Pragmatic Randomized Controlled Trial Research Articles

Behavioral skills training for teaching safety skills to mental health service providers compared to training-as-usual: a pragmatic randomized control trial.

Violence in the healthcare workplace has been a global concern for over two decades, with a high prevalence of violence towards healthcare workers reported. Workplace violence has become a healthcare quality indicator and embedded in quality improvement initiatives of many healthcare organizations. The Centre for Addiction and Mental Health (CAMH), Canada's largest mental health hospital, provides all clinical staff with mandated staff safety training for self-protection and team-control skills. These skills are to be used as a last resort when a patient is at imminent risk of harm to self or others. The purpose of this study is to compare the effectiveness of two training methods of this mandated staff safety training for workplace violence in a large psychiatric hospital setting. Using a pragmatic randomized control trial design, this study compares two approaches to teaching safety skills CAMH's training-as-usual (TAU) using the 3D approach (description, demonstration and doing) and behavioural skills training (BST), from the field of applied behaviour analysis, using instruction, modeling, practice and feedback loop. Staff were assessed on three outcome measures (competency, mastery and confidence), across three time points: before training (baseline), immediately after training (post-training) and one month later (follow-up). This study was registered with the ISRCTN registry on 06/09/2023 (ISRCTN18133140). With a sample size of 99 new staff, results indicate that BST was significantly better than TAU in improving observed performance of self-protection and team-control skills. Both methods were associated with improved skills and confidence. However, there was a decrease in skill performance levels at the one-month follow-up for both methods, with BST remaining higher than TAU scores across all three time points. The impact of training improved staff confidence in both training methods and remained high across all three time points. The study findings suggest that BST is more effective than TAU in improving safety skills among healthcare workers. However, the retention of skills over time remains a concern, and therefore a single training session without on-the-job-feedback or booster sessions based on objective assessments of skill may not be sufficient. Further research is needed to confirm and expand upon these findings in different settings.

Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). All clinical outcomes improved significantly over 1 year in the overall sample (statistical significance [P] <0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

VaNoLaH trial: a study protocol—a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy

IntroductionHysterectomy is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with...

Abstract 3942: Mailed at-home self-sampling for HPV testing increases screening participation among under-screened patients in a U.S. safety net health system: Results of the PRESTIS trial

Abstract Background: In global settings, self-sampling for human papillomavirus (HPV) testing is associated with a pooled 2-fold increase in cervical cancer screening participation over usual care among underscreened persons. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Trial is the first pragmatic randomized controlled trial (RCT) in the U.S. to evaluate the effectiveness of mailed at-home self-sampling for HPV testing in a safety net health system setting. Safety net systems provide care to medically underserved individuals at elevated cervical cancer risk. We hypothesized that patients who were mailed a self-sampling kit would have greater screening participation compared with those receiving usual care; and that patient navigation, a patient-centered intervention to address barriers to care, would further increase participation. Methods: PRESTIS is a three-arm pragmatic RCT of n=2,270 patients in a U.S. safety net health system who are under-screened for cervical cancer (i.e., no Pap in 3.5 years or Pap/HPV co-test in 5.5 years). Eligible participants were identified through the electronic health record (EHR) and randomized to arms: 1) telephone recall to provider-performed screening (usual care); 2) telephone recall + mailed self-sampling kit for HPV testing; or 3) telephone recall + mailed self-sampling kit + telephone-based patient navigation. Self-sampled swabs were tested for high-risk (HR)-HPV. HR-HPV+ patients were navigated to clinical follow-up. The primary outcome, incidence of screening participation, was ascertained by EHR review at 6 months post-randomization and defined as return of a completed kit or attendance for provider-performed screening. Results: Participants were enrolled 02/2020-08/2023. Primary outcomes have been ascertained for n=2,115 participants. Participants were predominantly Hispanic/Latina (68.6%); 53.4% indicated Spanish as primary language; and 60.3% were uninsured. Mean age was 47.9 years (SD: 10.4 years); median time since last screening test was 9.5 years (range: 1.6-21.7 years). In intent-to-treat analyses, screening participation was 15.3% (95% CI 13.0% - 17.9%) in Arm 1; 44.0% (40.4% - 47.6%) in Arm 2; and 51.4% (47.7% - 55.0%) in Arm 3. Relative incidence of screening in Arms 2 and 3 versus Arm 1 was 2.90 (2.42 - 3.47) and 3.36 (2.82 - 4.01), respectively. Relative incidence of screening in Arm 3 versus Arm 2 was 1.16 (1.04 - 1.29). Conclusion: Compared with usual care, mailed at-home self-sampling increased screening participation among an under-screened population by almost three-fold when used alone and over 3.3-fold when combined with telephone-based patient navigation. After FDA approval, self-sampling for HR-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations. Citation Format: Jane R. Montealegre, Elizabeth Y. Chiao, Matthew L. Anderson, Susan G. Hilsenbeck, Shaun Bulsara, Susan L. Parker, Maria Daheri, Trisha L. Amboree, Kathleen M. Schmeler, Maria L. Jibaja-Weiss, Mohammad Zare, Ashish A. Deshmukh, Michael E. Scheurer. Mailed at-home self-sampling for HPV testing increases screening participation among under-screened patients in a U.S. safety net health system: Results of the PRESTIS trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3942.

The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial

BackgroundThe use of computer-aided detection (CADe) has increased the adenoma detection rates (ADR) during colorectal cancer (CRC) screening/surveillance in randomized controlled trials (RCT) but has not shown benefit in real-world implementation studies. We performed a single-center pragmatic RCT to evaluate the impact of real-time CADe on ADR in colonoscopy performed by community gastroenterologists. MethodsWe enrolled 1100 patients undergoing colonoscopy for CRC screening, surveillance, positive fecal-immunohistochemical tests, and diagnostic indications at one community-based center from 09/2022 to 03/2023. Patients were randomly assigned (1:1) to traditional-colonoscopy or real-time CADe Blinded pathologists analyzed histopathologic findings. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy (APC), sessile-serrated lesion detection rate (SSLDR), and non-neoplastic resection rate. ResultsThe median age was 55.5 (IQR 50-62), 61% were female, 72.7% were Hispanic ethnicity, and 9.1% had inadequate bowel preparation. The ADR for the CADe group was significantly higher than the traditional-colonoscopy group (42.5% vs. 34.4%, p=0.005). The mean APC was significantly higher in the CADe group compared to the traditional-colonoscopy group (0.89±1.46 vs. 0.60±1.12, p<0.001). The improvement in adenoma detection was driven by increased detection of <5 mm adenomas. CADe had a higher SSLDR than traditional-colonoscopy (4.7% vs. 2.0%, p=0.01) The improvement in ADR with CADe was significantly higher in the first half of the study (47.2% vs. 33.7%, p=0.002) compared to the second half (38.7% vs. 34.9%, p=0.33). ConclusionsIn a single-center pragmatic randomized controlled trial, real-time CADe modestly improved ADR and APC in average-detector community endoscopists. (ClinicalTrials.gov number, NCT05963724).

The HOMESIDE Study-A Research Project to Support People Living With Dementia and Their Family Caregivers: Preliminary Report on Reading Intervention.

The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022. The study design was a three-arm parallel-group single-blinded, pragmatic RCT with a sample size of 432 dyads. Dyads were randomly allocated to one of three treatment conditions: Music Intervention plus Standard Care; or Reading Intervention plus Standard Care; or Standard Care only. The Reading Intervention (RI) within the HOMESIDE RCT aimed to evoke shared discussion, reminiscence, meaningful shared experiences and consequently enrich everyday life, interaction and the emotional connection between the caregiver (CG) and carereceiver (CR); as well as to enhance activities of daily living and to promote relaxation or stimulation as appropriate. This paper describes the underlying conceptual framework, the content, and delivery of the Reading Intervention within the HOMESIDE RCT.

Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide

IntroductionAcute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct...

Treating insomnia in people who are incarcerated: a feasibility study of a multicomponent treatment pathway.

Around 60% of people who are incarcerated have insomnia; 6-10 times more prevalent than the general population. Yet, there is no standardized, evidence-based approach to insomnia treatment in prison. We assessed the feasibility of a treatment pathway for insomnia in a high-secure prison to inform a future randomized controlled trial (RCT) and initial efficacy data for sleep and mental health outcomes. We used a within-participants pre-post design. The stepped-care pathway included: self-management with peer support, environmental aids, and cognitive behavioral therapy for insomnia (CBTi). Assessment measures for insomnia, well-being, mood, anxiety, suicidality, overall health, sleepiness, fatigue, and cognitive functioning were administered at baseline and pathway exit. Feasibility criteria included eligibility to participate, CBTi uptake, and assessment completion. Forty-two adult males who are incarcerated were approached of which 95.2% were eligible. Of those deemed eligible, most participated (36/40, 90.0%). Most who completed baseline completed post-assessments (28/36, 77.8%) and of these, most showed improvements in their subjective sleep (27/28, 96.4%). Large reductions were found from pre- to posttreatment in insomnia severity (d = -1.81, 95% CI: 8.3 to 12.9) and 57.0% reported no clinically significant insomnia symptoms at post-assessment. There was no overall change in actigraphy-measured sleep. Large treatment benefits were found for depression, anxiety, well-being, and cognitive functioning, with a medium benefit on suicidal ideation. The treatment pathway for insomnia in prison was feasible and may be an effective treatment for insomnia in people who are incarcerated, with additional promising benefits for mental health. A pragmatic RCT across different prison populations is warranted. This paper is part of the Sleep and Circadian Health in the Justice System Collection.

Pilot randomized controlled trial of EMBOLDEN: a novel co-designed community-based intervention to enhance mobility in older adults.

Introduction: Physical mobility and social participation are essential for maintaining independence and improving quality of life with aging. These are also interrelated, with barriers to mobility leading to social isolation, as well as poor physical and mental health. Most mobility-enhancing interventions in older adults have been designed by researchers without public input and delivered in controlled settings. This traditional approach to intervention design and testing may not meet the needs of older adults or prove effective in real-world implementation. To have sustained real-world impact, a model aimed at improving mobility that is person-centred, supports social network engagement, and leverages existing community health and social services is more likely to realize impacts. The EMBOLDEN intervention is a novel evidence-informed and contextually relevant community program. A Strategic Guiding Council comprised of older adults and health and social service providers co-designed the 3-month, multi-component group-based program to enhance mobility in older adults living in neighbourhoods experiencing health inequities. In this analysis, we present the implementation results of our pilot randomized controlled trial (RCT).&#x0D; Aims &amp; Methods: The pilot trial aimed to explore the feasibility and implementation of a multi-component intervention to improve mobility in older adults in preparation for a large effectiveness-implementation pragmatic RCT (EMBOLDEN, NCT05008159). Core intervention components include physical activity, healthy eating, socialization, and system navigation. Community-dwelling older adults (≥55 years) living in one neighbourhood in Hamilton, Canada, were randomized (2:1) to either: a weekly 90-minute virtual group program for 9 weeks (intervention) or continued normal routine (control). The intervention team integrated providers from recreation, primary care, and public health. A Community Advisory Board, including older adults and local providers, informed intervention modifications and implementation. Data were collected through participant quantitative surveys, study documentation, and qualitative interviews with participants and interventionists. Survey data were analyzed descriptively; survey open-text data, intervention team documentation, and transcripts were analyzed using content analysis. Process outcomes included program acceptability, intervention fidelity, implementation barriers and facilitators, and intervention feasibility/acceptability to participants and interventionists. &#x0D; &#x0D; Results: 11 participants were enrolled; 10 were randomized (6 INT; 4 CON). Participant age ranged from 57-76 years. Most participants identified as female (73%), had a total household income of &lt;$50,000 (73%) and lived alone (55%). Five participants received the allocated intervention. Quantitative and qualitative data collection are complete; analyses are underway. Intervention participants expressed perceived changes to their behaviours related to program outcomes: mobility and health; as well as increased awareness of community supports. Intervention group participants expressed positive experiences with the intervention and perceived impacts on their health and community connections. However, participants expressed a preference for in-person delivery. Interventionists gained experience delivering this multi-component intervention as a team. The COVID-19 pandemic impacted intervention duration (9 vs. 12 weeks), mode of delivery (virtual vs. in-person), and recruitment. Adaptations for the RCT include in-person delivery, longer duration, and new recruitment approaches.&#x0D; Conclusions: This pilot trial demonstrated that implementing the EMBOLDEN intervention was feasible and acceptable to participants and interventionists. The team gained important insight into modifications necessary for the larger, pragmatic RCT.

Quality of life measures and cost analysis of biologic versus synthetic mesh for ventral hernia repair: The Preventing Recurrence in Clean and Contaminated Hernias randomized clinical trial

BackgroundAlthough the most durable method for ventral hernia repairs involves using mesh, whether to use biologic mesh versus synthetic mesh remains controversial. This study aimed to compare synthetic and biologic meshes with respect to patient-reported quality of life scores and costs after ventral hernia repair surgeries. MethodsThis study is part of the Preventing Recurrence in Clean and Contaminated Hernias (PRICE) pragmatic randomized control trial conducted from March 2014 through October 2018. Patients were randomized 1:1 to undergo ventral hernia repair using either a biologic or synthetic mesh. The coprimary outcomes were 2-year changes in Visual Analog Scale, Activities Assessment Scale, Hernia-Related Quality-of-Life Survey, and Short-Form 36 Health Survey (SF-36) quality-of-life scores from repair. The secondary outcome was the overall cost per patient. ResultsAmong the 165 patients included in the study, 82 were randomized to biologic meshes and 83 to synthetic meshes. There were no significant differences in the performance between the 2 mesh types with regard to quality-of-life measures using a mixed model approach. This result was consistent even when performing subgroup analysis based on wound contamination. However, nonparametric tests comparing the differences in quality-of-life measures from preoperative to 24-month postoperative timepoints revealed that the synthetic mesh group showed a greater reduction in disability than biologic mesh for the SF-36 (median [interquartile range] of 20 [5–30] vs 6 [1–20], P = .025). This difference was due to reductions in the physical role limitations (62 [0–100] vs 0 [0–50], P = .018) and the pain (38 [12–50] vs 12 [0–25], P = .012) domains of the SF-36. Overall cost per patient was greater for biologic meshes (mean [95% confidence interval] of $80,420 [$66,485–$94,355] vs $61,036 [$48,946–$73,125], P = .038), regardless of insurance type. ConclusionIn this randomized clinical trial, there were no differences in changes in quality-of-life scores at the 2-year timepoint except for the SF-36, where the synthetic mesh may be associated with less pain and physical role limitations than the biologic mesh. Overall costs per patient were less for synthetic than biologic mesh.

The effects of introducing virtual reality communication simulation in students' learning in a fundamentals of nursing practicum: A pragmatic randomized control trials

AimThis study was conducted to examine the effectiveness of a virtual reality communication simulation (VRCS) in teaching communication skills in fundamentals of nursing practicum. BackgroundEffective communication skills are an integral part of the nursing profession and the foundation of high-quality nursing care. Effective communication not only addresses the needs of patients but is also necessary for maintaining patient safety. Many studies have reported the inadequacy of nursing students in communicating with patients. Nursing students often experience stress due to their lack of adequate skills to communicate effectively with patients and their family members. DesignA pragmatic randomized controlled trial research with four within-subjects assessments (at the baseline (T0), 1st week (T1) and 3rd week (T2) of the clinical practice and 1 week after the end of the clinical practice (T3)) and between-subjects assessments. Settings and participantsEighty-four nursing students at a university of Science and Technology in central Taiwan. MethodsThe students were randomly assigned to an experimental group (n = 42) and a control group (n = 42). The experimental group received a VRCS, whereas the control group received the nurse–patient communication teaching video. The data were collected from April 2022 to August 2022. The Kalamazoo Essential Element Communication Checklist, Communication Self-Assessment Scale, Learning Satisfaction Questionnaire and Stress Scale for Nursing Students in Clinical Practice were used for data collection. ResultsAt baseline, the control group had higher scores on communication ability and confidence compared with the experimental group (t = −3.91, p <.001; and t = −2.35, p =.021). In the first week of clinical practice, the experimental group had significantly higher mean scores for communication ability compared with the control group (β = 15.99, 95 % confidence interval [CI] 13.79, 18.18) and communication confidence and learning satisfaction compared with controls at T1, T2 and T3 of the clinical practice (all, p <.001). The clinical practice stress scores of the experimental group were significantly lower than those of the control group at T1, T2 and T3 of the clinical practice (all, p <.05). ConclusionsThe newly developed VRCS is acceptable and worthwhile for training nursing students to develop communication abilities. This study suggests that VRCS practice should be arranged as early as possible in fundamentals of nursing practice courses and before the fundamentals of nursing practicum so as to facilitate the learning of effective communication. Follow-up research is needed to evaluate the long-term effects of virtual reality education in nursing practice.

Home- versus clinic-based exercise intervention in patients with heart failure (EXIT-HF trial): a pragmatic randomized controlled trial

Abstract Background The limited accessibility partially explains the low uptake of cardiac rehabilitation (ExCR) for heart failure (HF). Home-based programs might address those obstacles but few data from randomized trials are available. Purpose To compare the effectiveness of a home-based versus clinic-based ExCR intervention in HF patients. Methods Single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial (1:1 and after COVID-19 2:1 home- vs clinic-based). Adult HF patients referred to our cardiac rehabilitation (CR) unit were randomized to either a clinic-based (24 supervised sessions at a CR unit of a tertiary hospital over 12 weeks) or home-based (4 supervised ExT sessions to familiarize with the training protocol and the remaining sessions continued at home) over 12 weeks. Exercise training protocol consisted of a combination of endurance (at 60%-80% of peak oxygen uptake [VO2peak] and resistance training (elastic bands). The primary endpoint was the change in VO2peak at the end of the 12-week program. Secondary outcomes included adherence (&amp;gt;80% of sessions attendance) and change of Minnesota Living with HF Questionnaire (MLHFQ) scores. Results 120 patients (mean age 64±11 years; 64% men) were randomized: 44 to clinic- and to 76 home-based intervention. 41% had an ischemic cardiomyopathy, 27% had an ICD/CRT, the mean LVEF was 36±11% (62% had LVEF &amp;lt;40%), 73% were on NYHA class II, and the median NT-proBNP was 361 [IQR 170-1008] ng/mL. Intervention groups were well balanced, including basal VO2peak that was similar between groups (17.8±4.8 vs 18.1±5.2 mL/min/Kg; p=0.75). Adherence was similar between groups (87.5% vs 82.5%; p=0.50). At week 12, on average, patients increased VO2 peak by 0.9±2.5 mL/min/Kg compared to baseline (p&amp;lt;0.001). No significant differences were found between clinic- and home-based interventions (p=0.25). Consistently, the MLHFQ total score decreased significantly overall (-10.3±1.7 points; p&amp;lt;0.001), with no significant differences between groups (p=0.91). The drop-out rate was 14% and 17% in clinic- and home-based groups, respectively. Conclusions The clinical impact of home-based CR program on peakVO2 and health-related quality of life of HF patients was similar to a standard supervised clinic-based one. Our data support the home-based program as an effective alternative way of delivering CR in HF.

A feasibility and pilot additive randomised control trial of attachment security priming during behavioural activation.

There is some initial evidence that attachment security priming may be useful for promoting engagement in therapy and improving clinical outcomes. This study sought to assess whether outcomes for behavioural activation delivered in routine care could be enhanced via the addition of attachment security priming. This was a pragmatic two-arm feasibility and pilot additive randomised control trial. Participants were recruited with depression deemed suitable for a behavioural activation intervention at Step 2 of a Talking Therapies for Anxiety and Depression service. Ten psychological wellbeing practitioners were trained in implementing attachment security priming. Study participants were randomised to either behavioural activation (BA) or BA plus an attachment prime. The diagrammatic prime was integrated into the depression workbook. Feasibility outcomes were training satisfaction, recruitment, willingness to participate and study attrition rates. Pilot outcomes were comparisons of clinical outcomes, attendance, drop-out and stepping-up rates. All practitioners recruited to the study, and training satisfaction was high. Of the 39 patients that were assessed for eligibility, 24 were randomised (61.53%) and there were no study drop-outs. No significant differences were found between the arms with regards to drop-out, attendance, stepping-up or clinical outcomes. Further controlled research regarding the utility of attachment security priming is warranted in larger studies that utilise manipulation checks and monitor intervention adherence.

The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial

BackgroundThis study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care on health outcomes, self-management, patient experience, and health and social service use costs in older adults (≥ 55 years) with stroke and multimorbidity (≥ 2 chronic conditions).MethodsThis pragmatic randomized controlled trial (RCT) included older adults discharged from hospital to community with stroke and multimorbidity using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional (IP) team, and included care coordination/system navigation support, phone/video visits, monthly IP team conferences, and an online resource to support system navigation. The primary outcome was risk of hospital readmission (all cause) after six-months. Secondary outcomes included physical and mental functioning, stroke self-management, patient experience, and health and social service use costs. The intention-to-treat principle was used to conduct the primary and secondary analyses.ResultsNinety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). No significant between-group differences were seen for baseline to six-month risk of hospital readmission. Differences favouring the intervention group were seen in the following secondary outcomes: physical functioning (SF-12 PCS mean difference: 5.10; 95% CI: 1.58–8.62, p = 0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51—11.50, p = 0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p = 0.005). No between-group differences were found in total healthcare costs or other secondary outcomes.ConclusionsAlthough participation in the TCSI did not impact hospital readmissions, there were improvements in physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs. Challenges associated with the COVID-19 pandemic, including the shift from in-person to virtual delivery, and re-deployment of interventionists could have influenced the results. A larger pragmatic RCT is needed to determine intervention effectiveness in diverse geographic settings and ethno-cultural populations and examine intervention scalability.Trial registrationClinicalTrials.gov Identifier: NCT04278794. Registered May 2, 2020.

Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial

IntroductionThe limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. ObjectivesTo compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. MethodsThis is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups’ patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combination of endurance [(at 60%–80% of peak oxygen uptake (VO2peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4–5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO2peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses. ResultsPatients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in Portugal comparing the traditional CR program with a home-based program in HF patients. Our study results will better inform healthcare professionals who care for HF patients regarding CR.

A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study

BackgroundDelirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.MethodsThe study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants’ own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals.DiscussionFindings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care.Trial registrationThe feasibility study was registered: ISRCTN15676570

“I thought it was for guys that did needles”: Medication perceptions and lay expertise among medical research participants

IntroductionAlthough randomized controlled trials (RCTs) examine “objective” indicators of safety and efficacy of investigational drugs, participants may not perceive study medications as neutral entities. Some medications are imbued with social and cultural meaning, such as stigmatized medications for opioid use disorders. Such perceptions surrounding substance use treatments can extend to the research context and shape RCT participants' experiences with and adherence to study medications. MethodsConsidering these complexities in substance use research, we conducted a nested qualitative study within a multi-site, pragmatic RCT in Canada testing two treatments (methadone versus buprenorphine/naloxone) for opioid use disorder. Between 2017 and 2020, we conducted 115 interviews with 75 RCT participants across five trial sites in British Columbia, Alberta, Ontario, and Quebec. ResultsUsing an abductive coding approach, we characterized participants by their previous experience with medication for opioid use disorder and by their exposure to drug culture and drug scenes. Across these experience types, we identified systematic differences around participants' perceptions of the study medications, sources of information and expertise, and medication stigma. ConclusionOur findings illustrate the critical importance of social context in shaping medication beliefs and study experiences among people who use drugs, with implications for the conduct of future RCTs in substance use.

Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma – protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial

IntroductionThe top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was ‘Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people...

Telemedicine for follow-up of systemic lupus erythematosus during the 2019 coronavirus pandemic: A pragmatic randomized controlled trial.

Patients with systemic lupus erythematous were vulnerable to severe coronavirus disease 2019 infection and the negative impact of disrupted healthcare delivery. Telemedicine has been a popular alternative to standard in-person care during the pandemic despite the lack of evidence. This was a 1-year pragmatic randomized-controlled trial. Patients followed at the lupus nephritis clinic were randomized to either telemedicine or standard follow-up in a 1:1 ratio. Patients in the telemedicine group were followed up via videoconferencing. Standard follow-up group patients continued conventional in-person outpatient care. The primary outcome of the study was the proportion of patients in low disease activity after 1 year. Secondary outcomes included cost-of-illness, safety, and various patient-reported outcomes. From 6/2020 to 12/2021, 144 patients were randomized and 141 patients (telemedicine: 70, standard follow-up: 71) completed the study. At 1 year, 80.0% and 80.2% of the patients in the telemedicine group and standard follow-up group were in lupus low disease activity state or complete remission, respectively (p = 0.967). Systemic lupus erythematous disease activity indices, number of flares and frequency of follow-ups were also similar. There were no differences in the cost-of-illness, quality of life or mental health scores. However, significantly more patients in the telemedicine group (41.4% vs 5.6%; p < 0.001) required switch of mode of follow-up and higher proportion of them had hospitalization during the study period (32.9% vs 15.5%; p = 0.016). Being in the telemedicine group or not in low disease activity at baseline were the independent predictors of hospitalization (odds ratio: 2.6; 95% confidence interval: 1.1-6.1, odds ratio: 2.7, 95% confidence interval: 1.1-6.7, respectively) in the post hoc analysis. In patients with systemic lupus erythematous, telemedicine predominant follow-up resulted in similar 1-year disease control compared to standard care. However, it needed to be complemented by in-person visits, especially in patients with unstable disease.

Can mindfulness-based interventions improve outcomes in cognitive-behavioural therapy for chronic insomnia disorder in the general population? Systematic review and meta-analysis.

Cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line therapy for adults with chronic insomnia disorder (ID), which is characterized by hyperarousal. Mindfulness-based interventions (MBIs) are protocols aimed at stress reduction based on non-judgmental attention control in the present moment. However, MBIs have been increasingly used without a clear scientific basis. The objective of this analysis was to examine if MBIs could be useful as a component of the CBT-I therapeutic system through a systematic review and meta-analysis of randomized controlled trials (RCTs) and non-randomized studies (NRS) searched in PubMed, PsycINFO, Cochrane and WoS. The Insomnia Severity Index (ISI) was the primary outcome, while the Pittsburgh Sleep Quality Index (PSQI) and a composite sleep variable (CSV) were secondary outcomes. Thirteen articles corresponding to nine studies (three pragmatic RCTs, three explanatory RCTs and three NRS) were included. The omnibus test found that MBIs had a small to medium effect size on ISI nearing signification when comparing active control groups in the pretest-posttest period [Δ = 0.44, p= 0.07], a medium, non-significant, effect size on PSQI [Δ = 0.52, p= 0.18], and a significant though small effect size on CSV [Δ = 0.05, p< 0.01]. No heterogeneity was found. The analysis could not demonstrate that MBIs, combined with CBT-I components in some studies, positively affected ID in the general adult population. This was probably due to the lack of pragmatic designs and suitable measuring instruments. Recommendations are made for designing further studies to address these issues.