IN-ADVANCE CLINICAL TRIAL
Research type
Research Study
Full title
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)
IRAS ID
270472
Contact name
Gordon Linklater
Contact email
Sponsor organisation
NHS Highland
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
As part of a Horizon 2020 funded project that is taking place across 9 partner organisations, and clinically across 5 EU countries, this clinical trial aims to consider whether the use of stratification to identify patients who may benefit from early intervention within the context of palliative care. Specifically, it looks at the potential for the deployment of a Needs Assessment, that could enable patients not currently in receipt of any form of palliative care services to obtain a variety of interventions and support that might improve their quality of life, over a more extended period that the short term weeks or occasionally months long support that they currently receive. The specific patient focus is for those patients suffering from severe COPD or are multi-morbid with respiratory issues - palliative care services are often directed at patients with cancer, but it is felt by clinicians that other clinical conditions, in this case, severe lung disease or a situation in which severe lung disease is a component, would also benefit from extra and earlier intervention and support. Using a small Randomised Controlled Trial design, the study will be in two stages. In Stage 1 the patients will be randomised to standard of care, or to a Palliative Care Needs Assessment, while in Stage 2 participants will be randomised to Care as Usual or another intervention (depending on what is selected by each site in the five participating sites). These will include a technology supported self-care approach, and coordinated cross service comprehensive intervention designed to improve the effectiveness and efficiency of existing services available to patients. In addition to the interventions within the trial, patients will also be expected to complete assessments and satisfaction questionnaires, and with their written informed consent, clinical outcome data will be gathered.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0415
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion