Service user and healthcare staff influence in the development of a complex intervention for alcohol misuse: the experience of the KLIFAD study (Preprint)

BACKGROUND Mortality from alcohol-related liver disease has risen significantly for three decades. Transient elastography (TE) is a non-invasive test providing a numerical marker of liver disease. Preliminary evidence suggests that receiving TE can reduce alcohol consumption. The KLIFAD (Does knowledge of liver fibrosis affect high risk drinking behaviour?) study has developed a complex intervention in which people receiving alcohol treatment are provided with access to TE, accompanied by scripted feedback tailored to disease state, and access to video narratives describing alcohol misuse recovery after receiving TE. Recovery narratives are included due to preliminary evidence from mental health studies which suggest that access to digital narratives describing recovery from mental health problems can help people affected by mental health problems, including through mechanisms with potential to be transferable to an alcohol treatment setting, for example by increasing hope for the future, enabling learning from the experience of others, or promoting help-seeking behaviours. OBJECTIVE To develop the KLIFAD Intervention to the point that it could be delivered in a feasibility trial; to produce knowledge relevant to clinicians and researchers developing interventions making use of biomarkers of disease. METHODS In research activity one, standardised scripted feedback was developed by the study, and then iterated through focus groups with people who had experienced alcohol misuse and transient elastography, and key alcohol workers with experience of delivering transient elastography. We report critical design considerations identified through focus groups, in the form of sensitizing concepts. In research activity two, a video production guide was co-produced to enable the production of impactful video-based recovery narratives, and a PPI panel was consulted for recommendations on how best to integrated recovery narratives into an alcohol treatment setting. We report PPI recommendations and an overview of video form and content. RESULTS Through research activity one, we learnt that patient feedback has not been standardised in prior use of transient elastography, that receiving a numeric marker can provide an objective target that motivates and rewards recovery, and that key alcohol workers regularly tailor information to their clients. Through research activity two, we developed a video production guide asking narrators what recovery means to them, what helped their recovery, and what they have learned about recovery. We produced ten recovery narratives and collected PPI recommendations on maximising impact and safety. These led to the production of unplanned videos presenting carer and clinician perspectives, and a choice to limit narrative availability to alcohol treatment settings, where support is available around distressing content. These choices will be evaluated through a feasibility RCT [ISRCTN16922410]. CONCLUSIONS Providing an objective target that motivates and rewards recovery is a candidate change mechanism for complex interventions integrating biomarkers of disease. Recovery narratives can contain distressing content; intervention developers should attend to safe usage. INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2021-054954