Results
psychiatric
ADVERSE EVENTS, SECONDARY, DISORDERS
We recruited general practices from January 2018 to January 2020, and participants between June 2018 and February 2020. We randomly assigned 39 general practices to either the PARTNERS2 intervention group (20 practices, 116 participants) or control group (19 practices, 82 participants) (Consolidated Standards of Reporting Trials (CONSORT) diagram.The two allocated groups were broadly similar in terms of most baseline characteristics of participants (Cluster and participant characteristics at baselineData are displayed as A care partner was in place for at least 70% of the intervention period for 75% (15 out of 20) of the intervention practices, and the majority of intervention group participants (91%) had at least one care partner interaction of any type. The level of participant engagement with the intervention is summarised in Supplementary Table 1 available at None of the general practices withdrew from the trial after randomisation, although one practice that only recruited one participant was not included in the comparative analyses because the participant withdrew before follow-up. Primary analysis of the primary outcome included 99 (85.3%) of the 116 randomised participants in the intervention group and 71 (86.6%) of the 82 participants in the control group. The primary outcome results, mean overall MANSA score, are reported in Primary outcome, overall Manchester Short Assessment of Quality of Life score at baseline and follow-up: primary modified intention-to-treat analyses and prespecified sensitivity analysesData are displayed as mean (s.d.) [range] unless otherwise specified. mITT, modified intention to treat; ITT, intention to treat; CACE, complier-average causal effect; MANSA, Manchester Short Assessment of Quality of Life.Adjusted for baseline MANSA and including random effects for general practice.Treatment effect is the between-group difference in the change in MANSA between baseline and follow-up.Adjusted for baseline MANSA, stratification variables (practice size and locality) and including random effects for general practice.The CACE estimate is the mean difference between those in the intervention group who complied with the intervention (CACE(i) None of the secondary outcomes differed significantly between allocated groups (Secondary outcomes at baseline and follow-up: primary modified intention-to-treat analyses and prespecified sensitivity analysesData are displayed as mean (s.d.) [range], unless otherwise specified. ICC, intracluster correlation; TUS, Time Use Survey; WEMWBS, Warwick-Edinburgh Mental Wellbeing Scale; SWEMWBS, Short Warwick-Edinburgh Mental Wellbeing Scale; Brief INSPIRE, XXX; QPR-15, Questionnaire about the Process of Recovery; ICECAP-A, ICEpop CAPability measure; EQ-5D-5L, five-level EuroQol five-dimensional.Adjusted for baseline MANSA and including random effects for general practice.Treatment effect is the between-group difference in the change in MANSA between baseline and follow-up.Adjusted for baseline MANSA, stratification variables (practice size and locality) and including random effects for general practice.Planned inferential analyses not undertaken because of high levels of missing data for the Brief INSPIRE outcome measure.Safety outcomes and serious adverse events are summarised in Supplementary Table 6. There were seven acute mental health episodes recorded (three classified as ‘treated’ and four as ‘untreated’, according to protocol criteria). Twenty-eight serious adverse events in 18 participants were reported. Eleven serious adverse events were categorised as related to psychiatric disorders. None of the serious adverse events were deemed to be related to the intervention or trial procedures.