Clinical trial NCT03482700: Impact of Specialist Led Integrated Care in COPD
Official title: The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: COPD; GP Surgeries
Lead sponsor: Heart of England NHS Trust
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2018-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of provision of guideline-based care in intervention and control practices for patients.
timeFrame: 1 Year
Secondary outcomes:
measure: Referral Outcome
timeFrame: 1 Year
measure: Unscheduled Outcome
timeFrame: 1 Year
measure: COPD Outcomes
timeFrame: 1 Year
measure: Healthcare Outcomes
timeFrame: 1 Year
measure: Medications Outcomes
timeFrame: 1 Year
measure: Biochemical markers of disease Outcomes
timeFrame: 1 Year
measure: Radiological Outcomes
timeFrame: 1 Year
measure: Lung Function Outcomes
timeFrame: 1 Year
measure: Death Outcome
timeFrame: 1 Year
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Dr. Sarah Pountain
state: West Midlands
Study officials:
affiliation: Heart of England NHS Foundation Trust
name: Alice Turner, MD
role: PRINCIPAL_INVESTIGATOR
References: