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Clinical Trials/NCT03491800
NCT03491800
Completed
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country53 target enrollmentMay 23, 2018
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of North Carolina, Chapel Hill
Enrollment
53
Locations
1
Primary Endpoint
Percent of Eligible Participants Who Enroll
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2018
End Date
August 15, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

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.

Outcomes

Primary Outcomes

Percent of Eligible Participants Who Enroll

Time Frame: 6 months

The investigators will assess enrollment success into the study among those considered eligible. Investigators aim to have at least 50% of eligible participants enroll into the trial.

Secondary Outcomes

  • Mean Acceptability Checklist Score(Within 2 days after receiving checklist)
  • Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale(Up to 1 month after clinic visit)
  • Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale(Up to 1 month after clinic visit)
  • Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale(Up to 1 month after)
  • Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale(Up to 1 month after.)
  • Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale(Up to 1 month after)
  • Mean Score on Communication With Physicians Measure(Up to 1 month after clinic visit)
  • Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale(Up to 1 month after)
  • Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)(Up to 1 month after clinic visit)

Study Sites (1)

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