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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Other | Usual standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Arm | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Referral Outcome | Referral to secondary care | 1 Year |
| Unscheduled Outcome | Unscheduled healthcare consultations (ED attendance, hospital admissions) |
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Inclusion Criteria:
Exclusion Criteria:
• 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.
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| Name | Affiliation | Role |
|---|---|---|
| Alice Turner, MD | Heart of England NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sarah Pountain | Birmingham | West Midlands | B9 5SS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38446828 | Derived | 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. | |
| 38286619 | Derived | Patel 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. |
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No IPD plan
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
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|
| Control Arm | Behavioral | Usual standard of care |
|
| 1 Year |
| COPD Outcomes | COPD exacerbations | 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 | 1 Year |
| Medications Outcomes | medications prescribed | 1 Year |
| Biochemical markers of disease Outcomes | FBC, U&E, LFT, CRP, AAT level/phenotype, and sputum culture results taken for patient | 1 Year |
| Radiological Outcomes | number of CT scans or Chest X rays done | 1 Year |
| Lung Function Outcomes | Lung function tests measured when clinically indicated, FEV1 (l) and FEV1 (% predicted), FEV1/FVC | 1 Year |
| Death Outcome | Death within 12 month follow-up | 1 Year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |