Condition category
Respiratory
Date applied
08/01/2015
Date assigned
11/02/2015
Last edited
22/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 Augustl 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Purdy

ORCID ID

Contact details

School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
-
sarah.purdy@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17828

Study information

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)

Acronym

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
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/129792/PRO-12-130-53.pdf

Ethics approval

Frenchay REC, 12/09/2014, ref: 14/SW/1057

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Intervention

The intervention is the delivery of a COPD care bundles at either the point of admission to or discharge from hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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. Patient and carer experience; Timepoint(s): at end of 12-month data collection
9. Time taken to deliver COPD care bundles; Timepoint(s): post-admission or pre-discharge
10. Total number of COPD admissions; Timepoint(s): monthly
11. 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.

Overall trial start date

01/05/2014

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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

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

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Bristol

Sponsor details

c/o Christine Nileshwar
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Services and Delivery Research Programme (Grant Codes: HS&DR/12/130/53)

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

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26916196

Publication citations

Additional files

Editorial Notes

22/11/2016: trial end date changed from 30/04/17 to 31/08/2017. 07/10/2016: Publication reference added.