Effectiveness of a guideline implementation tool for supporting management of mental health complications after mild traumatic brain injury versus usual care in primary care: a triple-blind, cluster-randomised controlled trial

This is the authors' abstract. We don't add key points for this paper.

Background Clinical practice guidelines for mild traumatic brain injury emphasise proactive management of mental health complications. We evaluated the effectiveness of an automated guideline implementation tool for reducing the risk of mental health disorders after mild traumatic brain injury compared with usual care. Methods We conducted a triple-blind (patient, provider, and assessor), cluster-randomised controlled trial. Adults (age 18–69 years) with recent (<72 h) mild traumatic brain injury were recruited from six emergency departments and two urgent care centres in the Greater Vancouver Area, BC, Canada. Enrolled patient participants identified a primary care clinic where they could access follow-up care. There were no additional eligibility criteria for primary care clinics. The clinics were randomised (1:1) to usual care or the intervention (guideline implementation tool) using a concealed permuted block sequence generated by a statistician independent from the study. When a subsequently enrolled patient participant nominated a clinic that already been randomised, that clinic's allocation was entered manually. Participants were masked to the study hypotheses and the difference between the two interventions. Clinics were masked to the same and not informed that their behaviour was an outcome of interest. Outcome assessors were masked to randomisation allocations. The intervention comprised sending letters to participants and their designated clinics at 2 weeks and 12 weeks post-injury: generic letters about mild traumatic brain injury in the usual care group, and tailored letters with actionable mental health screening test results and recommendations about mental health disorders after mild traumatic brain injury in the intervention group. The main outcome measure was new or worsened mental health disorder (major depressive episode, any anxiety disorder, or post-traumatic stress disorder, excluding disorders deemed to be pre-existing and stable) at 26 weeks, as assessed by the Mini International Neuropsychiatric Interview V.7.0.2. Analyses were performed in all enrolled participants associated with a randomised clinic using generalised estimation equations that accounted for clustering and incorporated inverse probability weights to address potential attrition bias. The trial was registered at ClinicalTrials.gov (NCT04704037) and is completed. Findings Between Feb 1, 2021, and Nov 1, 2022, 4062 patients were approached for potential study inclusion, of whom 537 participants were enrolled from 269 randomised clinics (clusters, which included one to 13 patients [median 1]), with a retention rate of 93%. 136 clinics with 283 patients were assigned to the intervention and 133 clinics with 254 patients were assigned to usual care. All enrolled patients were included in the analysis of the primary outcome. 142 (56%) of 254 participants in the usual care group and 145 (51%) of 283 participants in the intervention group identified as women. 171 (67%) of 254 participants in the usual care group and 176 (62%) of 283 participants in the intervention group were White. The median age was 38·0 years (IQR 29·0–51·0) in the usual care group and 33 years (25·5–49·0) in the intervention group. At a median of 27 weeks (IQR 23–28) post-injury, 77 (30%) of 254 participants in the usual care group and 84 (30%) of 283 in the intervention group developed a new or worsening mental health disorder. The estimated between-group difference in the primary outcome was –1·5% (95% CI –10·3 to 7·3). Three (1%) of the 499 participants who completed the outcome assessment reported being distressed by the study procedures. No other adverse events were reported. Interpretation The guideline implementation tool designed for proactive management of mental health complications after mild traumatic brain injury did not result in clinically meaningful reductions in the risk of mental health disorders at 26 weeks post-injury compared with usual care. A more intensive implementation intervention is likely to be necessary to achieve this outcome. Funding Canadian Institutes for Health Research.