Sarah E. Brewer et al. · 2020 · BMJ Open · Open access
INTRODUCTION: Vaccination against influenza and pertussis in pregnancy offers a 'two-for-one' opportunity to protect mother and child. Pregnant patients have increased risk of severe disease from influenza and newborns have increased risk of severe disease from both influenza and pertussis. Obstetricians need communication tools to support their self-efficacy and effectiveness in communicating the importance of immunisation during pregnancy and ultimately improving maternal vaccination rates. METHODS AND ANALYSIS: We describe the protocol for a pragmatic study testing the feasibility and potential impact of a clinician communication strategy on maternal vaccination uptake. This study will be conducted in five prenatal care settings in Colorado, USA. The Motivational Interviewing for Maternal Immunisation strategy involves training prenatal care providers to use motivational interviewing in the vaccine conversation with pregnant patients. Our primary outcomes will be the adoption and implementation of the intervention measured using the Enhanced RE-AIM/Practical Robust Implementation and Sustainability Model for dissemination and implementation. Secondary outcomes will include provider time spent, fidelity to Motivational Interviewing and self-efficacy measured through audio recorded visits and provider surveys, patients' visit experience based on audio recorded visits and follow-up interviews, and maternal vaccine uptake as measured through chart reviews. ETHICS AND DISSEMINATION: This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION NUMBER: NCT04302675.
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Kjeld Andersen et al. · 2019 · Addiction · Open access
AIM: To examine whether adding the Community Reinforcement Approach for Seniors (CRA-S) to Motivational Enhancement Therapy (MET) increases the probability of treatment success in people aged ≥ 60 years with alcohol use disorder (AUD). DESIGN: A single blind multi-centre multi-national randomized (1 : 1) controlled trial. SETTING: Out-patient settings (municipal alcohol treatment clinics in Denmark, specialized addiction care facilities in Germany and a primary care clinic in the United States). PARTICIPANTS: Between January 2014 and May 2016, 693 patients aged 60+ years and fulfilling DSM-5 criteria for AUD participated in comparing MET (n = 351) and MET + CRA-S (n = 342). INTERVENTION AND COMPARATOR: MET (comparator) included four manualized sessions aimed at increasing motivation to change and establishing a change plan. CRA-S (intervention) consisted of up to eight further optional, manualized sessions aimed at helping patients to implement their change plan. CRA-S included a specially designed module on coping with age and age-related problems. MEASUREMENTS: The primary outcome was either total alcohol abstinence or an expected blood alcohol concentration of ≤ 0.05% during the 30 days preceding the 26 weeks follow-up (defined as success) or blood alcohol concentration of > 0.05% during the follow-up period (defined as failure). This was assessed by self-report using the Form 90 instrument. The main analysis involved complete cases. FINDINGS: The follow-up rate at 26 weeks was 76.2% (76.9% in the MET group and 76.0% in the MET + CRA-S group). The success rate in the MET group was 48.9% [95% confidence interval (CI) = 42.9-54.9%] versus 52.3% (95% CI = 46.2-58.3%) in the MET + CRA-S group. The odds of success in the two conditions did not differ (odds ratio = 1.22. 95% CI = 0.86-1.75, P = 0.26, Bayes factor = 0.10). Sensitivity analyses involving alternative approaches to missing values did not change the results. CONCLUSIONS: In older adults with an alcohol use disorder diagnosis, adding the 'community reinforcement approach for seniors' intervention to brief out-patient motivational enhancement therapy treatment did not improve drinking outcome.
Douglas J. Opel et al. · 2020 · BMJ Open · Open access
INTRODUCTION: A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake. METHODS AND ANALYSIS: We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy. ETHICS AND DISSEMINATION: This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION NUMBER: NCT03885232.
Sallie J. Weaver et al. · 2014 · BMJ Quality & Safety · Open access
BACKGROUND: Patients are safer and receive higher quality care when providers work as a highly effective team. Investment in optimising healthcare teamwork has swelled in the last 10 years. Consequently, evidence regarding the effectiveness for these interventions has also grown rapidly. We provide an updated review concerning the current state of team-training science and practice in acute care settings. METHODS: A PubMed search for review articles examining team-training interventions in acute care settings published between 2000 and 2012 was conducted. Following identification of relevant reviews with searches terminating in 2008 and 2010, PubMed and PSNet were searched for additional primary studies published in 2011 and 2012. Primary outcomes included patient outcomes and quality indices. Secondary outcomes included teamwork behaviours, knowledge and attitudes. RESULTS: Both simulation and classroom-based team-training interventions can improve teamwork processes (eg, communication, coordination and cooperation), and implementation has been associated with improvements in patient safety outcomes. Thirteen studies published between 2011 and 2012 reported statistically significant changes in teamwork behaviours, processes or emergent states and 10 reported significant improvement in clinical care processes or patient outcomes, including mortality and morbidity. Effects were reported across a range of clinical contexts. Larger effect sizes were reported for bundled team-training interventions that included tools and organisational changes to support sustainment and transfer of teamwork competencies into daily practice. CONCLUSIONS: Overall, moderate-to-high-quality evidence suggests team-training can positively impact healthcare team processes and patient outcomes. Additionally, toolkits are available to support intervention development and implementation. Evidence suggests bundled team-training interventions and implementation strategies that embed effective teamwork as a foundation for other improvement efforts may offer greatest impact on patient outcomes.
Line Kildal Bragstad et al. · 2019 · BMC Medical Research Methodology · Open access
BACKGROUND: Evaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis. METHODS: This study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way. RESULTS: The results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study. CONCLUSIONS: This evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02338869; registered 10/04/2014.
Jocelyn Catty et al. · 2008 · The British Journal of Psychiatry · Open access
BACKGROUND: An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. AIMS: To determine which patients with severe mental illness do well in vocational services and which process and service factors are associated with better outcomes. METHOD: Patient characteristics and early process variables were tested as predictors of employment outcomes. Service characteristics were explored as predictors of the effectiveness of IPS. RESULTS: Patients with previous work history, fewer met social needs and better relationships with their vocational workers were more likely to obtain employment and work for longer. Remission and swifter service uptake were associated with working more. Having an IPS service closer to the original IPS model was the only service characteristic associated with greater effectiveness. CONCLUSIONS: The IPS service was found to be more effective for all vocational outcomes. In addition, maintaining high IPS fidelity and targeting relational skills would be a valuable focus for all vocational interventions, leading to improved employment outcomes. Motivation to find work may be decreased by satisfaction with current life circumstances.
Steve Iliffe et al. · 2014 · Health Technology Assessment · Open access
BACKGROUND: Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements. OBJECTIVE: To evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years. DESIGN: The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care. SETTING: Forty-three UK-based general practices in London and Nottingham/Derby. PARTICIPANTS: A total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial. INTERVENTIONS: The FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking. MAIN OUTCOME MEASURES: The primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial. RESULTS: In total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants. The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99; p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93). CONCLUSION: The FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms. TRIAL REGISTRATION: This trial is registered as ISRCTN43453770. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.
Abstract Objective: To see whether a behaviourally based group parenting programme, delivered in regular clinical practice, is an effective treatment for antisocial behaviour in children. Design: Controlled trial with permuted block design with allocation by date of referral. Setting: Four local child and adolescent mental health services. Participants: 141 children aged 3-8 years referred with antisocial behaviour and allocated to parenting groups (90) or waiting list control (51). Intervention: Webster-Stratton basic videotape programme administered to parents of six to eight children over 13-16 weeks. This programme emphasises engagement with parental emotions, rehearsal of behavioural strategies, and parental understanding of its scientific rationale. Main outcome measures: Semistructured parent interview and questionnaires about antisocial behaviour in children administered 5-7 months after entering trial; direct observation of parent-child interaction. Results: Referred children were highly antisocial (above the 97th centile on interview measure). Children in the intervention group showed a large reduction in antisocial behaviour; those in the waiting list group did not change (effect size between groups 1.06 SD (95% confidence interval 0.71 to 1.41), P<0.001). Parents in the intervention group increased the proportion of praise to ineffective commands they gave their children threefold, while control parents reduced it by a third (effect size between groups 0.76 (0.16 to 1.36), P=0.018). If the 31 children lost to follow up were included in an intention to treat analysis the effect size on antisocial behaviour was reduced by 16%. Conclusions: Parenting groups effectively reduce serious antisocial behaviour in children in real life conditions. Follow up is needed to see if the children's poor prognosis is improved and criminality prevented. What is already known on this topic Children who persistently display a high level of antisocial behaviour are at high risk of social rejection, juvenile delinquency, and long term unemployment; the cost to society is high While some behaviourally based parenting programmes have been shown to be effective in university centre trials with volunteers or specially selected cases, most trials of psychological treatments for children in real life settings have shown no effect What this study adds An evidence based intervention is available for use in regular clinical practice that effectively reduces antisocial behaviour in referred children The intervention works well with children at risk of criminality from a combination of highly antisocial behaviour, multiple psychopathology, and social deprivation
Amy M. Kilbourne et al. · 2004 · Milbank Quarterly · Open access
Randomized controlled trials have demonstrated the efficacy and cost-effectiveness of using treatment models for major depression in primary care settings. Nonetheless, translating these models into enduring changes in routine primary care has proved difficult. Various health system and organizational barriers prevent the integration of these models into primary care settings. This article discusses barriers to introducing and sustaining evidence-based depression management services in community-based primary care practices and suggests organizational and financial solutions based on the Robert Wood Johnson Foundation Depression in Primary Care Program. It focuses on strategies to improve depression care in medical settings based on adaptations of the chronic care model and discusses the challenges of implementing evidence-based depression care given the structural, financial, and cultural separation between mental health and general medical care.
Stanislaw Schukajlow et al. · 2023 · ZDM · Open access
Emotions and motivation are important for learning and achievement in mathematics. In this paper, we present an overview of research on students' emotions and motivation in mathematics. First, we briefly review how early research has developed into the current state-of-the-art and outline the following key characteristics of emotions and motivation: objects, valence, temporal stability (vs. variability), and situational specificity (vs. generality). Second, we summarize major theories in the field (the control-value theory of achievement emotions, expectancy-value theory of achievement-related motivation, self-determination theory of human motivation, and social-cognitive theory of self-efficacy). Third, we present an overview of instructional characteristics that have been shown to foster emotions and motivation. Fourth, we provide an overview of the contributions to the special issue on "Emotions and Motivation in Mathematics Education and Educational Psychology." Finally, we suggest directions for future research in the field with respect to advancing theory, improving measurement, and considering diversity and inclusion.