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

NCT06164457 | Unknown

• 1 other identifier: REB22-1370
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coronary Artery Disease; Patient Acceptance of Health Care; Physician-Patient Relations

Keywords

coronary artery disease; patient reported outcome measures; cardiac science; communication assessment; quality improvement; feasibility

Outcome Measures

Primary Outcomes (3)

• 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.

  Usage metrics will be collected during the intervention period (~4 months)

• 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.

  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.

• 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.

  Patients will complete a post-visit survey following each visit during both the control and intervention period (~8 months).

Study Arms (2)

Control Group

NO INTERVENTION

Patients in this group will attend their cardiology appointment as normal. No intervention present.

Intervention Group

EXPERIMENTAL

Patients in this group will complete the ePROM patient survey in advance of their care visit.

Other: ePROM Survey

Interventions

ePROM Survey OTHER

The 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).\[8\]

Intervention Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Upcoming outpatient visit with a study cardiologist in the next 14-28 day

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Cumming School of Medicine, University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

Department of Medicine, University of Alberta

Calgary, Alberta, T6G2R3, Canada

Location

Related Publications (10)

• Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J, Valderas J, Black N. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018 Sep 15;2:42. doi: 10.1186/s41687-018-0061-6. eCollection 2018 Dec.

  PMID: 30294712 BACKGROUND

• Ishaque S, Karnon J, Chen G, Nair R, Salter AB. A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs). Qual Life Res. 2019 Mar;28(3):567-592. doi: 10.1007/s11136-018-2016-z. Epub 2018 Oct 3.

  PMID: 30284183 BACKGROUND

• Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.

  PMID: 17574367 BACKGROUND

• Chan PS, Jones PG, Arnold SA, Spertus JA. Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):640-7. doi: 10.1161/CIRCOUTCOMES.114.000967. Epub 2014 Sep 2.

  PMID: 25185249 BACKGROUND

• Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.

  PMID: 33284428 BACKGROUND

• Moser A, Stuck AE, Silliman RA, Ganz PA, Clough-Gorr KM. The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. J Clin Epidemiol. 2012 Oct;65(10):1107-16. doi: 10.1016/j.jclinepi.2012.04.007. Epub 2012 Jul 20.

  PMID: 22818947 BACKGROUND

• Levis B, Sun Y, He C, Wu Y, Krishnan A, Bhandari PM, Neupane D, Imran M, Brehaut E, Negeri Z, Fischer FH, Benedetti A, Thombs BD; Depression Screening Data (DEPRESSD) PHQ Collaboration; Che L, Levis A, Riehm K, Saadat N, Azar M, Rice D, Boruff J, Kloda L, Cuijpers P, Gilbody S, Ioannidis J, McMillan D, Patten S, Shrier I, Ziegelstein R, Moore A, Akena D, Amtmann D, Arroll B, Ayalon L, Baradaran H, Beraldi A, Bernstein C, Bhana A, Bombardier C, Buji RI, Butterworth P, Carter G, Chagas M, Chan J, Chan LF, Chibanda D, Cholera R, Clover K, Conway A, Conwell Y, Daray F, de Man-van Ginkel J, Delgadillo J, Diez-Quevedo C, Fann J, Field S, Fisher J, Fung D, Garman E, Gelaye B, Gholizadeh L, Gibson L, Goodyear-Smith F, Green E, Greeno C, Hall B, Hampel P, Hantsoo L, Haroz E, Harter M, Hegerl U, Hides L, Hobfoll S, Honikman S, Hudson M, Hyphantis T, Inagaki M, Ismail K, Jeon HJ, Jette N, Khamseh M, Kiely K, Kohler S, Kohrt B, Kwan Y, Lamers F, Asuncion Lara M, Levin-Aspenson H, Lino V, Liu SI, Lotrakul M, Loureiro S, Lowe B, Luitel N, Lund C, Marrie RA, Marsh L, Marx B, McGuire A, Mohd Sidik S, Munhoz T, Muramatsu K, Nakku J, Navarrete L, Osorio F, Patel V, Pence B, Persoons P, Petersen I, Picardi A, Pugh S, Quinn T, Rancans E, Rathod S, Reuter K, Roch S, Rooney A, Rowe H, Santos I, Schram M, Shaaban J, Shinn E, Sidebottom A, Simning A, Spangenberg L, Stafford L, Sung S, Suzuki K, Swartz R, Tan PLL, Taylor-Rowan M, Tran T, Turner A, van der Feltz-Cornelis C, van Heyningen T, van Weert H, Wagner L, Li Wang J, White J, Winkley K, Wynter K, Yamada M, Zhi Zeng Q, Zhang Y. Accuracy of the PHQ-2 Alone and in Combination With the PHQ-9 for Screening to Detect Major Depression: Systematic Review and Meta-analysis. JAMA. 2020 Jun 9;323(22):2290-2300. doi: 10.1001/jama.2020.6504.

  PMID: 32515813 BACKGROUND

• Vaughan Dickson V, Lee CS, Yehle KS, Mola A, Faulkner KM, Riegel B. Psychometric Testing of the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). Res Nurs Health. 2017 Feb;40(1):15-22. doi: 10.1002/nur.21755. Epub 2016 Sep 30.

  PMID: 27686630 BACKGROUND

• Davis FD. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13: 319-340.

  BACKGROUND

• Dalton M, Kruger D, Sajobi TT, Southern D, Wilson T, Har BJ, Graham MM, Wilton SB, James MT. Individualized Electronic Patient-Reported Outcome Measures As a Communication Aid in Outpatient Cardiology Care: A Study Protocol. CJC Open. 2025 Feb 18;7(5):678-685. doi: 10.1016/j.cjco.2025.02.009. eCollection 2025 May.

  PMID: 40433203 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stephen B Wilton, MD, MSc

  APPROACH Research Group, Libin Cardiovascular Institute, Cumming School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen B WIlton, MD, MSc

CONTACT

4032207102; sbwilton@ucalgary.ca

Maria E Dalton, MSc.

CONTACT

4032106215; maria.dalton1@ucalgary.ca

Study Design

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

Model Details: Pre-post intervention

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)