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

NCT ID: NCT03491800

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2018-08-15

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Question/Topic Prompt List

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.

Group Type: OTHER

Question/Topic Prompt List

Intervention Type: 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.

Interventions

Question/Topic Prompt List

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal Wiley Cené, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC School of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR001111

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-2573

Identifier Type: -

Identifier Source: org_study_id