The impact of removing financial incentives and/or audit and feedback on chlamydia testing in general practice: A cluster randomised controlled trial (ACCEPt-able)

Background Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed. Methods and findings We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16–29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5–AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference −8.8%; 95% CI −10.5% to −7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference −7.1%; 95% CI −9.6% to −4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was −0.9% (95% CI −3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference −9.5%; 95% CI −11.7% to −7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference −6.4%; 95% CI −8.6% to −4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was −2.6% (95% CI −5.4% to −0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only. Conclusions Audit/feedback is more effective than financial incentives of AU$5–AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12614000595617

Effectiveness Of A Staff Training Program To Stimulate Physical Activity In Homecare: A Cluster RCT

Reablement encourages older adults to do things themselves rather than having things done for them. To implement reablement in practice homecare staff needs the right knowledge, attitude, skills and support. This study evaluated the effectiveness of the “Stay Active at Home” reablement training program. A 12-month cluster-RCT was conducted, involving staff (n=313) and clients (n=264) from 10 homecare teams, five of which were trained. Effects were evaluated using data from accelerometers, physical performance tests, questionnaires and electronic patient records. No beneficial effects were observed in older adults for sedentary behavior; daily, physical, and psychological functioning; and falls. In homecare staff there were no statistically significant differences between study groups for self-efficacy and outcome expectations scores except for higher self-efficacy scores in more compliant staff (adjusted mean difference: 1.9 [95% CI 0.1, 3.7]). No differences were observed for any cost category except for domestic help costs in the intervention group (adjusted mean difference: €-173 [95% CI -299, -50]). The probability that “Stay Active at Home” is cost-effective compared to usual care at a willingness-to-pay of €20,000 was 19.7%/ daily minute of sedentary time averted, 19.2%/ percent of sedentary time averted as proportion of wake/wear time, and 5.9%/QALY gained, respectively. The reablement training program needs further development based on the lessons learned before wider implementation.

Conducting a Cluster RCT on Medication Safety in Nursing Units Overtaxed by the COVID-19 Pandemic

Medication errors continue to harm many hospitalized patients. In other high-risk industries, voluntary incident reporting is widely used to improve safety. Reporting is widely used in hospitals, but not as effectively. This AHRQ-funded cluster RCT will assess the effects of the SAFE Loop, which includes five enhancements in incident reporting implemented on hospital nursing units. Analyses will compare changes in nurses’ attitudes toward reporting, event reporting rates, report quality, and medication event rates between intervention and control arms. The COVID-19 pandemic has created both obstacles and opportunities. The intervention requires study staff to engage nursing unit directors, attend daily nursing “huddles”, and train overtaxed front-line nurses in a geographic area greatly impacted by COVID-19 surges. This created uncertainty around the best time to start the trial. Conversely, we have collected unique data on the implications of COVID-19 for medication safety while testing our instruments during the trial preparation phase.

Assessing Fidelity to and Satisfaction with the “Adolescent Coping with Depression Course” (ACDC) Intervention in a Randomized Controlled Trial

This paper aims at describing the process for assessing the intervention fidelity of a randomized controlled trial (RCT) of an “Adolescent Coping with Depression Course” (ACDC) and to assess the participants’ satisfaction with the intervention. We applied the comprehensive fidelity model developed by the National Institutes of Health’s Behavior Change Consortium to examine how our intervention met the fidelity requirements under five categories. Data came from a two-arm parallel cluster RCT. Both qualitative and quantitative analyses of the ACDC intervention using the comprehensive fidelity model indicated that the level of fidelity in this study did not reach 100%. However, it was approaching a high level of treatment fidelity. Participants also expressed high levels of satisfaction (M = 3.65, SD = .95). This analysis is important to show how appropriately the intervention was implemented, areas for improvement to increase its fidelity, and to ensure the internal and external validity of the findings. Trial Registration: ISRCTN registry ISRCTN19700389. Registered 6 October 2015. https://doi.org/10.1186/ISRCTN19700389. Full Protocol: 10.1186/s12888-016-0954-y

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 perform POCUS-GRA are the two most important barriers. Our objective is to assess the feasibility of a proposed multicentre, stepped-wedge cluster randomised clinical trial (RCT) to assess the impact of a knowledge-to-practice (KTP) intervention on delirium.DesignOpen-label feasibility study.SettingAn academic tertiary care Canadian ED (annual visits 60 000).ParticipantsEmergency physicians working at least one ED shift per week, excluding those already performing POCUS-GRA more than four times per year.InterventionA KTP intervention, including 2-hour structured training sessions with procedure bundle and email reminders.Primary and secondary outcome measuresThe primary feasibility outcome is the proportion of eligible physicians that completed training and subsequently performed POCUS-GRA. Secondary outcome is the time needed to complete POCUS-GRA. We also test the feasibility of the enrolment, consent and randomisation processes for the future stepped-wedge cluster RCT (NCT02892968).ResultsOf 36 emergency physicians, 4 (12%) were excluded or declined participation. All remaining 32 emergency physicians completed training and 31 subsequently treated at least one eligible patient. Collectively, 27/31 (87.1%) performed 102 POCUS-GRA blocks (range 1–20 blocks per physician). The median (IQR) time to perform blocks was 15 (10–20) min, and reduction in pain was 6/10 (3–7) following POCUS-GRA. There were no reported complications.ConclusionOur KTP intervention, consent process and randomisation were feasible. The time to perform POCUS-GRA rarely exceeded 30 min, Our findings reinforce the existing data on the safety and effectiveness of POCUS-GRA, mitigate perceived barriers to more widespread adoption and demonstrate the feasibility of trialling this intervention for the proposed stepped-wedge cluster RCT.Trial registration numberClinicaltrials.gov #02892968

How Does Green Dot Bystander Training in High School and Beyond Impact Attitudes Toward Violence and Sexism in a Prospective Cohort?

Bystander interventions are recognized as “promising” programming to reduce sexual violence. Gaps in current evaluations include limited follow-up post-training (beyond 24 months) and knowledge of additional bystander training during follow-up. In this prospective cohort study, nested in a cluster randomized controlled trial (RCT), three cohorts of high school (HS) seniors were recruited (Fall 2013-2015) and followed through Spring 2018 ( n = 1,831). Training was based on their school cluster RCT assignment and receipt of additional Green Dot (GD) training after HS. Training was hypothesized to be associated with lower scores indicating less acceptance of violence or sexism. Sixty percent reported GD training after HS (68.7% of 986 in intervention and 50% of 845 in control conditions). No significant differences ( p < .05) were observed by GD training for four of the five violence acceptance or sexism attitudinal measures at recruitment or final surveys. For “ambivalent sexism” alone was there a significant reduction in scale scores over time in the intervention versus control condition. Additional GD training after the RCT significantly reduced neither violence acceptance nor sexism scores over time. GD training does not appear to have a consistent longer-term impact on reducing violence acceptance and sexism.

Epidemiology and associated factors of polypharmacy in older patients in primary care: a northern Italian cross-sectional study

Background A precondition for developing strategies to reduce polypharmacy and its well-known harmful consequences is to study its epidemiology and associated factors. The objective of this study was to analyse the prevalence of polypharmacy (defined as ≥8 prescribed drugs), of potentially inappropriate medications (PIMs) and major drug-drug interactions (DDIs) among community-dwelling general practice patients aged ≥75 years and to identify characteristics being associated with polypharmacy. Methods This cross-sectional study is derived from baseline data (patients’ demographic/biometric characteristics, diagnoses, medication-related data, cognitive/affective status, quality of life) of a northern-Italian cluster-RCT. PIMs and DDIs were assessed using the 2012 Beers criteria and the Lexi-Interact® database. Data were analysed using descriptive methods, Wilcoxon rank-sum tests, Fisher’s exact tests and Spearman correlations. Results Of the eligible patients aged 75+, 13.4% were on therapy with ≥8 drugs. Forty-three general practitioners and 579 patients participated in the study. Forty five point nine percent of patients were treated with ≥1 Beers-listed drugs. The most frequent PIMs were benzodiazepines/hypnotics (19.7% of patients) and NSAIDs (6.6%). Sixty seven point five percent of patients were exposed to ≥1 major DDI, 35.2% to ≥2 major DDIs. Antithrombotic/anticoagulant medications (30.4%) and antidepressants/antipsychotics (23.1%) were the most frequently interacting drugs. Polypharmacy was significantly associated with a higher number of major DDIs (Spearman’s rho 0.33, p < 0.001) and chronic conditions (Spearman’s rho 0.20, p < 0.001), higher 5-GDS scores (thus, lower affective status) (Spearman’s rho 0.12, p = 0.003) and lower EQ-5D-5L scores (thus, lower quality of life) (Spearman’s rho − 0.14, p = 0.001). Patients’ age/sex, 6-CIT scores (cognitive status), BMI or PIM use were not correlated with the number of drugs. Conclusions The prevalence of polypharmacy, PIMs and major DDIs was considerable. Results indicate that physicians should particularly observe their patients with multiple conditions, reduced health and affective status, independently from other patients’ characteristics. Careful attention about indication, benefit and potential risk should be paid especially to patients on therapy with specific drug classes identified as potentially inappropriate or prone to major DDIs in older persons (e.g., benzodiazepines, NSAIDs, protonic pump inhibitors, antithrombotics/anticoagulants, antidepressants/antipsychotics). Trial registration The cluster-RCT on which this cross-sectional analysis is based was registered with Current Controlled Trials Ltd. (ID ISRCTN: 38449870) on 2013-09-11.