Heart Failure Clinical Trial

Patient and Family Partners in Heart Failure Care: Pilot Test of a Pre-visit Question Prompt List to Enhance Engagement During Medical Visits

Summary

The purpose of this study is to conduct a pilot study in 30 Heart Failure (HF) patients and visit companions (i.e., a family member who accompanies the patient to medical visits), to evaluate a pre- visit question/topic prompt list, designed to enhance patient and family member engagement during visits by providing a list of questions or topics that they may want to discuss with their health care provider.

View Full Description

Full Description

Participants in this study will include 30 HF patients or dyads (i.e., a patient and family member who accompanies the patient into the examination room at a visit). While our study primarily will target HF dyads, if the investigators encounter recruitment difficulties, unaccompanied HF patients (i.e., HF patients who do not have a family member who can participate in the study with them) will also be enrolled.

Procedures (methods): Single group pre-post study design.

After providing informed consent, HF patients or dyads will receive the prompt list while in the waiting room prior to their visit. Completing the prompt list involves two steps. In step 1, participants will independently select from a predetermined list of questions (within topic areas) that they would like to ask their health care provider. The questions/topics were developed by other HF patients and family members in another phase of the study. Also, patients will be asked to choose behaviors they would like their family member to engage in during the visit (e.g., write down the provider's instructions, ask questions), from a structured list developed based on prior research. Family members will identify which behaviors they are willing to perform. In step 2, patients or dyads will collectively prioritize which questions/topics to discuss during the visit. Each dyad member will receive a prompt list to complete in the clinic waiting room immediately before their appointment.

All visits will be audio-taped to assess effects of the intervention on communication behaviors during the visit. All participants will complete a questionnaire at baseline, 2 days after the audio-taped clinic visit, and at 3 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient Eligibility Criteria

Ambulatory adult patients ≥ 30 years old
Receive care in the University of North Carolina at Chapel Hill Cardiology practice
Have a clinical diagnosis of HF
Currently prescribed a loop diuretic
Have a New York Heart Association class II-IV
Must speak English
Have a working telephone or live with the patient

Family Member Eligibility Criteria

≥ 18 years old and able to give informed consent
Must be willing to participate in the intervention activities and provide informed consent
Must speak English
Have a working telephone or live with the patient

Health Care Provider Eligibility Criteria

Must be an MD or advance practice provider (NP or PA) in the University of North Carolina at Chapel Hill Cardiology or General Internal Medicine practice
Must be willing to have an enrolled patient visit audio-taped

Exclusion Criteria:

For patients:

blindness,
terminal illness with life expectancy <1 year (based on physician estimation),
currently on or anticipated to start dialysis within 1 year,
oxygen dependent chronic obstructive pulmonary disease,
residency in a nursing home, or
psychiatric illness that would interfere with protocol completion.

Study is for people with:

Heart Failure

Estimated Enrollment:

53

Study ID:

NCT03491800

Recruitment Status:

Completed

Sponsor:

University of North Carolina, Chapel Hill

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

UNC School of Medicine
Chapel Hill North Carolina, 27599, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

53

Study ID:

NCT03491800

Recruitment Status:

Completed

Sponsor:


University of North Carolina, Chapel Hill

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider