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Early interventions for palliative care

Clinical trial of outcomes from early interventions for palliative care patients - a stratified approach for severe respiratory illness and multimorbidities using a pilot randomised controlled trial (InAdvance)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24825698
Enrollment
400
Registered
2020-12-17
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Later-stage respiratory disease and multi-morbidity late stages (COPD/multimorbidity) patients (and their carers and healthcare professionals (HCP) Respiratory

Interventions

Current interventions as of 13/09/2023: The Stage One intervention is a Palliative Care Needs Assessment
this will take place at one visit, either face-to-face or remotely, by trained personnel, with a follow-up of 12 months (T1, T2, T3, T4). These occur at each of the 4 European sites - NHS Highland (UK

Sponsors

NHS Highland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 13/09/2023: Patient: 1. Severe respiratory illness related to COPD or has respiratory disease as part of multimorbid state or has multi-morbid severe condition (Heart Failure etc) 2. Over the age of 55 3. Identified using the stratification model as being appropriate for receiving support / palliative care 4. Able to give written informed consent 5. Carer/HCP related to the patient participating also included as long as able to give written informed consent/adult Previous participant inclusion criteria: Patient: 1. Severe respiratory illness related to COPD or has respiratory disease as part of multimorbid state 2. Over the age of 55 3. Identified using the stratification model as being appropriate for receiving support / palliative care 4. Able to give written informed consent 5. Carer/HCP related to the patient participating also included as long as able to give written informed consent/adult

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 13/09/2023: Stage One Measured at baseline, 6 weeks, 6 months, 12 months and 18 months 1. Quality of life (EQ-5D-5L) 2. Intensity of symptoms (POS1/POS2) 3. Functional status (PPSv2) Previous primary outcome measures: Stage One Measured at baseline, 6 weeks, 6 months, 12 months and 18 months 1. Quality of life (EQ-5D-5L) 2. Intensity of symptoms (POS1/POS2) 3. Functional status (PPSv2) Stage 2 Measured at baseline, 6 weeks, 6 months, 12 months and 18 months 1. Quality of life (EQ-5D-5L) 2. Intensity of symptoms (POS1/POS2) 3. Functional status (PPSv2)

Secondary

MeasureTime frame
Measured at baseline, 6 weeks, 6 months, 12 months and 18 months (unless otherwise noted): 1. Emotional distress (HADS) 2. Within-trial cost analysis of participants’ service use and out of pocket expenses measured using patient interview 3. For carers: caregiving burden (brief ZBI) 4. Perceived quality of care is assessed among patients and carers using a 5-point Likert scale 5. Treatment adherence measured using the Treatment Acceptability/Adherence Scale and the Medical Outcomes Study tool 6. Treatment adherence, acceptability, appropriateness and feasibilty will assessed by qualitative interview with staff using data collection tools based on the Consolidated Framework for Implementation Research (CFIR) at baseline and 18 months 7. Cost categories measured for cost-consequence analysis and cost-effectiveness to be calculated at 18 months: 7.1. The intervention costs: Resource units consumed and their unit costs will be collected using uniform reporting templates. Depending on the intervention, resource units may concern the minutes spent by health and social care professionals (e.g. medical specialists, nurses, social workers, other therapists), diagnostic procedures (e.g. medical imaging, laboratory services), consumables (e.g. drugs, fluids and disposables) and overheads. 7.2. Other healthcare costs will be measured with the Medical Consumption Questionnaire (MCQ), which will be completed by patients. The MCQ includes questions related to frequently occurring contacts with health care providers. 7.3. Informal care costs will be determined by multiplying the number of hours taking care of the patient with corresponding hourly productivity costs. The number of hours taking care of the patient will be collected using items from the Valuation of Informal Care Questionnaire (VICQ).

Countries

Greece, Portugal, Scotland, Spain, United Kingdom

Contacts

Public ContactFrances Hines
frances.hines@nhs.scot+44 (0)1463255822

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026