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

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ClinicalTrials.gov Identifier: NCT03491800
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
North Carolina Translational and Clinical Sciences Institute
RTI International
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Question/Topic Prompt List Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Health Services Research
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
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Percent of screened candidates who enroll [ Time Frame: 6 months ]
    The investigators will assess enrollment rate into the study. The investigators aim to have at least 50% of screened individuals or dyads consent and enroll (enrollment rate)


Secondary Outcome Measures :
  1. Number of participants indicating that the checklist was helpful for facilitating communication with their health care provider. [ Time Frame: 2 day follow-up ]
    The investigators will assess the perceived value of the checklist using a series 13 questions developed for this study. Each question is scored using a 6-point Likert response scale where 1=strongly disagree and 6=strongly agree. Higher scores mean higher perceived value of the checklist.

  2. Mean score on the Self-Care of Heart Failure Index [ Time Frame: 1 month follow-up ]
    The investigators will use the Self-Care of Heart Failure Index (SCHFI) to measure self-care maintenance and self-care management. The 10-item self-care maintenance scale assesses behaviors used to maintain physiologic stability (e.g., adherence to medications, frequent weighing).

  3. Mean score Self-care of heart failure Index self-care confidence subscale [ Time Frame: 1 month follow-up ]
    The investigators will use the the 6-item subscale of the Self-Care of Heart Failure Index to assess self-confidence in performing behaviors and make decisions to control heart failure symptoms. The subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care confidence). Scores ≥ 70 are reflective of "adequate" self-care confidence. A change in scale score of one-half of a standard deviation or more is considered clinically significant.

  4. Mean score on confidence in communicating with health care providers communication behaviors [ Time Frame: 1 month follow-up ]
    The investigators will use the Perceived efficacy in patient-physician interactions (PEPPI) measure, a 6-item measure which assesses confidence (self-efficacy) in communicating with health care providers. Each question is scored using a 5-point likert scale (0= not at all confident to 5=very confident). Higher scores indicate greater confidence in communicating with health care providers.

  5. Mean score on patients' communication behaviors [ Time Frame: 1 month follow-up ]
    The investigators will use the Communication with Physicians measure by Lorig, a 3-item measure which assesses the frequency of patients' engagement in communication behaviors during medical visits, including, preparing a list of questions, asking questions about treatment, and discussing personal problems with provider. Each question is answered using a 6-point Likert scale ranging from 0=never to 5=always. Higher scores indicate more active engagement in communication during medical visits.

  6. Mean score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) [ Time Frame: 1 month follow-up ]
    The CC-SCHFI is a 22-item measure (across 3 sub-scales) that assesses the contribution of caregivers to the self-care maintenance and self-care management of HF patients as well as their confidence in their ability to contribute to the patients' HF self-care. Each of the 3 subscales uses a 4-point Likert scale (never or rarely, sometimes, frequently, always or daily), with a standardized score from 0 to 100; higher scores indicate higher contribution to self-care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491800


Locations
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United States, North Carolina
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
RTI International
Investigators
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Principal Investigator: Crystal Wiley Cené, MD, MPH University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03491800    
Other Study ID Numbers: 17-2573
UL1TR001111 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases