scholarly journals Improving patient experiences of mental health inpatient care: a randomised controlled trial

2017 ◽  
Vol 48 (3) ◽  
pp. 488-497 ◽  
Author(s):  
T. Wykes ◽  
E. Csipke ◽  
P. Williams ◽  
L. Koeser ◽  
S. Nash ◽  
...  
Keyword(s):  
Mental Health ◽  
Staff Training ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Self Report ◽  
Cluster Randomised Trial ◽  
Therapeutic Environment ◽  
Training Costs ◽  
Randomised Controlled ◽  
The Uk

BackgroundPoorer patient views of mental health inpatient treatment predict both further admissions and, for those admitted involuntarily, longer admissions. As advocated in the UK Francis report, we investigated the hypothesis that improving staff training improves patients’ views of ward care.MethodCluster randomised trial with stepped wedge design in 16 acute mental health wards randomised (using the ralloc procedure in Stata) by an independent statistician in three waves to staff training. A psychologist trained ward staff on evidence-based group interventions and then supported their introduction to each ward. The main outcome was blind self-report of perceptions of care (VOICE) before or up to 2 years after staff training between November 2008 and January 2013.ResultsIn total, 1108 inpatients took part (616 admitted involuntarily under the English Mental Health Act). On average 51.6 staff training sessions were provided per ward. Involuntary patient's perceptions of, and satisfaction with, mental health wards improved after staff training (N582, standardised effect −0·35, 95% CI −0·57 to −0·12, p = 0·002; interaction p value 0·006) but no benefit to those admitted voluntarily (N469, −0.01, 95% CI −0.23 to 0.22, p = 0.955) and no strong evidence of an overall effect (N1058, standardised effect −0.18 s.d., 95% CI −0.38 to 0.01, p = 0.062). The training costs around £10 per patient per week. Resource allocation changed towards patient perceived meaningful contacts by an average of £12 (95% CI −£76 to £98, p = 0.774).ConclusionStaff training improved the perceptions of the therapeutic environment in those least likely to want an inpatient admission, those formally detained. This change might enhance future engagement with all mental health services and prevent the more costly admissions.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

scholarly journals Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241704
Author(s):  
Jennifer Wild ◽  
Shama El-Salahi ◽  
Michelle Degli Esposti ◽  
Graham R. Thew
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Report ◽  
Post Traumatic Stress ◽  
Emergency Responders ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

scholarly journals Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e023679
Author(s):  
Joyce Yeung ◽  
Lee Middleton ◽  
Kostas Tryposkiadis ◽  
Amy Kerr ◽  
Jane Daniels ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Local Anaesthetics ◽  
Chest Wall Resection ◽  
Thoracic Epidural ◽  
American Society ◽  
Randomised Controlled ◽  
The Uk

ObjectivesThoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB.DesignA randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible.SettingTwo adult thoracic centres in the UK.ParticipantsAll adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy.ResultsAll patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns.ConclusionsA large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably.Trial registration numberISRCTN45041624

Recruiting people with HIV to an online self-management support randomised controlled trial: barriers and facilitators

Sexual Health ◽  
2019 ◽  
Vol 16 (4) ◽  
pp. 340
Author(s):  
Karen M. Klassen ◽  
Tanya Millard ◽  
Julia Stout ◽  
Karalyn McDonald ◽  
Sarity Dodson ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Management Program ◽  
Self Management ◽  
Cluster Randomised Trial ◽  
Management Support ◽  
Factors Associated ◽  
Challenges And Opportunities ◽  
Study Sites ◽  
Randomised Controlled

Background Recruitment of people to randomised trials of online interventions presents particular challenges and opportunities. The aim of this study was to evaluate factors associated with the recruitment of people with HIV (PWHIV) and their doctors to the HealthMap trial, a cluster randomised trial of an online self-management program. Methods: Recruitment involved a three-step process. Study sites were recruited, followed by doctors caring for PWHIV at study sites and finally PWHIV. Data were collected from study sites, doctors and patient participants. Factors associated with site enrolment and patient participant recruitment were investigated using regression models. Results: Thirteen study sites, 63 doctor participants and 728 patient participants were recruited to the study. Doctors having a prior relationship with the study investigators (odds ratio (OR) 13.3; 95% confidence interval (CI) 3.0, 58.7; P = 0.001) was positively associated with becoming a HealthMap site. Most patient participants successfully recruited to HealthMap (80%) had heard about the study from their HIV doctor. Patient enrolment was associated with the number of people with HIV receiving care at the site (β coefficient 0.10; 95% CI 0.04, 0.16; P = 0.004), but not with employing a clinic or research nurse to help recruit patients (β coefficient 55.9; 95% CI –2.55, 114.25; P = 0.06). Conclusion: Despite substantial investment in online promotion, a previous relationship with doctors was important for doctor recruitment, and doctors themselves were the most important source of patient recruitment to the HealthMap trial. Clinic-based recruitment strategies remain a critical component of trial recruitment, despite expanding opportunities to engage with online communities.

scholarly journals Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025788 ◽  
Author(s):  
Deborah M Broadbent ◽  
Christopher J Sampson ◽  
Amu Wang ◽  
Lola Howard ◽  
Abigail E Williams ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Screening Programme ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Variable Interval ◽  
Randomised Controlled ◽  
The Uk

IntroductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.Methods and analysisPWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.Ethics and disseminationEthical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.Trial registration numberISRCTN87561257; Pre-results.

scholarly journals Effectiveness of a peer-led adolescent mental health intervention on HIV virological suppression and mental health in Zimbabwe: protocol of a cluster-randomised trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Silindweyinkosi Chinoda ◽  
Abigail Mutsinze ◽  
Victoria Simms ◽  
Rhulani Beji-Chauke ◽  
Ruth Verhey ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorder ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Virological Suppression ◽  
Cluster Randomised Trial ◽  
Depression Symptoms ◽  
Cluster Randomised ◽  
Living With Hiv

Abstract Background Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters – CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone. Methods We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life. Conclusions This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes. Trial registration: PACTR201810756862405. 08 October 2018.

scholarly journals Vocational rehabilitation in early psychosis: cluster randomised trial

2014 ◽  
Vol 205 (2) ◽  
pp. 145-150 ◽  
Author(s):  
Tom Craig ◽  
Geoff Shepherd ◽  
Miles Rinaldi ◽  
Jo Smith ◽  
Sarah Carr ◽  
...  
Keyword(s):  
Motivational Interviewing ◽  
Controlled Trial ◽  
Clinical Status ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Care Coordinator ◽  
Occupational Outcomes ◽  
Intervention Teams ◽  
Attitudinal Barriers ◽  
Randomised Controlled

BackgroundIndividual placement and support (IPS) is effective in helping patients return to work but is poorly implemented because of clinical ambivalence and fears of relapse.AimsTo assess whether a motivational intervention (motivational interviewing) directed at clinical staff to address ambivalence about employment improved patients' occupational outcomes.MethodTwo of four early intervention teams that already provided IPS were randomised to receive motivational interviewing training for clinicians, focused on attitudinal barriers to employment. The trial was registered with the International Standard Randomised Controlled Trial Register (ISRCTN71943786).ResultsOf 300 eligible participants, 159 consented to the research. Occupational outcomes were obtained for 134 patients (85%) at 12-month follow-up. More patients in the intervention teams than in the IPS-only teams achieved employment by 12 months (29/68 v. 12/66). A random effects logistic regression accounting for clustering by care coordinator, and adjusted for participants' gender, ethnicity, educational and employment history and clinical status scores, confirmed superiority of the intervention (odds ratio = 4.3, 95% CI 1.5–16.6).ConclusionsEmployment outcomes were enhanced by addressing clinicians' ambivalence about their patients returning to work.

scholarly journals The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds—a modular transdiagnostic intervention for mood, stressor-related and anxiety disorders in adults

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e024546 ◽  
Author(s):  
Melissa Black ◽  
Caitlin Hitchcock ◽  
Anna Bevan ◽  
Cliodhna O Leary ◽  
James Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Building Blocks ◽  
Self Report ◽  
Mental Wellbeing ◽  
Feasibility Trial ◽  
Randomised Controlled ◽  
The Uk ◽  
Later Phase ◽  
Phase Trial

IntroductionAnxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The Healthy and Resilient Mind Programme: Building Blocks for Mental Wellbeing (HARMONIC) trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds (SHM)), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.Methods/analysisWe outline a patient-level two-arm randomised controlled trial (HARMONIC) that comparesSHMto treatment-as-usual for individuals aged >18 years (n=50) with comorbid mood, anxiety, obsessive-compulsive or trauma/stressor disorders diagnoses, recruited from outpatient psychological services within the UK National Health Service (NHS). The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability ofSHM, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial.Ethics and disseminationThis trial protocol has been approved by the Health Research Authority of the NHS of the UK (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops and a trial website.Trial registrationNCT03143634; Pre-results.

scholarly journals Does soccer headgear reduce the incidence of sport-related concussion? A cluster, randomised controlled trial of adolescent athletes

2019 ◽  
Vol 54 (7) ◽  
pp. 408-413 ◽  
Author(s):  
Timothy McGuine ◽  
Eric Post ◽  
Adam Yakuro Pfaller ◽  
Scott Hetzel ◽  
Allison Schwarz ◽  
...  
Keyword(s):  
High School ◽  
Proportional Hazards ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cox Proportional Hazards ◽  
Soccer Players ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

BackgroundThere have been no large randomised controlled trials to determine whether soccer headgear reduces the incidence or severity of sport-related concussion (SRC) in US high school athletes.ObjectiveWe aimed to determine whether headgear reduces the incidence or severity (days out from soccer) of SRCs in soccer players.Methods2766 participants (67% female, age 15.6±1.2) (who undertook 3050 participant years) participated in this cluster randomised trial. Athletes in the headgear (HG) group wore headgear during the season, while those in the no headgear (NoHG) group did not. Staff recorded SRC and non-SRC injuries and soccer exposures. Multivariate Cox proportional hazards models were used to examine time-to-SRC between groups, while severity was compared with a Wilcoxon rank-sum test.Results130 participants (5.3% female, 2.2% male) sustained an SRC. The incidence of SRC was not different between the HG and NoHG groups for males (HR: 2.00 (0.63–6.43) p=0.242) and females (HR: 0.86 (0.54–1.36) p=0.520). Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0–018.8) days) and the NoHG group (13.0 (9.0–18.8) days).ConclusionsSoccer headgear did not reduce the incidence or severity of SRC in high school soccer players.Trial registration numberNCT02850926.

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