Impact of Specialist Led Integrated Care in COPD

NCT03482700 | Unknown

• 1 other identifier: 2017069RM
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; GP Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Referral Outcome

  1 Year

• Unscheduled Outcome

  1 Year

• COPD Outcomes

  1 Year

• Healthcare Outcomes

  1 Year

• Medications Outcomes

  1 Year

Study Arms (2)

Intervention

OTHER

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

Control

OTHER

Usual standard of care

Behavioral: Control Arm

Interventions

Intervention Arm BEHAVIORAL

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

Control Arm BEHAVIORAL

Usual standard of care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart of England NHS Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

Dr. Sarah Pountain

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related Publications (2)

• Patel K, Smith DJ, Huntley CC, Channa SD, Pye A, Dickens AP, Gale N, Turner AM. Exploring the causes of COPD misdiagnosis in primary care: A mixed methods study. PLoS One. 2024 Mar 6;19(3):e0298432. doi: 10.1371/journal.pone.0298432. eCollection 2024.

  PMID: 38446828 DERIVED

• Patel K, Pye A, Edgar RG, Beadle H, Ellis PR, Sitch A, Dickens AP, Turner AM. Cluster randomised controlled trial of specialist-led integrated COPD care (INTEGR COPD). Thorax. 2024 Feb 15;79(3):209-218. doi: 10.1136/thorax-2023-220435.

  PMID: 38286619 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice Turner, MD

  Heart of England NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 29, 2018
• Study Start: December 6, 2017
• Primary Completion: June 3, 2019
• Study Completion: March 1, 2020
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)