Trials
-
Randomized Controlled Trial Multicenter Study Comparative Study
Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial.
A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. ⋯ This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake.
-
Randomized Controlled Trial Multicenter Study
Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial.
Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. ⋯ This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context.
-
Randomized Controlled Trial Multicenter Study
Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial.
Psychologically informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled due to back pain. ⋯ This study will be the first randomized controlled trial of the PGAP in chronic pain patients and will provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in the context of the Irish health service.
-
Randomized Controlled Trial Multicenter Study
Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial.
Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence. ⋯ The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.
-
Randomized Controlled Trial Multicenter Study Comparative Study
DiaSurg 2 trial--surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial--DRKS00004550.
Type 2 diabetes mellitus (T2DM) is a disease with high prevalence, associated with severe co-morbidities as well as being a huge burden on public health. It is known that glycemic control decreases long-term morbidity and mortality. The current standard therapy for T2DM is medical treatment. Several randomized controlled trials (RCTs) performed in obese patients showed remission of T2DM after bariatric surgery. Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese, insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM. This study aims at investigating whether Roux-en-Y gastric bypass (RYGB) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality. ⋯ The DiaSurg2 trial will yield long-term data (8 years) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or standardized medical care.