This initial funding award for application development will lead to additional funding for the successful team to conduct the full substantive trial.
The National Institute of Health and Care Excellence (NICE) has issued guidance ‘NG64 Drug misuse prevention: targeted interventions’ and ‘CG51 Drug misuse in over 16s: psychosocial interventions’. Together these recommend that assessment of risk and vulnerability to drug misuse (cannabis, stimulants, sedatives, opioid, medicine use not as prescribed and other psychoactive substance-related problems) should occur during contact with statutory and other services, including mental health and criminal justice settings. In addition, brief interventions to reduce drug misuse should be embedded in a range of key settings. The guidance also identifies ‘at-risk’ populations in which screening is advised. These include, for example, people with mental health problems, those who are homeless and those who are unemployed.
Existing drug and alcohol services widely deliver alcohol Extended Brief Interventions (EBI) to higher risk drinkers accessing specialist drug treatment services (that is, people who are misusing drugs and are also drinking at higher risk, but non-dependent or mildly dependent, levels). In some areas, alcohol specialist practitioners deliver alcohol EBI in non-specialist settings as a form of early intervention and route into treatment, where clinically indicated. The development of a best practice drug EBI model for use in the UK would mean that drug and alcohol services could similarly offer interventions to people using drugs at increasing or higher risk levels in their services (ie. primary alcohol users with mild to moderate drug misuse) and in the wider community.
We are interested in receiving a one-stage proposal to:
- establish a research team with appropriate skills and expertise
- to develop an application to complete a 2-phase evaluation (pilot and feasibility, followed by a trial/s) on the effectiveness and cost-effectiveness of targeted drug screening and brief interventions (SBIs) including extended brief interventions in reducing drug use and associated harm in health, social care and justice settings in the UK, including a comparison of effectiveness between settings.
This is a novel opportunity to address the specific needs of a key stakeholder and is likely to have a significant impact on the way drug SBIs are delivered across the UK in the future.
In order to develop an application for a full trial, key areas of work which will need to be completed and detailed for the Application Development Award include (but are not limited to):
- Review and analysis of how similar types of SBI tools/interventions might be of use/implemented in the UK context and are already used in other international settings.
- Scoping current use of existing drug SBI tools/interventions in UK settings to identify learning/best practice examples throughout the course of the award and feed learning into research design.
- Identification and engagement of relevant stakeholders. For example, discussions with specific communities and population groups, policy makers, local drug and alcohol services, practitioners in the primary settings (described above) and service users.
- Investigations with key stakeholders (for example, specific age groups or settings) to inform where and how drug SBIs might be targeted within any given setting.
- Development of new academic and/or practitioner partnerships to support anticipated drug SBI research. For example, research expertise with particular interventions or drugs, within particular settings.
- Design of the Phase 1 pilot and feasibility phase of this study with a clear description of plan for progression to Phase 2.
Other areas of work that could be considered as part of an Application Development Award include:
- Consideration of how CoVID-19 might impact a future study/evaluation.
- An economic evaluation is seen as essential to understand whether any effective interventions are also cost-effective, particularly if there is scope to upscale.
To note, we welcome applications from teams that propose innovative approaches to undertake this work, as well as demonstrating how researchers from non-traditional health disciplines might be engaged in the research.
This Application Development Award funding opportunity is for applications up to £100k for a maximum of 12 months duration and we anticipate funding two-three awards.
All research teams successfully awarded an application development award would then be in competition for a further award to complete a more substantial two-phase trial within a subsequent three-year period. Decision to proceed to full study would be based on the proposal and an interview with the applying research team.
The substantive, two-phase trial is envisaged as follows, but will be defined by the contents and outcomes of the application development awards:
Phase 1, a pilot of feasibility and acceptability of the ASSIST-Lite (Alcohol, Smoking and Substance Involvement Screening Tool – Lite) already adapted for UK settings, and brief intervention (BI) and extended brief intervention (EBI) approaches. This includes developing (including testing) BI and EBI tailored to the UK and substance categories, in collaboration with specialists in the field and people who use drugs. Screening and brief interventions should be aimed at ‘at risk’ adults (over 18s, not currently in specialist drug treatment [DN]), and capture qualitative data on the feasibility and acceptability of:
- drug SBI tools in different settings (staff and service users)
- minimal, moderate and intensive interventions (staff and service users)
- delivery of these interventions by drug specialist and non-specialist practitioners
The study should include those groups typically excluded from such research (ie. those with severe mental illness (SMI), older people or those with alcohol dependence) with the aim of proposing a drug SBI model that can be adapted in practice according to setting and population group, and identify the facilitators and barriers to implementation generally and by setting and population group. This will inform the development of training for practitioners to support the wider roll-out of drug SBI.
Phase 2, a multi-site, trial with appropriate methodology, evaluating the effectiveness and cost-effectiveness of targeted drug SBI interventions (including minimal, moderate and intensive interventions) identified in phase 1 for adults for reducing substance misuse/associated risks and the relative effectiveness of these approaches across two-three different settings, identified as the most acceptable/feasible in Phase 1 capturing:
- the relative effectiveness of the components of the SBI interventions.
- the cost effectiveness of screening and different levels of intervention within each setting.
- duration of effect with follow-up at 3, 6, 12 months and possibly 2 and 3 years.
Study design and methodology
Due to the typical ‘stepped care’ approach with SBI (i.e. screened non-responders to a BI leaflet could be offered more intensive brief interventions), proposals might include an adaptive intervention model.
Outcome measures for service users should include reduced risk scores (screening), reduced frequency/dose drug use (self-reported and clinical), and risk/harm reduction scores (self-reported and clinical) and incidence of referral into specialist drug treatment. Research teams might also include mental health measures (General Anxiety Disorder 7 (GAD-7), Patient Health Questionnaire 9 (PHQ-9) and/or Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)). Staff attitudes should also be measured, captured pre- and post-trial. This could potentially be done using a version of the Alcohol and Alcohol Problems Perception Questionnaire (SAAPPQ), adapted to cover illicit drugs. Semi-structured interviews with staff and service users should capture barriers and enablers. A cost effectiveness of the SBI interventions in various settings should be carried out to support future commissioning decisions.
Applicants will be expected to demonstrate how they plan to work in partnership with key stakeholders such as the services using the tools as well as service users and commissioners of services. Careful consideration should be given as to how the research will be co-designed, taking into account primary care and clinical governance requirements.
Proposals must demonstrate how they fulfil the need for outcomes to influence future uptake of the SBI model; providing insight around adoption and adaption according to the needs of service users and staff implementing the SBI model, and how this fits into existing care or service pathways in various settings. As new versions of SBI tools are adapted for the UK, it is important applicants consider how these could be evaluated/incorporated into the existing study.
We may introduce ‘stop-go’ monitoring review points into the funding of the substantial study (specifically, post the phase 1 pilot phase) and expect interim outputs during the lifespan of the project to allow the research to inform on-going use of the ASSIST-Lite tool (as of October 2020) in mental health and other health and social care settings. Applicants are required to demonstrate skills and knowledge within the team to support evaluations across the various settings and demonstrate the ability to produce evidence at speed, whilst still paying attention to the need for rigorous and credible research.
Successful applicants will be expected to begin the work within two months of the funding decision being communicated. Successful applicants will be expected to produce a final report to be published on the NIHR website. Any other outputs (e.g. journal articles) must be accessible in line with NIHR’s Open Access policy.