Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
Healthy Volunteers
ID06164457

Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease: a Pilot Study

Led by University of Calgary · Updated on 2026-05-14

200

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility and acceptability of the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools among patients with known or suspected coronary artery disease and their cardiologists. This pilot interventional study aims to determine whether using these tools in routine outpatient cardiology care supports effective communication and management of symptoms, and to prepare for a larger clinical trial. The study includes both patients and cardiologists in Alberta outpatient cardiology practices. The study has two main periods: a control period where patients attend cardiology appointments as usual without the ePROM survey, and an intervention period where patients complete the APPROACH ePROM survey before their visit. Cardiologists receive training on using the ePROM Clinician Report during the intervention period, which summarizes patient survey results to aid clinical care. The intervention period lasts approximately four months or until 30 patients per practice are enrolled. Patients complete a single clinic visit during the study without long-term follow-up. Participants will be screened and recruited before their outpatient cardiology visit, providing baseline demographic and clinical information. During the intervention period, patients complete the ePROM survey online at least 72 hours before their appointment, with support and reminders provided. After visits, patients complete surveys assessing communication and satisfaction, and clinicians provide feedback on the report's acceptability and utility. The study collects usage data and patient and clinician perceptions to assess the intervention's impact on care processes and communication over about eight months.

CONDITIONS

Brief Title

Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 40 years
  • Known coronary artery disease or suspected coronary artery disease with stable angina or similar symptoms
  • Able to communicate in English or willing to have an English-speaking family member or friend assist with survey completion
  • Access to the internet, valid email address, and a web-enabled device for survey completion
  • Upcoming outpatient visit with a study cardiologist in the next 14 to 28 days
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Control Period

Duration - Up to 4 months or until 30 patients enrolled per practice, whichever is soonest

Participants attend their cardiology appointment as usual without completing the ePROM survey. After the visit, they complete a post-visit electronic survey assessing communication effectiveness and satisfaction with care.

1 cardiology appointment visit and 1 post-visit electronic survey

Intervention Period

Duration - Up to 4 months or until 30 patients enrolled per practice, whichever is soonest

Participants complete the ePROM patient survey before their cardiology appointment. Clinicians receive a report summarizing the survey results to support the clinical visit. Participants then complete a post-visit electronic survey assessing communication and satisfaction.

1 pre-visit survey, 1 cardiology appointment visit, and 1 post-visit electronic survey

Trial Site Locations

Total: 2 locations

1

Cumming School of Medicine, University of Calgary

Calgary, Alberta, Canada, T2N1N4

Actively Recruiting

2

Department of Medicine, University of Alberta

Calgary, Alberta, Canada, T6G2R3

Actively Recruiting

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Research Team

S

Stephen B WIlton, MD, MSc

M

Maria E Dalton, MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis.

Joanne Greenhalgh, Kate Gooding, Elizabeth Gibbons...

https://pubmed.ncbi.nlm.nih.gov/30294712

Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool.

Gregory Makoul, Edward Krupat, Chih-Hung Chang

https://pubmed.ncbi.nlm.nih.gov/17574367

The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance.

André Moser, Andreas E Stuck, Rebecca A Silliman...

https://pubmed.ncbi.nlm.nih.gov/22818947

Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis.

Brooke Levis, Ying Sun, Chen He...

https://pubmed.ncbi.nlm.nih.gov/32515813

Individualized Electronic Patient-Reported Outcome Measures As a Communication Aid in Outpatient Cardiology Care: A Study Protocol.

Maria Dalton, Denise Kruger, Tolulope T Sajobi...

https://pubmed.ncbi.nlm.nih.gov/40433203