The Herts and Minds study: feasibility of a randomised controlled trial of Mentalization-Based Treatment versus usual care to support the wellbeing of children in foster care.

BACKGROUND: There is a lack of well-designed randomized controlled trials (RCTs) to investigate the efficacy of psychological therapies for children in foster care with emotional and behavioural difficulties. Mentalization-based therapy (MBT) focuses on supporting the carer-child relationship by promoting reflective capacity. This study examined the feasibility and acceptability of an RCT of MBT, delivered in a family-format, for children who are in foster care in the UK. METHOD: Herts and Minds was a phase II, blinded feasibility RCT with follow-up of at 12 and 24 weeks post-randomisation. Participants were children (age 5-16) in foster care referred to a targeted mental health service, who had some level of difficulty as identified by the Strengths and Difficulties Questionnaire (SDQ). Aims were to assess: the feasibility of recruitment processes and study uptake; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; establish acceptability and credibility of MBT as an intervention for children in foster care; establish feasibility and acceptability to participants of conducting an RCT; and estimate the likely treatment efficacy effect size. Participants were randomly allocated to either MBT (n = 15) or Usual Clinical Care (UCC) (n = 21) individually or in sibling groups. A range of qualitative and quantitative data was gathered to assess feasibility. RESULTS: Feasibility was established with regard to: capacity to recruit participants to a study; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; acceptability and credibility of MBT; and feasibility and acceptability to participants of conducting an RCT. A number of issues made it difficult to estimate a likely treatment efficacy effect size. CONCLUSION: With modifications, it is feasible to run an RCT of MBT for children in foster care. Both the therapy and research design were acceptable to participants, but modifications may be needed regarding both the timing of assessments and the identification of appropriate primary outcome measures. Given the lack of evidenced based therapies for this population, such a trial would be a significant contribution to the field. Findings may be useful for other groups planning clinical trials of psychological therapies for children in foster care. TRIAL REGISTRATION: ISRCTN 90349442 . The trial was retrospectively registered on 6 May 2016.

Psychological Determinants of Medication Adherence in Stroke Survivors: a Systematic Review of Observational Studies.

BACKGROUND: Medications targeting stroke risk factors have shown good efficacy, yet adherence is suboptimal. To improve adherence, its determinants must be understood. To date, no systematic review has mapped identified determinants into the Theoretical Domains Framework (TDF) in order to establish a more complete understanding of medication adherence. PURPOSE: The aim of this study was to identify psychological determinants that most influence stroke survivors' medication adherence. METHODS: In line with the prospectively registered protocol (PROSPERO CRD42015016222), five electronic databases were searched (1953-2015). Hand searches of included full text references were undertaken. Two reviewers conducted screening, data extraction and quality assessment. Determinants were mapped into the TDF. RESULTS: Of 32,825 articles, 12 fulfilled selection criteria (N = 43,984 stroke survivors). Tested determinants mapped into 8/14 TDF domains. Studies were too heterogeneous for meta-analysis. Three TDF domains appeared most influential. Negative emotions ('Emotions' domain) such as anxiety and concerns about medications ('Beliefs about Consequences' domain) were associated with reduced adherence. Increased adherence was associated with better knowledge of medications ('Knowledge' domain) and stronger beliefs about medication necessity ('Beliefs about Consequences' domain). Study quality varied, often lacking information on sample size calculations. CONCLUSIONS: This review provides foundations for evidence-based intervention design by establishing psychological determinants most influential in stroke survivors' medication adherence. Six TDF domains do not appear to have been tested, possibly representing gaps in research design. Future research should standardise and clearly report determinant and medication adherence measurement to facilitate meta-analysis. The range of determinants explored should be broadened to enable more complete understanding of stroke survivors' medication adherence.

The Herts and minds study: evaluating the effectiveness of mentalization-based treatment (MBT) as an intervention for children in foster care with emotional and/or behavioural problems: a phase II, feasibility, randomised controlled trial.

BACKGROUND: A significant proportion of children in the social care system in England present with mental health problems, with the majority experiencing some form of emotional and behavioural difficulties. The most effective treatments for these children are currently unknown, partly due to a lack of robust, controlled studies. Researchers have identified a number of obstacles to conducting well-designed research with this population, making the need to test the feasibility of a randomised controlled trial especially important. METHODS/DESIGN: This protocol outlines a two-arm, randomised control feasibility trial to explore the acceptability and credibility of mentalization-based treatment (MBT) as a treatment for reducing emotional and behavioural difficulties in looked after children and to test the possibility of addressing a number of methodological challenges to conducting high-quality research with this population. MBT is a relatively new intervention which, in the adaptation of the model tested here, includes many of the features of therapy identified in NICE guidelines as necessary to support children in care. The two arms are MBT and usual clinical care (UCC). The study will take place in Hertfordshire Partnership University NHS Foundation Trust with follow-up at 12 and 24 weeks. DISCUSSION: This study will aim to ascertain whether it is worthwhile and feasible to progress to testing the intervention in a full-scale definitive randomised controlled trial (RCT). This study therefore has the potential to improve our understanding of the obstacles to conducting high-quality research with this very vulnerable population, and in the medium term, could help to improve the stability of foster placements and the emotional well-being of children in care. TRIAL REGISTRATION: ISRCTN90349442.

Application of a theoretical framework for behavior change to hospital workers' real-time explanations for noncompliance with hand hygiene guidelines.

BACKGROUND: Insufficient use of behavioral theory to understand health care workers' (HCWs) hand hygiene compliance may result in suboptimal design of hand hygiene interventions and limit effectiveness. Previous studies examined HCWs' intended, rather than directly observed, compliance and/or focused on just 1 behavioral model. This study examined HCWs' explanations of noncompliance in "real time" (immediately after observation), using a behavioral theory framework, to inform future intervention design. METHODS: HCWs were directly observed and asked to explain episodes of noncompliance in "real-time." Explanations were recorded, coded into 12 behavioral domains, using the Theory Domains Framework, and subdivided into themes. RESULTS: Over two-thirds of 207 recorded explanations were explained by 2 domains. These were "Memory/Attention/Decision Making" (87, 44%), subdivided into 3 themes (memory, loss of concentration, and distraction by interruptions), and "Knowledge" (55, 26%), with 2 themes relating to specific hand hygiene indications. No other domain accounted for more than 18 (9%) explanations. CONCLUSION: An explanation of HCW's "real-time" explanations for noncompliance identified "Memory/Attention/Decision Making" and "Knowledge" as the 2 behavioral domains commonly linked to noncompliance. This suggests that hand hygiene interventions should target both automatic associative learning processes and conscious decision making, in addition to ensuring good knowledge. A theoretical framework to investigate HCW's "real-time" explanations of noncompliance provides a coherent way to design hand hygiene interventions.

How do osteoporosis patients perceive their illness and treatment? Implications for clinical practice.

UNLABELLED: Non-adherence inhibits successful treatment of osteoporosis. This study used a theoretical framework to explore osteoporosis patients' cognitive and emotional representations of their illness and medication, using both interviews and drawing. We recorded some misconceptions patients have about their condition and medication which could act as barriers to treatment adherence. PURPOSE: Despite the high efficacy of current treatments in reducing fracture risk, poor adherence is still a problem in osteoporosis. This qualitative study aims to inform the development of a psychological intervention to increase adherence through the investigation of osteoporosis patients' perceptions of their illness and medication. The self-regulation model (Leventhal) provided the framework for the study. METHOD: Participants were 14 female outpatients from a London teaching hospital who suffer with osteoporosis or osteopenia. Data were collected using both semi-structured interviews and drawings. Drawings were used to elicit participants' visual representations (imagery) of their condition. RESULTS: We found that patients held illness and medication beliefs that were not in accord with current scientific evidence. Interviews revealed that participants had good knowledge of what osteoporosis is, but they had low understanding of the role of medication in reducing fracture risk, various concerns about the side effects of medication, poor understanding of the causes of osteoporosis and uncertainty about how it can be controlled. Additionally, drawings elicited more information about the perceived effects of osteoporosis and emotional reactions to the condition. CONCLUSIONS: Osteoporosis sufferers need a better understanding of their fracture risk and what they can do to control their condition. Concerns about medication need to be addressed in order to improve adherence, particularly in relation to the management of side effects. Since drawings of osteoporosis were found to arouse emotions, it is concluded that risk communication in osteoporosis could benefit from using visual images.

The Feedback Intervention Trial (FIT)--improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial.

INTRODUCTION: Achieving a sustained improvement in hand-hygiene compliance is the WHO's first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness. METHODS: Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. PRIMARY OUTCOME: direct blinded hand hygiene compliance (%). RESULTS: All 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). INTENTION TO TREAT ANALYSIS: Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001) & ITUs (2.09 [1.55-2.81]; p<0.001) equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form) but not ACE wards. CONCLUSION: Despite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention's effect in different settings. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65246961.

"The dirty hand in the latex glove": a study of hand hygiene compliance when gloves are worn.

BACKGROUND AND OBJECTIVE: Wearing of gloves reduces transmission of organisms by healthcare workers' hands but is not a substitute for hand hygiene. Results of previous studies have varied as to whether hand hygiene is worse when gloves are worn. Most studies have been small and used nonstandardized assessments of glove use and hand hygiene. We sought to observe whether gloves were worn when appropriate and whether hand hygiene compliance differed when gloves were worn. DESIGN: Observational study. PARTICIPANTS AND SETTING: Healthcare workers in 56 medical or care of the elderly wards and intensive care units in 15 hospitals across England and Wales. METHODS: We observed hand hygiene and glove usage (7,578 moments for hand hygiene) during 249 one-hour sessions. Observers also recorded whether gloves were or were not worn for individual contacts. RESULTS: Gloves were used in 1,983 (26.2%) of the 7,578 moments for hand hygiene and in 551 (16.7%) of 3,292 low-risk contacts; gloves were not used in 141 (21.1%) of 669 high-risk contacts. The rate of hand hygiene compliance with glove use was 41.4% (415 of 1,002 moments), and the rate without glove use was 50.0% (1,344 of 2,686 moments). After adjusting for ward, healthcare worker type, contact risk level, and whether the hand hygiene opportunity occurred before or after a patient contact, glove use was strongly associated with lower levels of hand hygiene (adjusted odds ratio, 0.65 [95% confidence interval, 0.54-0.79]; P < .0001). CONCLUSION: The rate of glove usage is lower than previously reported. Gloves are often worn when not indicated and vice versa. The rate of compliance with hand hygiene was significantly lower when gloves were worn. Hand hygiene campaigns should consider placing greater emphasis on the World Health Organization indications for gloving and associated hand hygiene. TRIAL REGISTRATION: National Research Register N0256159318.

Technical note: Assessment of blinding of hand hygiene observers in randomized controlled trials of hand hygiene interventions.

Trials evaluating interventions to improve health care workers' hand hygiene compliance use directly observed compliance as a primary outcome measure. Observers should be blinded to the intervention and the effectiveness of blinding assessed to prevent systematic bias. The literature has not addressed this issue, and this study describes a robust and pragmatic method for assessing the adequacy of blinding in hand hygiene intervention trials.