| OUTCOMES |
|
Type of outcome
|
Outcome
|
Timepoint(s) at which outcome measured
|
| Secondary Outcome |
Secondary Clinical objective - Survival 90 days after index hospital admission. Outcome Measure - Disaggregated primary outcome measure. Participant alive at 90 days |
90 days |
| Primary Outcome |
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.
|
90 days after dates of index hospital admission |
| Secondary Outcome |
Secondary Clinical Objective - Prevalence of undiagnosed multimorbidity. Outcome Measures - Participants diagnosed with new multimorbid disease (≥2 of HIV, HTN or DM) from index admission |
Recruitment, 30, 60 and 90 days |
| Secondary Outcome |
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) |
Recruitment, 30, 60 and 90 days |
| Secondary Outcome |
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 |
Recruitment, 30, 60 and 90 days |
| Secondary Outcome |
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 |
Recruitment, 30, 60 and 90 days |
| Secondary Outcome |
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 |
90 days after date of index hospital admission with possible modelling over the lifetime horizon for a hypothetical patient cohort |
| Secondary Outcome |
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. |
Evaluated at 90 days after the date of index hospital admission by summing costs incurred during the index hospital stay, between discharge and 30 day follow up period, between 30 and 60 day followup |
| Secondary Outcome |
Secondary Health Economic Objective - HRQoL measures (EQ5D-5L and visual analogue scale). Outcome Measures - Mean and separately median change in QALY per person calculated using the area under the curve methodology and summed by arm. |
Evaluated at 90 days after date of index hospital admission, using the utility scores obtained for each patient at initial, 30, 60 and 90 days to calculate area under the curve, with possible modellin |
| Secondary Outcome |
Secondary Health Economic Objective - Health system costs in intervention vs control. Outcome Measures - Estimated cost to health system of implementing intervention vs. standard care (includes medication, tests conducted, inpatient stay costs, staff costs, overheads such as electricity, water etc. and consumable costs). |
Cost modelling to esitmate annual cost per hospital of rolling out intervention |
| Secondary Outcome |
Intervention reach, effectiveness, adoption, fidelity and maintenance |
Longitudinal assessment throughout the trial |
| Secondary Outcome |
Determine and map care processes and patient pathways |
90 days |
| Primary Outcome |
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) |
90 days after date of index hospital admission with possible modelling over the lifetime horizon for a hypotherical patient cohort |
| Primary Outcome |
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
|
90 days |
| Secondary Outcome |
Secondary Clinical Objective - Hospital re-admission rate 90 days after index hospital admission. outcome Measures - Disaggregated primary outcome measure. Participant requires repeat hospital admission within 90 days |
90 days |
| Secondary Outcome |
Secondary Process Evaluation Objective - To examine key secondary implementation outcomes including fidelity, acceptability, adoption, appropriateness, feasibility, and sustainability of the intervention. Outcome Measures - i. The extent to which the intervention is implemented as intended and whether any adaptations were made
ii. Positive and negative effects of the intervention in the short and intermediate terms
iii. Participation of the target population in the intervention
iv. Extent of uptake of the intervention in hospital and community settings
v. Sustainability of the intervention’s benefits
|
Longitudinal assessment throughout the trial |
| Secondary Outcome |
Secondary Process Evaluation Objective - To assess how health system context at cluster/hospital and country level affect intervention fidelity and or outcomes. Outcome Measures - i. Organisation/integration of patient care (patient flow, NCD management, NCD treatment guidelines, clinical records, OPD service integration)
ii. Availability of essential technologies and tools (monthly drug stock audit)
iii. Human resources for health (dedicated staff for relevant NCDs and HIV, in post/staff vacancy levels)
iv. Availability of core medicines (monthly drug stock audit)
|
For i - ii at baseline, midline and endline. For iii-iv monthly staff and drug stick audits in intervention and control clusters. |
| Secondary Outcome |
Secondary Health Economic Objective - Cost utility of intervention vs. control (incremental cost per QALY gained compared to a range of relevant thresholds) from the societal perspective, measured at 90 days from hospital admission. Outcome Measures - Societal (i.e. health system and patient) cost per additional QALY gained in intervention, versus standard care |
90 days after the date of hospital admission with the possible modelling over the lifetime horizon for a hypothetical patient cohort |
| Secondary Outcome |
Secondary Health Economic Objective - Investigation into the socioeconomic status of patients diagnosed with multimorbidity (pooled sample). Outcome measures - Participant data on household construction materials, water sources, sanitation access and ownership of various items will be used to construct a wealth index score using principle components analysis, that will be used to categorise households into wealth quintiles relative to the socioeconomic status in each country which will be obtained from the most recent Demographic and Health Survey analysis. |
Evaluated using data obtained during index hospital admission |
| Secondary Outcome |
Secondary Health Economic Objective - Cost effectiveness of intervention vs. control using the primary clinical outcome as effectiveness measure from the health system perspective - Outcome Measures - Health system cost per additional person alive and not having had unplanned hospital readmission in intervention, versus standard care |
Evaluated at 90 days after the date of index hospital admission, with the possible modelling over the lifetime horizon for a hypothetical patient cohort |