Feasibility and Pilot Testing of "My Heart and CKD" Online Shared Decision Aid

NCT06920927 | Not Yet Recruiting

• 1 other identifier: REB22-0289
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

Many people with kidney disease also have heart disease. The procedures used to diagnose and treat heart disease (e.g., angiograms, angioplasty, or surgery) can improve symptoms and cardiovascular outcomes, but pose greater risks of kidney complications for people with chronic kidney disease. It's therefore important that patients with kidney disease and their health care providers understand the benefits versus risks of these procedures and use that information to make informed decisions regarding their health care. Prior research done with patients with kidney disease and their health care providers has led to the develop of a decision aid designed to help doctors provide personalized information on the benefits versus risks of having a heart procedure, as well as help patients communicate their own values and preferences to their doctor. This information is crucial for shared decision making, as previous research has shown that preferences and values vary for individual patients with kidney diseases, and should be incorporated into the decision-making process for heart disease management. The decision aid, called "My Heart Care and CKD", supports shared decision-making between patients with kidney disease and heart their care providers. This trial will implement and evaluate this decision aid within cardiovascular care in a pilot trial in Canada.

Conditions

Chronic Kidney Disease; Coronary Artery Disease

Keywords

Decision aid; Shared decision making

Outcome Measures

Primary Outcomes (5)

• Decisional Conflict Scale (O'Connor -8 question)

  Patient's perceptions of modifiable factors contributing to uncertainty with their decision such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

  Following patient-physician encounter (within 2 weeks)

• Patient Nine-item Shared Decision-Making Questionnaire (SDM-Q-9)

  Assessment of patient's perceived level of involvement in decision-making related to their own treatment.

  Following patient-physician encounter (within 2 weeks)

• Knowledge of Treatment Risks

  Patient's knowledge of the risks of kidney failure versus a heart attack in the future associated with the treatment choices of invasive versus optimal medical management presented in the decision aid

  Following patient-physician encounter (within 2 weeks)

• Accuracy of Risk Perception

  Whether a patient's perception of risk of the risk of kidney failure corresponds to the estimated risk of this outcome for a similar person receiving invasive management as presented in the decision aid

  Following patient-physician encounter (within 2 weeks)

• Value-Choice Congruence

  Whether a patient's choice of invasive versus optimal medical management is consistent with their most important stated values

  Following patient-physician encounter (within 2 weeks)

Secondary Outcomes (6)

• Preferred Choice

  Following patient physician encounter (within 2 weeks) and 3 months later

• Actual Choice

  Following patient-physician encounter (within 2 weeks)

• Adherence to Chosen Option

  Three months following the patient-physician encounter

• Decisional Regret Scale (O-Connor - 5 question)

  Three months following the patient-physician encounter

• Acceptability Scale (O'Connor - 10 question)

  Following patient-physician encounter (within 2 weeks)

Study Arms (2)

Decision aid intervention

EXPERIMENTAL

Patients in this group will receive care from their physician incorporating the use of the decision aid.

Other: Decision aid

Usual Care

NO INTERVENTION

Patients in this group will receive usual care from their physician without the use of the decision aid.

Interventions

Decision aid OTHER

Decision aid for use by physicians and patients with CKD when deciding upon an invasive vs a conservative approach to management of coronary artery disease.

Decision aid intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years of age or older)
• Chronic kidney disease
• Coronary artery disease (non-ST elevation acute coronary syndrome (ACS) or symptoms or signs of stable coronary heart disease)
• Able to communicate in English or French or through a support person who speaks English or French
• Patient has the cognitive ability or has a surrogate decision maker capable of participating in shared decision making based on the discretion of the attending physician

You may not qualify if:

• End stage kidney failure already being treated with dialysis or with an eGFR \< 10mL/min/1.73m2
• ST-elevation myocardial infarction
• Patient is not expected to survive to hospital discharge

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator
• Alberta Health services: collaborator

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 0M9, Canada

Location

Related Publications (3)

• Wilson T, Javaheri P, Finlay J, Hazlewood G, Wilton SB, Sajobi T, Levin A, Pearson W, Connolly C, James MT. Treatment Preferences for Cardiac Procedures of Patients With Chronic Kidney Disease in Acute Coronary Syndrome: Design and Pilot Testing of a Discrete Choice Experiment. Can J Kidney Health Dis. 2021 Jan 27;8:2054358120985375. doi: 10.1177/2054358120985375. eCollection 2021.

  PMID: 33552527 BACKGROUND

• Finlay J, Wilson T, Javaheri PA, Pearson W, Connolly C, Elliott MJ, Graham MM, Norris CM, Wilton SB, James MT. Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study. CMAJ Open. 2020 Dec 10;8(4):E860-E868. doi: 10.9778/cmajo.20200039. Print 2020 Oct-Dec.

  PMID: 33303572 BACKGROUND

• Wilson TA, Hazlewood GS, Sajobi TT, Wilton SB, Pearson WE, Connolly C, Javaheri PA, Finlay JL, Levin A, Graham MM, Tonelli M, James MT. Preferences of Patients With Chronic Kidney Disease for Invasive Versus Conservative Treatment of Acute Coronary Syndrome: A Discrete Choice Experiment. J Am Heart Assoc. 2023 Mar 21;12(6):e028492. doi: 10.1161/JAHA.122.028492. Epub 2023 Mar 9.

  PMID: 36892063 BACKGROUND

Related Links

• Shared Decision-Making for Heart and Kidney Disease

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Coronary Artery Disease

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Matthew T James, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pantea Javaheri, MRSc

CONTACT

1 (403) 220 2465; pantea.javaheri@ucalgary.ca

Study Design

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

Model Details: Cluster randomized stepped wedge design

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)