COPDINTEGR-COPDNCT03482700
Impact of Specialist Led Integrated Care in COPD
A study testing Intervention Arm in people with COPD, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Practices will be eligible for inclusion if they give consent to data collection and are part of the EBHO.
- Patients from the practices will be eligible if they are coded to have COPD within the GP record. In addition patients who are not coded to have COPD in the GP record, but who have a hospital admission with a primary diagnosis of COPD within the enrolment period for practices (first 3 months) will be eligible.
Who cannot join
- Patients will only be excluded if they are proven not to have COPD at specialist assessment, or during the follow up period, as determined by changes in medical coding within the GP record. If patients are assessed by the specialist and the diagnosis is not felt to be robust, enrolment will be suspended until this matter can be clarified by use of post bronchodilator spirometry and/or other required parts of their clinical care.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dr. Sarah Pountain
Birmingham, West Midlands, B9 5SS
About this study
Official title: The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD
This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices.
Read the detailed description
This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. It will be run from the Heart of England NHS Foundation Trust, which will provide the specialist input and oversight, and up to 40 practices across the Eastern Birmingham Health Organisation with approximately 2200 patients with COPD confirmed by their current medical practitioner. Each practice will be randomised to either the intervention or control group. The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. Treatment will be at the discretion of the clinician and is not specified in the trial protocol. The investigators anticipate that the treatment recommendations in the intervention arm may include referral to pulmonary rehabilitation and reduction in the use of inhaled corticosteroids, which are prescribed at high rates in our locality. The control group will be seen by the usual staff at their practice. These patients will not be seen by the trial team and their data will be extracted remotely using electronic systems.
The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices. Secondary outcomes will include: referral to secondary care, unscheduled healthcare consultations (ED attendance, hospital admissions), COPD exacerbations, healthcare costs, medications prescribed, biochemical markers of disease, radiological investigations, lung function tests measured when clinically indicated, and death within 12 month follow-up period.
- Conditions
- COPD
- Being tested
- Intervention Arm, Control Arm
- Keywords
- COPD; GP Surgeries
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmBehavioural
The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations.
Control ArmBehavioural
Usual standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. Receives: Behavioral: Intervention Arm |
| Control | Other | Usual standard of care Receives: Behavioral: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of provision of guideline-based care in intervention and control practices for patients.
This will be done via the number of patients concordant with local guidelines (where care is defined by medication received and non-pharmacological interventions received, and they must receive smoking cessation, pulmonary rehabilitation, self-management plan and appropriate COPD medications in order to be guideline compliant)
Measured: 1 Year
Secondary outcomes (9)
Referral Outcome
Referral to secondary care
Measured: 1 Year
Unscheduled Outcome
Unscheduled healthcare consultations (ED attendance, hospital admissions)
Measured: 1 Year
COPD Outcomes
COPD exacerbations
Measured: 1 Year
Healthcare Outcomes
mean cost per patient in £ of the total cost of hospital attendances, GP visits, medications and vaccines during the study period
Measured: 1 Year
Medications Outcomes
medications prescribed
Measured: 1 Year
Biochemical markers of disease Outcomes
FBC, U\&E, LFT, CRP, AAT level/phenotype, and sputum culture results taken for patient
Measured: 1 Year
Radiological Outcomes
number of CT scans or Chest X rays done
Measured: 1 Year
Lung Function Outcomes
Lung function tests measured when clinically indicated, FEV1 (l) and FEV1 (% predicted), FEV1/FVC
Measured: 1 Year
Death Outcome
Death within 12 month follow-up
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start6 Dec 2017
- Primary completion3 Jun 2019
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: An intervention group and a control group. The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. The control group will receive the usual standard of care.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Alice Turner, MD, Principal investigator, Heart of England NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482700
- Sponsor's protocol ID
- 2017069RM
- Acronym
- INTEGR-COPD
- Status last verified
- Oct 2019
- First submitted
- 16 Feb 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD plan
Publications
Patel K, Smith DJ, Huntley CC, Channa SD, Pye A, Dickens AP, Gale N, Turner AM. Exploring the causes of COPD misdiagnosis in primary care: A mixed methods study. PLoS One. 2024 Mar 6;19(3):e0298432. doi: 10.1371/journal.pone.0298432. eCollection 2024.
PubMed 38446828Patel K, Pye A, Edgar RG, Beadle H, Ellis PR, Sitch A, Dickens AP, Turner AM. Cluster randomised controlled trial of specialist-led integrated COPD care (INTEGR COPD). Thorax. 2024 Feb 15;79(3):209-218. doi: 10.1136/thorax-2023-220435.
PubMed 38286619
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD
- ClinicalTrials.gov ID
- NCT03482700
- Acronym / sponsor ID
- INTEGR-COPD / 2017069RM
- Conditions
- COPD
- Keywords
- COPD; GP Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices.
Detailed description
This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. It will be run from the Heart of England NHS Foundation Trust, which will provide the specialist input and oversight, and up to 40 practices across the Eastern Birmingham Health Organisation with approximately 2200 patients with COPD confirmed by their current medical practitioner. Each practice will be randomised to either the intervention or control group. The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. Treatment will be at the discretion of the clinician and is not specified in the trial protocol. The investigators anticipate that the treatment recommendations in the intervention arm may include referral to pulmonary rehabilitation and reduction in the use of inhaled corticosteroids, which are prescribed at high rates in our locality. The control group will be seen by the usual staff at their practice. These patients will not be seen by the trial team and their data will be extracted remotely using electronic systems.
The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices. Secondary outcomes will include: referral to secondary care, unscheduled healthcare consultations (ED attendance, hospital admissions), COPD exacerbations, healthcare costs, medications prescribed, biochemical markers of disease, radiological investigations, lung function tests measured when clinically indicated, and death within 12 month follow-up period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups: An intervention group and a control group. The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. The control group will receive the usual standard of care.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Intervention ArmThe intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. |
| Control | Other | Behavioral: Control ArmUsual standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Practices will be eligible for inclusion if they give consent to data collection and are part of the EBHO.
- Patients from the practices will be eligible if they are coded to have COPD within the GP record. In addition patients who are not coded to have COPD in the GP record, but who have a hospital admission with a primary diagnosis of COPD within the enrolment period for practices (first 3 months) will be eligible.
Key exclusion criteria (1 listed)
- Patients will only be excluded if they are proven not to have COPD at specialist assessment, or during the follow up period, as determined by changes in medical coding within the GP record. If patients are assessed by the specialist and the diagnosis is not felt to be robust, enrolment will be suspended until this matter can be clarified by use of post bronchodilator spirometry and/or other required parts of their clinical care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ArmThe intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations. | Behavioural | Intervention |
| Control ArmUsual standard of care | Behavioural | Control |
Primary outcome
Rates of provision of guideline-based care in intervention and control practices for patients.
Time frame: 1 Year
This will be done via the number of patients concordant with local guidelines (where care is defined by medication received and non-pharmacological interventions received, and they must receive smoking cessation, pulmonary rehabilitation, self-management plan and appropriate COPD medications in order to be guideline compliant)
9 secondary outcomes
Referral Outcome
Time frame: 1 Year
Unscheduled Outcome
Time frame: 1 Year
COPD Outcomes
Time frame: 1 Year
Healthcare Outcomes
Time frame: 1 Year
Medications Outcomes
Time frame: 1 Year
Biochemical markers of disease Outcomes
Time frame: 1 Year
Radiological Outcomes
Time frame: 1 Year
Lung Function Outcomes
Time frame: 1 Year
Death Outcome
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Derived from this study: PubMed 38446828Patel K, Smith DJ, Huntley CC, Channa SD, Pye A, Dickens AP, Gale N, Turner AM. Exploring the causes of COPD misdiagnosis in primary care: A mixed methods study. PLoS One. 2024 Mar 6;19(3):e0298432. doi: 10.1371/journal.pone.0298432. eCollection 2024.
- Derived from this study: PubMed 38286619Patel K, Pye A, Edgar RG, Beadle H, Ellis PR, Sitch A, Dickens AP, Turner AM. Cluster randomised controlled trial of specialist-led integrated COPD care (INTEGR COPD). Thorax. 2024 Feb 15;79(3):209-218. doi: 10.1136/thorax-2023-220435.
- Individual participant dataSharing planned: No. No IPD plan
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Turner, MD principal investigator
Heart of England NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with COPD, run by Heart of England NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of provision of guideline-based care in intervention and control practices for patients. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.