Integrating Values Based Communication in Heart Failure Management

NCT07794930 | Not Yet Recruiting

• 1 other identifier: 104431
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Living with heart failure for adults over age 50 is hard. Older adults have to take many medicines to address heart failure and other health problems. That group of individuals must decide which medications to take and which devices to use to support heart health. Doctors, nurses, and social workers help patients understand these options but do not always know what is most important to them. Talking with patients about what the patients are hoping for, what the patients are worried about, and how much the patients understand about the illness is called a serious illness conversation, and it is hard to do. Doctors, nurses, and social workers are very busy and worry about upsetting patients by bringing up hard topics. The Serious Illness Care Program helps doctors, nurses, and social workers have these conversations by giving the staff a script to follow on what to say. The program also includes ways to make sure staff remember to have the conversation, a brief training, and how to document what is said during the conversation. But, nobody has studied the Serious Illness Care Program in a heart failure clinic, so it has not been customized to meet the needs of heart failure teams or older adults with heart failure. Many programs that are supposed to help patients fail in the real world. One reason is that patients do not include the needs of those who will receive and deliver it. Before this project, the team interviewed heart failure doctors, nurses, social workers, and other staff at a heart failure clinic. As well as interviewing older adults and care partners. The team asked staff how the Serious Illness Care Program can be changed to fit the needs and work in the clinic. The program includes a conversation guide that helps the team know what to say, so the study team asked patients and care partners what the thoughts on the language used and the topics covered. Then, the team practiced putting the program in place at the clinic and trained clinicians on using the Serious Illness Care Program with older adults and family members. Now the team wants to see if the heart failure team likes it and if it is doable. The team will also ask patients and care partners about the conversation and about feelings of anxiety before, during, and after the conversation. Lastly, the team will ask the individuals before and after the conversation about patients' knowledge of heart failure and how prepared the care partner feels to care for the individual. The team also want to explore how the program helps clinicians understand patients' symptoms, quality of life, and illness knowledge. Ultimately, this project establishes a structured framework to facilitate goals-of-care discussions between heart failure teams, patients, and families. These conversations empower patients to make immediate and future medical decisions aligned with personal values and lifestyle preferences. This values-based decision-making process optimizes care delivery and supports patients in achieving optimal health outcomes.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• The Survey of Illness Beliefs in Heart Failure

  Survey of Illness Beliefs in Heart Failure: 14-item measure of the accuracy of patients' beliefs about heart failure. Items are rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Responses are scored to reflect accurate versus inaccurate illness beliefs, producing a total score ranging from 0 to 14. Higher scores indicate more accurate illness beliefs (better outcome).

  At enrollment, then at 1 month and 3 months post intervention

Secondary Outcomes (2)

• Anxiety

  Trait anxiety will be measured at enrollment and at 1month and 3 months post-intervention. State anxiety will be measured 24-48 hours prior to intervention and again 24-48 hours post intervention.

• Caregiver Preparedness

  This survey will be administered at enrollment, then again at 1 month and 3 months post-intervention.

Other Outcomes (7)

• Kansas City Cardiomyopathy Questionnaire (KCQQ-12)

  At enrollment and 1 month and 3 months post intervention.

• Clinician-Patient Concordance in New York Heart Association Functional Class

  Immediately following the clinician encounter

• Quality of Communication

  One time 24-48 hours post-intervention.

Study Arms (1)

Serious Illness Care Program for Heart Failure (SICP-HF)

EXPERIMENTAL

Participants receive the Serious Illness Care Program adapted for heart failure (SICP-HF). Clinicians are trained to integrate the communication intervention into routine outpatient heart failure care. Patients, care partners, and clinic staff participate in implementation and evaluation activities.

Behavioral: Serious Illness Care Program for Heart Failure (SICP-HF)

Interventions

Serious Illness Care Program for Heart Failure (SICP-HF) BEHAVIORAL

The Serious Illness Care Program adapted for heart failure is a behavioral communication intervention that includes clinician training and use of a structured Serious Illness Conversation Guide to facilitate values-based communication during the routine heart failure care. The intervention is implemented in an outpatient cardiology clinic and evaluated using a pre-post design.

Serious Illness Care Program for Heart Failure (SICP-HF)

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adult patients with a diagnosis of heart failure.
• Care partners providing support to an enrolled patient.
• Heart failure clinic staff participating in implementation of the intervention.
• Able to provide informed consent.
• English speaking.

You may not qualify if:

• Severe cognitive impairment affecting the ability to provide informed consent or follow study procedures.
• Major psychiatric disorders that interfere with participation.
• Non-English speaking.
• Clinic staff who do not work in the heart failure clinic.
• Students are not eligible to participate.

Sponsors & Collaborators

• Abigail Latimer: lead
• American Heart Association: collaborator

Study Sites (1)

Norton Heart & Vascular Institute - Advanced Heart Failure & Recovery Program

Louisville, Kentucky, 40241, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Abigail Latimer

CONTACT

8592571267; abbie.latimer@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

US (1)