The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study

Background: In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods: Educators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results: Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions: The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT

Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

BackgroundThe benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.Methods/DesignThe DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.DiscussionThe DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. Trial registration Current Controlled Trials ISRCTN61568050

Understanding the Socioeconomic and Health Challenges of the Medicaid Expansion Population in Oregon.

Following the Patient Protection and Affordable Care Act, Medicaid eligibility in the United States expanded to include low-income adults. One key challenge for organizations and providers serving the Medicaid population was predicting if and how this change would alter the composition of enrollees. This study characterized demographics, socioeconomic challenges, and health of the expansion and non-expansion Medicaid populations in a metropolitan area in Oregon using a survey and Medicaid claims. Results showed that the expansion population has more men and non-English speakers than the non-expansion population. They also have greater education and employment, but face similar socioeconomic challenges including struggling to meet basic needs and housing instability. This study also found comparable self-reported physical and mental health, but lower prevalence of physical or mental health diagnoses and several ambulatory care reactive conditions including hypertension, obesity, and type 2 diabetes. The authors concluded that expansion and non-expansion populations differ in sex, language, education, employment, and health, but they face similar socioeconomic challenges. This information is useful for organizations coordinating and providing care to Medicaid members so they can understand the needs of the population and set appropriate population health management strategies

Identifying underlying constructs of childhood adversity in a low-income population.

BACKGROUND: Extensive research has documented the association between adverse childhood experiences (ACEs) and poor outcomes later in life, as well as the high prevalence of ACEs in the American population. Studies consistently find that over half of American adults have experienced at least one ACE. Despite this, research on the long-term impacts of ACEs is challenging due to the complex nature of adversity. OBJECTIVE: Our study aimed to define underlying constructs of adversity, and explore how they changed throughout childhood, in a low-income population. PARTICIPANTS AND SETTING: We fielded a survey to Medicaid-enrolled adults in the Portland, OR metropolitan area. METHODS: Our survey captured different experiences in childhood, including relationships and support, educational challenges, housing and employment stability, neighborhood environment, discrimination, abuse, neglect, and household dysfunction; questions were asked for 6-12 and 13-18 years of age. We then used factor analysis to identify underlying constructs of adversity in the two age ranges. RESULTS: We identified two factors - Inadequate Emotional Support and Instability - in each age range. Inadequate Emotional Support remained consistent in both time periods while the Instability factor changed, expanding from household-centric experiences in childhood to a wider variety of experiences in adolescence. Additionally, a number of variables did not load on either factor in either age range. CONCLUSIONS: These results underscore the importance of expanding how we think about instability specifically, and childhood adversity in general

Title: efficacy of a food parenting intervention for mothers with low income to reduce preschooler’s solid fat and added sugar intakes: a randomized controlled trial

Abstract Background Few interventions have shown efficacy to influence key energy balance behaviors during the preschool years. Objective A randomized controlled trial (RCT) was used to evaluate the efficacy of Food, Fun, and Families (FFF), a 12 week authoritative food parenting intervention for mothers with low-income levels, to reduce preschool-aged children’s intake of calories from solid fat and added sugar (SoFAS). Methods Mothers were randomly assigned to receive FFF (n = 59) or to a delayed treatment control (n = 60). The primary outcome was children’s daily energy intake from SoFAS at the end of the 12 week intervention, controlling for baseline levels, assessed by 24-h dietary recalls. Secondary outcomes included children’s daily energy intake, children’s BMI z-scores, and meal observations of maternal food parenting practices targeted in FFF (e.g. providing guided choices). Results Participating mothers were predominantly African American (91%), with 39% educated beyond high school and 66% unemployed. Baseline demographics and child SoFAS intakes did not differ by group. Lost to follow-up was 13% and did not differ between groups. At post-intervention, FFF children consumed ~ 94 kcal or 23% less daily energy from SoFAS than children in the control group, adjusting for baseline levels (307.8 (95%CI = 274.1, 341.5) kcal vs. 401.9 (95%CI = 369.8, 433.9) kcal, FFF vs. control; p < 0.001). FFF mothers also displayed a greater number of authoritative parenting practices when observed post-intervention with their child at a buffet-style meal (Wilcoxon z = − 2.54, p = 0.012). Neither child total daily energy intake nor BMI z-scores differed between groups post-intervention. Conclusions Findings demonstrate the initial efficacy of an authoritative food parenting intervention for families with low-income to reduce SoFAS intake in early childhood. Additional research is needed to evaluate longer-term effects on diet and growth. Trial registration Retrospectively registered at ClinicalTrials.gov: #NCT03646201