Integrating Values Based Communication in Heart Failure Management

NCT07794930 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-31

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794930 on ClinicalTrials.gov