Impact of Specialist Led Integrated Care in COPD

COPD Clinical Trial

— INTEGR-COPD  

Official title:

The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03482700
• Other study ID #: 2017069RM
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2019
• Source: Heart of England NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2020
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Intervention Arm
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 Arm
Usual standard of care

Locations

Country	Name	City	State
United Kingdom	Dr. Sarah Pountain	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
Heart of England NHS Trust	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Referral Outcome	Referral to secondary care	1 Year
Secondary	Unscheduled Outcome	Unscheduled healthcare consultations (ED attendance, hospital admissions)	1 Year
Secondary	COPD Outcomes	COPD exacerbations	1 Year
Secondary	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
Secondary	Medications Outcomes	medications prescribed	1 Year
Secondary	Biochemical markers of disease Outcomes	FBC, U&E, LFT, CRP, AAT level/phenotype, and sputum culture results taken for patient	1 Year
Secondary	Radiological Outcomes	number of CT scans or Chest X rays done	1 Year
Secondary	Lung Function Outcomes	Lung function tests measured when clinically indicated, FEV1 (l) and FEV1 (% predicted), FEV1/FVC	1 Year
Secondary	Death Outcome	Death within 12 month follow-up	1 Year