Cluster-randomized Trial Research Articles

Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention

BackgroundMental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being.MethodsA stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices.DiscussionThe Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being.Trial registrationClinicalTrials.gov NCT05611112. Registered on October 28, 2022.

A Trial of Automated Outbreak Detection to Reduce Hospital Pathogen Spread

BackgroundDetection and containment of hospital outbreaks currently depend on variable and personnel-intensive surveillance methods. Whether automated statistical surveillance for outbreaks of health care–associated pathogens allows earlier containment efforts that would reduce the size of outbreaks is unknown.MethodsWe conducted a cluster-randomized trial in 82 community hospitals within a larger health care system. All hospitals followed an outbreak response protocol when outbreaks were detected by their infection prevention programs. Half of the hospitals additionally used statistical surveillance of microbiology data, which alerted infection prevention programs to outbreaks. Statistical surveillance was also applied to microbiology data from control hospitals without alerting their infection prevention programs. The primary outcome was the number of additional cases occurring after outbreak detection. Analyses assessed differences between the intervention period (July 2019 to January 2022) versus baseline period (February 2017 to January 2019) between randomized groups. A post hoc analysis separately assessed pre–coronavirus disease 2019 (Covid-19) and Covid-19 pandemic intervention periods.ResultsReal-time alerts did not significantly reduce the number of additional outbreak cases (intervention period versus baseline: statistical surveillance relative rate [RR]=1.41, control RR=1.81; difference-in-differences, 0.78; 95% confidence interval [CI], 0.40 to 1.52; P=0.46). Comparing only the prepandemic intervention with baseline periods, the statistical outbreak surveillance group was associated with a 64.1% reduction in additional cases (statistical surveillance RR=0.78, control RR=2.19; difference-in-differences, 0.36; 95% CI, 0.13 to 0.99). There was no similarly observed association between the pandemic versus baseline periods (statistical surveillance RR=1.56, control RR=1.66; difference-in-differences, 0.94; 95% CI, 0.46 to 1.92).ConclusionsAutomated detection of hospital outbreaks using statistical surveillance did not reduce overall outbreak size in the context of an ongoing pandemic. (Funded by the Centers for Disease Control and Prevention; ClinicalTrials.gov number, NCT04053075. Support for HCA Healthcare’s participation in the study was provided in kind by HCA.)

Barriers to dental utilization among Medicaid-enrolled young children from primary care practices in Northeast Ohio.

To evaluate the individual and community factors that contribute to dental utilization among young children on Medicaid utilizing the Anderson Model and the Socio-Ecological Framework. This observational cross-sectional study was conducted using baseline data (socio-demographics, clinical dental need) from a cluster-randomized hybrid effectiveness-implementation trial among 1021 child-parent dyads recruited from primary care practices across northeast Ohio. The baseline data were then linked to dental Medicaid claims data (categorized as any dental visit, volume, and type in the past 12 months) and ICD-10 codes from the child's EHR data (individual-level) together with Dental Health Provider Shortage Area (HPSA) status and Area Deprivation Index (ADI) which were obtained at the neighbourhood-level using home address of each dyad (community-level). Multivariable analyses using generalized estimating equations (GEE) accounted for clustering by practice, and models included individual-level alone, and individual + community-level factors to evaluate their effects on dental utilization. Medicaid claims data indicated that among the 1021 children (mean age: 4.3 ± 1.1 years; 54.4% males; 43.8% Black, Non-Hispanic), a majority of children were seeing the dentist at least once a year by the age of 4 (56.1%). The mean ADI of their neighbourhoods was 109.22 (20.2) and 27.5% lived in a HPSA area. The GEE analyses revealed that individual factors such as older children, parents being married, and continuous Medicaid enrollment were associated with significantly higher dental utilization. Among community factors, being in a HPSA had an OR = 1.53 (CI: 1.03, 2.27) associated with higher dental utilization. Being in a HPSA was associated with higher dental utilization possibly due to dentists or safety net dental clinics in these areas accepting Medicaid-eligible children.

Stewardship Prompts to Improve Antibiotic Selection for Urinary Tract Infection

Urinary tract infection (UTI) is the second most common infection leading to hospitalization and is often associated with gram-negative multidrug-resistant organisms (MDROs). Clinicians overuse extended-spectrum antibiotics although most patients are at low risk for MDRO infection. Safe strategies to limit overuse of empiric antibiotics are needed. To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO risk estimates could reduce use of empiric extended-spectrum antibiotics for treatment of UTI. Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time and risk-based CPOE prompts; 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in noncritically ill adults (≥18 years) hospitalized with UTI with an 18-month baseline (April 1, 2017-September 30, 2018) and 15-month intervention period (April 1, 2019-June 30, 2020). CPOE prompts recommending empiric standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics who have low estimated absolute risk (<10%) of MDRO UTI, coupled with feedback and education. The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy. Safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes were assessed using generalized linear mixed-effect models to assess differences between the baseline and intervention periods. Among 127 403 adult patients (71 991 baseline and 55 412 intervention period) admitted with UTI in 59 hospitals, the mean (SD) age was 69.4 (17.9) years, 30.5% were male, and the median Elixhauser Comorbidity Index count was 4 (IQR, 2-5). Compared with routine stewardship, the group using CPOE prompts had a 17.4% (95% CI, 11.2%-23.2%) reduction in empiric extended-spectrum days of therapy (rate ratio, 0.83 [95% CI, 0.77-0.89]; P < .001). The safety outcomes of mean days to ICU transfer (6.6 vs 7.0 days) and hospital length of stay (6.3 vs 6.5 days) did not differ significantly between the routine and intervention groups, respectively. Compared with routine stewardship, CPOE prompts providing real-time recommendations for standard-spectrum antibiotics for patients with low MDRO risk coupled with feedback and education significantly reduced empiric extended-spectrum antibiotic use among noncritically ill adults admitted with UTI without changing hospital length of stay or days to ICU transfers. ClinicalTrials.gov Identifier: NCT03697096.

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia

Pneumonia is the most common infection requiring hospitalization and is a major reason for overuse of extended-spectrum antibiotics. Despite low risk of multidrug-resistant organism (MDRO) infection, clinical uncertainty often drives initial antibiotic selection. Strategies to limit empiric antibiotic overuse for patients with pneumonia are needed. To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO infection risk estimates could reduce empiric extended-spectrum antibiotics for non-critically ill patients admitted with pneumonia. Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time MDRO risk-based CPOE prompts; n = 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in non-critically ill adults (≥18 years) hospitalized with pneumonia. There was an 18-month baseline period from April 1, 2017, to September 30, 2018, and a 15-month intervention period from April 1, 2019, to June 30, 2020. CPOE prompts recommending standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics during the empiric period who have low estimated absolute risk (<10%) of MDRO pneumonia, coupled with feedback and education. The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy and safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes compared differences between baseline and intervention periods across strategies. Among 59 hospitals with 96 451 (51 671 in the baseline period and 44 780 in the intervention period) adult patients admitted with pneumonia, the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men, and the median (IQR) Elixhauser comorbidity count was 4 (2-6). Compared with routine stewardship, the group using CPOE prompts had a 28.4% reduction in empiric extended-spectrum days of therapy (rate ratio, 0.72 [95% CI, 0.66-0.78]; P < .001). Safety outcomes of mean days to ICU transfer (6.5 vs 7.1 days) and hospital length of stay (6.8 vs 7.1 days) did not differ significantly between the routine and CPOE intervention groups. Empiric extended-spectrum antibiotic use was significantly lower among adults admitted with pneumonia to non-ICU settings in hospitals using education, feedback, and CPOE prompts recommending standard-spectrum antibiotics for patients at low risk of MDRO infection, compared with routine stewardship practices. Hospital length of stay and days to ICU transfer were unchanged. ClinicalTrials.gov Identifier: NCT03697070.

Retraction Note: Children’s physical activity level and sedentary behaviour in Norwegian early childhood education and care: effects of a staff-led cluster-randomised controlled trial

This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1186/s12889-024-18629-0.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Even worse for Black girls: the longitudinal association of racial bullying with the initiation of alcohol and tobacco use.

We used Poisson's linear regression to examine the association between racial bullying (RB) and the initiation of alcohol and tobacco uses after 9 months. Two cluster-randomized controlled trials were conducted in 2019 with children in grades five (girls: 50.0%; 10 years old: 82.0%; White: 36.8%; Black: 58.7%; others: 4.5%) and seven (girls: 49.5%; 12 years old: 78.1%; White: 33.2%; Black: 60.4%; others: 6.4%) from 30 public schools in the municipality of São Paulo, Brazil. We restricted our analyses to 2 subsets of students in each grade: those who reported no lifetime alcohol use at baseline and those who reported no lifetime baseline tobacco use. At baseline, 16.2% of fifth and 10.7% of seventh graders reported suffering from RB in the 30 days before data collection. After 9 months, 14.9% of fifth graders started using alcohol and 2.5%, tobacco. Among seventh graders, the figures were 31.2% and 7.7%, respectively. RB predicted the initiation of use of alcohol (risk ratio [RR]= 1.36; 95% CI, 1.07-1.70) and tobacco (RR= 1.81; 95% CI, 1.14-2.76) among seventh graders, with race-gender differences, particularly in Black girls (alcohol: RR= 1.45; 95% CI, 1.07-1.93; tobacco: RR= 2.34; 95% CI, 1.31-3.99). School-based programs and policies must explicitly address issues related to racism and gender in alcohol and tobacco prevention strategies.

Cost Analysis of Short Messaging Service and Peer Navigator Interventions for Linking and Retaining Adults Recently Diagnosed With HIV in Care in South Africa.

Large proportions of people living with HIV (PLHIV) in sub-Saharan Africa are not linked to or retained in HIV care. There is a critical need for cost-effective interventions to improve engagement and retention in care and inform optimal allocation of resources. We estimated costs associated with a short message service (SMS) plus peer navigation (SMS+PN) intervention; an SMS-only intervention; and standard of care (SOC), within the I-Care cluster-randomized trial to improve HIV care engagement for recently diagnosed PLHIV. We employed a uniform cost data-collection protocol to quantify resources used and associated costs for each intervention. Compared with SOC, the SMS+PN intervention cost $1284 ($828-$2859) more per additional patient linked to care within 30 days and $1904 ($1158-$5343) more per additional patient retained in care at 12 months, while improving linkage by 24% (95% CI: 11 to 36) and retention by 16% (95% CI: 6 to 26). By contrast, the SMS-only intervention cost $198 ($93-dominated) more per additional patient linked to care and $697 ($171-dominated) more per additional patient retained in care but was not significantly associated with improvements in linkage (12%; 95% CI: -1 to 25) or retention (3%; 95% CI: -7 to 14) compared with SOC. The efficiency of the SMS+PN intervention could be improved by 46%, to $690 more per additional patient linked and $1023 more per additional patient retained in care, if implemented within the Department of Health using more efficient distribution of staff resources. Findings suggest that scale-up of the SMS+PN intervention could benefit patients, improving care and health outcomes while being cost-effective.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): a nested cross-sectional assessment of falls risk within a cluster randomised trial

BackgroundTo investigate the feasibility of using the Stopping Elderly Accidents, Deaths and Injuries (STEADI) Falls Risk Tool Kit during community-based eye health screenings to assess falls risk of participants enrolled...

‘Does it matter how old I feel?’ The role of subjective age in a psychosocial intervention for improving depressive symptomatology among older adults in Brazil (PROACTIVE)

Objectives Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An important psychological marker that affects individuals’ aging experience relates to how old people feel. Known as subjective age, this marker has been shown to be a risk factor for experiencing greater depressive symptoms if individuals report feeling older than their (chronological) age. In this study, we perform secondary analyses of the PROACTIVE cluster-randomized controlled trial to examine the role of subjective age. Method The sample included 715 Brazilian older adults (74% female, M age 68.6, SD = 6.9, age range: 60–94 years) randomized to intervention (n = 360, 74% female, M age 68.4, SD = 6.6, age range: 60–89 years) or control (n = 355, 74% female, M age 68.9, SD = 7.2, age range: 60–94 years) arms. Here our primary outcome was depressive symptoms at the 8-month follow-up assessed with the 9-item Patient Health Questionnaire (PHQ-9) as a continuous variable. Our previous analyses demonstrated improved recovery from depression at follow-up in the intervention compared with the control arm. Results Relevant main effects and interactions in regression models for PHQ-9 presented here found that those reporting older subjective age had worse depressive symptoms at follow-up but that they benefitted more from the intervention when initial levels of depression were high. For participants who reported younger subjective ages the intervention showed positive effects that were independent of initial levels of depression. Conclusion Our findings emphasize the importance of investigating possible underlying mechanisms that can help clarify the impact of mental health interventions.

Impact of shared decision-making on women's childbirth preferences: A cluster randomised controlled trial

BackgroundMidwives provide counselling for birth plans (BPs) to women during prenatal care; however, the impact of individualised BP counselling interventions based on shared decision-making (SDM) regarding women's preferences is unknown. MethodsThis randomised cluster trial included four primary healthcare units. Midwives provided BP counselling based on SDM to women in the intervention group (IG) during prenatal care along with a handout about evidence-based recommendations. Women in the control group (CG) received standard BP counselling from midwives. The main outcome was preference changes concerning BPs. ResultsA total of 461 (95.5 %) pregnant women received BP counselling (IG, n = 247; CG, n = 214). Women in the IG changed their BP preferences for 13 items compared with those in the CG. These items were: using an unique space during birth (81.1 % vs 51.6 %; p < 0.001), option for light graduation (63 % vs 44.7 %; p < 0.001), listening to music (57.3 % vs 43.6 %; p = 0.006), drinking fluids during labour (84.6 % vs 93.6 %; p = 0.005), continuous monitoring (59 % vs 37.8 %; p < 0.001); desire for natural childbirth (36.6 % vs 25 %; p = 0.014), epidural analgesia (55.1 % vs 43.6 %; p = 0.023); breathing techniques (65.2 % vs 50.5 %; p = 0.003), massage (74.9 % vs 55.3 %; p < 0.001); birthing ball use (81.9 % vs 56.9 %; p < 0.001), spontaneous pushing (49.3 % vs 28.7 %; p < 0.001), choosing birth position (69.6 % vs 41.5 %) and delayed umbilical cord clamping (67.8 % vs 44.1 %; p = 0.001). ConclusionSDM counselling, together with a handout about evidence-based recommendations on childbirth and newborn care, produced more changes in women's preferences expressed in the BP than standard counselling.

Training and coaching early childhood teachers to foster social, emotional, and behavioral competence of children in Turkey.

A growing evidence base demonstrates the effectiveness of teacher training and coaching interventions to improve teacher- and child-level outcomes in high-income countries. However, more information is needed to show the benefits of these interventions in low- and middle-income countries (LMICs). To provide an evidence base for LMICs, we conducted a cluster-randomized controlled trial examining the efficacy of a teacher training and coaching intervention for promoting children's social, emotional, and behavioral competence, Reaching Educators and Children (REACH) Classroom Check-Up (CCU), on teachers' behaviors, teacher-child relationship quality, and children's social competence and problem behaviors. Participants included 20 early childhood teachers and 175 children (4-6 year olds) in Turkey. Findings indicate that REACH CCU increased teachers' positive behaviors and teacher behaviors that support social, emotional, and behavioral competence of children, while reducing teachers' negative behaviors. Teachers in REACH CCU demonstrated an increased level of closeness and reduced levels of conflict with children in their classrooms. Furthermore, REACH CCU improved teacher-reported social competence and reduced problem behaviors of children. Results provide evidence that REACH CCU is a promising approach for improving teachers' behaviors, teacher-child relationship quality, and children's social, emotional, and behavioral competence, especially in LMICs. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The effects of adding social-emotional learning to a comprehensive education intervention in El Salvador on teacher well-being: a mixed methods evaluation

ABSTRACT This article employs a mixed-method approach to assess the effects of El Salvadorian Integrated Systems of Full-Time Inclusive Schools (SI-EITP), which offers in-service teacher professional development (TPD) combined with a socioemotional learning intervention, on teacher well-being. Findings from the cluster-randomized controlled trial with no baseline show null results for most teacher well-being outcomes analyzed. Interviews suggest limited effects on teachers’ mindfulness and emotion regulation and indicate that teachers’ participation in TPD was potentially increasing their stress levels and emotion exhaustion. We recommend that TPD program designs consider how the delivery mode and intensity may influence teachers’ stress.

Neglecting students’ socio-emotional skills magnified learning losses during the pandemic

Did the dramatic learning losses from remote learning in the context of COVID-19 stem at least partly from schools having overlooked students’ socio-emotional skills—such as their ability to self-regulate emotions, their mental models, motivation, and grit—during the emergency transition to remote learning? We study this question using a cluster-randomized control trial with 18,256 high-school students across 87 schools in the State of Goiás, Brazil. The intervention sent behavioral nudges through text messages to students or their caregivers, targeting their socio-emotional skills during remote learning. Here we show that these messages significantly increased standardized test scores relative to the control group, preventing 7.5% of learning losses in math and 24% in Portuguese, consistent with the hypothesis that neglecting students’ socio-emotional skills magnified learning losses during the pandemic.

Something Happened with the Way We Work: Evaluating the Implementation of the Reducing Coercion in Norway (ReCoN) Intervention in Primary Mental Health Care.

Current policies to reduce the use of involuntary admissions are largely oriented towards specialist mental health care and have had limited success. We co-created, with stakeholders in five Norwegian municipalities, the 'Reducing Coercion in Norway' (ReCoN) intervention that aims to reduce involuntary admissions by improving the way in which primary mental health services work and collaborate. The intervention was implemented in five municipalities and is being tested in a cluster randomized control trial, which is yet to be published. The present study evaluates the implementation process in the five intervention municipalities. To assess how the intervention was executed, we report on how its different elements were implemented, and what helped or hindered implementation. We assessed the process using qualitative methods. Data included detailed notes from quarterly progress interviews with (i) intervention coordinators and representatives from (ii) user organisations and (iii) carer organisations. Finally, an end-of-intervention evaluation seminar included participants from across the sites. The majority of intervention actions were implemented. We believe this was enabled by the co-creating process, which ensured ownership and a good fit for the local setting. The analysis of facilitators and barriers showed a high degree of interconnectedness between different parts of the intervention so that success (or lack thereof) in one area affected the success in others. Future implementation should pay attention to enhanced planning and training, clarify the role and contribution of service user and carer involvement, and pay close attention to the need for implementation support and whether this should be external or internal to services. It is feasible to implement a complex intervention designed to reduce the use of involuntary admissions in general support services, such as the Norwegian primary mental health services. This could have implications for national and international policy aimed at reducing the use of involuntary care.

Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease

BackgroundDespite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking.MethodsIn this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient’s electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death.ResultsWe assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P=0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%).ConclusionsIn this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.)

Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial

BackgroundDentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations.MethodsThis multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12–25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant’s electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants’ perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.).DiscussionThis real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA.ClinicalTrials.govNCT06275191.

Substance use and adolescent mental health during the COVID-19 pandemic in Brazil: a longitudinal approach

ObjectiveTo describe the changes in alcohol and drug use by Brazilian adolescents during the COVID-19 pandemic (April-August 2021), and to analyze the relationship between alcohol use changes and psychiatric symptomatology. MethodsA secondary analysis with a longitudinal approach was performed with data from a cluster-randomized controlled trial, conducted in 73 public middle schools in three Brazilian cities, to evaluate the effectiveness of a drug use prevention program. The sample included 535 students (61% girls; Mage = 15.2 years). Data were collected pre-intervention (February-March 2019), after 9 months (November-December 2019), and after 26 months (April-August 2021), when the students were in their first year of high school. The authors analyzed drug use prevalence (alcohol, binge drinking, tobacco, inhalants, marijuana, cocaine, and crack) in a lifetime, past year, and past month periods, and the association between alcohol use change subsamples with psychiatric symptoms. Logistic regressions were adjusted by sex, age, socioeconomic status, city, and group (control and intervention). ResultsThe present findings suggest that the COVID-19 pandemic led to a decrease in past-year substance use and in past-month substance use frequency, despite the gradually increased (but decelerating) prevalence of lifetime use. However, some adolescents initiated, maintained, or increased the frequency of their alcohol use. Mainly, they were more likely to present behavioral problems, as well as symptoms of inattentive hyperactivity, and peer and emotional problems. ConclusionsDespite the extensive decline in substance use during the pandemic period, these results suggest an association between previous mental health conditions and behavioral risk factors, leading to increased alcohol consumption and behavioral disorders manifestations.

Assessing treatment effect heterogeneity in the presence of missing effect modifier data in cluster-randomized trials.

Understanding whether and how treatment effects vary across subgroups is crucial to inform clinical practice and recommendations. Accordingly, the assessment of heterogeneous treatment effects based on pre-specified potential effect modifiers has become a common goal in modern randomized trials. However, when one or more potential effect modifiers are missing, complete-case analysis may lead to bias and under-coverage. While statistical methods for handling missing data have been proposed and compared for individually randomized trials with missing effect modifier data, few guidelines exist for the cluster-randomized setting, where intracluster correlations in the effect modifiers, outcomes, or even missingness mechanisms may introduce further threats to accurate assessment of heterogeneous treatment effect. In this article, the performance of several missing data methods are compared through a simulation study of cluster-randomized trials with continuous outcome and missing binary effect modifier data, and further illustrated using real data from the Work, Family, and Health Study. Our results suggest that multilevel multiple imputation and Bayesian multilevel multiple imputation have better performance than other available methods, and that Bayesian multilevel multiple imputation has lower bias and closer to nominal coverage than standard multilevel multiple imputation when there are model specification or compatibility issues.