NCT03491800

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

Completed NA Results posted Last updated 22 August 2024

What this trial tests

NA trial testing Question/Topic Prompt List in Heart Failure in 53 participants. Completed in 15 August 2018.

Timeline

23 May 2018

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	53
Start date	23 May 2018
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Question/Topic Prompt List

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

University of North Carolina, Chapel Hill

Who can join

30 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Eligible Participants Who Enroll Primary · 6 months

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.

Group	Value	95% CI
Patient and Companions	44

Mean Acceptability Checklist Score Secondary · Within 2 days after receiving checklist

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.

Easier to talk to doctor

Group	Value	95% CI
Accompanied Patients	5.09	± 1.16
Companions	5.04	± 1.36
Unaccompanied Patients	4.86	± 1.46

Existing questions matched what I wanted to ask

Group	Value	95% CI
Accompanied Patients	5.35	± 1.30
Companions	5.13	± 1.42
Unaccompanied Patients	5.14	± 0.69

Adequate time in waiting room to finish checklist

Group	Value	95% CI
Accompanied Patients	5.48	± 1.20
Companions	5.52	± 1.20
Unaccompanied Patients	5.29	± 1.89

Easy to fill out

Group	Value	95% CI
Accompanied Patients	5.86	± 0.35
Companions	5.95	± 0.21
Unaccompanied Patients	6.00	± 0.00

Instructions clear and understandable

Group	Value	95% CI
Accompanied Patients	5.95	± 0.21
Companions	5.91	± 0.29
Unaccompanied Patients	5.29	± 1.89

Easy to use during discussion with Dr

Group	Value	95% CI
Accompanied Patients	5.89	± 0.32
Companions	5.94	± 0.24
Unaccompanied Patients	5.50	± 1.23

Would use checklist at next appt

Group	Value	95% CI
Accompanied Patients	5.00	± 1.75
Companions	5.12	± 1.58
Unaccompanied Patients	4.33	± 1.86

Checklist helped to get more questions asked

Group	Value	95% CI
Accompanied Patients	5.39	± 1.34
Companions	5.35	± 1.27
Unaccompanied Patients	4.83	± 1.60

Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale Secondary · Up to 1 month after clinic visit

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

Baseline

Group	Value	95% CI
Accompanied Patients	69.17	± 14.43
Unaccompanied Patients	66.25	± 6.29

1 Month Follow-Up

Group	Value	95% CI
Accompanied Patients	61.67	± 31.72
Unaccompanied Patients	62.50	± 6.45

Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale Secondary · Up to 1 month after clinic visit

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.

Baseline

Group	Value	95% CI
Accompanied Patients	76.20	± 9.72
Unaccompanied Patients	81.10	± 12.76

1 Month Follow-Up

Group	Value	95% CI
Accompanied Patients	76.51	± 12.70
Unaccompanied Patients	76.66	± 9.43

Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale Secondary · Up to 1 month after

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.

Baseline

Group	Value	95% CI
Accompanied Patients	67.48	± 19.44
Unaccompanied Patients	60.23	± 12.39

1 Month Follow-Up

Group	Value	95% CI
Accompanied Patients	70.51	± 15.67
Unaccompanied Patients	61.16	± 13.16

Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale Secondary · Up to 1 month after.

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.

Baseline

Group	Value	95% CI
Companions	68.24	± 25.98

1 Month Follow-Up

Group	Value	95% CI
Companions	73.29	± 22.02

Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale Secondary · Up to 1 month after

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.

Baseline

Group	Value	95% CI
Companions	57.72	± 23.37

1 Month Follow-Up

Group	Value	95% CI
Companions	57.42	± 26.18

Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale Secondary · Up to 1 month after

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.

Baseline

Group	Value	95% CI
Companions	75.56	± 14.46

1 Month Follow-Up

Group	Value	95% CI
Companions	72.22	± 14.81

Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI) Secondary · Up to 1 month after clinic visit

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.

Baseline

Group	Value	95% CI
Accompanied Patients	3.68	± 0.32
Companions	3.83	± 0.31
Unaccompanied Patients	3.52	± 0.56

1 Month Follow-Up

Group	Value	95% CI
Accompanied Patients	3.76	± 0.29
Companions	3.81	± 0.33
Unaccompanied Patients	3.78	± 0.39

Mean Score on Communication With Physicians Measure Secondary · Up to 1 month after clinic visit

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.

Baseline

Group	Value	95% CI
Accompanied Patients	3.35	± 1.31
Unaccompanied Patients	3.00	± 1.66

1 Month Follow-Up

Group	Value	95% CI
Accompanied Patients	3.45	± 0.99
Unaccompanied Patients	2.72	± 0.98

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.