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

NCT03491800 | Completed Results

• 2 other identifiers: 17-2573UL1TR001111
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percent of Eligible Participants Who Enroll

  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.

  6 months

Secondary Outcomes (9)

• 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.

Study Arms (1)

Question/Topic Prompt List

OTHER

The Question/Topic Prompt List is provided to HF Patients and their family member (if applicable) for completion prior to being seen by the doctor.

Behavioral: Question/Topic Prompt List

Interventions

Question/Topic Prompt List BEHAVIORAL

A written document containing suggested questions that the family member and/or patient may want to ask the health care provider during the visit. A section is included for the patient to check which behaviors they would like for their family member to engage in during the visit and space is provided for the family member to check which behaviors they are willing to perform during the visit.

Question/Topic Prompt List

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• RTI International: collaborator

Study Sites (1)

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Crystal Wiley Cené, MD, MPH, FAHA
• Organization: University of North Carolina at Chapel Hill

crystal_cene@med.unc.edu

919-445-6783

Study Officials

• Crystal Wiley Cené, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Given the nature of the intervention and it's intended purpose (i.e., to enhance communication with participants and health care providers), it is not possible to blind participants, care providers, or the investigators.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individual patients and dyads (i.e., a HF patient and family member) will receive the question/topic prompt list immediately before their clinic visit

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 9, 2018
• Study Start: May 23, 2018
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: August 22, 2024
• Results First Posted: August 13, 2020

Record last verified: 2019-02

Locations

US (1)