Association between systolic blood pressure and cardiovascular inpatient cost moderated by peer-support intervention among adult patients with type 2 diabetes : a 2-cohort study

Objectives People with type 2 diabetes and increased systolic blood pressure (SBP) are at high risk of cardiovascular disease (CVD). In this study, we aimed to investigate the association between CVD-related hospital payments and SBP and tested whether this association is influenced by diabetes peer support. Methods Two cohorts comprising people with type 2 diabetes were included in the study. The first cohort comprised 4,704 patients with type 2 diabetes assessed between 2008 and 2009 from 18 general practices in Cambridgeshire and followed up to 2009–2011. The second cohort comprised 1,121 patients with type 2 diabetes from post-trial follow-up data, recruited between 2011 and 2012 and followed up to 2015. SBP was measured at baseline. Inpatient payments for CVD hospitalization within 2 years since baseline was the main outcome. The impact of 1:1, group or combined diabetes peer support and usual care were investigated in the second cohort. Adjusted mean CVD inpatient payments per person were estimated using a 2-part model after adjusting for baseline characteristics. Results A “hockey-stick” relationship between baseline SBP and estimated CVD inpatient payment was identified in both cohorts, with a threshold at 133 to 141 mmHg, suggesting increased payments for patients with SBP below and above the threshold. The combined peer-support intervention altered the aforementioned association, with no increased payment with SBP above the threshold, and payment slightly decreased with SBP beyond the threshold. Conclusions SBP maintained between 133 and 141 mmHg is associated with the lowest CVD disease management costs for patients with type 2 diabetes. Combined peer-support intervention could significantly decrease CVD-related hospital payments

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial

Derivation and external validation of risk algorithms for cerebrovascular (re)hospitalisation in patients with type 2 diabetes: Two cohorts study

Aims Cerebrovascular disease is one of more typical reasons for hospitalisation and re-hospitalisation in people with type 2 diabetes. We aimed to derive and externally validate two risk prediction algorithms for cerebrovascular hospitalisation and re-hospitalisation. Methods Two independent cohorts were used to derive and externally validate the two risk scores. The development cohort comprises 4704 patients with type 2 diabetes registered in 18 general practices across Cambridgeshire. The validation cohort includes 1121 type 2 patients from a post-trial cohort data. Outcomes were cerebrovascular hospitalisation within two years and cerebrovascular re-hospitalisation within ninety days of the previous cerebrovascular hospitalisation. Logistic regression was applied to derive the two risk scores for cerebrovascular hospitalisation and re-hospitalisation from development cohort, which were externally validated in the validation cohort. Results The incidence of cerebrovascular hospitalisation and re-hospitalisation was 3.76% and 1.46% in the development cohort, and 4.99% and 1.87% in the external validation cohort. Age, gender, body mass index, blood pressures, and lipid profiles were included in the final model. Model discrimination was similar in both cohorts, with all C-statistics > 0.70, and very good calibration of observed and predicted individual risks. Conclusion Two new risk scores that quantify individual risks of cerebrovascular hospitalisation and re-hospitalisation have been well derived and externally validated. Both scores are on the basis of a few of clinical measurements that are commonly available for patients with type 2 diabetes in primary care settings and could work as tools to identify individuals at high risk of cerebrovascular hospitalisation and re-hospitalisation

Comparison of high and low intensity contact between secondary and primary care to detect people at ultra-high risk for psychosis: study protocol for a theory-based, cluster randomized controlled trial.

BACKGROUND: The early detection and referral to specialized services of young people at ultra-high risk (UHR) for psychosis may reduce the duration of untreated psychosis and, therefore, improve prognosis. General practitioners (GPs) are usually the healthcare professionals contacted first on the help-seeking pathway of these individuals. METHODS/DESIGN: This is a cluster randomized controlled trial (cRCT) of primary care practices in Cambridgeshire and Peterborough, UK. Practices are randomly allocated into two groups in order to establish which is the most effective and cost-effective way to identify people at UHR for psychosis. One group will receive postal information about the local early intervention in psychosis service, including how to identify young people who may be in the early stages of a psychotic illness. The second group will receive the same information plus an additional, ongoing theory-based educational intervention with dedicated liaison practitioners to train clinical staff at each site. The primary outcome of this trial is count data over a 2-year period: the yield - number of UHR for psychosis referrals to a specialist early intervention in psychosis service - per primary care practice. DISCUSSION: There is little guidance on the essential components of effective and cost-effective educational interventions in primary mental health care. Furthermore, no study has demonstrated an effect of a theory-based intervention to help GPs identify young people at UHR for psychosis. This study protocol is underpinned by a robust scientific rationale that intends to address these limitations. TRIAL REGISTRATION: Current Controlled Trials ISRCTN70185866.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Does electronic monitoring influence adherence to medication? Randomized controlled trial of measurement reactivity.

BACKGROUND: Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence. PURPOSE: To test the reactive effect of electronic monitoring in a randomized controlled trial. METHODS: A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5-25) and HbA1c at 8 weeks. RESULTS: Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI -0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), -1.02 [-2.73 to 0.71, p = 0.25]). CONCLUSIONS: Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359)

Development and external validation of risk scores for cardiovascular hospitalization and rehospitalization in patients with diabetes

Context Cardiovascular disease (CVD) is a common and costly reason for hospitalisation and re-hospitalisation among patients with type 2 diabetes. Objective This study aimed to develop and externally validate two risk prediction models for cardiovascular hospitalisation and cardiovascular re-hospitalisation. Design Two independent prospective cohorts. Setting The derivation cohort includes 4,704 patients with type 2 diabetes from 18 general practices in Cambridgeshire. The validation cohort comprises 1,121 patients with type 2 diabetes from post-trial follow-up data. Main Outcome Measure Cardiovascular hospitalisation over 2 years and cardiovascular re-hospitalisation after 90 days of the prior CVD hospitalisation. Results The absolute rate of cardiovascular hospitalisation and re-hospitalisation was 12.5% and 6.7% in the derivation cohort, and 16.3% and 7.0% in the validation cohort. Discrimination of the models was similar in both cohorts, with C statistics above 0.70, and excellent calibration of observed and predicted risks. Conclusion Two new prediction models that quantify risks of cardiovascular hospitalisation and re-hospitalisation have been developed and externally validated. They are based on a small number of clinical measurements that are available for patients with type 2 diabetes in many developed countries in primary care settings and could serve as the tools to screen the population at high risk of cardiovascular hospitalisation and re-hospitalisation

Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials

Background: Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. Methods: The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). Results: In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61). Conclusions: Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population

Peer-mentoring for first-time mothers from areas of socio-economic disadvantage: A qualitative study within a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Non-professional involvement in delivering health and social care support in areas of socio-economic deprivation is considered important in attempting to reduce health inequalities. However, trials of peer mentoring programmes have yielded inconsistent evidence of benefit: difficulties in implementation have contributed to uncertainty regarding their efficacy. We aimed to explore difficulties encountered in conducting a randomised controlled trial of a peer-mentoring programme for first-time mothers in socially disadvantaged areas, in order to provide information relevant to future research and practice. This paper describes the experiences of lay-workers, women and health professionals involved in the trial.</p> <p>Methods</p> <p>Thematic analysis of semi-structured interviews with women (n = 11) who were offered peer mentor support, lay-workers (n = 11) who provided mentoring and midwives (n = 2) who supervised the programme, which provided support, from first hospital antenatal visit to one year postnatal. Planned frequency of contact was two-weekly (telephone or home visit) but was tailored to individuals' needs.</p> <p>Results</p> <p>Despite lay-workers living in the same locality, they experienced difficulty initiating contact with women and this affected their morale adversely. Despite researchers' attempts to ensure that the role of the mentor was understood clearly it appeared that this was not achieved for all participants. Mentors attempted to develop peer-mentor relationships by offering friendship and sharing personal experiences, which was appreciated by women. Mentors reported difficulties developing relationships with those who lacked interest in the programme. External influences, including family and friends, could prevent or facilitate mentoring. Time constraints in reconciling flexible mentoring arrangements with demands of other commitments posed major personal difficulties for lay-workers.</p> <p>Conclusion</p> <p>Difficulties in initiating contact, developing peer-mentor relationships and time constraints pose challenges to delivering lay-worker peer support. In developing such programmes, awareness of potential difficulties and of how professional support may help resolve these should improve uptake and optimise evaluation of their effectiveness.</p> <p>Trial Registration Number: ISRCTN55055030</p