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Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up.

ABSTRACT: Introduction:A new dental contract being tested in England places patients into traffic light categories according to risk (Red?=?High risk). This reflects health policy which emphasises patients' shared responsibility for their health, and a growing expectation that clinicians discuss health risk in consultations. Alongside this, there are technological developments such as scans and photographs which have generated new, vivid imagery which may be used to communicate risk information to patients. However, there is little evidence as to whether the form in which risk information is given is important. Methods:The PREFER study is a pragmatic, multi-centre, three-arm, patient-level randomised controlled trial, based in four NHS dental practices, from which 400 high/medium risk patients will be recruited. The study compares three ways of communicating risk information at dental check-ups: 1) verbal only (usual care); 2) a Traffic Light graphic with verbal explanation; 3) a Quantitative Light-Induced Fluorescence (QLF) photograph showing, for example, patches of red fluorescence where dental plaque has been present for two days or more (with a verbal explanation). The study assesses patient preferences using the economic preference-based valuation methodology Willingness-to-Pay (WTP). Any changes in oral self-care (for example in tooth-brushing), will be measured by self-report, and clinical outcome data collected by clinicians and extracted from QLF photographs. Predictors and moderators of any behaviour change will be explored using demographic characteristics and psychological variables from the Extended Parallel Process Model. A cost-benefit framework will explore the financial implications for NHS dentistry of the three risk presentation methods.

SUBMITTER: Harris R

PROVIDER: S-EPMC6022252 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up.

Harris Rebecca R Vernazza Christopher C Laverty Louise L Lowers Victoria V Brown Stephen S Burnside Girvan G Ternent Laura L Higham Susan S Steele Jimmy J

Contemporary clinical trials communications 20180507

<h4>Introduction</h4>A new dental contract being tested in England places patients into traffic light categories according to risk (Red = High risk). This reflects health policy which emphasises patients' shared responsibility for their health, and a growing expectation that clinicians discuss health risk in consultations. Alongside this, there are technological developments such as scans and photographs which have generated new, vivid imagery which may be used to communicate risk information to ...[more]

PMID: 30023454

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Project description:BackgroundSubstance misuse is now encountered in settings beyond addiction specialty care, with schools a point-of-contact for student access to behavioral health services. Marijuana is a leading impetus for adolescent treatment admissions despite declining risk perception, for which the Teen Marijuana Check-Up (TMCU)-a tailored adaptation of motivational enhancement therapy-offers an efficacious service option. To bridge the knowledge gap concerning effective and affordable technical assistance strategies for implementing empirically supported services, the described trial will test such a strategy to facilitate school-based TMCU implementation.MethodsA type II effectiveness/implementation hybrid trial will test a novel strategy for a TMCU purveyor to provide technical assistance on an 'as-needed' basis when triggered by a fidelity drift alarm bell, compared to resource-intensive 'gold-standard' technical assistance procedures of prior efficacy trials. Trial procedures adhere to the EPIS framework as follows: (1) initial mixed-method exploration of the involved school contexts and identification of TMCU interventionist candidates in elicitation interviews; (2) interventionist preparation via a formally evaluated training process involving a two-day workshop and sequence of three training cases; (3) post-training implementation for 24 months for which trained interventionists are randomized to 'as-needed' or 'gold-standard' technical assistance and self-referring students randomized (in 2:1 ratio) to TMCU or waitlist/control; and (4) examination of TMCU sustainment via interventionist completion of biannual outcome assessments, cost analyses, and exit interviews. Hypothesized effects include non-differential influence of the competing technical assistance methods on both TMCU fidelity and intervention effectiveness, with lesser school costs for the 'as-needed' than 'gold-standard' technical assistance and greater reduction in the frequency of marijuana use expected among TMCU-exposed students relative to those assigned to waitlist/control.DiscussionThis trial-occurring in Washington state as legislative, fiscal, and sociocultural forces converge to heighten exposure of American adolescents to marijuana-related harms-is set to advance understanding of best implementation practices for this and other efficacious, school-based interventions through examination of a data-driven technical assistance method. If shown to be clinically useful and affordable, the concept of a fidelity drift alarm could be readily translated to other empirically supported services and in other health settings.Trial registrationClinicalTrials.gov NCT03111667 registered 7 April 2017.

Project description:The periodic health check-up has been a fundamental part of routine medical practice for decades, despite a lack of consensus regarding its value in health promotion and disease prevention. A large-scale Danish population-based preventive programme 'Check your health' was developed based on available evidence of screening and successive accepted treatment, prevention for diseases and health promotion, and is closely aligned with the current health care system.The objective of the 'Check your health' [CORE] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years, and to establish the cost-effectiveness.The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals. All individuals within a well-defined geographical area in the Central Denmark Region, Denmark (DK) were randomised to be offered a preventive health check (Intervention group, n = 5250) or to maintain routine access to healthcare until a delayed intervention (Comparison group, n = 5255). The programme consists of a health examination which yields an individual risk profile, and according to this participants are assigned to one of the following interventions: (a) referral to a health promoting consultation in general practice, (b) behavioural programmes at the local Health Centre, or (c) no need for follow-up.The primary outcomes at 4 years follow-up are: ten-year-risk of fatal cardiovascular event (Heart-SCORE model), physical activity level (self-report and cardiorespiratory fitness), quality of life (SF12), sick leave and labour market attachment. Cost-effectiveness will be evaluated according to life years gained, direct costs and total health costs. Intention to treat analysis will be performed.Results from the largest Danish health check programme conducted within the current healthcare system, spanning the sectors which share responsibility for the individual, will provide a scientific basis to be used in the development of systems to optimise population health in the 21st century.The trial has registered at ClinicalTrials.gov with an ID: NCT02028195 (7. March 2014).

Project description:BACKGROUND:Research has established that skillful family management during adolescence protects youth from a variety of mental health and behavioral problems. Interventions associated with this research have focused on parenting skills as the mediator that links early risk factors with a profile of later behavioral risk, including problem behavior, substance use, and school failure. Fortunately, positive changes in family management skills have been linked to meaningful improvements in adolescent behavior, and these improvements have been significant across a variety of cultural groups. OBJECTIVE:We describe the background, research design, and intervention components of an electronic health version of the Family Check-Up program that is targeting middle school children and is being evaluated in a randomized controlled trial for its usability, feasibility, and efficacy. METHODS:We used an iterative formative research process to develop an electronic health version of the Family Check-Up program. In our ongoing randomized controlled trial, eligible families are randomly assigned to 1 of 3 conditions: Family Check-Up Online-only (n?100), Family Check-Up Online + Coach (n?100), and a waitlist control condition (middle school as usual; n?100). We are conducting assessments at baseline, 3 months following randomization (posttest), and at follow-ups scheduled for 6 months and 12 months. RESULTS:This randomized controlled trial project was funded in 2015. Participant recruitment was completed in spring 2018 and enrollment is ongoing. Follow-up assessments will be completed in 2019. CONCLUSIONS:The innovative Family Check-Up Online program has the potential to help address many of the barriers that more traditional school-based behavioral mental health implementation strategies have yet to solve, including staffing and resources to implement family-centered support within schools. TRIAL REGISTRATION:ClinicalTrials.gov NCT03060291; https://clinicaltrials.gov/ct2/show/NCT03060291 (Archived by WebCite at http://www.webcitation.org/70f8keeN4). TRIAL REGISTRATION:RR1-10.2196/11106.

Project description:BackgroundThrough many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients.Methods/designThe non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2?<?9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium-free days; highest RIFLE score; days until discharge from the intensive care unit (within 28 days); days until the participant is without mechanical ventilation (within 28 days); and proportion of patients with a major cardiovascular outcome. Explorative outcomes will be: all cause mortality at 28 days after randomisation; days until discharge from the intensive care unit; days until the participant is without mechanical ventilation; days until discharge from the hospital; organ failure.Trial size: we will include 700 participants (2?×?350) in order to detect or reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%).DiscussionThe trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.Trial registerClinicalTrials.gov NCT0196768, 09.01.2014.

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Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up.

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Presenting information on dental risk: PREFER study protocol for a randomised controlled trial involving patients receiving a dental check-up.

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