Multimorbidity-associated emergency hospital admissions: a “screen and link” strategy to improve outcomes for high-risk patients in Malawi and Tanzania

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202310588244868

Enrollment

3000

Registered

2023-10-23

Start date

2024-02-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory System HIV/AIDS Nutritional, Metabolic, Endocrine Kidney Disease Cardiology

Interventions

Baseline Period

Period 2 Control and Intervention Arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adults (=18) acutely admitted to hospital with a medical presentation (unplanned admissions) • Diagnosed with =2 of diabetes mellitus, hypertension and HIV-infection. • Alive after two days of hospital admission OR well enough to be discharged from hospital within two days of admission • Lives within hospital catchment area • Participant likely to stay at their current home location for the next 3 months • Contactable on discharge by telephone (either directly or through a carer)

Exclusion criteria

Exclusion criteria: • Surgical, obstetric or trauma hospital admission. • Presentation with suspected secondary complication of primary disease (e.g., stroke, myocardial infarction, end stage renal disease) • Participant refusal • Pregnancy • Detainees or prisoners • Planned medical admission for investigation

Design outcomes

Primary

Measure	Time frame
Primary Clinical Objective - Aggregated primary outcome measure consisting of survival and hospital re-admission data. Survival will be determined if the patient is alive 90 days after the date of index hospital admission. Hospital readmission will be determined if the participant required repeat all cause unplanned hospital admission within 90 days after index hospital admission. Admission will be defined as requirement for an overnight stay within a healthcare facility. ;Principle Health Economic Outcome - Cost-utility of intervention vs.standard care (incremental cost per QALY gained compared to relevant thresholds expressed on the costeffectiveness acceptability curve);Principle Process Evaluation Objective - Understand under what context and through what mechanisms an enhanced diagnostic, protocolised treatment and patient centred care intervention will enhance integrated care for patients with multimorbidity and will modify patient outcomes in a cluster randomized trial in secondary care hospitals Outcome Measures - Explain ‘what worked for whom, in what condition and why’ with a focus on: Intervention fidelity and quality: What was implemented and how Change mechanism: How did the delivered intervention produce change Context: How did context affect implementation and outcomes	—

Measure

Time frame

Primary Clinical Objective - Aggregated primary outcome measure consisting of survival and hospital re-admission data. Survival will be determined if the patient is alive 90 days after the date of index hospital admission. Hospital readmission will be determined if the participant required repeat all cause unplanned hospital admission within 90 days after index hospital admission. Admission will be defined as requirement for an overnight stay within a healthcare facility. ;Principle Health Economic Outcome - Cost-utility of intervention vs.standard care (incremental cost per QALY gained compared to relevant thresholds expressed on the costeffectiveness acceptability curve);Principle Process Evaluation Objective - Understand under what context and through what mechanisms an enhanced diagnostic, protocolised treatment and patient centred care intervention will enhance integrated care for patients with multimorbidity and will modify patient outcomes in a cluster randomized trial in secondary care hospitals Outcome Measures - Explain ‘what worked for whom, in what condition and why’ with a focus on: Intervention fidelity and quality: What was implemented and how Change mechanism: How did the delivered intervention produce change Context: How did context affect implementation and outcomes

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Secondary

Measure	Time frame
Secondary Clinical objective - Survival 90 days after index hospital admission. Outcome Measure - Disaggregated primary outcome measure. Participant alive at 90 days;Secondary Clinical Objective - Prevalence of undiagnosed multimorbidity. Outcome Measures - Participants diagnosed with new multimorbid disease (=2 of HIV, HTN or DM) from index admission;Secondary Clinical Objective - Measures of disease control (e.g. blood pressure, HBA1c, HIV viraemia). Outcome Measures - Measurement of biological markers of disease control at enrolment and 90 day follow up. Hypertension (blood pressure), diabetes (HBA1c) and HIV (HIV viral load);Secondary Clinical Objective - Prevalence of new end-organ complications relevant to primary disease (e.g., stroke, myocardial infarction, chronic kidney disease). Outcome Measures - Presence or absence of new relevant clinically diagnosed secondary complications (e.g., stroke, myocardial infarction, chronic kidney disease), including cause of death where applicable;Secondary Clinical Objective - Disability free survival at 90 days. Outcome Measures - Disability will be measured using the Washington Group Short Set on Functioning (18) at admission and subsequent follow up visits;Secondary Health Economic Objective - Cost-effectiveness of intervention vs. control (using primary clinical outcome as an outcome as the effectiveness measure) from the societal perspective. Outcome Measures - Societal (i.e. health system plus patient) cost per additional person alive and not having had unplanned hospital readmission in intervention, versus standard care;Secondary Health Economic Objective - Patient costs in intervention vs control clusters. Outcome Measures - Mean and (separately) median cost per patient in intervention vs standard care (includes medical and non-medical out-of-pocket expenses for the patient and accompanying person/s) for the multimorbid conditions.;Secondary Health Economic Objective - HRQoL measures (EQ5D-5L and visual analogue s	—

Measure

Time frame

Secondary Clinical objective - Survival 90 days after index hospital admission. Outcome Measure - Disaggregated primary outcome measure. Participant alive at 90 days;Secondary Clinical Objective - Prevalence of undiagnosed multimorbidity. Outcome Measures - Participants diagnosed with new multimorbid disease (=2 of HIV, HTN or DM) from index admission;Secondary Clinical Objective - Measures of disease control (e.g. blood pressure, HBA1c, HIV viraemia). Outcome Measures - Measurement of biological markers of disease control at enrolment and 90 day follow up. Hypertension (blood pressure), diabetes (HBA1c) and HIV (HIV viral load);Secondary Clinical Objective - Prevalence of new end-organ complications relevant to primary disease (e.g., stroke, myocardial infarction, chronic kidney disease). Outcome Measures - Presence or absence of new relevant clinically diagnosed secondary complications (e.g., stroke, myocardial infarction, chronic kidney disease), including cause of death where applicable;Secondary Clinical Objective - Disability free survival at 90 days. Outcome Measures - Disability will be measured using the Washington Group Short Set on Functioning (18) at admission and subsequent follow up visits;Secondary Health Economic Objective - Cost-effectiveness of intervention vs. control (using primary clinical outcome as an outcome as the effectiveness measure) from the societal perspective. Outcome Measures - Societal (i.e. health system plus patient) cost per additional person alive and not having had unplanned hospital readmission in intervention, versus standard care;Secondary Health Economic Objective - Patient costs in intervention vs control clusters. Outcome Measures - Mean and (separately) median cost per patient in intervention vs standard care (includes medical and non-medical out-of-pocket expenses for the patient and accompanying person/s) for the multimorbid conditions.;Secondary Health Economic Objective - HRQoL measures (EQ5D-5L and visual analogue s

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Countries

Malawi, Tanzania

Contacts

Public ContactAmy Smith

Programme Coordinator

amy.smith@lstmed.ac.uk+441517029575

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026