Implementing Individualized Patient Reported Outcome Measures in Routine Care of Patients With Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Calgary
About this trial
Investigators recently developed the APPROACH electronic patient reported outcome (ePROM) Survey and Clinician Report tools to collect individual results from online quality of life and health status surveys for patients with coronary heart disease, and report them back to their treating clinicians. This pilot interventional study uses a pre-post design to assess whether implementing the ePROM system into routine care is feasible and acceptable to patients and physicians, and to inform feasibility for a larger clinical trial. Specifically, the investigators aim to evaluate use of the ePROM Patient Survey and Clinician Report among eligible outpatients with known or suspected coronary artery disease and their cardiologists. Additionally, the investigators aim to determine if the use of the APPROACH ePROMs Clinician Report in routine medical encounters is acceptable (based on administrative burden, ease of use, and time required) to patients and clinicians, and supports effective communication for management of symptoms of coronary artery disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age at least 40 years.
either (i) known coronary artery disease (defined as a history of myocardial infarction, percutaneous or surgical coronary revascularization, or documentation of obstructive coronary artery disease on previous invasive or CT angiography) or (ii) suspected coronary artery disease (defined as stable angina or anginal equivalent symptoms) as the reason for referral to a cardiologist.
Able to communicate in English or be 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.
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
ePROM Survey
Other interventionThe APPROACH ePROM survey consists of several well validated PROM instruments, including the Seattle Angina Questionnaire 7-item version,\[4\] the EuroQol EQ5D-5L,\[5\] the Medical Outcomes Study Social Support Scale (8 item version),\[6\] the Patient Health Questionnaire 2-item and 9-item (PHQ2/9) depression screening tools\[7\], and the Self-Care of Coronary Heart Disease Inventory (SC-CHDI-V3).\[8\]
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ePROM usage metrics
data extract for the ePROM Patient Survey will be prepared, summarizing the proportion of patients who completed the survey, as well as scale-level and item-level missingness among completers. Quantitative data for each component subscale (SAQ-7, EQ5D-5L and VAS, MOS SSS, PHQ2/PHQ9, CAS) will be summarized. Our target is a ≥70% survey response rate, with ≥ 90% item-level completion rate among respondents.
Time frame
Usage metrics will be collected during the intervention period (~4 months)2
Acceptability of the Clinician Report to clinicians
Participating cardiologists will be asked to complete an evaluation of their experience using the ePROM Clinician Report. This will be collected using a brief electronic survey administered after each study visit in the intervention period. This post-visit survey will be complemented by a single exit interview with participating physicians at study's end. The exit interview will assess the following using a semi-structured interview format with qualitative analysis.
Time frame
Post-visit surveys will be completed following every patient visit during the intervention period (~4 months), the exit interview will occur at the end of the intervention period.3
Acceptability and utility of the ePROM Patient Survey and Clinician Report to patients
Participating patients will be sent an electronic survey within 48 hours after their scheduled clinic visit, with a reminder phone call 4-7 days later to those who have not yet completed it.
Time frame
Patients will complete a post-visit survey following each visit during both the control and intervention period (~8 months).Sponsors and contacts
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Source ClinicalTrials.gov