Does ensuring people go home from hospital on the right inhalers after an exacerbation of chronic obstructive pulmonary disease reduce the risk of being re-admitted to hospital?
| ISRCTN | ISRCTN16732324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16732324 |
| IRAS number | 309854 |
| Secondary identifying numbers | IRAS 309854, CPMS 52972 |
- Submission date
- 01/09/2022
- Registration date
- 08/09/2022
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that cause breathing difficulties. This study tests if optimising the inhaled medicines of people living with COPD who have been admitted to hospital with a chest infection called an 'exacerbation', helps reduce the risk of death and readmission to hospital over the following 3 months. This is a preliminary study called a 'feasibility study' that will tell us if a full-size study to answer the question is possible.
Who can participate?
Patients aged 18 years and over who have been admitted to hospital with an exacerbation of COPD
What does the study involve?
Participants' clinicians will use a new tool to see if they are on the right inhalers. If not, they will suggest making a switch. Participants will then be phoned at 30 and 90 days to see how they got on with the new inhalers(s) if inhalers were switched, and to see if they were re-admitted to hospital. Some participants and some clinicians too will undergo more in-depth interviews about inhaler switching in this way.
What are the possible benefits and risks of participating?
The benefit to taking part is that there will be a closer look at the inhalers people are using. If there is a switch, the new inhaler(s) may not suit the person so well.
Where is the study run from?
The study is being run from the Royal Free Hospital in London, with people also invited to take part in Birmingham and Newcastle (all in the UK).
When is the study starting and how long is it expected to run for?
February 2022 to July 2023
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Ms Anne-Marie Preston, anne-marie.preston@nhs.net
Contact information
Principal Investigator
UCL Respiratory
University College London
London
NW3 2QG
United Kingdom
 ORCID ID |
0000-0002-7246-6040 |
|---|---|
| Phone | +44 (0)2077940500 |
| j.hurst@ucl.ac.uk |
Scientific
UCL Respiratory
University College London
London
NW3 2QG
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| j.hurst@ucl.ac.uk |
Public
Royal Free London NHS Foundation Trust
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| anne-marie.preston@nhs.net |
Study information
| Study design | Feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Optimised inhalers to reduce chronic obstructive pulmonary disease exacerbation re-admissions and mortality: a feasibility study |
| Study acronym | OPTIHALE |
| Study objectives | This study will test the hypothesis that re-admissions and mortality after a hospitalised chronic obstructive pulmonary disease (COPD) exacerbation can be reduced by optimising both inhaled drug prescription and device prior to discharge. This is a feasibility study. |
| Ethics approval(s) | Approved 01/07/2022, Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham HRA1 Meeting Room, NG1 6FS, UK; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 22/WM/0125 |
| Health condition(s) or problem(s) studied | Exacerbations of chronic obstructive pulmonary disease (COPD) |
| Intervention | Participants' clinicians will use a new tool to see if they are on the right inhalers. If not, they will suggest making a switch. Participants will then be phoned at 30 and 90 days to see how they got on with the new inhalers(s) if inhalers were switched, and to see if they were re-admitted to hospital. Some participants and some clinicians too will undergo more in-depth interviews about inhaler switching in this way. |
| Intervention type | Other |
| Primary outcome measure | The primary aim of this study is to establish the feasibility of a future definitive trial; as such the feasibility outcomes are to measure: 1. The proportion of patients prescribed incorrect inhaled medicine, according to NICE guidance, assessed by review of the prescription chart and admission documentation prior to discharge 2. The proportion of patients with critical inhaler device errors, assessed by direct observation of technique prior to discharge 3. The proportion of patients with insufficient peak inspiratory flow rate for their current device, assessed using the In-Check device prior to discharge 4. The proportion of patients willing to have inhalers changed where a change is indicated, assessed by asking the patient prior to discharge 5. Of those eligible for an inhaler change, the proportion of patients in which the change is made and if not why not, by assessing the discharge prescription and interview with clinicians at the point of discharge 6. Of those who had an inhaler change, the continuation of that change in the community assessed by patient interview at 30 and 90 days 7. Patient perception of inhaled medication assessed using the Feeling of Satisfaction with Inhaler (FSI-10) questionnaire prior to discharge and at 30- and 90 days 8. Loss to follow-up at 30 and 90 days 9. Challenges in data collection assessed by interviews with clinicians using the tool throughout the study period 10. The time taken to collect the data and deliver the inhaler selection tool, assessed by timing use of the tool at the point of use 11. The first language distribution of patients with COPD at the three sites, to understand the need for translation of trial materials, assessed by interviews with patients prior to discharge |
| Secondary outcome measures | In addition, to inform the power calculation for a definitive study, the researchers will assess: 1. The mortality rate at 30 and 90 days, by review of electronic patient records 2. The all-cause re-admission rate at 30 and 90 days, by patient interview 3. The acceptability of the intervention is assessed using qualitative interviews. Then, based on input from trial participants and clinicians, the researchers will further refine and develop the inhaler selection tool. These interviews will be conducted after discharge. |
| Overall study start date | 01/02/2022 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | To screen 300 participants for enrolment |
| Key inclusion criteria | 1. In hospital with an exacerbation of COPD 2. Age 18 years or over 3. Able to provide informed consent |
| Key exclusion criteria | Discharge home with palliative care |
| Date of first enrolment | 03/10/2022 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
NW3 2QG
United Kingdom
Birmingham
B15 2GW
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Pond Street
London
NW3 2PF
England
United Kingdom
| Phone | +44 (0)2077940500 |
|---|---|
| rf.randd@nhs.net | |
| Website | http://www.royalfree.nhs.uk/ |
"ROR" |
https://ror.org/04rtdp853 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication and dissemination will be through conference abstracts and peer-review journals. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 04/03/2024 | 19/07/2024 | Yes | No |
Editorial Notes
19/07/2024: Publication reference added.
03/10/2022: Internal review.
02/09/2022: Trial's existence confirmed by the NIHR.
