Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial

Abstract Background Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in their own treatment as a key to health behavior change. Research on the benefit of having patients choose their treatment from among options, in contrast to being assigned to a treatment by experts, has been limited. Consequently, we designed a rigorous test of patient self-matching to determine whether it does improve retention, adherence, and outcome in alcoholism treatment. Methods/design The present study is being conducted as a randomized controlled trial. Four hundred consecutive patients aged 18 years or older will be enrolled and randomized to either self-matching or expert-matching to one of five different treatment approaches. All patients entering the alcohol outpatient clinic in Odense are offered the opportunity to participate in the study. Exclusion criteria are cognitive dysfunction as measured with the Mini Mental State Examination, and non-Danish- or non-English-speaking individuals. The following instruments will be administered at intake to provide standardized measures of alcohol problems: the Addiction Severity Index, Timeline Followback, the World Health Organization quality of life questionnaire, the NEO Five-Factor Inventory 3, and the Personal Happiness Form. For each outcome measure, two analyses will be conducted. Intention-to-treat analyses (ITT) will be carried out with all patients, regardless of whether they complete the interventions or are reinterviewed. Regarding incomplete data, multiple imputations will be used together with ITT analysis. Completer analyses will also be carried out with patients who complete their respective interventions. The primary outcome is decrease in number of monthly excessive drinking days 6 months after initiation of treatment. Secondary outcomes are compliance and 2 quality of life. The influence of personality traits on outcome will also be examined in both groups. Discussion The debate on matching patients to treatment has been going on for decades. This study will cast light on this issue by focusing on patients’ choice and thereby clarifying if patients’ perceived autonomy yields better outcomes. Trial registration ClinicalTrials.gov, NCT03278821. Registered on 12 September 2017