Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke.

2021

72

2021 Jul 15

1748-5908

<p><strong>BACKGROUND: </strong>Routine evidence-based tobacco use treatment minimizes cancer-specific and all-cause mortality, reduces treatment-related toxicity, and improves quality of life among patients receiving cancer care. Few cancer centers employ mechanisms to systematically refer patients to evidence-based tobacco cessation services. Implementation strategies informed by behavioral economics can increase tobacco use treatment engagement within oncology care.</p>

<p><strong>METHODS: </strong>A four-arm cluster-randomized pragmatic trial will be conducted across nine clinical sites within the Implementation Science Center in Cancer Control Implementation Lab to compare the effect of behavioral economic implementation strategies delivered through embedded messages (or "nudges") promoting patient engagement with the Tobacco Use Treatment Service (TUTS). Nudges are electronic medical record (EMR)-based messages delivered to patients, clinicians, or both, designed to counteract known patient and clinician biases that reduce treatment engagement. We used rapid cycle approaches (RCA) informed by relevant stakeholder experiences to refine and optimize our implementation strategies and methods prior to trial initiation. Data will be obtained via the EMR, clinician survey, and semi-structured interviews with a subset of clinicians and patients. The primary measure of implementation is penetration, defined as the TUTS referral rate. Secondary outcome measures of implementation include patient treatment engagement (defined as the number of patients who receive FDA-approved medication or behavioral counseling), quit attempts, and abstinence rates. The semi-structured interviews, guided by the Consolidated Framework for Implementation Research, will assess contextual factors and patient and clinician experiences with the nudges.</p>

<p><strong>DISCUSSION: </strong>This study will be the first in the oncology setting to compare the effectiveness of nudges to clinicians and patients, both head-to-head and in combination, as implementation strategies to improve TUTS referral and engagement. We expect the study to (1) yield insights into the effectiveness of nudges as an implementation strategy to improve uptake of evidence-based tobacco use treatment within cancer care, and (2) advance our understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how patients with cancer who smoke are best engaged in tobacco use treatment and may lead to future research focused on scaling this approach across diverse centers.</p>

<p><strong>TRIAL REGISTRATION: </strong>Clinicaltrials.gov, NCT04737031 . Registered 3 February 2021.</p>

10.1186/s13012-021-01139-7

Implement Sci

34266468

Early Childhood Sleep Intervention in Urban Primary Care: Clinician and Caregiver Perspectives.

2020

2020 May 20

1465-735X

<p><strong>BACKGROUND: </strong>Despite significant income-related disparities in pediatric sleep, few early childhood sleep interventions have been tailored for or tested with families of lower socio-economic status (SES). This qualitative study assessed caregiver and clinician perspectives to inform adaptation and implementation of evidence-based behavioral sleep interventions in urban primary care with families who are predominantly of lower SES.</p>

<p><strong>METHODS: </strong>Semi-structured interviews were conducted with (a) 23 caregivers (96% mothers; 83% Black; 65% ≤125% U.S. poverty level) of toddlers and preschoolers with insomnia or insufficient sleep and (b) 22 urban primary care clinicians (physicians, nurse practitioners, social workers, and psychologists; 87% female; 73% White). Guided by the Consolidated Framework for Implementation Research, the interview guide assessed multilevel factors across five domains related to intervention implementation. Qualitative data were analyzed using an integrated approach to identify thematic patterns across participants and domains.</p>

<p><strong>RESULTS: </strong>Patterns of convergence and divergence in stakeholder perspectives emerged across themes. Participants agreed upon the importance of child sleep and intervention barriers (family work schedules; household and neighborhood factors). Perspectives aligned on intervention (flexibility; collaborative and empowering care) and implementation (caregiver-to-caregiver support and use of technology) facilitators. Clinicians identified many family barriers to treatment engagement, but caregivers perceived few barriers. Clinicians also raised healthcare setting factors that could support (integrated care) or hinder (space and resources) implementation.</p>

<p><strong>CONCLUSIONS: </strong>Findings point to adaptations to evidence-based early childhood sleep intervention that may be necessary for effective implementation in urban primary care. Such adaptations could potentially reduce significant pediatric sleep-related health disparities.</p>

10.1093/jpepsy/jsaa024

J Pediatr Psychol

32430496