ABSTRACT
BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).
Subject(s)
Adrenal Cortex Hormones/therapeutic use , Asthma/epidemiology , Black or African American , Medication Adherence/statistics & numerical data , Adult , Asthma/drug therapy , Drug Therapy, Combination , Feasibility Studies , Female , Hispanic or Latino , Humans , Male , Middle Aged , Patient Selection , Pilot Projects , Practice Guidelines as Topic , Pragmatic Clinical Trials as Topic , Surveys and Questionnaires , United States/epidemiologyABSTRACT
BACKGROUND: For at least the past two decades, medical educators have worked to improve patient communication and health care delivery to diverse patient populations; despite efforts, patients continue to report prejudice and bias during their clinical encounters. Targeted instruction in implicit bias recognition and management may promote the delivery of equitable care, but students at times resist this instruction. Little guidance exists to overcome this resistance and to engage students in implicit bias instruction; instruction over time could lead to eventual skill development that is necessary to mitigate the influence of implicit bias on clinical practice behaviors. OBJECTIVE: To explore student perceptions of challenges and opportunities when participating in implicit bias instruction. APPROACH: We conducted a qualitative study that involved 11 focus groups with medical students across each of the four class years to explore their perceptions of challenges and opportunities related to participating in such instruction. We analyzed transcripts for themes. KEY RESULTS: Our analysis suggests a range of attitudes toward implicit bias instruction and identifies contextual factors that may influence these attitudes. The themes were (1) resistance; (2) shame; (3) the negative role of the hidden curriculum; and (4) structural barriers to student engagement. Students expressed resistance to implicit bias instruction; some of these attitudes are fueled from concerns of anticipated shame within the learning environment. Participants also indicated that student engagement in implicit bias instruction was influenced by the hidden curriculum and structural barriers. CONCLUSIONS: These insights can inform future curriculum development efforts. Considerations related to instructional design and programmatic decision-making are highlighted. These considerations for implicit bias instruction may provide useful frameworks for educators looking for opportunities to minimize student resistance and maximize engagement in multi-session instruction in implicit bias recognition and management.
