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Impact of Specialist Led Integrated Care in COPD (INTEGR-COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482700
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Heart of England NHS Trust

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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Intervention Arm Behavioral: Control Arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : June 3, 2019
Estimated Study Completion Date : March 1, 2020

Arm Intervention/treatment
Intervention
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.
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
Usual standard of care
Behavioral: Control Arm
Usual standard of care




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Referral Outcome [ Time Frame: 1 Year ]
    Referral to secondary care

  2. Unscheduled Outcome [ Time Frame: 1 Year ]
    Unscheduled healthcare consultations (ED attendance, hospital admissions)

  3. COPD Outcomes [ Time Frame: 1 Year ]
    COPD exacerbations

  4. Healthcare Outcomes [ Time Frame: 1 Year ]
    mean cost per patient in £ of the total cost of hospital attendances, GP visits, medications and vaccines during the study period

  5. Medications Outcomes [ Time Frame: 1 Year ]
    medications prescribed

  6. Biochemical markers of disease Outcomes [ Time Frame: 1 Year ]
    FBC, U&E, LFT, CRP, AAT level/phenotype, and sputum culture results taken for patient

  7. Radiological Outcomes [ Time Frame: 1 Year ]
    number of CT scans or Chest X rays done

  8. Lung Function Outcomes [ Time Frame: 1 Year ]
    Lung function tests measured when clinically indicated, FEV1 (l) and FEV1 (% predicted), FEV1/FVC

  9. Death Outcome [ Time Frame: 1 Year ]
    Death within 12 month follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482700


Locations
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United Kingdom
Dr. Sarah Pountain
Birmingham, West Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
Heart of England NHS Trust
AstraZeneca
Investigators
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Principal Investigator: Alice Turner, MD Heart of England NHS Foundation Trust
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Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT03482700    
Other Study ID Numbers: 2017069RM
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart of England NHS Trust:
COPD; GP Surgeries