Admission and discharge care bundles for COPD

ISRCTN	ISRCTN13022442
DOI	https://doi.org/10.1186/ISRCTN13022442
Protocol serial number	17828
Sponsor	University of Bristol
Funder	Health Services and Delivery Research Programme (Grant Codes: HS&DR/12/130/53)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Prof Sarah Purdy
Scientific

School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Email	sarah.purdy@bristol.ac.uk

Study information

Primary study design	Observational
Study design	Non-randomised; Observational: before-and-after, controlled; Design type: Mixed method - quantitative and qualitative
Secondary study design	Mixed method - quantitative and qualitative
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	COPD re-admission rates; Timepoint(s): 28 days post-discharge
Key secondary outcome measure(s)	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.
Completion date	31/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	76
Total final enrolment	69
Key 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
Key exclusion criteria	1. People admitted to hospital with COPD where this is not the primary cause of admission 2. Elective admissions for COPD
Date of first enrolment	01/02/2015
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Bristol

School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	25/02/2016		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v2.0	30/04/2016	02/03/2017	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.