Chronic Obstructive Pulmonary DiseaseNCT05309356
Using Clinical Prediction Models to Improve Treatment for Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing ACCEPT Decision Intervention and Comparator in people with Chronic Obstructive Pulmonary Disease, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ACCEPT Decision Intervention and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,130 participants
- Where
- 2 sitesCanada
- Study dates
- 21 Mar 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are a legal Canadian resident
- Aged 35 years and older
- Can speak English
- Have a diagnosis of COPD
Who cannot join
- Are under 35 years of age
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
The Lung Centre, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Prabjit Barn, PhD, 604-875-4111 ext. 23137, prabjit.barn@vch.ca
Chris Carlsten, MD, MPH
- Recruiting
St Paul's Hospital, Heart and Lung Centre
Vancouver, British Columbia, V6Z1Y6
Alexander Lin, BA, 604-418-1207, alexander.lin@ubc.ca
Don Sin, MD, MPH
About this study
Official title: IMplementing Predictive Analytics Towards Efficient COPD Treatments (IMPACT) Study
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.
Read the detailed description
COPD is a heterogenous and progressive disease of the airways that affects millions of people worldwide. However, current treatment guidelines fail to provide personalised, patient-centered disease management. In contrast, precision medicine emphasizes the tailoring of disease management to patient characteristics and values to optimize patient care and outcomes. Clinical prediction models (CPMs) are major enablers of precision medicine, and facilitate targeted therapies to patients who will benefit the most from them.
The investigators developed a CPM called ACCEPT that improves risk stratification for COPD patients by predicting the risk of exacerbation at an individual level and thereby enabling personalized, preventive disease management. Using a stepped wedged cluster randomized controlled trial (RCT), the investigators aim to evaluate the impact of integrating ACCEPT into routine COPD care at two outpatient respiratory clinics in Vancouver, British Columbia, Canada.
The 'stepped wedged' RCT has a cross-over design, with treatment assignment done in a uni-directional, staggered format that will provide opportunities to control for time trend. The total duration of the study is 30 months. There will be a one-month phase in period with patient recruitment and data collection starting on month two. The last physician assignment will occur in month 18, and patient recruitment will continue until month 24. Follow-up data will be collected until month 30 to ensure six months of follow-up data for all patients.
Primary and secondary outcomes will be analysed using generalized estimating equations to account for possible clustering of endpoints (multiple visits for each physician). Further, following the intention to treat principle, clusters (physicians) will be analyzed according to their randomized crossover time irrespective of whether crossover was achieved at the desired time.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ACCEPT Decision Intervention, Comparator
- Keywords
- Precision medicine, Clinical prediction models, Medication adherence, Prescription appropriateness, Decision aid
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCEPT Decision InterventionOther
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.
ComparatorOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual care (Control) | Active comparator | Routine COPD patient care. Receives: Other: Comparator |
| ACCEPT Decision Intervention | Experimental | 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). Receives: Other: ACCEPT Decision Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription appropriateness
Binary variable indicating the concordance between the physician- and ACCEPT-based treatment recommendations (0: discordant prescription, 1: concordant prescription). We will compare the percentage of prescription appropriateness between the two study arms.
The prescription recommended by the physician during the clinical encounter will be recorded. After the encounter, a research coordinator will interview the patient, use ACCEPT to produce the ACCEPT-based optimal treatment for the patient.
The physician prescription will be considered concordant if it is the same as the prescription based on the ACCEPT recommendation (or if ACCEPT suggests more than one eligible prescription, the physician prescription is one of them), otherwise it will be considered discordant.
Measured: Cross-sectional: data collected during each patients initial study visit for the duration of the trial (24 months)
Secondary outcomes (5)
Medication adherence
Medication adherence will be measured by the Medication Possession Ratio, defined as the ratio of the total days' supply dispensed to the total days' supply prescribed during the study period. This outcome will be assessed by linking patient data to BC's administrative health databases using each individual's unique Personal Health Number.
Measured: 1 year before and 1 year after initial study visit (day 1).
Rate of moderate or severe exacerbations
This outcome will be assessed by linking patient data to BC's administrative health databases using each individual's unique Personal Health Number. Moderate exacerbations will be defined any outpatient physician visit for COPD followed by filling prescriptions for antibiotic or oral corticosteroids. Severe exacerbations will be define as hospital admission with the main discharge code of COPD.
Measured: 1 year before and 1 year after initial study visit.
Self-reported medication adherence and beliefs
COPD-specific Beliefs about Medicines Questionnaire (BMQ)
Measured: BMQ-COPD will be administered at baseline (study visit 1, day 1), month 3, and month 6
Impact of COPD on patient's daily life
Measured by the COPD Assessment Test (CAT)
Measured: CAT will be administered at baseline (study visit 1, day 1), month 3, and month 6
COPD patient's Quality of Life
Measured by the EuroQoL 5-dimension (EQ5D) questionnaire
Measured: EQ5D will be administered at baseline (study visit 1, day 1), month 3, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start21 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will conduct a prospective, pragmatic two-year stepped-wedged cluster RCT to evaluate the impact of ACCEPT on the process of care, patient-reported, and clinical outcomes. The trial was designed based on 24 participating physicians, comprising the study clusters. All physicians will be assigned to the comparator arm (usual care) at the beginning of the study. After 6 months, under a sequential rollout, two randomly selected physicians will be reassigned to the intervention arm (ACCEPT) every month.
- Masking
- None (open label)
- Enrolment
- 1,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services, Vancouver Coastal Health
- Responsible party
- Principal investigator, Mohsen Sadatsafavi, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309356
- Sponsor's protocol ID
- H21-02348
- Other IDs
- F20-05804
- Status last verified
- May 2023
- First submitted
- 14 Mar 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data sets collected as part of this study, with the exception of the administrative health data, will be shared via the DRYAD initiative. The Dryad Digital Repository is a curated resource that makes research data discoverable, freely reusable, and citable. Dryad provides a general-purpose home for a wide diversity of data types. Study investigators will share anonymized (free from patient identifiers as well as any sensitive data that might identify specific patients \[e.g., extremely rare comorbid conditions\]). The linked administrative health data, however, will not be shared, as such data are under the stewardship of British Columbia's Ministry of Health and is protected by the provincial Freed of Information and Protection of Privacy Act which prohibits its sharing.
Publications
Michaux KD, Metcalfe RK, Burns P, Conklin AI, Hoens AM, Smith D, Struik L, Safari A, Sin DD, Sadatsafavi M; IMPACT Study Group. IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study. Diagn Progn Res. 2023 Feb 14;7(1):3. doi: 10.1186/s41512-023-00140-6.
PubMed 36782301
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMplementing Predictive Analytics Towards Efficient COPD Treatments (IMPACT) Study
- ClinicalTrials.gov ID
- NCT05309356
- Acronym / sponsor ID
- H21-02348
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Precision medicine, Clinical prediction models, Medication adherence, Prescription appropriateness, Decision aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,130 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Providence Health & Services, Vancouver Coastal Health
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COPD is a heterogenous and progressive disease of the airways that affects millions of people worldwide. However, current treatment guidelines fail to provide personalised, patient-centered disease management. In contrast, precision medicine emphasizes the tailoring of disease management to patient characteristics and values to optimize patient care and outcomes. Clinical prediction models (CPMs) are major enablers of precision medicine, and facilitate targeted therapies to patients who will benefit the most from them.
The investigators developed a CPM called ACCEPT that improves risk stratification for COPD patients by predicting the risk of exacerbation at an individual level and thereby enabling personalized, preventive disease management. Using a stepped wedged cluster randomized controlled trial (RCT), the investigators aim to evaluate the impact of integrating ACCEPT into routine COPD care at two outpatient respiratory clinics in Vancouver, British Columbia, Canada.
The 'stepped wedged' RCT has a cross-over design, with treatment assignment done in a uni-directional, staggered format that will provide opportunities to control for time trend. The total duration of the study is 30 months. There will be a one-month phase in period with patient recruitment and data collection starting on month two. The last physician assignment will occur in month 18, and patient recruitment will continue until month 24. Follow-up data will be collected until month 30 to ensure six months of follow-up data for all patients.
Primary and secondary outcomes will be analysed using generalized estimating equations to account for possible clustering of endpoints (multiple visits for each physician). Further, following the intention to treat principle, clusters (physicians) will be analyzed according to their randomized crossover time irrespective of whether crossover was achieved at the desired time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct a prospective, pragmatic two-year stepped-wedged cluster RCT to evaluate the impact of ACCEPT on the process of care, patient-reported, and clinical outcomes. The trial was designed based on 24 participating physicians, comprising the study clusters. All physicians will be assigned to the comparator arm (usual care) at the beginning of the study. After 6 months, under a sequential rollout, two randomly selected physicians will be reassigned to the intervention arm (ACCEPT) every month.
| Arm | Type | Receives |
|---|---|---|
| Usual care (Control) | Active comparator | Other: ComparatorRoutine COPD patient care. |
| ACCEPT Decision Intervention | Experimental | Other: ACCEPT Decision InterventionClinical 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). |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are a legal Canadian resident
- Aged 35 years and older
- Can speak English
- Have a diagnosis of COPD
Key exclusion criteria (1 listed)
- Are under 35 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCEPT Decision InterventionThe 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. | Other | ACCEPT Decision Intervention |
| ComparatorThe 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). | Other | Usual care (Control) |
Primary outcome
Prescription appropriateness
Time frame: Cross-sectional: data collected during each patients initial study visit for the duration of the trial (24 months)
Binary variable indicating the concordance between the physician- and ACCEPT-based treatment recommendations (0: discordant prescription, 1: concordant prescription). We will compare the percentage of prescription appropriateness between the two study arms. The prescription recommended by the physician during the clinical encounter will be recorded. After the encounter, a research coordinator will interview the patient, use ACCEPT to produce the ACCEPT-based optimal treatment for the patient. The physician prescription will be considered concordant if it is the same as the prescription based on the ACCEPT recommendation (or if ACCEPT suggests more than one eligible prescription, the physician prescription is one of them), otherwise it will be considered discordant.
5 secondary outcomes
Medication adherence
Time frame: 1 year before and 1 year after initial study visit (day 1).
Rate of moderate or severe exacerbations
Time frame: 1 year before and 1 year after initial study visit.
Self-reported medication adherence and beliefs
Time frame: BMQ-COPD will be administered at baseline (study visit 1, day 1), month 3, and month 6
Impact of COPD on patient's daily life
Time frame: CAT will be administered at baseline (study visit 1, day 1), month 3, and month 6
COPD patient's Quality of Life
Time frame: EQ5D will be administered at baseline (study visit 1, day 1), month 3, and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 36782301Michaux KD, Metcalfe RK, Burns P, Conklin AI, Hoens AM, Smith D, Struik L, Safari A, Sin DD, Sadatsafavi M; IMPACT Study Group. IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study. Diagn Progn Res. 2023 Feb 14;7(1):3. doi: 10.1186/s41512-023-00140-6.
- Individual participant dataSharing planned: Yes. All data sets collected as part of this study, with the exception of the administrative health data, will be shared via the DRYAD initiative. The Dryad Digital Repository is a curated resource that makes research data discoverable, freely reusable, and citable. Dryad provides a general-purpose home for a wide diversity of data types. Study investigators will share anonymized (free from patient identifiers as well as any sensitive data that might identify specific patients [e.g., extremely rare comorbid conditions]). The linked administrative health data, however, will not be shared, as such data are under the stewardship of British Columbia's Ministry of Health and is protected by the provincial Freed of Information and Protection of Privacy Act which prohibits its sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCEPT Decision Intervention and Comparator in people with Chronic Obstructive Pulmonary Disease, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Sadatsafavi, MD, PhD ((604) 827-3020, mohsen.sadatsafavi@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.