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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Question/Topic Prompt List


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Question/Topic Prompt List<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Acceptability Checklist Score | The investigators will assess the perceived value of the checklist using a series of 11 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. | Within 2 days after receiving checklist | 
| Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale | The SCHFI was used to measure self-care management. The 10-item self-care management scale assesses decision-making in response to HF symptoms. Of note, the self-care management questions are answered and scored only if the respondent endorses having experienced dyspnea or ankle swelling within the past month.The subscale score is standardized, with scores ranging from 0-100 (higher scores indicate greater self-care management). Scores ≥ 70 are reflective of adequate self-care management. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after clinic visit | 
| Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale | The SCHFI was used to measure self-care maintenance. The 10-item self-care maintenance scale assesses behaviors used to maintain physiologic stability (e.g., adherence to medications, frequent weighing).This subscale score is standardized, with scores ranging from 0-100 (higher scores indicates greater self-care maintenance). Scores ≥ 70 are reflective of adequate self-care maintenance. A change in scale score of one-half of a standard deviation or more is considered clinically significant. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after clinic visit | 
| Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale | The 6-item subscale of the SCHFI was used to assess self-confidence in performing behaviors and making 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. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after | 
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale | The CC-SCHFI is a 22-item measure (across 3 sub-scales) that was used to assess 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. This 6-item subscale 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 confidence in ability to contribute to the patient's self-care. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after. | 
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale | 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. This 10- item subscale 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 maintenance. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after | 
| Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale | 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. This 6-item subscale 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 the patient's self-care management. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after | 
| Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) | The PEPPI is 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. Measured at Baseline, 2-Day Follow-Up, and during the 1 Month Follow-Up. | Up to 1 month after clinic visit | 
| Mean Score on Communication With Physicians Measure | The Communication with Physicians measure by Lorig was used. It is a 3-item measure assessing 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. Measured at Baseline and during the 1 Month Follow-Up. | Up to 1 month after clinic visit |