Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research question
What is the clinical and cost-effectiveness of rescue packs to reduce the risk of hospital re-admission following an acute exacerbation of chronic obstructive pulmonary disease (COPD)?
- Intervention: Rescue packs issued on discharge, with education on how to use it and support in decision of when to use – to be defined and justified by applicants.
- Patient group: Patients with COPD who have been discharged following admission to hospital with an acute exacerbation of COPD – to be defined and justified by applicants.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Setting: Secondary care.
- Comparator: Best standard care – to be defined and justified by applicants.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
- Important outcomes: All cause readmissions at 90 days.
Other outcomes: COPD-related readmissions at 30 and 90 days; rescue pack usage; health-care resource utilisation; all-cause mortality; quality of life (COPD Assessment Test); adverse effects; health literacy and fidelity to use of rescue pack advice; self-efficacy; cost-effectiveness; antimicrobial resistance.
Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant). - Minimum duration of follow-up: 12 months from recruitment.
Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
COPD is a common chronic inflammatory lung disease that causes obstructed airflow in the lungs and affects more than 1 million people in the UK. COPD accounts for approximately 30,000 deaths each year in the UK and is the second largest cause of emergency admissions. Symptoms include breathlessness, persistent chesty cough and wheezing, and frequent chest infections. Patients experience flare ups of their symptoms, known as exacerbations, which impact negatively on quality of life and can result in hospitalisation. Patients who have previously had an exacerbation are at an increased risk of future exacerbations, with almost a quarter of patients being re-admitted to hospital within 30 days. Early recognition and prompt treatment of exacerbations may reduce severity and the need for hospital admission, as well as improving recovery time and quality of life for the patient.
NICE recommend offering patients who’ve previously had an exacerbation a ‘rescue pack’, which refers to a short course of oral corticosteroids and antibiotics to keep at home, which can be used at the start of an exacerbation. Whilst rescue packs are used in practice, there is considerable variation in the level of support and education that patients receive to enable them to understand how and when (and when not) to correctly use their medication to prevent misuse. Many exacerbations are not caused by bacterial infections so will not respond to antibiotics. Overuse of antibiotics increases the risk of antimicrobial resistance both at an individual and societal level. Overuse of corticosteroids is associated with long term side effects such as osteoporosis and diabetes. However, under-use risks missing the potential benefit of earlier treatment reducing the severity of the exacerbation and risk of hospitalisation.
There is also equipoise around the use of rescue packs amongst clinicians and controversy around if rescue packs should be part of the ‘discharge bundle’. Most supportive evidence for the use of rescue packs is from studies assessing their use as part of a comprehensive, multi-component self-management intervention, as opposed to being used with simpler action plans as used in routine practice. Whilst evidence suggests that self-management interventions may reduce hospital admissions and improve quality of life, there is a need to better understand the risks and benefits of rescue packs specifically, particularly in the highest risk post-exacerbation period. Therefore, the HTA Programme would like to commission an RCT to determine whether rescue packs issued with education on how and when to use it, are clinically and cost-effective in the post-exacerbation period, to reduce the risk of readmission. The HTA programme welcomes studies that consider health inequalities and ethnicity.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted on-line no later than 1pm on the 30 November 2022. Applications will be considered by the HTA Funding Committee at its meeting in January 2023.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2023.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us by email at htacommissioning@nihr.ac.uk.