2 Minute Medicine Rewind December 13, 2021

Stratified care vs stepped care for depression: A cluster randomized clinical trial | Depressive disorders

1. A stratified care model for management of depression, where patients are initially screened into low-intensity or high-intensity treatment categories, was associated with higher rates of reliable and clinically significant improvements (RCSI) in depression symptoms, compared to a stepped care model.

2. A stratified care model was associated with a higher proportion of patients accessing high-intensity treatments, and a modest increase in cost, compared to a stepped care model where patients initially receive low-intensity treatment unless symptoms persist.

Evidence Rating Level: 1 (Excellent)

Currently, depression management guidelines highlight the use of a stepped care model: This model starts patients out with less intense and costly interventions, such as guided self-help, and for those who still experience depressive symptoms, more involved interventions are implemented, such as cognitive behavioural therapy. In England, a systematic review of this model found a large effect size between pre- and post-treatment (Cohen d = 0.87). However, the effect size was diminished in patients with comorbid conditions, personality disorder traits, low SES, and other factors that could have increased the likelihood of more complex interventions being required. Therefore, a stratified care model has been proposed and evaluated with retrospective cohort studies: This model involves patients being screened into low-intensity or high-intensity treatment categories, based on their conditions. The current cluster randomized controlled trial compared the proportion of reliable and clinically significant improvement (RCSI) of depression symptoms in patients under the stepped care versus stratified care models. This study involved evenly randomizing 30 practitioners from 4 psychological therapy services in Northern England into the stepped and stratified care groups, resulting in 951 patients total with 583 in stratified care and 368 in stepped care. An initial assessment was conducted by each practitioner, with the stratified care group using an online program that employed artificial intelligence to analyze the inputted data from the assessment, and create a personalized recommendation on low or high-intensity treatment. This system was intended to fast-track patients with complex cases or where psychotherapy was the only intervention indicated. The results showed that 52.3% in the stratified group had significantly improved depression based on PHQ-9 score, compared to 45.1% in the stepped care group (odds ratio 1.40, 95% CI 1.04-1.87, p = 0.03). Stratified care patients also had more treatment sessions, with a median of 6 (IQR 3-9) compared to 5 in stepped care (IQR 3-8). This is due 56.9% of stratified care patients accessing high-intensity treatments, compared to 29.1% in stepped care (p < 0.001). Furthermore, the additional cost per patient for stratified care was estimated to be $139.83 (95% CI $90.32-$189.48, p < 0.001). Overall, this study demonstrated that a stratified care model was associated with improved outcomes for depression, more patients accessing high-intensity treatments, and a modest increase in cost.

Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial

1. A telephone outreach program to remotely manage toxicity-related symptoms from breast cancer chemotherapy did not change the number of emergency department visits or hospital admissions between treatments.

Evidence Rating Level: 1 (Excellent)

As chemotherapy is now delivered in outpatient settings, toxicity-related events now happen between visits to cancer care centres. One study showed that 42% of chemotherapy patients visited an emergency department (ED) or was admitted to hospital between treatments. Therefore, a remote intervention between treatments has been proposed to provide education and manage toxic effects from chemotherapy. A pilot telephone outreach strategy for breast cancer chemotherapy patients, facilitated by oncology nurses, was found to be associated with fewer hospital visits when compared to historical data. The current multicentre, cluster randomized controlled trial analyzed the effectiveness of this telephone outreach program compared no outreach, examining outcomes such as number of ED visits, patient reported toxicity, and quality of life. The study involved 20 cancer centres in Ontario, Canada, which were evenly randomized to remote management or care as usual, resulting in 278 intervention patients and 283 control patients. The patients had stage I-III breast cancer and were beginning adjuvant or neoadjuvant chemotherapy. Those in the remote management group received the Symptom Self-Management Booklet (patient edition), and were called by oncology nurses twice after treatment: The first was 24-72 hours after, and the second was 8-10 days after. These calls were meant to assess the presence of toxicity-related symptoms, and the nurses provided guidance on managing the symptoms based on the Symptom Self-Management Booklet (provide edition). Overall, the study found that 47% of all patients visited the ED or were admitted to hospital at least once during treatment. There was no significant difference in the mean number of visits, with 0.91 for remote management (standard deviation 0.28) and 0.94 for control (SD 0.40), resulting in a mean difference of -0.024 (95% CI -0.24 to 0.15, p = 0.85). In terms of patient reported outcomes, 48% in the intervention reported at least one grade 3 toxicity, versus 58% in the control (p = 0.0053). Furthermore, no differences in anxiety, depression, and self-efficacy were identified. In conclusion, no change in number of hospital visits was found when implementing the remote management strategy for toxicity from breast cancer chemotherapy, although this strategy is certainly relevant to the current COVID-19 pandemic, when telehealth options are continuously improving access to healthcare providers and health information.

Multifactorial falls prevention programme compared with usual care in UK care homes for older people: Multicentre cluster randomised controlled trial with economic evaluation

1. The Guide to Action Care Home (GtACH) programme trained care home staff to identify fall risk and prevent falls, which significantly reduced the fall rate 91-180 days post-training, compared to care homes without the GtACH training.

Evidence Rating Level: 1 (Excellent)

The care home population experiences three times the number of falls as those of the same age, living in the community. Falls can create substantial personal, economic, and functional burden, with many patients never being able to return to their prior level of function. 40% of hospital admissions from care homes were fall-related. A program from the United Kingdom to prevent falls in care homes, known as the Guide to Action Care Home (GtACH) programme, was tested in a feasibility randomized trial, with results warranting a full trial. The current multicentre randomized controlled trial aimed to compare the number of falls in care homes with the GtACH programme implemented and without, as well as the overall cost effectiveness. In total, 84 care homes were randomized, with 39 employing the GtACH programme (with 775 patients) and 45 assigned to care as usual (882 patients). In the GtACH group, 1-hour training was delivered to 71% of all care home staff, including cleaners, gardeners, and cooks. These sessions were taught by a falls specialist, and manuals were provided to participants that included a falls incident chart for pattern detection, and a risk for drug falls chart. The primary outcome was the fall rate from 91-180 days following randomization, as recorded by staff. The cost effectiveness was measured using quality adjusted life years (QALYs), with capable care homer residents compleing the EuroQoL proxy (EQ-5D-5L-P) and Dementia Quality of Life utility measure (DEMQOL-P-U). Overall, the study found a significantly lower fall rate for the GtACH cohort, which was 6.0 per 1000 resident days compared to 10.4/1000 resident days in usual care, resulting in an incidence rate ratio of 0.57 (95% CI 0.45-0.71, p < 0.001). Fewer falls in the GtACh cohort were also observed between 1 and 90 days, but not beyond 180 days. As well, fewer patients had fractures in the GtACH group 181-360 days post-randomization, but no other differences were found for fractures in other time periods, and other secondary outcomes such as physical mobility and dependence. The cost analysis found an incremental cost per QALY of £4544 (based on the EQ-5D-5L-P) and £20,889 (based on the DEMQOL-P-U), with a cost per averted fall of £191. An acceptability curve found a 92% probability that the GtACH programme was cost effective using the EQ-5D-5L-P QALYs. In conclusion, the GtACH programme is a cost-effective intervention that reduced the fall rate among the care home patient population.

Twenty-year change in severity and outcome of ischemic and hemorrhagic strokes

1. From 2000 to 2019 in Japan, neurological stroke severity decreased for ischemic stroke and intracranial hemorrhage, but not for subarachnoid hemorrhage.

2. Functional outcomes improved for ischemic stroke, in part due to the use of acute reperfusion therapy, whereas no definitive improvements were observed for hemorrhagic stroke.

Evidence Rating Level: 2 (Good)

In Japan, new advances in stroke management have been introduced in the last 20 years, with intravenous thrombolysis in 2005, mechanical thrombectomy in 2001, and stent retrievers for thrombectomy in 2015. Although the incidence and mortality of stroke as decreased, the trends in strokes severity and functional outcomes are unclear. Population registries from Austria and Israel both showed decreased severity in ischemic stroke (IS) and intracerebral hemorrhage (ICH) from the mid-2000s to mid-2010s, but did not assess functional outcomes. Therefore, the current study based in Japan assessed trends from 2000 to 2019 in neurological severity, short-term functional outcomes, and in-hospital mortality of IS, ICH, and subarachnoid hemorrhage (SAH). Neurological severity of IS and ICH were assessed with the National Institutes of Health Stroke Score (NIHSS), and the World Federation of Neurological Surgeons (WFNS) grading for SAH. Functional outcomes at hospital discharge were scored on the modified Rankin Scale (mRS) as 0-2 for favourable outcomes, and 5-6 for unfavourable outcomes. Overall, the study population consisted of 183,080 patients: 135,266 with IS, 36,014 with ICH, and 11,800 with SAH. The study found that all NIHSS scores decreased over the 20 year study period in all stroke types and IS subtypes, including after adjusting by age and stroke history. However, no decrease was found for WFNS grading in SAH. For IS patients, the proportion of favourable functional outcomes increased significantly after adjusting for age (odds ratio 1.015, 95% CI 1.011-1.018 for men, OR 1.020, 95% CI 1.015-1.024 for women). But favourable outcomes stagnated after adjusting for NIHSS scores and stroke history, and stagnated when adjusting for reperfusion therapy in women (OR 0.997, 95% CI 0.991-1.003) but decreased in men (OR 0.990, 95% CI 0.985-0.994). Unfavourable outcomes and mortality were also decreased over time in IS. For ICH patients, the proportion of favourable outcomes decreased, whereas unfavourable outcomes and mortality decreased in women, but not men. For SAH patients, no changes in favourable outcomes were identified, whereas unfavourable outcomes and mortality decreased. Altogether, this longitudinal study showed that over the last 20 years, stroke severity was decreased for ischemic stroke and intracranial hemorrhage, and functional outcomes for ischemic stroke have improved, in part due to reperfusion therapy, whereas hemorrhagic stroke functional outcomes have not definitively improved.

Effectiveness and safety of NOAC versus warfarin in patients with atrial fibrillation and aortic stenosis

1. For patients with concomitant atrial fibrillation and aortic stenosis, non-vitamin K antagonist oral anticoagulants (NOACs) were less effective in preventing thromboembolism than warfarin, but were more safe than warfarin in terms of preventing major bleeding.

Evidence Rating Level: 2 (Good)

Around 16-36% of patients with aortic stenosis, a form of valvular heart disease (VHD), will also have atrial fibrillation (AF). These conditions together put patients at a higher risk of both thromboembolism and bleeding, which underlies the importance of weighing the risks and benefits of anticoagulants. Currently, the oral anticoagulants used for AF patients are either warfarin or non-vitamin K antagonist oral anticoagulants (NOACs). However, randomized controlled trials that compared the two classes excluded patients with VHD. Although guidelines allow NOACs to be used in AF patients with aortic stenosis (without a mechanical valve), the effectiveness and safety of NOACs compared to warfarin for this population is unknown. Therefore, the current observational study based in Denmark compared the effectiveness and safety of these two oral anticoagulants, with the effectiveness outcome being ischemic stroke or systemic embolism, and the safety outcome being a hospital admission for major bleeding. Nationwide registries were used to identify patients with a first-time prescription for a NOAC or warfarin, between 2013 and 2018, who had both AF and aortic stenosis within 30 days after the prescription. There were 2,357 patients prescribed NOACs and 1,369 prescribed warfarin. The target follow-up time was 3 years, but the median follow-up was 14 months (IQR 6-23 months). Overall, the study found a hazards ratio for thromboembolism of 1.62 (95% CI 1.08-2.45) for NOACs compared to warfarin, with the estimated 3-year thromboembolic-free survival being 94.0% for NOACs and 96.0% for warfarin. Contrastingly, the study found an HR for major bleeding of 0.73 (95% CI 0.59-0.91) for NOACs compared to warfarin, with the 3-year major bleeding-free survival of 87.6% for NOACs and 83.6% for warfarin. In conclusion, when compared to warfarin, there was lower effectiveness for NOACs due to a greater risk of thromboembolism, but a better safety profile for NOACs due to decreased risk of major bleeding, and so the optimal choice for oral anticoagulants is not entirely clear from this study.

Image: PD

©2021 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.