Recruiting

Clinical Prediction Models

Sponsor:

University of British Columbia

Code:

NCT05309356

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

ACCEPT Decision Intervention

Comparator

Study Details

Brief summary:

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease of the lungs that affects more than 2.5 million Canadians. Patients with COPD experience episodes of lung attacks (or exacerbations). During these attacks, patients experience an intense increase in symptoms, such as breathlessness and cough. It is challenging to decide which patients should be put on treatments that would reduce the risk of such lung attacks. The digitization of health records in many clinics and hospitals means complex risk prediction algorithms can be used to predict the risk of lung attacks to enable personalized care. In this study, our team will implement a risk prediction tool (called ACCEPT) into the electronic health records in two teaching hospitals in Vancouver, British Columbia (BC), Canada. A clinical study will be conducted to evaluate if the use of this tool results in patients with COPD receiving better care with better outcomes, and if they are more satisfied with the care they are receiving.

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT05309356

Start date

Mar 21, 2023

Status verified date

May, 2023

Completion date

Jul, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are a legal Canadian resident
  • Aged 35 years and older
  • Can speak English
  • Have a diagnosis of COPD

Exclusion Criteria:

• Are under 35 years of age

Study Design

Enrollment

1130 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Usual care (Control)

Routine COPD patient care.

experimental: ACCEPT Decision Intervention

Clinical prediction model (ACCEPT)-based treatment recommendations: The ACCEPT tool will display the predicted risk of exacerbations, and the corresponding treatment recommendations to the physicians. These recommendations will be provided in a non-mandatory 'directive' format where the physician can override the recommendation, but is required to provide a justification (pre-set choices and a free text).

Interventions

ACCEPT Decision Intervention

The intervention consists of the CPM (ACCEPT) that is integrated with a decision aid, together called the ACCEPT Decision Intervention (ADI). The ADI will provide physicians with a quantification of the exacerbation risk for each patient and the corresponding treatment recommendation, as well as information about the benefits and risks of different inhaled therapies to discuss with the patients. The intervention also includes a 1-page take-home pamphlet on evidence-based risk behaviour factor modification for COPD, tailored to the treatment recommendation.

Comparator

The patient will receive the physician-recommended treatment for COPD (usual care). All physicians will be provided refresher training on the Canadian Thoracic Society COPD guidelines during the phase in period (month 1).

Primary outcome measure

  • Prescription appropriateness [ Time Frame: Cross-sectional: data collected during each patients initial study visit for the duration of the trial (24 months) ]

Central Contacts and Locations

Central contacts

Mohsen Sadatsafavi, MD, PhD

(604) 827-3020mohsen.sadatsafavi@ubc.ca

Don Sin, MD, MPH

(604) 806-8395Don.Sin@hli.ubc.ca

Locations

St Paul's Hospital, Heart and Lung Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Alexander Lin, BA

604-418-1207alexander.lin@ubc.ca

Principal Investigator:

Don Sin, MD, MPH

More Information

Sponsor

University of British Columbia

Last update posted

May 10, 2023

Last verified

May, 2023

Keywords

  • Precision medicine
  • Clinical prediction models
  • Medication adherence
  • Prescription appropriateness
  • Decision aid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-05-10.