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

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

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.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Behavioral: Intervention Arm; Behavioral: Control Arm

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
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B9 5SS
      • Dr. Sarah Pountain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: Control; Usual standard of care	Behavioral: Control Arm; Usual standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral Outcome	Referral to secondary care	1 Year
Unscheduled Outcome	Unscheduled healthcare consultations (ED attendance, hospital admissions)	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

Collaborators and Investigators

• Sponsor: Heart of England NHS Trust
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Alice Turner, MD, Heart of England NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2017
• Primary Completion (ACTUAL): June 3, 2019
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: COPD; GP Surgeries
• Other Study ID Numbers: 2017069RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No