Trials
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Randomized Controlled Trial Pragmatic Clinical Trial
Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial.
Hospital readmissions remain highly prevalent despite being the target of policies and financial penalties. Evidence comparing the effectiveness and costs of interventions to reduce readmissions is lacking, leaving healthcare systems with little guidance on how to improve quality and avoid costly penalties. Effective interventions likely need to bridge inpatient and outpatient settings, incorporate information technology, and use dedicated providers. Such complex innovations will require rigorous evaluation. The framework of quality improvement research provides an approach that both improves care locally and contributes to closing the current knowledge gaps for readmissions. In this trial, we will study a comprehensive intervention that incorporates these recommendations into an integrated practice unit, called transition services, with an aim of reducing 30-day readmission rates. ⋯ The hospital transition program under study is complex and integrates the latest recommendations for readmission reduction strategies. As healthcare systems innovate to address readmissions through such complex interventions, there is significant benefit for stakeholders to have a clear understanding of the potential reach, cost, and real-world effectiveness. The pragmatic methods described here provide a template for conducting quality improvement research that fits seamlessly into existing care delivery and improvement efforts, leading to better-informed strategic decisions and the investments necessary to transform care and value for patients.
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Randomized Controlled Trial Multicenter Study
Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial.
The evidence for the benefits of online cognitive behaviour therapy (CBT)-based programmes delivered in a clinical context is clear, but this evidence does not translate to online CBT-based stress management programmes delivered within a workplace context. One of the challenges to the delivery of online interventions is programme engagement; this challenge is even more acute for interventions delivered in real-world settings such as the workplace. The purpose of this pilot study is to explore the effect of an online facilitated discussion group on engagement, and to estimate the potential effectiveness of an online CBT-based stress management programme. ⋯ To our knowledge this is the first study to explore the effect of an online discussion group on the engagement and effectiveness of an online CBT-based stress management intervention. This study could provide a solution to the growing problem of poor employee psychological health and begin to address the challenge of increasing engagement with Internet-delivered health interventions.
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Randomized Controlled Trial
Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman's Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial.
Globally, 220 million women experience an unmet need for family planning. A newly designed female condom, the Woman's Condom (WC), has been developed featuring an improved design. It is the first dual-protection, female-initiated contraceptive that is a premium, higher price point product. However, market availability alone will not increase uptake. In February 2016 the WC will be distributed with a strong media campaign and interpersonal communication (IPC) outreach intervention. The impact of these on knowledge, acceptability, and use of the WC will be measured. ⋯ Increasing uptake of dual prevention measures (such as the WC) may reduce incidence of sexually transmitted infections/HIV and unplanned pregnancies. It is important to ensure young, urban adults have access to new contraceptive methods; and, understanding how mass media and IPC impact contraceptive knowledge, acceptability, and use is critical to reduce unmet need.
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Randomized Controlled Trial Multicenter Study Comparative Study
The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.
The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. ⋯ The RESPITE trial's primary outcome is the proportion of women who have an epidural placed for pain relief in labour in each arm.
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Randomized Controlled Trial
'Walk This Way' - a pilot of a health coaching intervention to reduce sedentary behaviour and increase low intensity exercise in people with serious mental illness: study protocol for a randomised controlled trial.
People with serious mental illness (SMI) (psychosis, bipolar disorder and major depressive disorder) experience a considerable risk of premature mortality because of cardiovascular disease. Recent research has demonstrated that this population spends almost 13 h per day being sedentary. Sedentary behaviour is an independent risk factor for cardiovascular disease and mortality. Given the potential for physical activity to improve health and well-being in people with SMI, we developed a pilot randomised controlled trial (RCT) to evaluate a coaching intervention aimed at reducing sedentary behaviour and increasing physical activity in people with SMI. Our primary aim was to assess the acceptability and feasibility of the intervention. Secondary aims were to see if the Walk This Way (WTW) intervention decreased sedentary behaviour and increased activity levels. ⋯ To our knowledge, WTW is the first RCT to investigate the impact of a health coaching intervention targeting sedentary behaviour in people with SMI. It is hoped that if the intervention is feasible and acceptable, further large scale study can be developed and implemented in routine care.