Clinical trial NCT03491800: Patient and Family Partners in Heart Failure Care: Pilot Test of a Pre-visit Question Prompt List to Enhance Engagement During Medical Visits
Official title: Patient and Family Partners in Heart Failure: Pilot Test of a Pre-visit Question Prompt List to Enhance Engagement of Heart Failure Patients and Family Members During Medical Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: RTI International
First posted: 2018-04-09
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individual patients and dyads (i.e., a HF patient and family member) will receive the question/topic prompt list immediately before their clinic visit
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Percent of Eligible Participants Who Enroll
timeFrame: 6 months
Secondary outcomes:
measure: Mean Acceptability Checklist Score
timeFrame: Within 2 days after receiving checklist
measure: Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale
timeFrame: Up to 1 month after clinic visit
measure: Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale
timeFrame: Up to 1 month after clinic visit
measure: Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale
timeFrame: Up to 1 month after
measure: Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale
timeFrame: Up to 1 month after.
measure: Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale
timeFrame: Up to 1 month after
measure: Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale
timeFrame: Up to 1 month after
measure: Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)
timeFrame: Up to 1 month after clinic visit
measure: Mean Score on Communication With Physicians Measure
timeFrame: Up to 1 month after clinic visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Crystal Wiley Cené, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: