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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491800
• Other study ID #: 17-2573
• Secondary ID: UL1TR001111
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: February 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	UNC School of Medicine	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute, RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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