolled chronic disease. Having successfully completed recruitment, this study is uniquely poised to assess the effectiveness of the medical assistant health coaching model, to describe barriers and facilitators to implementation, and to develop a business case for sustainability. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT-01220336.

Preliminary nonclinical toxicity, pharmacokinetics, and pharmacodynamics of ALXN4100TPO, a thrombopoietin receptor agonist, in CD2F1 mice.

ALXN4100TPO, a thrombopoietin (TPO) receptor agonist, increases platelets, abrogates radiation-induced thrombocytopenia and affords significant survival benefit to lethally irradiated mice. This preliminary nonclinical safety study assessed effects of a single subcutaneous (sc) administration of ALXN4100TPO in CD2F1 mice randomized into naïve, control antibody (ALXN4200, 100 mg/kg), low (1 mg/kg), medium (10 mg/kg), or high (100 mg/kg) ALXN4100TPO doses. End points included clinical observations, body weight changes, hematology, histopathology, pharmacokinetics, pharmacodynamics by measuring platelet counts, and endogenous TPO (eTPO) levels. Salient findings were prominent increase in platelet counts and end cells of myeloid and lymphoid lineages; elevated megakaryopoiesis in bone marrow; and extramedullary hematopoiesis in spleen and liver. Serum ALXN4100TPO levels were maximum 24 hours after administration, with a half-life of 13 days. Endogenous TPO levels were elevated in 10 and 100 mg/kg ALXN4100TPO-treated groups. In conclusion, ALXN4100TPO (1-100 mg/kg, sc) treatment in CD2F1 mice resulted in profound pharmacological changes in the hematopoietic tissue; however, no life-threatening adverse events were observed.

Pulmonary Specialist-Supported Health Coaching Delivered by Lay Personnel Improves Receipt of Quality Care for Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.

Purpose: Half of people living with chronic obstructive pulmonary disease (COPD) do not receive high-quality, evidenced-based care as described in international guidelines. We conducted secondary data analysis of a previously published study to assess the ability of a model of lay health coaching to improve provision of guideline-based care in a primary care setting. Methods: As part of a randomized controlled trial, we recruited English- and Spanish-speaking patients with moderate to severe COPD from primary care clinics serving a low-income, predominantly African American population. Participants were randomized to receive usual care or 9 months of health coaching from primary care personnel informed by a pulmonary specialist practitioner. Outcome measures included prescription of appropriate inhaler therapy, participation in COPD-related education, engagement with specialty care, prescription of smoking cessation medications, and patient ratings of the quality of care. Results: Baseline quality measures did not differ between study arms. At 9 months, coached patients were more likely (increase of 9.3% over usual care; P=0.014) to have received guideline-based inhalers compared to those in usual care. Coached patients were more likely to engage with pulmonary specialty care (increase of 8.3% over usual care with at least 1 visit; P=0.04) and educational classes (increase of 5.3% over usual care; P=0.03). Receipt of smoking cessation medications among patients smoking at baseline in the health coaching group increased 21.1 percentage points more than in usual care, a difference near statistical significance (P=0.06). Conclusions: Health coaching may improve the provision of quality chronic illness care for conditions such as COPD.

"She Showed Me How to Help Myself": A Qualitative Study of Health Coaching for Management of Chronic Obstructive Pulmonary Disease.

OBJECTIVE: To explore attitudes and beliefs about the role of health coaching for vulnerable populations, including people experiencing substance use or homelessness. METHODS: From May-July 2016, we conducted semi-structured qualitative interviews with patients, primary care clinicians, pulmonary specialists, and health coaches participating in a study of health coaching for chronic obstructive pulmonary disease (COPD). We developed a codebook and applied it in Atlas.ti, generating themes for frequently occurring codes. RESULTS: All stakeholder groups (n=20 patients, 11 primary care clinicians, three specialists, and two health coaches), reported improved COPD management and behavior change, even for patients experiencing substance use or homelessness. Clinicians observed greater symptom awareness and prioritization of COPD during the medical visit. The strength of the health coaching relationship and flexibility of the role were key to its effectiveness. CONCLUSION: Lay health coaching may provide a model to meet the needs of highly vulnerable populations with COPD.

Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease.

RATIONALE: Socioeconomically disadvantaged patients with chronic obstructive pulmonary disease (COPD) often face barriers to evidence-based care that are difficult to address in public care settings with limited resources. OBJECTIVES: To determine the benefit of health coaching for patients with moderate to severe COPD relative to usual care. METHODS: We conducted a randomized controlled trial of 9 months of health coaching versus usual care for English- or Spanish-speaking patients at least 40 years of age with moderate to severe COPD. Primary outcomes were COPD-related quality of life and the dyspnea subscale of the Chronic Respiratory Disease Questionnaire. Secondary outcomes were self-efficacy for managing COPD, exercise capacity (6-min walk test), and number of COPD exacerbations. Additional outcomes were COPD symptoms, lung function (forced expiratory volume in 1 s percent predicted), smoking status, bed days owing to COPD, quality of care (Patient Assessment of Chronic Illness Care), COPD knowledge, and symptoms of depression (Patient Health Questionnaire). Outpatient visits, emergency department visits, and hospitalizations were assessed by review of medical records. Generalized linear modeling was used to adjust for baseline values and account for clustering by clinic. RESULTS: Of 192 patients enrolled, 158 (82%) completed 9 months of follow-up. There were no significant differences between study arms for the primary or secondary outcomes. At 9 months, patients in the coached group reported better quality of care (mean Patient Assessment of Chronic Illness Care score, 3.30 vs. 3.18; adjusted P = 0.02) and were less likely to report symptoms of moderate to severe depression (Patient Health Questionnaire score, ≥15) than those in the usual care arm (6% vs. 20%; adjusted P = 0.01). During the study, patients in the coaching arm had 48% fewer hospitalizations related to COPD (0.27/patient/yr vs. 0.52/patient/yr), but this difference was not significant in the adjusted analysis. CONCLUSIONS: These results help inform expectations regarding the limitations and benefits of health coaching for patients with COPD. They may be useful to health policy experts in assessing the potential value of reimbursement and incentives for health coaching-type activities for patients with chronic disease. Clinical trial registered with www.clinicaltrials.gov (NCT02234284).

The impact of health coaching on medication adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a randomized controlled trial.

BACKGROUND: Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes. We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence. METHODS: This was a nonblinded, randomized, controlled, pragmatic intervention trial. English- or Spanish-speaking patients, age 18 to 75 years, with poorly controlled type 2 diabetes, hypertension, and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care. RESULTS: Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days (of the last 7) on which patient took all prescribed medications. The proportion of medications completely concordant increased in the coached group versus the usual care group (difference in change, 10%; P = .05). The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group (difference in change, 17%; P = .013). The mean number of adherent days increased in the coached but not in the usual care group (difference in change, 1.08; P < .001). CONCLUSIONS: Health coaching by medical assistants significantly increases medication concordance and adherence.

Clinician perspectives on working with health coaches: A mixed methods approach.

We sought to understand how health coaches affect the work of primary care clinicians and influence their perception of patient care. As a mixed methods hypothesis-generating study, we administered a structured post-visit survey and conducted in-depth individual interviews with primary care clinicians who worked with health coaches at two urban community health centers. Survey responses were compared using t tests. Interviews were transcribed and analyzed using Atlas.ti software and modified grounded theory. Surveys were completed by 15 of 17 clinicians for 61% of eligible patient visits (269/441). Compared to usual care patients, clinicians rated visits with health-coached patients as less demanding (2.44 vs. 3.06, p < .001) and were more likely to feel that they had adequate time with their patient (3.96 vs. 3.57, p < .001). Qualitative findings expanded upon these results and uncovered four key health coach activities thought to improve patient care. Through developing a rapport with patients over time and working with patients between medical visits, health coaches (a) empower patients by offering self-management support, (b) bridge communication gaps between clinicians and patients, (c) assist patients in navigating the health care system, and (d) act as a point of contact for patients.