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

• ClinicalTrials.gov Identifier: NCT03482700
• Recruitment Status: Active, not recruiting
• First Posted: March 29, 2018
• Last Update Posted: October 28, 2019
• Sponsor: Heart of England NHS Trust
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Heart of England NHS Trust

Tracking Information

• First Submitted Date: February 16, 2018
• First Posted Date: March 29, 2018
• Last Update Posted Date: October 28, 2019
• Actual Study Start Date: December 6, 2017
• Actual Primary Completion Date: June 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2018)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 21, 2019)

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

Original Secondary Outcome Measures (submitted: March 28, 2018)

• Referral Outcome [ Time Frame: 1 Year ]
  Referral to secondary care
• Unscheduled Outcome [ Time Frame: 1 Year ]
  Unscheduled healthcare consultations (ED attendance, hospital admissions)
• COPD Outcomes [ Time Frame: 1 Year ]
  COPD exacerbations
• 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
• Medications Outcomes [ Time Frame: 1 Year ]
  medications prescribed
• Biochemical markers of disease Outcomes [ Time Frame: 1 Year ]
  Biochemical markers of disease
• Radiological Outcomes [ Time Frame: 1 Year ]
  number of CT scans or Chest X rays done
• Lung Function Outcomes [ Time Frame: 1 Year ]
  Lung function tests measured when clinically indicated, FEV1 (l) and FEV1 (% predicted), FEV1/FVC
• Death Outcome [ Time Frame: 1 Year ]
  Death within 12 month follow-up

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Specialist Led Integrated Care in COPD
• Official Title: The Impact of Specialist Led Integrated Care on Guideline Adherence and Outcomes in COPD
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.
• Behavioral: Control Arm
  Usual standard of care

Study Arms

• 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.
  Intervention: Behavioral: Intervention Arm
• Control
  Usual standard of care
  Intervention: Behavioral: Control Arm

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 28, 2018): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2020
• Actual Primary Completion Date: June 3, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03482700
• Other Study ID Numbers: 2017069RM
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No IPD plan

• Responsible Party: Heart of England NHS Trust
• Study Sponsor: Heart of England NHS Trust
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: Alice Turner, MD; Heart of England NHS Foundation Trust

• PRS Account: Heart of England NHS Trust
• Verification Date: October 2019