Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network

Background: Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. Methods: A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Results: Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and dommunication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not donducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to successful recruitment. Conclusions: In the mental health context, researcher access to potential trial participants is multiply influenced. Gatekeeping clinicians are faced with competing priorities and resources constrain research activity. It seems that environmental adjustment predicated on equitable resource allocation is needed if clinicians in NHS mental health services are to fully support the conduct of randomised controlled trials. Whilst cultural transformation, requiring changes in assumptions and values, is complex, our findings suggest that attention to practical matters can support this and highlight issues requiring careful consideration

Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial

Background: Poor adherence to treatment diminishes its individual and public health benefit. Financial incentives, provided on the condition of treatment attendance, could address this problem. Injecting drug users are a high-risk group for hepatitis B virus (HBV) infection and transmission, but adherence to vaccination programmes is poor. We aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy. Methods: In our cluster randomised controlled trial, we enrolled participants at 12 National Health Service drug treatment services in the UK that provided opioid substitution therapy and nurse-led HBV vaccination with a super-accelerated schedule (vaccination days 0, 7, and 21). Clusters were randomly allocated 1:1:1 to provide vaccination without incentive (treatment as usual), with fixed value contingency management (three £10 vouchers), or escalating value contingency management (£5, £10, and £15 vouchers). Both contingency management schedules rewarded on-time attendance at appointments. The primary outcome was completion of clinically appropriate HBV vaccination within 28 days. We also did sensitivity analyses that examined vaccination completion with full adherence to appointment times and within a 3 month window. The trial is registered with Current Controlled Trials, number ISRCTN72794493. Findings: Between March 16, 2011, and April 26, 2012, we enrolled 210 eligible participants. Compared with six (9%) of 67 participants treated as usual, 35 (45%) of 78 participants in the fixed value contingency management group met the primary outcome measure (odds ratio 12·1, 95% CI 3·7–39·9; p<0·0001), as did 32 (49%) of 65 participants in the escalating value contingency management group (14·0, 4·2–46·2; p<0·0001). These differences remained significant with sensitivity analyses. Interpretation: Modest financial incentives delivered in routine clinical practice significantly improve adherence to, and completion of, HBV vaccination programmes in patients receiving opioid substitution therapy. Achievement of this improvement in routine clinical practice should now prompt actual implementation. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown

The cost-effectiveness of financial incentives to achieve heroin abstinence in individuals with heroin use disorder starting new treatment episodes: A cluster randomised controlled trial-based economic evaluation

OBJECTIVES: Cost-effectiveness analysis of two 12-week contingency management (CM) schedules targeting heroin-abstinence or attendance at weekly keyworker appointments for opioid agonist treatment (OAT), compared to treatment as usual (TAU). METHODS: Cost-effectiveness analysis was conducted alongside a cluster randomised trial of 552 patients from 34 clusters (drug treatment clinics) randomly allocated 1:1:1 to OAT plus weekly keyworker appointments with either: i) CM targeted at heroin-abstinence (CM Abstinence); ii) CM targeted at on-time attendance at weekly appointments (CM Attendance); or, iii) no CM (TAU). The primary cost-effectiveness analysis at 24 weeks post-randomisation took a societal cost perspective with effects measured in heroin-negative urine samples. RESULTS: At 24-weeks, mean differences in weekly heroin-negative urine results compared with TAU were 0.252 (95%CI -0.397 to 0.901) for CM Abstinence and 0.089 (95%CI -0.223 to 0.402) for CM Attendance. Mean differences in costs were £2562 (95%CI £32 to £5092) for CM Abstinence and £317 (95%CI -£882 to £1518) for CM Attendance. Incremental cost-effectiveness ratios were £10,167 per additional heroin-free urine for CM Abstinence and £3,562 for CM Attendance with low probabilities of cost-effectiveness of 3.5% and 36%, respectively. Results were sensitive to timing of follow-up for CM Attendance, which dominated TAU (better outcomes, lower costs) at 12-weeks, with an 88.4% probability of being cost-effective. Probability of cost-effectiveness remained low for CM Abstinence (8.6%). CONCLUSIONS: Financial incentives targeted toward heroin-abstinence and treatment-attendance were not cost-effective over the 24-week follow-up. However, CM Attendance was cost-effective over the treatment period (12-weeks), when participants were receiving keyworker appointments and incentives