Sequalae of critical illness Other
Conditions
Interventions
Patients will be randomised on a 1:1 ratio using Sealed Envelopes software.
Group 1: Usual Care
People in this group will be provided with the usual care that is currently given to patients who have
Sponsors
Queen's University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults >18 years old 2. Currently admitted to hospital following admission to an intensive care unit for at least 48 hours 3. Multimorbidity: two or more current medical conditions 4. Able to participate in the intervention and with trial procedures
Exclusion criteria
Exclusion criteria: 1. Unable to provide consent 2. Life expectancy of less than 6 months (as determined by the patients treating clinician) 3. Discharged to a rehabilitation unit, or care home with/without nursing care 4. Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Process evaluation: feasibility and acceptability of intervention delivery The following will be assessed for every intervention visit: 1. Fidelity (protocol adherence), assessed as the proportion of intervention components which are delivered as intended (i.e. as per the protocol). Reasons for delivery outside protocol will be recorded within explanatory notes 2. Time required for intervention delivery 3. Factors influencing intervention delivery (including participant and contextual factors, assessed through healthcare utilisation data, intervention checklist explanatory notes and semi-structured interviews. This includes examination of the content of existing care provision and follow-up (e.g. medical, rehabilitation and social) and its interactions and compatibility with the intervention. 4. Perceived benefits and harms, evaluated through participant, carer, and healthcare professional semi-structured interviews 5. Acceptability of Intervention delivery for participants, evaluated through the acceptability questionnaires and semi-structured interviews Process evaluation: feasibility and acceptability of procedures for a future trial 1. Reach (recruitment rate) and reasons for refused consent, measured at baseline 2. Participant attrition rate and reasons for attrition, measured throughout the study period 3. Completeness of the proposed baseline and outcome measures data for future trial and reasons for failure to collect baseline and outcome measures, measured at 6 weeks, 3, 6 and 12 months 4. Acceptability of clinical trial procedures for participants, measured at all intervention visits Process evaluation: feasibility and acceptability from the perspective of informal carers To assess how the change in the patient’s care impacts their informal carers (if available) we will request that the participant’s carer also completes two questionnaires (EQ-5D-5L and multimorbidity treatment burden questionnaire) at 6 weeks and 6 months, an acceptability questionnair | — |
Secondary
| Measure | Time frame |
|---|---|
| Main trial outcomes: The following will be measured at 6 weeks, 3, 6 and 12 months: 1. Hospital readmissions (scheduled and unscheduled) 2. Hospital-free days 3. Mortality 4. Healthcare resource utilisation (scheduled and unscheduled) including emergency department attendances, hospital admissions, outpatient appointments, General Practitioner attendances, and General Practice Out of Hours attendances. 5. Concomitant medications The following will be measured at baseline, 6 weeks and 6 months: 1. Health-related quality of life measured using the EQ-5D-5L questionnaire 2. Treatment burden measured using the Multimorbidity Treatment Burden Questionnaire (MTBQ) 3. Self-efficacy measured using the Self-Efficacy to Manage Chronic Disease Scale 4. Psychological function measured using the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder Questionnaire (GAD-7) 5. Cognitive function measured using the Montreal Cognitive Assessment BLIND (MoCA-BLIND) 6. Physical Function measured using the 30 second sit to stand test | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactJonathan Stewart
Outcome results
None listed