Cluster-randomized Clinical Trial Research Articles

Health Within Reach-a Patient-Centered Intervention to Increase Hepatitis B Screening Among Asian Americans: a Randomized Clinical Trial.

There are few studies to date of interventions to increase viral hepatitis screening among Asian Americans, who have high rates of chronic hepatitis B (HBV) infection. To develop, implement, and test the efficacy of a mobile application (Hepatitis App) delivered in four languages to increase HBV screening among Asian Americans. Cluster-randomized clinical trial. Four hundred fifty-two Asian American patients ≥ 18years of age, who had no prior HBV testing, and received primary care within two healthcare systems in San Francisco, CA. The intervention group received the Hepatitis App, delivering interactive video education on viral hepatitis in English, Cantonese, Mandarin, or Vietnamese and a provider printout (Provider Alert) and Provider Panel Notification. The comparison group received a mobile application delivering nutrition and physical activity education and Provider Panel Notification. Primary outcomes were patient-provider discussion about HBV and documentation of a HBV screening test within 3months post-intervention. Secondary outcome was documentation of an order for a HBV screening test. Participants had a mean age of 57years and were 64% female, 80% foreign-born, and 44% with limited English fluency. At post-visit, over 80% of intervention participants reported they liked using the Hepatitis App. At 3-month follow-up, the intervention group was more likely than the comparison group (all P < 0.001) to have discussed HBV with their provider (70% vs.16%), have a HBV test ordered (44% vs.10%), and receive a HBV test (38% vs.8%). In multivariable analyses, the intervention odds ratio for HBV test ordering was 7.6 (95% CI: 3.9, 14.8) and test receipt was 7.5 (95% CI: 3.6, 15.5). A multi-lingual educational intervention using a mobile application in primary care clinics was well received by Asian American patients, enhanced patient-provider communication about HBV, and increased HBV screening. Technology can improve healthcare quality among Asian Americans. ClinicalTrials.gov NCT02139722 ( https://clinicaltrials.gov/ct2/show/NCT02139722 ).

Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial.

Nutrition education andcounseling is the first-line approach in nutritional support for adult cancer patients; however, it is not well implemented in many clinical settings. This study aims to determine the effect of an evidence-based nutrition education and counseling (NEC) program on nutrition status among cancer patients receiving radiotherapy. This cluster-randomized clinical trial enrolled cancer patients receiving radiotherapy from ten radiotherapy units in three hospitals. Randomization was conducted at the unit level (five units into the NEC group and five units into the usual care group). The primary outcome was nutrition status after radiotherapy measured by the Patient-Generated Subjective Global Assessment (PG-SGA). Secondary outcomes included nutrition-related blood biomarkers after radiotherapy and the use of artificial nutrition and treatment interruption during radiotherapy. A total of 468 patients were enrolled (241 in the NEC and 227 in the usual care group); 196 patients were female with a mean age (SD) of 59.8 (11.9). No difference was found between the NEC and usual care groups in nutrition status and blood biomarkers at baseline. After radiotherapy, patients in the NEC group had lower PG-SGA scores (5.6 vs 6.9; MD = -1.3, p < 0.001) and lower malnutrition rate (56.0% vs 70.5%; OR = 0.5; p = 0.004) compared with the usual care group. The usages of artificial nutrition and treatment interruption during radiotherapy and the level of blood biomarkers after radiotherapy did not differ between groups. Nutrition education and counseling is an effective approach in reducing malnutrition and can be generalized to multiple radiotherapy settings. REGISTERED UNDER CLINICALTRAILS. None.

Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial.

Background:Many patients who would benefit from a kidney transplant never receive one. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) pragmatic, cluster-randomized clinical trial is testing whether a multi-component quality improvement intervention, provided in chronic kidney disease (CKD) programs (vs. usual care), can help patients with CKD with no recorded contraindications to kidney transplant complete more steps toward receiving a transplant (primary outcome of the trial). The EnAKT LKD intervention has 4 components: (1) quality Improvement teams and administrative support, (2) improved transplant education for patients and healthcare providers, (3) access to support and (4) program-level performance monitoring.Objective:To conduct a process evaluation of the EnAKT LKD quality improvement intervention to determine if the components were delivered, received, and enacted as designed (fidelity), and if the intervention addressed intended barriers (mechanisms of change).Design:A mixed-methods process evaluation informed by new practice implementation and theories of behavior change.Setting:Chronic kidney disease programs in Ontario, Canada, began receiving the EnAKT LKD intervention on November 1, 2017 and will continue to receive it until December 31, 2021. The process evaluation (interviews and surveys) will occur alongside the trial, between December 2020 to May 2021.Participants:Healthcare providers (eg, dialysis nurses, nephrologists, members of the multi-care kidney clinic team) at Ontario’s 27 CKD programs.Methods:We will survey and interview healthcare providers at each CKD program, and complete an intervention implementation checklist. Quantitative data from the surveys and the intervention implementation checklist will assess fidelity to the intervention, while quantitative and qualitative data from surveys and interviews will provide insight into the mechanisms of change.Limitations:The long trial period may result in poor participant recall.Conclusion:This process evaluation will enhance interpretation of the trial findings, guide improvements in the intervention components, and inform future implementation.Trial registration:Clinicaltrials.gov; identifier: NCT03329521.

Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE).

In Southeast Europe (SEE) standard treatment of patients with psychosis is largely based on pharmacotherapy with psychosocial interventions rarely available. DIALOG+ is a digital psychosocial intervention designed to make routine care therapeutically effective. This trial simultaneously examined effectiveness of DIALOG+ versus standard care on clinical and social outcomes (Aim 1) and explored intervention fidelity (Aim 2). A hybrid type II effectiveness-implementation, cluster-randomized trial was conducted in five SEE countries: Bosnia and Herzegovina, Kosovo*, Montenegro, North Macedonia, and Serbia.The intervention was offered to patients six times across 12months instead of routine care. The outcomes were subjective quality of life (primary), clinical symptoms, satisfaction with services, and economic costs. Intervention fidelity was operationalized as adherence to the protocol in terms of frequency, duration, content, and coverage. Data were analyzed using multilevel regression. A total of 81 clinicians and 468 patients with psychosis were randomized to DIALOG+ or standard care. The intervention was delivered with high fidelity. The average number of delivered sessions was 5.5 (SD=2.3) across 12months. Patients in the intervention arm had better quality of life (MANSA) at 6months (p=0.03). No difference was found for other outcomes at 6months. Due to disruptions caused by the COVID-19 pandemic, 12-month data were not interpretable. DIALOG+ improved subjective quality of life of individuals with psychosis at 6months (after four sessions), albeit with small effect size. The intervention has the potential to contribute to holistic care of patients with psychosis.

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial.

Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) is a quality improvement intervention designed to enhance access to kidney transplantation and living kidney donation. We conducted a cluster-randomized clinical trial to evaluate the effect of the intervention versus usual care on completing key steps toward receiving a kidney transplant. To prespecify the statistical analysis plan for the EnAKT LKD trial. The EnAKT LKD trial is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized, superiority, clinical trial. Randomization was performed at the level of the chronic kidney disease (CKD) programs (the "clusters"). Twenty-six CKD programs in Ontario, Canada. More than 10 000 patients with advanced CKD (ie, patients approaching the need for dialysis or receiving maintenance dialysis) with no recorded contraindication to receiving a kidney transplant. The trial data (including patient characteristics and outcomes) will be obtained from linked administrative health care databases (the "registry"). Stratified covariate-constrained randomization was used to allocate the 26 CKD programs (1:1) to provide the intervention or usual care from November 1, 2017, to December 31, 2021 (4.17 years). CKD programs in the intervention arm received the following: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant waitlist, and (4) patient receives a kidney transplant from a living or deceased donor. Using an intent-to-treat approach, the primary outcome will be analyzed using a patient-level constrained multistate model adjusting for the clustering in CKD programs. The EnAKT LKD trial period is November 1, 2017, to December 31, 2021. We expect to analyze and report the results once the data for the trial period is available in linked administrative health care databases. The EnAKT LKD trial is registered with the U.S. National Institute of Health at clincaltrials.gov (NCT03329521 available at https://clinicaltrials.gov/ct2/show/NCT03329521). Version 1.0 August 26, 2022.

Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

Objective:The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care.Methods:The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia.Conclusion:According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results. ClinicalTrials.gov registration: NCT03920501

Implementing an Online Program to Change Benzodiazepine Prescription: Protocol of a Hybrid Type 1 Cluster-Randomised Trial

Introduction: Excessive benzodiazepine (BZD) prescription has long been considered a serious mental health concern in many countries. Many interventions using different methodologies have been implemented to change BZD prescription patterns in primary health care settings, with limited positive results. Objectives: The primary objective of our study was to analyse the effectiveness and implementation process of an intervention aimed at changing BZD prescription patterns in a primary health care setting in Portugal. Methodology: We chose as methodology an effectiveness-implementation hybrid type 1 intervention. Our intervention was based on the development of an online platform, named ePrimaPrescribe, which was delivered using a Digital Behaviour Change Intervention (DBCI), using a two-arm cluster-randomised clinical trial. Results: We primarily aimed to evaluate the effectiveness of our DBCI in changing BZD prescription patterns using the frequency of BZD prescriptions issued per month as an outcome measure. Secondarily, we aimed to analyse the effect of ePrimaPrescribe on antidepressant prescriptions, to study the effect of the platform on diagnosis registration associated with BZDs and antidepressant prescription, and to perform a cost analysis considering the monthly National Health Service spending on BZD co-payments. Finally, we aimed to analyse the implementation process using quantitative and qualitative methods. Conclusion: With this study, we expect to contribute with a cost-effective intervention to change the complex matter of excessive BZD prescriptions, and also to improve insight into the challenges to intervention implementation processes in primary health care settings. We believe that our findings are relevant not only to the specific setting where the study was implemented, but also to all countries where primary health care plays a central role in care provision.

Stratified Care vs Stepped Care for Depression

Depression is a major cause of disability worldwide. Although empirically supported treatments are available, there is scarce evidence on how to effectively personalize psychological treatment selection. To compare the clinical effectiveness and cost-effectiveness of 2 treatment selection strategies: stepped care and stratified care. This multisite, cluster randomized clinical trial recruited participants from the English National Health Service from July 5, 2018, to February 1, 2019. Thirty clinicians working across 4 psychological therapy services were randomly assigned to provide stratified (n = 15) or stepped (n = 15) care. In stepped care, patients sequentially access low-intensity guided self-help followed by high-intensity psychotherapy. In stratified care, patients are matched with either low- or high-intensity treatments at initial assessment. Data were analyzed from May 18, 2020, to October 13, 2021, using intention-to-treat principles. All clinicians used the same interview schedule to conduct initial assessments with patients seeking psychological treatment for common mental disorders, but those in the stratified care group received a personalized treatment recommendation for each patient generated by a machine learning algorithm. Eligible patients received either stratified or stepped care (ie, treatment as usual). The preregistered outcome was posttreatment reliable and clinically significant improvement (RCSI) of depression symptoms (measured using the 9-item Patient Health Questionnaire). The RCSI outcome was compared between groups using logistic regression adjusted for baseline severity. Cost-effectiveness analyses compared incremental costs and health outcomes of the 2 treatment pathways. A total of 951 patients were included (618 women among 950 with data available [65.1%]; mean [SD] age, 38.27 [14.53] years). The proportion of cases of RCSI was significantly higher in the stratified care arm compared with the stepped care arm (264 of 505 [52.3%] vs 134 of 297 [45.1%]; odds ratio, 1.40 [95% CI, 1.04-1.87]; P = .03). Stratified care was associated with a higher mean additional cost per patient (£104.5 [95% CI, £67.5-£141.6] [$139.83 (95% CI, $90.32-$189.48)]; P < .001) because more patients accessed high-intensity treatments (332 of 583 [56.9%] vs 107 of 368 [29.1%]; χ2 = 70.51; P < .001), but this additional cost resulted in an approximately 7% increase in the probability of RCSI. In this cluster randomized clinical trial of adults with common mental disorders, stratified care was efficacious and cost-effective for the treatment of depression symptoms compared with stepped care. Stratified care can improve depression treatment outcomes at a modest additional cost. isrctn.org Identifier: ISRCTN11106183.

Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients

Given that hypotonic maintenance intravenous fluids (IVF) may cause hospital-acquired harm, in November 2018, the American Academy of Pediatrics released a clinical practice guideline recommending the use of isotonic IVF for patients aged 28 days to 18 years without contraindications. No recommendations were made regarding laboratory monitoring; however, unnecessary laboratory tests may contribute to health care waste and harm patients. To examine the effect of a quality improvement intervention bundle on (1) increasing the mean proportion of hours per hospital day with exclusive isotonic IVF use to at least 80% and (2) decreasing the mean proportion of hospital days with laboratory tests obtained. This stepped-wedge, cluster randomized clinical trial (Standardization of Fluids in Inpatient Settings [SOFI]) was sponsored by a national quality improvement collaborative and was conducted across 106 US pediatric hospitals. The SOFI intervention period was from September 2019 to March 2020. Hospital sites were exposed to educational materials, a clinical algorithm and order set for IVF use, electronic medical record interventions to reduce laboratory testing, and "harms of overtesting" cards. Primary outcomes were mean proportion of hours per hospital day receiving exclusive isotonic IVF and mean proportion of hospital days with laboratory test values obtained. Secondary measures included total IVF duration per hospital day, daily patient weight measurement while receiving IVF, serum sodium testing, and adverse events. Baseline data were collected for 2 months; intervention period data, 7 months. Outcomes were analyzed using linear mixed-effects regression models. A total of 106 hospitals were randomly assigned to 1 of 3 intervention start dates (wedges), and 100 hospitals (94%) completed the study. In total, 5215 hospitalizations were reviewed before the intervention, and 6724 hospitalizations were reviewed after the intervention. Prior to interventions, the mean (SD) proportion of hours per day with exclusive isotonic IVF use was 88.5% (31.7%). Interventions led to an absolute increase of 5.4% (95% CI, 3.9%-6.9%) above baseline in exclusive isotonic IVF use but did not change the proportion of hospital days during which a laboratory test value was obtained (estimated difference, 0.1%; 95% CI, -1.5% to 1.7%; P = .90), IVF use duration (estimated difference, -1.2%; 95% CI, -2.9% to 0.4%), serum sodium testing, or adverse events. There was an absolute increase of 4.4% (95% CI, 2.6%-6.2%) in the mean proportion of hospital days with a patient weight measurement while receiving IVF. In this stepped-wedge, cluster randomized clinical trial, an intervention bundle significantly improved the use of isotonic maintenance IVF without a concomitant increase in adverse events or electrolyte testing. Further work is required to deimplement laboratory testing. ClinicalTrials.gov Identifier: NCT03924674.

Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care

Evidence-based parenting interventions play a crucial role in the sustained reduction of adolescent behavioral health concerns. Guiding Good Choices (GGC) is a 5-session universal anticipatory guidance curriculum for parents of early adolescents that has been shown to reduce substance use, depression symptoms, and delinquent behavior. Although prior research has demonstrated the effectiveness of evidence-based parenting interventions at achieving sustained reductions in adolescent behavioral health concerns, public health impact has been limited by low rates of uptake in community and agency settings. Pediatric primary care is an ideal setting for implementing and scaling parent-focused prevention programs as these settings have a broad reach, and prevention programs implemented within them have the potential to achieve population-level impact. The current investigation, Guiding Good Choices for Health (GGC4H), tests the feasibility and effectiveness of implementing GGC in 3 geographically and socioeconomically diverse large integrated healthcare systems. This pragmatic, cluster randomized clinical trial will compare GGC parenting intervention to usual pediatric primary care practice, and will include approximately 3750 adolescents; n = 1875 GGC intervention and n = 1875 usual care. The study team hypothesizes that adolescents whose parents are randomized into the GGC intervention arm will show reductions in substance use initiation, the study's primary outcomes, and other secondary (e.g., depression symptoms, substance use prevalence) and exploratory outcomes (e.g., health services utilization, anxiety symptoms). The investigative team anticipates that the implementation of GGC within pediatric primary care clinics will successfully fill an unmet need for effective preventive parenting interventions.Trial registration: Clinicaltrials.govNCT04040153

Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial

BackgroundLow back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. MethodsThe SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain.The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DiscussionThe SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care.Trial registration number: NCT03083886

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

Chinese Medicine Formula Huashibaidu Granule Early Treatment for Mild COVID-19 Patients: An Unblinded, Cluster-Randomized Clinical Trial

Background: Previous research suggested that Chinese Medicine (CM) Formula Huashibaidu granule might shorten the disease course in coronavirus disease 2019 (COVID-19) patients. This research aimed to investigate the early treatment effect of Huashibaidu granule in well-managed patients with mild COVID-19.Methods: An unblinded cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. Two cabins were randomly allocated to a CM or control group, with 204 mild COVID-19 participants in each cabin. All participants received conventional treatment over a 7 day period, while the ones in CM group were additionally given Huashibaidu granule 10 g twice daily. Participants were followed up to their clinical endpoint. The primary outcome was worsening symptoms before the clinical endpoint. The secondary outcomes were cure and discharge before the clinical endpoint and alleviation of composite symptoms after the 7 days of treatment.Results: All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (P > 0.05). The number of worsening patients in the CM group was 5 (2.5%), and that in the control group was 16 (7.8%) with a significant difference between groups (P = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (P = 0.151).Conclusion: Seven days of early treatment with Huashibaidu granule reduced the likelihood of worsening symptoms in patients with mild COVID-19. Our study supports Huashibaidu granule as an active option for early treatment of mild COVID-19 in similar well-managed medical environments.Clinical Trial Registration:www.chictr.org.cn/showproj.aspx?proj=49408, identifier: ChiCTR2000029763.

Adecuación de la prescripción en pacientes mayores polimedicados en atención primaria. Ensayo clínico controlado aleatorizado por grupos PHARM-PC

ObjectivesTo assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs. DesignProspective, open, controlled and cluster-randomized clinical trial. SettingSix primary care clinics from Balearic Islands. ParticipantsForty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care. InterventionPIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician. MeasurementsProportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed. Statistical planFollowing an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI). ResultsAfter intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources. ConclusionsPIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.

\u201cI must, and I can live with that\u201d: a thematic analysis of patients\u2019 perspectives on polypharmacy and a digital decision support system for GPs

BackgroundTo investigate patients’ perspectives on polypharmacy and the use of a digital decision support system to assist general practitioners (GPs) in performing medication reviews.MethodsQualitative interviews with patients or informal caregivers recruited from participants in a cluster-randomized controlled clinical trial (cRCT). The interviews were transcribed verbatim and analyzed using thematic analysis.ResultsWe conducted 13 interviews and identified the following seven themes: the patients successfully integrated medication use in their everyday lives, used medication plans, had both good and bad personal experiences with their drugs, regarded their healthcare providers as the main source of medication-related information, discussed medication changes with their GPs, had trusting relationships with them, and viewed the use of digital decision support tools for medication reviews positively. No unwanted adverse effects were reported.ConclusionsDespite drug-related problems, patients appeared to cope well with their medications. They also trusted their GPs, despite acknowledging polypharmacy to be a complex field for them. The use of a digital support system was appreciated and linked to the hope that reasons for selecting specific medication regimens would become more comprehensible. Further research with a more diverse sampling might add more patient perspectives.Trial registrationClinicalTrials.gov, NCT03430336. Registered on February 6, 2018.

Effectiveness of training physical therapists in pain neuroscience education for patients with chronic spine pain: a cluster-randomized trial.

Chronic spinal pain poses complex challenges for health care around the world and is in need of effective interventions. Pain neuroscience education (PNE) is a promising intervention hypothesized to improve pain and disability by changing individuals' beliefs, perceptions, and expectations about pain. Pain neuroscience education has shown promise in small, controlled trials when implemented in tightly controlled situations. Exploration of promising interventions through more pragmatic methodologies is a crucial but understudied step towards improving outcomes in routine clinical care. The purpose was to examine the impact of pragmatic PNE training on clinical outcomes in patients with chronic spine pain. The cluster-randomized clinical trial took place in 45 outpatient physical therapist (PT) clinics. Participants included 108 physical therapists (45 clinics and 16 clusters) and 319 patients. Clusters of PT clinics were randomly assigned to either receive training in PNE or no intervention and continue with usual care (UC). We found no significant differences between groups for our primary outcome at 12 weeks, Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test {mean difference = 1.05 (95% confidence interval [CI]: -0.73 to 2.83), P = 0.25}. The PNE group demonstrated significant greater improvements in pain self-efficacy at 12 and 2 weeks compared with no intervention (mean difference = 3.65 [95% CI: 0.00-7.29], P = 0.049 and = 3.08 [95% CI: 0.07 to -6.09], P = 0.045, respectively). However, a similar percentage of participants in both control (41.1%) and treatment (44.4%) groups reported having received the treatment per fidelity question (yes or no to pain discussed as a perceived threat) at 2 weeks. Pragmatic PT PNE training and delivery failed to produce significant functional changes in patients with chronic spinal pain but did produce significant improvement in pain self-efficacy over UC PT.

Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units

There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit. To determine if a sedation and ventilator liberation protocol intervention reduces the duration of invasive mechanical ventilation in infants and children anticipated to require prolonged mechanical ventilation. A pragmatic multicenter, stepped-wedge, cluster randomized clinical trial was conducted that included 17 hospital sites (18 pediatric intensive care units) in the UK sequentially randomized from usual care to the protocol intervention. From February 2018 to October 2019, 8843 critically ill infants and children anticipated to require prolonged mechanical ventilation were recruited. The last date of follow-up was November 11, 2019. Pediatric intensive care units provided usual care (n = 4155 infants and children) or a sedation and ventilator liberation protocol intervention (n = 4688 infants and children) that consisted of assessment of sedation level, daily screening for readiness to undertake a spontaneous breathing trial, a spontaneous breathing trial to test ventilator liberation potential, and daily rounds to review sedation and readiness screening and set patient-relevant targets. The primary outcome was the duration of invasive mechanical ventilation from initiation of ventilation until the first successful extubation. The primary estimate of the treatment effect was a hazard ratio (with a 95% CI) adjusted for calendar time and cluster (hospital site) for infants and children anticipated to require prolonged mechanical ventilation. There were a total of 8843 infants and children (median age, 8 months [interquartile range, 1 to 46 months]; 42% were female) who completed the trial. There was a significantly shorter median time to successful extubation for the protocol intervention compared with usual care (64.8 hours vs 66.2 hours, respectively; adjusted median difference, -6.1 hours [interquartile range, -8.2 to -5.3 hours]; adjusted hazard ratio, 1.11 [95% CI, 1.02 to 1.20], P = .02). The serious adverse event of hypoxia occurred in 9 (0.2%) infants and children for the protocol intervention vs 11 (0.3%) for usual care; nonvascular device dislodgement occurred in 2 (0.04%) vs 7 (0.1%), respectively. Among infants and children anticipated to require prolonged mechanical ventilation, a sedation and ventilator liberation protocol intervention compared with usual care resulted in a statistically significant reduction in time to first successful extubation. However, the clinical importance of the effect size is uncertain. isrctn.org Identifier: ISRCTN16998143.

Point-of-care ultrasound-guided regional anaesthesia in older ED patients with hip fractures: a study to test the feasibility of a training programme and time needed to complete nerve blocks by ED physicians after training

ObjectivesPoint-of-care ultrasound-guided regional anaesthesia (POCUS-GRA) provides safe, rapid analgesia for older people with hip fractures but is rarely performed in the emergency department (ED). Self-perceived inadequate training and time to...

TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil

IntroductionDaily multidisciplinary rounds (DMRs) consist of systematic patient-centred discussions aiming to establish joint therapeutic goals for the next 24 hours of intensive care unit (ICU) care. The aim of the...