N/A N=53 Health Services Research

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03491800 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2020

Primary outcome: Primary: Percent of Eligible Participants Who Enroll — 44 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Question/Topic Prompt List (Behavioral)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Eligible Participants Who Enroll	44	—
SECONDARY Mean Acceptability Checklist Score	5.09; 5.04; 4.86; 5.35; 5.13; 5.14	—
SECONDARY Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale	69.17; 66.25; 61.67; 62.50	0.30
SECONDARY Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale	76.20; 81.10; 76.51; 76.66	0.90
SECONDARY Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale	67.48; 60.23; 70.51; 61.16	0.40
SECONDARY Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale	68.24; 73.29	0.21
SECONDARY Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale	57.72; 57.42	0.95
SECONDARY Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale	75.56; 72.22	0.52
SECONDARY Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)	3.68; 3.83; 3.52; 3.76; 3.81; 3.78	0.23
SECONDARY Mean Score on Communication With Physicians Measure	3.35; 3.00; 3.45; 2.72	0.60

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03491800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.