Nurse-led palliative care for multidrug-resistant tuberculosis: a parallel, single-blind, pragmatic, randomised controlled trial in Uganda.

BACKGROUND

People with multidrug-resistant tuberculosis experience burdensome symptoms, clinical uncertainty, and high mortality. Palliative care is a designated essential health service under Universal Health Coverage. We aimed to test the hypothesis that receipt of additional nurse-led palliative care would improve patient-reported outcomes for patients with multidrug-resistant tuberculosis, compared with usual care.

METHODS

This single-masked, parallel pragmatic randomised controlled trial recruited adults from three public hospitals in Uganda (Mulago National Referral Hospital Kampala, Gulu Regional Referral Hospital, and Mbale Regional Referral Hospital). Inclusion criteria for the study were adults aged 18 years and older with a confirmed bacteriological diagnosis of multidrug-resistant tuberculosis (not responsive to isoniazid or rifampicin) who were registered at the respective study site clinics and who were able to give informed consent. Participants were randomly assigned (1:1) to the intervention (additional nurse-led care) or the standard care control group using randomly permuted blocks stratified by treatment centre. Intervention group participants received nurse-led person-centred holistic assessment, care planning, symptom control, and psychosocial support delivered on inpatient wards or at home. Fortnightly appointments alternated between face-to-face visits and telephone follow-up. Researchers were masked to participant group allocation. The primary outcome was multidimensional palliative care-related symptoms and concerns measured using the African Palliative Care Association Integrated Palliative Outcome Scale, measured monthly from baseline to the primary 4-month endpoint, analysed using a linear mixed-effect model, applying the intention-to-treat principle to analyse participants by allocated group. The trial was registered on the ISRCTN registry (ISRCTN13664346) and is complete.

FINDINGS

Between Dec 18, 2019, and Sept 10, 2020, 178 individuals were initially assessed for eligibility, 24 were excluded for not meeting inclusion criteria, declining to participate, or being too ill to participate, and 154 participants were recruited and randomly assigned to the intervention group or the control group. 76 were assigned to the nurse-led palliative care group and 78 were assigned to the control group. 52 (34%) participants were female and 102 (66%) were male and participants had an overall median age of 38 years (IQR 31-46). From the linear mixed-effects model the intervention had a significant positive effect compared with standard care (5·12 scale-points [95% CI 2·89-7·21], p<0·0001) at the 4-month follow-up. The standardised effect size was 0·61 (95% CI 0·35-0·86).

INTERPRETATION

Additional nurse-led palliative care for patients with multidrug-resistant tuberculosis improved self-reported outcomes spanning physical, psychological, social, and spiritual domains, and increased medication adherence. Person-centred assessment and holistic care with pain and symptom control should be task-shifted into routine tuberculosis care.

FUNDING

Open Society Foundations.