Abstract
BACKGROUND: To our knowledge, there are no evidence-based implementation strategies for care cascade optimisation of mental, neurological, and substance use (MNS) disorder treatment in low-income and middle-income countries. This trial evaluated the effectiveness of the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) implementation strategy to improve MNS disorder care cascade outcomes in Mozambique. METHODS: We conducted a 3-year, cluster-randomised trial comparing an 8-month baseline period with a 2-year implementation period. All patients diagnosed with MNS disorders across government facilities in Mozambique were eligible. Eligible facilities were required to be naive to the SAIA-MH implementation strategy; currently providing MNS disorder services including prescribing medication; within a 3-h one-way drive from Chimoio City, Manica or Beira City, Sofala; have at least one psychiatric technician and one psychologist currently practising; and have at least 100 annual outpatient MNS disorder visits during 2020-21. Facilities were allocated to the SAIA-MH intervention or attentional placebo control (1:1) using constrained randomisation. Statistical analysts were masked during initial primary outcome assessment. The SAIA-MH strategy combines external facilitation, clinical consultation, and provider team meetings with system-engineering tools in a continuous quality improvement framework. The primary outcome was a combination of low functional impairment or functional improvement measured using the WHODAS 2.0. Secondary outcomes were medication adherence and appointment attendance. We involved people with related lived experience in all elements of the research and writing process. The study was registered at Clinicaltrials.gov, NCT05103033, and is completed. FINDINGS: Between Feb 4, 2022, and Oct 14, 2024, 3837 patients with MNS disorders (2153 in the intervention group and 1684 in the control group) attended 33 055 outpatient visits across 16 government facilities in Mozambique (eight intervention; eight attentional placebo control). The mean age was 26·0 years (SD 15·4; range 0-103), 2038 (53·1%) were male and 1800 (46·9%) were female, and 2581 (67·3%) were diagnosed with epilepsy. Ethnicity data were not collected. 966 patients in the intervention group (with 7697 visits) and 785 in the control group (with 3804 visits) who had their first visit during the study period, who completed the WHODAS 2.0 measurement at that visit, and who were aged 15 years or older, were included in the primary analysis of patient-visit-level functional improvement or low functional impairment to allow for examination of change from baseline. The SAIA-MH group showed 46·0 percentage points (95% CI 34·0 to 58·0; p<0·0001) higher functional improvement or low functional impairment, 18·1 percentage points (15·4 to 20·7; p<0·0001) higher medication adherence, and 18·4 percentage points (15·1 to 21·7; p<0·0001) higher appointment attendance than observed in the control group. Among non-adherent patient visits, the intervention group had 11·9 fewer non-adherent days than controls (95% CI -17·6 to -6·2; p<0·0001). WHODAS 2.0 scores decreased by 5·9 points more in the intervention group than the control group (95% CI -6·5 to -5·2; p<0·0001). One adverse event was reported during study implementation in the attentional placebo control group and was determined to be unrelated to study participation. INTERPRETATION: The SAIA-MH implementation strategy shows evidence of effectiveness in increasing patient functioning, appointment attendance, and medication adherence for patients with MNS disorders treated in outpatient primary care. Our findings warrant further research across implementation contexts to determine how differences in diagnostic and comorbidity case mix might influence the ability of SAIA-MH to reduce gaps in task-shared MNS care. FUNDING: National Institute of Mental Health TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.