Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol.
ABSTRACT: Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation.1500 people aged 40-69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in attendance between arms, and in an estimated 780 attenders, 80% power to detect a 0.2 sd difference in intention between arms.The DICISION trial is a rigorous pragmatic denominator based clinical trial of an informed choice invitation to diabetes screening, which addresses some key limitations of previous trials.
Project description:Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices.417 men and women aged 40-69 recruited from town centres in the UK were randomised to receive either an invitation for diabetes screening designed to facilitate informed choice or a standard type of invitation. Knowledge of the invitation, attitude towards diabetes screening, and intention to attend for diabetes screening were assessed two weeks later.Attitude was a strong predictor of screening intentions (? = .64, p = .001). Knowledge added to the model but was a weak predictor of intentions (? = .13, p = .005). However, invitation type did not predict attitudes towards screening but did predict knowledge (? = -.45, p = .001), which mediated a small effect of invitation type on intention (indirect ? = -.06, p = .017).These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial.
Project description:To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action.Randomised controlled trial.Four English general practices.1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening.Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem.The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders.The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference -1.8%, 95% confidence interval -7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type.Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services.Current Controlled Trials ISRCTN 73125647.
Project description:<h4>Objective</h4>To evaluate behavioural components and strategies associated with increased uptake and effectiveness of screening for coronary heart disease and diabetes with an implementation science focus.<h4>Design</h4>Realist review.<h4>Data sources</h4>PubMed, Web of Knowledge, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register and reference chaining. Searches limited to English language studies published since 1990.<h4>Eligibility criteria</h4>Eligible studies evaluated interventions designed to increase the uptake of cardiovascular disease (CVD) and diabetes screening and examined behavioural and/or strategic designs. Studies were excluded if they evaluated changes in risk factors or cost-effectiveness only.<h4>Results</h4>In 12 eligible studies, several different intervention designs and evidence-based strategies were evaluated. Salient themes were effects of feedback on behaviour change or benefits of health dialogues over simple feedback. Studies provide mixed evidence about the benefits of these intervention constituents, which are suggested to be situation and design specific, broadly supporting their use, but highlighting concerns about the fidelity of intervention delivery, raising implementation science issues. Three studies examined the effects of informed choice or loss versus gain frame invitations, finding no effect on screening uptake but highlighting opportunistic screening as being more successful for recruiting higher CVD and diabetes risk patients than an invitation letter, with no differences in outcomes once recruited. Two studies examined differences between attenders and non-attenders, finding higher risk factors among non-attenders and higher diagnosed CVD and diabetes among those who later dropped out of longitudinal studies.<h4>Conclusions</h4>If the risk and prevalence of these diseases are to be reduced, interventions must take into account what we know about effective health behaviour change mechanisms, monitor delivery by trained professionals and examine the possibility of tailoring programmes according to contexts such as risk level to reach those most in need. Further research is needed to determine the best strategies for lifelong approaches to screening.
Project description:In England, participation in breast cancer screening has been decreasing in the past 10 years, approaching the national minimum standard of 70%. Interventions aimed at improving participation need to be investigated and put into practice to stop this downward trend. We assessed the effect on participation of sending invitations for breast screening with a timed appointment to women who did not attend their first offered appointment within the NHS Breast Screening Programme (NHSBSP).In this open, randomised controlled trial, women in six centres in the NHSBSP in England who were invited for routine breast cancer screening were randomly assigned (1:1) to receive an invitation to a second appointment with fixed date and time (intervention) or an invitation letter with a telephone number to call to book their new screening appointment (control) in the event of non-attendance at the first offered appointment. Randomisation was by SX number, a sequential unique identifier of each woman within the NHSBSP, and at the beginning of the study a coin toss decided whether women with odd or even SX numbers would be allocated to the intervention group. Women aged 50-70 years who did not attend their first offered appointment were eligible for the analysis. The primary endpoint was participation (ie, attendance at breast cancer screening) within 90 days of the date of the first offered appointment; we used Poisson regression to compare the proportion of women who participated in screening in the study groups. All analyses were by intention to treat. This trial is registered with Barts Health, number 009304QM.We obtained 33?146 records of women invited for breast cancer screening at the six centres between June 2, 2014, and Sept 30, 2015, who did not attend their first offered appointment. 26?054 women were eligible for this analysis (12?807 in the intervention group and 13?247 in the control group). Participation within 90 days of the first offered appointment was significantly higher in the intervention group (2861 [22%] of 12?807) than in the control group (1632 [12%] of 13?247); relative risk of participation 1·81 (95% CI 1·70-1·93; p<0·0001).These findings show that a policy of second appointments with fixed date and time for non-attenders of breast screening is effective in improving participation. This strategy can be easily implemented by the screening sites and, if combined with simple interventions, could further increase participation and ensure an upward shift in the participation trend nationally. Whether the policy should vary by time since last attended screen will have to be considered.National Health Service Cancer Screening Programmes and Department of Health Policy Research Programme.
Project description:OBJECTIVE:The attendance rate for cervical cancer screening in Norway is currently suboptimal at 69%, and an in-depth understanding of postponement of cervical cancer screening from the perspective of non-attenders is lacking. This study aims to generate knowledge about how non-attenders for cervical cancer screening reflect on booking a screening appointment. METHODS:Using the Norwegian cervical cancer screening registry, we identified and recruited women who were non-attenders to screening. Nine focus group interviews were carried out, with 41 women participating in the interviews. RESULTS:Four main themes were generated, which provide a comprehensive understanding of how women who are overdue for screening reflect on their hesitancy to book a screening appointment: 'It's easy to forget about it', 'Women have to arrange their own appointment', 'It has to be a 'must'' and 'It's a humiliating situation'. CONCLUSION:The degree to which women regard screening as important is affected by the nudging strategies employed in the screening programme and the facilitation of attendance provided by healthcare services. Dependence on one's personal initiative to schedule a screening appointment and perception of a lack of responsibility on the part of healthcare services to attend screening may undermine informed and shared decision-making about screening attendance.
Project description:Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment.Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse.After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01).Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging.Clinicaltrials.gov NCT00865527.
Project description:<h4>Background</h4>Some women make an informed choice not to attend breast screening, whereas others may have forgotten about the appointment. We report on a randomised trial that investigates whether a reminder letter affects attendance.<h4>Methods</h4>Women scheduled for a breast screening appointment were randomised to either receive a reminder letter a few days before their breast screening appointment in addition to the standard invitation letter (intervention) or not (control). The primary outcome was attendance within 30 days of the first offered appointment. Secondary outcomes were attendance within 90 and 180 days.<h4>Results</h4>In all, 11,383 (49.9%) women were randomised to the intervention and 11,445 (50.1%) to the control. In the intervention arm, 7759 (68.2%) attended within 30 days of the first offered appointment compared with 7349 (64.2%) in the control arm. This difference was significant (P<0.001). The odds ratio (OR) (95% confidence interval) for the primary end point was 1.19 (1.13-1.26). This was not significantly affected by age, socioeconomic status or type of screen (prevalent or incident). Secondary endpoint analyses supported these results. Results did differ, however, between the different centres studied.<h4>Conclusions</h4>This study found that postal reminders increase breast screening uptake, and could be practicable to implement in the NHS Breast Screening Programme.
Project description:OBJECTIVE:To determine the feasibility of specialist screening practitioners (SSPs) offering patient navigation (PN) to facilitate uptake of bowel scope screening (BSS) among patients who do not confirm or attend their appointment. DESIGN:A single-stage phase II trial. SETTING:South Tyneside District Hospital, Tyne and Wear, England, UK. PARTICIPANTS:Individuals invited for BSS at South Tyneside District Hospital during the 6-month recruitment period were invited to participate in the study. INTERVENTION:Consenting individuals were randomly assigned to either the PN intervention or usual care group in a 4:1 ratio. The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required. If requested by the patient, another BSS appointment was then scheduled. PRIMARY OUTCOME MEASURE:The number of non-attenders in the intervention group who were navigated and then rebooked and attended their new BSS appointment. SECONDARY OUTCOME MEASURES:Barriers to BSS attendance, patient-reported outcomes including informed choice and satisfaction with BSS and the PN intervention, reasons for study non-participation, SSPs' evaluation of the PN process and a cost analysis. RESULTS:Of those invited to take part (n=1050), 152 (14.5%) were randomised into the study: PN intervention=109; usual care=43. Most participants attended their BSS appointment (PN: 79.8%; control: 79.1%) leaving 22 eligible for PN: only two were successfully contacted. SSPs were confident in delivering PN, but were concerned that low BSS awareness and information overload may have deterred patients from taking part in the study. Difficulty contacting patients was reported as a burden to their workload. CONCLUSIONS:PN, as implemented, was not a feasible intervention to increase BSS uptake in South Tyneside. Interventions to increase BSS awareness may be better suited to this population. TRIAL REGISTRATION NUMBER:ISRCTN13314752; Results.
Project description:Introduction. Male involvement in antenatal care (ANC) has been associated with improved prevention of mother-to-child transmission outcomes in Sub-Saharan Africa; yet it remains uncommon. We assess acceptability of male involvement from the male and female perspectives and potential incentives for men to attend ANC. Methods. Adult pregnant women and men attending primary healthcare at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, from October 2013 to January 2014, were recruited using stratified random sampling to ensure equal representation across gender and HIV status. Results. 300/332 individuals (93.8%) offered participation consented. Among the 150 women, 97% had a partner; the majority (92%) preferred partner attendance at ANC, and 14% reported partner attendance during this pregnancy. The 150 men had low knowledge of services rendered at ANC outside of pregnancy monitoring, and few (19%) had previously attended ANC. Blood pressure screening, fatherhood information, and HIV testing were identified by men as incentives for attendance. Women and men expressed high willingness to, respectively, deliver (95%) and respond (97%) to ANC letter invitations. Conclusion. Invitation letters to promote male involvement in ANC are highly acceptable to pregnant women and men. Focusing invitation messages on fatherhood and primary healthcare rather than HIV testing may provide greater motivation for male involvement.
Project description:To investigate whether appointments for screening timed in proximity to annual milestones (birthdays, Christmas and New Year) may be used as a strategy to improve attendance for screening for colorectal cancer.Randomised controlled trial.City of Oslo (urban) and Telemark county (urban and rural), Norway.12,960 screened adults (64.7% of those invited).Attendance rates for each week and month of assigned appointment.Attendance rates were significantly higher in December than the rest of the year (72.3% v 64.6%, P<0.001) in adults who received an invitation in the week of their birthday or were assigned to screening in the first or second week after their birthday (67.9% v 64.5%, P=0.007). This effect was most pronounced in the urban population of Oslo. In a multivariable logistic regression model, attendance improved in those who received an invitation in the week of their birthday or were assigned to screening in the first or second week after their birthday (odds ratio 1.15, 95% confidence interval 1.03 to 1.28) and those who were assigned to screening in December (odds ratio 1.45, 1.16 to 1.82).Attendance rates for screening for colorectal cancer were higher in December and around attendees' birthdays, the latter particularly in an urban population. Compliance with screening programmes may therefore be improved by timing invitations in proximity to annual milestones.Clinical Trials NCT00119912.