Heart Failure
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALSerious 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
Abigail Latimer
American Heart Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Survey of Illness Beliefs in Heart Failure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| Caregiver Preparedness | 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). |
Countries
United States
Contacts
CONTACTAbigail Latimer
Outcome results
None listed