Admission and discharge care bundles for COPD
| ISRCTN | ISRCTN13022442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13022442 |
| Secondary identifying numbers | 17828 |
- Submission date
- 08/01/2015
- Registration date
- 11/02/2015
- Last edited
- 07/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Avoiding unnecessary use of hospital services is one of the biggest challenges currently facing the NHS. Chronic obstructive pulmonary disease (COPD) is one of the most common lung diseases in the United Kingdom and accounts for 10% of hospital admissions each year. Nearly a third of these patients are readmitted to hospital within 28 days of discharge. COPD care bundles could play a key role in resolving the issue of unplanned admissions. Care bundles are a way of ensuring that staff provide a coordinated package of care to patients with COPD when they arrive at and are sent home from hospital. This study aims to evaluate the effectiveness of care bundles as a means of improving hospital care and reducing re-admissions for patients with COPD.
Who can participate?
This study will include a group of up to 20 hospitals in England and Wales who have already agreed to implement the COPD care bundles, and up to 20 ‘comparator’ hospitals who will not be delivering them.
What does the study involve?
By comparing how many patients are readmitted to each type of hospital over a two-year period, and what happens to patients during their stay, we will be able to assess how successful COPD care bundles are. More specifically, we will look at the number of patients admitted with COPD, the number of deaths of COPD patients while in hospital, the number of days spent in hospital by patients with COPD, the proportion of patients with COPD who are readmitted, the number of COPD patients seen and discharged from A&E, levels of satisfaction in patients with COPD, how patients with COPD are managed in hospital, and how much it costs to care for a patient with COPD in hospital and after discharge. Most of the information needed for this study is routinely collected by hospitals in the course of their own management activity.
What are the possible benefits and risks of participating?
The benefit of taking part in the study for either NHS Trusts or individual patients is the opportunity to participate in a national high-quality evaluation of service delivery which will provide new evidence on the effectiveness of an aspect of NHS care provision. The risks of participation are minimal.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
May 2014 to August 2017
Who is funding the study?
NIHR Health Services and Delivery Research (UK)
Who is the main contact?
Prof. Sarah Purdy
sarah.purdy@bristol.ac.uk
Contact information
Scientific
School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| sarah.purdy@bristol.ac.uk |
Study information
| Study design | Non-randomised; Observational: before-and-after, controlled; Design type: Mixed method - quantitative and qualitative |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed method - quantitative and qualitative |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An evaluation of the effectiveness of ‘care bundles’ as a means of improving hospital care and reducing hospital readmission for patients with chronic obstructive pulmonary disease (COPD) |
| Study hypothesis | This research seeks to evaluate the effectiveness of care bundles (i.e., a co-ordinated package of care) as a means of improving hospital care and reducing re-admissions for patients with chronic obstructive pulmonary disease (COPD). More details can be found at: http://www.nets.nihr.ac.uk/projects/hsdr/1213053 July 2014 V1 protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/129792/PRO-12-130-53.pdf April 2016 V2 protocol: see additional files |
| Ethics approval(s) | Frenchay REC, 12/09/2014, ref: 14/SW/1057 |
| Condition | Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory |
| Intervention | The intervention is the delivery of a COPD care bundle at either the point of admission to or discharge from hospital. |
| Intervention type | Other |
| Primary outcome measure | COPD re-admission rates; Timepoint(s): 28 days post-discharge |
| Secondary outcome measures | 1. Compliance with delivery of COPD care bundles; Timepoint(s): 12 months pre- and post- 2. COPD re-admission rates; Timepoint(s): 90-days post-hospital discharge 3. Costs of in-patient medications and procedures; Timepoint(s): 12 months pre-and post- 4. In-hospital mortality; Timepoint(s): 12-months pre- and post- 5. Length of stay for patients with COPD; Timepoint(s): at end of 12-month data collection 6. Mortality; Timepoint(s): 90-day post-hospital discharge 7. Overall re-admission rates; Timepoint(s): 28-days post-hospital discharge 8. Time taken to deliver COPD care bundles; Timepoint(s): post-admission or pre-discharge 9. Total number of COPD admissions; Timepoint(s): monthly 10. Total number of patients for whom COPD care bundle used; Timepoint(s): 12-months post-hospital data collection As with the primary outcome, the secondary outcomes of the study will be measured for a 12-month period pre-and post- a particular index date. This index date is the date upon which an individual implementation site i.e. NHS Trust began to deliver its COPD care bundle or, in the case of comparator sites, the date upon which an individual site's matched implementation site began to deliver its COPD care bundle. This approach will ensure that data are collected during the same ‘before’ and ‘after’ period for matched implementation and comparator sites. 12/12/2016: "Patient and carer experience; Timepoint(s): at end of 12-month data collection" outcome removed from April 2016 protocol. |
| Overall study start date | 01/05/2014 |
| Overall study end date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 76; UK Sample Size: 76; Description: 60 patients + 16 trusts. Study comprised of 3 levels of research. Level 1 is not consenting and uses publicly available data. Level 2 is 'consents' at a trust level and will recruit 'up to 16' trusts and level 3 is patient-consented case studies and aims to recruit 10 patients per site from 'up to 6 sites'. May also include some patient carers and healthcare professionals where available. Mixed method study combining both quantitative and qualitative approaches - no formal sample size calculation. Total final enrolment was 14 trusts and 55 participants for the qualitative study. |
| Total final enrolment | 69 |
| Participant inclusion criteria | 1. People over 18 years of age admitted to an acute hospital with COPD 2. Primary cause of admission is COPD (ICD10 diagnostic codes J41-44) Target Gender: Male & Female ; Lower Age Limit 18 years |
| Participant exclusion criteria | 1. People admitted to hospital with COPD where this is not the primary cause of admission 2. Elective admissions for COPD |
| Recruitment start date | 01/02/2015 |
| Recruitment end date | 31/07/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Christine Nileshwar
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/11/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/02/2016 | Yes | No | |
| Protocol file | version v2.0 | 30/04/2016 | 02/03/2017 | No | No |
| Results article | results | 01/06/2019 | 24/02/2020 | Yes | No |
| Results article | 25/03/2020 | 07/03/2023 | Yes | No | |
| Results article | 30/05/2019 | 07/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13022442_PROTOCOL_v2.0_30Apr16.pdf
- Uploaded 02/03/2017
Editorial Notes
07/03/2023: Publication references added.
24/02/2020: Publication reference added and the total final enrolment was added form the reference.
02/03/2017: uploaded protocol (not peer reviewed).
12/12/2016: One secondary outcome removed in April 2016 protocol.
22/11/2016: Trial end date changed from 30/04/17 to 31/08/2017.
07/10/2016: Publication reference added.
