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Integrating Values Based Communication in Heart Failure Management

28. august 2026 opdateret af: Abigail Latimer

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

During this trial, the team aims to enroll three separate groups of participants: patients, care partners, and clinicians. Care partners are not required to participate with patients, but may choose to. At participating sites, trained clinician participants will identify patients through standard workflows, and research assistants will also screen clinic schedules for potentially eligible patients. If appropriate and eligible, the clinician will contact patients to gauge interest in participating in the study. Patients will receive information by mail before the clinic visit where the intervention, the Serious Illness Conversation, will occur. The mailing will include a handout that prompts the patient to think about and pre-answer many of the questions the clinician may cover during the visit. Patients will consent and complete enrollment measures before the clinic visit. Patients may complete these measures via an electronic link or paper format. Follow-up links or paper versions of measures will be provided following the visit at the 24-48 hour mark, 1 month, and 3 months.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40241
        • Norton Heart & Vascular Institute - Advanced Heart Failure & Recovery Program

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Serious Illness Care Program for Heart Failure (SICP-HF)
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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Survey of Illness Beliefs in Heart Failure
Tidsramme: At enrollment, then at 1 month and 3 months post intervention
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety
Tidsramme: 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.
We will be using the State-Trait Anxiety Inventory (STAI), which is a 40-item self-report psychological test measuring two distinct types of anxiety: temporary, situation-based "state anxiety" and long-standing, baseline "trait anxiety". Administered to patient participants only. State anxiety (20 items) and trait anxiety (20 items) are subscales. Each subscale is scored from 20 to 80, with higher scores indicating greater anxiety (worse outcome).
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
Tidsramme: This survey will be administered at enrollment, then again at 1 month and 3 months post-intervention.
Preparedness for Caregiving Scale: 8-item measure assessing caregivers' perceived preparedness to provide care and manage caregiving-related tasks. Items are rated on a 5-point scale from 0 (not at all prepared) to 4 (very well prepared), with total scores ranging from 0 to 32. Higher scores indicate greater caregiver preparedness (better outcome).
This survey will be administered at enrollment, then again at 1 month and 3 months post-intervention.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kansas City Cardiomyopathy Questionnaire (KCQQ-12)
Tidsramme: At enrollment and 1 month and 3 months post intervention.
The KCCQ-12 is a survey for people with heart failure measuring physical limits, symptoms, quality of life, and social restrictions. 12-item patient-reported measure of health status in heart failure, including symptoms, physical limitations, social limitations, quality of life, and symptom stability. Scores are transformed to a 0-100 scale, with 0 representing the worst health status and 100 representing the best health status. Higher scores indicate better heart failure-related health status (better outcome).
At enrollment and 1 month and 3 months post intervention.
Clinician-Patient Concordance in New York Heart Association Functional Class
Tidsramme: Immediately following the clinician encounter
Concordance between the clinician's assessment of the patient's current New York Heart Association (NYHA) functional class (Class I-IV) and the patient's heart failure health status as assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Clinician responses will be categorized as concordant, discordant, or intermediate based on prespecified mapping of KCCQ-12 responses to NYHA functional class. Lower discordance indicates better clinician-patient assessment agreement.
Immediately following the clinician encounter
Quality of Communication
Tidsramme: One time 24-48 hours post-intervention.
CollaboRATE: 3-item patient-reported measure of the quality of shared decision-making during a healthcare encounter. Each item is scored from 0 (no effort was made) to 9 (every effort was made). The total score ranges from 0 to 27, with higher scores indicating greater perceived shared decision-making (better outcome).
One time 24-48 hours post-intervention.
Clinician-Patient Concordance in Quality of Life
Tidsramme: Immediately following the clinician encounter
Concordance between the clinician's assessment of the patient's current overall quality of life (excellent, very good, good, fair, or poor) and the patient's quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Clinician responses will be categorized as concordant, discordant, or intermediate based on prespecified mapping of KCCQ-12 responses. Higher concordance indicates better clinician-patient assessment agreement.
Immediately following the clinician encounter
Clinician-Patient Concordance in Heart Failure Symptom Frequency
Tidsramme: Immediately following the clinician encounter
Concordance between the clinician's assessment of the frequency of the patient's current heart failure symptoms (never, rarely, sometimes, often, or almost always) and the patient's symptom burden as assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Clinician responses will be categorized as concordant, discordant, or intermediate based on prespecified mapping of KCCQ-12 responses. Higher concordance indicates better clinician-patient assessment agreement.
Immediately following the clinician encounter
Clinician-Patient Concordance in Expected Health Status Trajectory
Tidsramme: Immediately following the clinician encounter
Concordance between the clinician's anticipated patient health status trajectory over the next 6-12 months (significant improvement, some improvement, approximately the same, some decline, significant decline, or uncertain) and the patient's current health status as assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Clinician responses will be categorized as concordant, discordant, or intermediate based on prespecified mapping of KCCQ-12 responses. Higher concordance indicates better clinician-patient assessment agreement.
Immediately following the clinician encounter
Clinician-Patient Concordance in Primary Factor Impacting Quality of Life
Tidsramme: Immediately following the clinician encounter
Concordance between the clinician's identification of the primary factor currently impacting the patient's quality of life (heart failure symptoms, other medical conditions/comorbidities, physical functioning or limitations, emotional/psychological concerns, social or family circumstances, financial or housing concerns, treatment burden/healthcare demands, other, or unable to assess) and the patient's reported health status and quality-of-life responses on the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Responses will be categorized as concordant, discordant, or intermediate according to prespecified mapping. Higher concordance indicates better clinician-patient assessment agreement.
Immediately following the clinician encounter

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abigail Latimer

Samarbejdspartnere

American Heart Association

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

18. august 2026

Først indsendt, der opfyldte QC-kriterier

28. august 2026

Først opslået (Faktiske)

31. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 104431

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