Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke.

2023

JCO2300355

07/2023

1527-7755

PURPOSE: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology.

METHODS: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients. We delivered electronic health record (EHR)-based nudges promoting TUT across four nudge conditions: patient only, clinician only, patient and clinician, or usual care. Nudges were designed to counteract cognitive biases that reduce TUT engagement. The primary outcome was TUT penetration, defined as the proportion of patients with documented TUT referral or a medication prescription in the EHR. Generalized estimating equations were used to estimate the parameters of a linear model.

RESULTS: From June 2021 to July 2022, we randomly assigned 246 clinicians in 95 clusters, and collected TUT penetration data from their encounters with 2,146 eligible patients who smoke receiving oncologic care. Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% 13.5%; OR = 3.64; 95% CI, 2.52 to 5.24; < .0001). Completer-only analysis (N = 1,795) showed similar impact (37.7% clinician nudge 13.5% usual care; OR = 3.77; 95% CI, 2.73 to 5.19; < .0001). Clinician type affected TUT penetration, with physicians less likely to provide TUT than advanced practice providers (ITT OR = 0.67; 95% CI, 0.51 to 0.88; = .004).

CONCLUSION: EHR nudges, informed by behavioral economics and aimed at oncology clinicians, appear to substantially increase TUT penetration. Adding patient nudges to the implementation strategy did not affect TUT penetration rates.

10.1200/JCO.23.00355

J Clin Oncol

37467454

Provider perspectives on clinical decision support to improve HIV prevention in pediatric primary care: a multiple methods study.

2023

18

02/2023

2662-2211

BACKGROUND: Clinical decision support (CDS) is a promising intervention for improving uptake of HIV testing and pre-exposure prophylaxis (PrEP). However, little is known regarding provider perspectives on acceptability, appropriateness, and feasibility of CDS for HIV prevention in pediatric primary care, a key implementation setting.

METHODS: This was a cross-sectional multiple methods study utilizing surveys and in-depth interviews with pediatricians to assess acceptability, appropriateness, and feasibility of CDS for HIV prevention, as well as to identify contextual barriers and facilitators to CDS. Qualitative analysis utilized work domain analysis and a deductive coding approach grounded in the Consolidated Framework of Implementation Research. Quantitative and qualitative data were merged to develop an Implementation Research Logic Model to conceptualize implementation determinants, strategies, mechanisms, and outcomes of potential CDS use.

RESULTS: Participants (n = 26) were primarily white (92%), female (88%), and physicians (73%). Using CDS to improve HIV testing and PrEP delivery was perceived as highly acceptable (median score 5), IQR [4-5]), appropriate (5, IQR [4-5]), and feasible (4, IQR [3.75-4.75]) using a 5-point Likert scale. Providers identified confidentiality and time constraints as two key barriers to HIV prevention care spanning every workflow step. With respect to desired CDS features, providers sought interventions that were integrated into the primary care workflow, standardized to promote universal testing yet adaptable to the level of a patient's HIV risk, and addressed providers' knowledge gaps and bolstered self-efficacy in providing HIV prevention services.

CONCLUSIONS: This multiple methods study indicates that clinical decision support in the pediatric primary care setting may be an acceptable, feasible, and appropriate intervention for improving the reach and equitable delivery of HIV screening and PrEP services. Design considerations for CDS in this setting should include deploying CDS interventions early in the visit workflow and prioritizing standardized but flexible designs.

10.1186/s43058-023-00394-7

Implement Sci Commun

36810099

Sustainable deimplementation of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis: study protocol for the Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial.

2022

72

10/2022

1748-5908

BACKGROUND: Methods of sustaining the deimplementation of overused medical practices (i.e., practices not supported by evidence) are understudied. In pediatric hospital medicine, continuous pulse oximetry monitoring of children with the common viral respiratory illness bronchiolitis is recommended only under specific circumstances. Three national guidelines discourage its use for children who are not receiving supplemental oxygen, but guideline-discordant practice (i.e., overuse) remains prevalent. A 6-hospital pilot of educational outreach with audit and feedback resulted in immediate reductions in overuse; however, the best strategies to optimize sustainment of deimplementation success are unknown.

METHODS: The Eliminating Monitor Overuse (EMO) trial will compare two deimplementation strategies in a hybrid type III effectiveness-deimplementation trial. This longitudinal cluster-randomized design will be conducted in Pediatric Research in Inpatient Settings (PRIS) Network hospitals and will include baseline measurement, active deimplementation, and sustainment phases. After a baseline measurement period, 16-19 hospitals will be randomized to a deimplementation strategy that targets unlearning (educational outreach with audit and feedback), and the other 16-19 will be randomized to a strategy that targets unlearning and substitution (adding an EHR-integrated clinical pathway decision support tool). The primary outcome is the sustainment of deimplementation in bronchiolitis patients who are not receiving any supplemental oxygen, analyzed as a longitudinal difference-in-differences comparison of overuse rates across study arms. Secondary outcomes include equity of deimplementation and the fidelity to, and cost of, each deimplementation strategy. To understand how the deimplementation strategies work, we will test hypothesized mechanisms of routinization (clinicians developing new routines supporting practice change) and institutionalization (embedding of practice change into existing organizational systems).

DISCUSSION: The EMO trial will advance the science of deimplementation by providing new insights into the processes, mechanisms, costs, and likelihood of sustained practice change using rigorously designed deimplementation strategies. The trial will also advance care for a high-incidence, costly pediatric lung disease.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT05132322 . Registered on November 10, 2021.

10.1186/s13012-022-01246-z

Implement Sci

36271399

Methodological progress note: Hybrid effectiveness-implementation clinical trials.

2022

08/2022

1553-5606

10.1002/jhm.12936

J Hosp Med

35934981

Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care.

2021

2021 Dec 16

1550-9397

<p><strong>STUDY OBJECTIVES: </strong>To describe the adaptation, feasibility, and initial outcomes of <em>Sleep Well!</em>, an intervention for early childhood insomnia and insufficient sleep, designed for families from lower-socioeconomic status (SES) backgrounds presenting to large metropolitan primary care sites.</p>

<p><strong>METHODS: </strong>Fifteen caregiver-child dyads (caregivers: 92.3% mothers; 80.0% Black; 53.3% ≤125% US poverty level; children: 73.3% female; 86.7% Black; age = 3.0 years) participated this multi-method, single-arm trial. A family advisory board of caregivers (N = 4) and a clinician advisory board of sleep experts, primary care clinicians, and psychologists (N = 13) provided intervention feedback throughout the pilot. Most adaptations were related to intervention delivery methods, with some related to sleep strategies. At post-intervention, caregivers completed surveys on intervention acceptability and cultural humility (primary outcomes) and completed semi-structured interviews. Caregivers also reported on child sleep pre- and post-intervention.</p>

<p><strong>RESULTS: </strong>Thirteen (86.6%) families completed <em>Sleep Well!&nbsp;</em>and 12 (80.0%) completed pre- and post-intervention measures. Caregivers reported strong intervention acceptability and cultural humility. There were pre-to-post reductions in child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration. Nighttime sleep duration and overall insufficient sleep also improved. Qualitative data also showed strong intervention acceptability and perceived flexibility, with few participation barriers.</p>

<p><strong>CONCLUSIONS: </strong>A brief, early childhood behavioral sleep intervention delivered in primary care with families from primarily lower-SES and/or racially minoritized backgrounds is feasible to implement, with strong retention rates, acceptability, and perceptions of cultural humility. Child sleep improvements are positive, and warrant replication in a randomized controlled trial.</p>

10.5664/jcsm.9822

J Clin Sleep Med

34910624

Medical stakeholder perspectives on implementing a computerized battery to identify neurocognitive impairments among youth in Botswana.

2021

1-9

2021 Oct 18

1360-0451

<p>HIV infection and exposure, common in Sub-Saharan Africa, are associated with pediatric neurocognitive impairment. Cognitive screening can identify impairments, but it is rarely used in this setting. The Penn Computerized Neurocognitive Battery (PennCNB), an evidence-based cognitive screening tool, was adapted for use in Botswana. To facilitate future implementation, 20 semi-structured interviews were conducted to elicit key stakeholders' perspectives on factors likely to be related to successful uptake of the PennCNB in clinical settings. An integrated analytic approach combining constructs from the Consolidated Framework for Implementation Research and modified grounded theory was used. Results underscore the need for cognitive screening in Botswana and the acceptability of the PennCNB. Implementation barriers include limited time and resources, whereas facilitators include standard procedures for introducing new tools into medical settings and for training implementers. Recommended implementation strategies include integrating screening into the existing workflow, implementing the tool in the medical and educational sectors, and targeting selection of children for assessment. This research addresses the research-to-practice gap by engaging in pre-implementation inquiry and designing for implementation. Results will inform the development of strategies to maximize the likelihood of successful implementation of the PennCNB to identify neurocognitive impairment in children in this high-need setting.</p>

10.1080/09540121.2021.1990202

AIDS Care

34663144

Evaluation of an Educational Outreach and Audit and Feedback Program to Reduce Continuous Pulse Oximetry Use in Hospitalized Infants With Stable Bronchiolitis: A Nonrandomized Clinical Trial.

2021

e2122826

2021 Sep 01

2574-3805

<p><strong>Importance: </strong>National guidelines recommend against continuous pulse oximetry use for hospitalized children with bronchiolitis who are not receiving supplemental oxygen, yet guideline-discordant use remains high.</p>

<p><strong>Objectives: </strong>To evaluate deimplementation outcomes of educational outreach and audit and feedback strategies aiming to reduce guideline-discordant continuous pulse oximetry use in children hospitalized with bronchiolitis who are not receiving supplemental oxygen.</p>

<p><strong>Design, Setting, and Participants: </strong>A nonrandomized clinical single-group deimplementation trial was conducted in 14 non-intensive care units in 5 freestanding children's hospitals and 1 community hospital from December 1, 2019, through March 14, 2020, among 847 nurses and physicians caring for hospitalized children with bronchiolitis who were not receiving supplemental oxygen.</p>

<p><strong>Interventions: </strong>Educational outreach focused on communicating details of the existing guidelines and evidence. Audit and feedback strategies included 2 formats: (1) weekly aggregate data feedback to multidisciplinary teams with review of unit-level and hospital-level use of continuous pulse oximetry, and (2) real-time 1:1 feedback to clinicians when guideline-discordant continuous pulse oximetry use was discovered during in-person data audits.</p>

<p><strong>Main Outcomes and Measures: </strong>Clinician ratings of acceptability, appropriateness, feasibility, and perceived safety were assessed using a questionnaire. Guideline-discordant continuous pulse oximetry use in hospitalized children was measured using direct observation of a convenience sample of patients with bronchiolitis who were not receiving supplemental oxygen.</p>

<p><strong>Results: </strong>A total of 847 of 1193 eligible clinicians (695 women [82.1%]) responded to a Likert scale-based questionnaire (71% response rate). Most respondents rated the deimplementation strategies of education and audit and feedback as acceptable (education, 435 of 474 [92%]; audit and feedback, 615 of 664 [93%]), appropriate (education, 457 of 474 [96%]; audit and feedback, 622 of 664 [94%]), feasible (education, 424 of 474 [89%]; audit and feedback, 557 of 664 [84%]), and safe (803 of 847 [95%]). Sites collected 1051 audit observations (range, 47-403 per site) on 709 unique patient admissions (range, 31-251 per site) during a 3.5-month period of continuous pulse oximetry use in children with bronchiolitis not receiving supplemental oxygen, which were compared with 579 observations (range, 57-154 per site) from the same hospitals during the baseline 4-month period (prior season) to determine whether the strategies were associated with a reduction in use. Sites conducted 148 in-person educational outreach and aggregate data feedback sessions and provided real-time 1:1 feedback 171 of 236 times (72% of the time when guideline-discordant monitoring was identified). Adjusted for age, gestational age, time since weaning from supplemental oxygen, and other characteristics, guideline-discordant continuous pulse oximetry use decreased from 53% (95% CI, 49%-57%) to 23% (95% CI, 20%-25%) (P &lt; .001) during the intervention period. There were no adverse events attributable to reduced monitoring.</p>

<p><strong>Conclusions and Relevance: </strong>In this nonrandomized clinical trial, educational outreach and audit and feedback deimplementation strategies for guideline-discordant continuous pulse oximetry use among hospitalized children with bronchiolitis who were not receiving supplemental oxygen were positively associated with clinician perceptions of feasibility, acceptability, appropriateness, and safety. Evaluating the sustainability of deimplementation beyond the intervention period is an essential next step.</p>

<p><strong>Trial Registration: </strong>ClinicalTrials.gov Identifier: NCT04178941.</p>

10.1001/jamanetworkopen.2021.22826

JAMA Netw Open

34473258

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

Barriers and Facilitators to Guideline-Adherent Pulse Oximetry Use in Bronchiolitis.

2021

23-30

2021 Jan

1553-5606

<p><strong>OBJECTIVE: </strong>Continuous pulse oximetry monitoring (cSpO) in children with bronchiolitis does not improve clinical outcomes and has been associated with increased resource use and alarm fatigue. It is critical to understand the factors that contribute to cSpO overuse in order to reduce overuse and its associated harms.</p>

<p><strong>METHODS: </strong>This multicenter qualitative study took place in the context of the Eliminating Monitor Overuse (EMO) SpO study, a cross-sectional study to establish rates of cSpO in bronchiolitis. We conducted semistructured interviews, informed by the Consolidated Framework for Implementation Research, with a purposive sample of stakeholders at sites with high and low cSpO use rates to identify barriers and facilitators to addressing cSpO overuse. Interviews were audio recorded and transcribed. Analyses were conducted using an integrated approach.</p>

<p><strong>RESULTS: </strong>Participants (n = 56) included EMO study site principal investigators (n = 12), hospital administrators (n = 8), physicians (n = 15), nurses (n = 12), and respiratory therapists (n = 9) from 12 hospitals. Results suggest that leadership buy-in, clear authoritative guidelines for SpO use incorporated into electronic order sets, regular education about cSpO in bronchiolitis, and visual reminders may be needed to reduce cSpO utilization. Parental perceptions and individual clinician comfort affect cSpO practice.</p>

<p><strong>CONCLUSION: </strong>We identified barriers and facilitators to deimplementation of cSpO for stable patients with bronchiolitis across children's hospitals with high- and low-cSpO use. Based on these data, future deimplementation efforts should focus on clear protocols for cSpO, EHR changes, and education for hospital staff on bronchiolitis features and rationale for reducing cSpO.</p>

10.12788/jhm.3535

J Hosp Med

33357326

Harnessing implementation science to optimize harm prevention in critically ill children: a pilot study of bedside nurse CLABSI bundle performance in the pediatric intensive care unit.

2020

2020 Aug 17

1527-3296

<p><strong>OBJECTIVES: </strong>Central-line associated bloodstream infection (CLABSI) is associated with increased mortality, morbidity, and cost in hospitalized children. An evidence-based bundle of care can decrease CLABSI, but bundle compliance is imperfect. We explored factors impacting bundle performance in the pediatric intensive care unit (PICU) by bedside nurses.</p>

<p><strong>METHODS: </strong>Single-center cross sectional electronic survey of PICU bedside nurses in an academic tertiary care center; using the COM-B (capability, opportunity, motivation) and TDF (theoretical domains framework) behavioral models to explore CLABSI bundle performance and identify barriers to compliance.</p>

<p><strong>RESULTS: </strong>We analyzed 160 completed surveys from 226 nurses (71% response rate). CLABSI knowledge was strong (capability). However, challenges related to opportunity were identified: 71% reported that patient care requirements impact bundle completion; 32% described the bundle as stressful; and CLABSI was viewed as the most difficult of all bundles. 75% reported being highly impacted by physician attitude toward the CLABSI bundle (motivation).</p>

<p><strong>CONCLUSIONS: </strong>PICU nurses are knowledgeable and motivated to prevent CLABSI, but face challenges from competing clinical tasks, limited resources, and complex family interactions. Physician engagement was specifically noted to impact nurse motivation to complete the bundle. Interventions that address these challenges may improve bundle performance and prevent CLABSI in critically ill children.</p>

10.1016/j.ajic.2020.08.019

Am J Infect Control

32818579