Table 2.
Summary of outcomes measures for the Task Sharing for the Care of Severe Mental Disorders in a Low-income Country (TaSCS) trial
| Outcome | Measure | Timing | |
|---|---|---|---|
| Primary outcome | |||
| 1 | SMD symptom severity | BPRS-E | Baseline, 12* and 18 months |
| Secondary outcomes | |||
| 1. | Functional impairment± | WHODAS 2.0 (12-item) | Baseline, 12 and 18 months |
| Local functioning scale | Baseline, 12 and 18 months | ||
| 2. | Relapse of mental disorder | LCS | Baseline, 12 and 18 months |
| 3. | Service use costs | CSRI | Baseline, 12 and 18 months |
| 4. | Satisfaction with mental health care | Mental health service satisfaction scale (MHSSS) | Baseline, 12 and 18 months |
| Qualitative in-depth interviews | From 6 months post-randomisation | ||
| 5. | Nutritional status | Body Mass Index | Baseline, 12 and 18 months |
| 6. | Service use for physical health conditions | CSRI | Baseline, 12 and 18 months |
| 7. | Medication side effects | ASC | Baseline, 12 and 18 months |
| 8 | Patient engagement and adherence | Medication Adherence Measure Clinic attendance | Baseline, 12 and 18 months |
| 9. | Perceived stigma | ISMI | Baseline, 12 and 18 months |
| 10. | Restraint± | Proportion chained, restrained or confined in last month | Baseline, 12 and 18 months |
| 11. | Quality of care | Document review | Monthly for 3 months, 6, 12 and 18 months |
| 13. | Adverse events (AEs) | LCS and project reporting mechanisms for AEs | Continuous for serious AEs 6-monthly for other AEs |
| Mediating variable | |||
| 1. | Therapeutic alliance | HAQ | Baseline, 12 and 18 months |
| Caregiver outcomes | |||
| 1. | Perceived stigma | FIS | Baseline, 12 and 18 months |
| 2. | Caregiver burden | FIS | Baseline, 12 and 18 months |
| 3. | Time burden of caring and opportunity costs | CSRI | Baseline, 12 and 18 months |
| Potential confounding variables | |||
| 1. | Sociodemographic characteristics | Structured self-report of age, sex and marital status | Baseline |
| 2. | Socio-economic status | Structured self-report of educational level, occupational status, food insecurity and family size | Baseline |
| 3. | Alcohol use disorder | FAST | Baseline |
| 4. | Khat use disorder | CIDI substance use module | Baseline |
| 5. | Medical co-morbidity or physical disability | Structured self-report | Baseline |
* Primary outcome; ± proxy version also administered to caregivers. BPRS-E, Brief Psychiatric Rating Scale, expanded version [6, 60]; WHODAS 2.0, World Health Organisation Disability Assessment Schedule, Version 2.0 [61]; LCS, Life Chart Schedule [62]; CSRI, Client Service Receipt Inventory [63, 64]; ASC, Antipsychotic Side Effect Checklist [65], Medication Adherence Measure [66]; ISMI, Internalised Stigma of Mental Illness [67]; HAQ, Helping Alliance Questionnaire [68]; FIS, Family Interview Schedule [69]; FAST, Fast Alcohol Screening Test [70]; CIDI, Composite International Diagnostic Interview [33]