Trial Outcomes & Findings for Patient and Family Partners in Heart Failure Care: Pilot Test of a Pre-visit Question Prompt List to Enhance Engagement During Medical Visits (NCT NCT03491800)
NCT ID: NCT03491800
Last Updated: 2024-08-22
Results Overview
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.
COMPLETED
NA
53 participants
6 months
2024-08-22
Participant Flow
Participant milestones
| Measure |
Accompanied Patients
The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
7
|
|
Overall Study
COMPLETED
|
23
|
23
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and 23 Companions
Baseline characteristics by cohort
| Measure |
Accompanied Patients
n=23 Participants
The Question/Topic Prompt List is provided to Heart Failure (HF) Patients and their family member (if applicable) for completion prior to being seen by the doctor.
|
Companions
n=23 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=7 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 13.9 • n=23 Participants
|
58.6 years
STANDARD_DEVIATION 16.0 • n=23 Participants
|
61.1 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 3.96 • n=53 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=23 Participants
|
19 Participants
n=23 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
6 Participants
n=7 Participants
|
52 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=23 Participants
|
11 Participants
n=23 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
6 Participants
n=7 Participants
|
29 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=53 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
7 Participants
n=7 Participants
|
53 Participants
n=53 Participants
|
|
Mean Score on the SCHFI - Maintenance Subscale
|
76.20 units on a scale
STANDARD_DEVIATION 9.72 • n=22 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and 23 Companions
|
—
|
81.10 units on a scale
STANDARD_DEVIATION 12.76 • n=6 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and 23 Companions
|
77.25 units on a scale
STANDARD_DEVIATION 10.64 • n=28 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and 23 Companions
|
|
Mean Score on the SCHFI - Management Subscale
|
69.17 units on a scale
STANDARD_DEVIATION 14.43 • n=12 Participants • This measure is completed by Accompanied and Unaccompanied patients only. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients and all companions
|
—
|
66.25 units on a scale
STANDARD_DEVIATION 6.29 • n=4 Participants • This measure is completed by Accompanied and Unaccompanied patients only. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients and all companions
|
68.44 units on a scale
STANDARD_DEVIATION 12.95 • n=16 Participants • This measure is completed by Accompanied and Unaccompanied patients only. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients and all companions
|
|
Mean Score on the SCHFI - Confidence Subscale
|
67.48 units on a scale
STANDARD_DEVIATION 19.44 • n=22 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and all companions.
|
—
|
60.23 units on a scale
STANDARD_DEVIATION 12.39 • n=6 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and all companions.
|
65.93 units on a scale
STANDARD_DEVIATION 18.40 • n=28 Participants • This measure is completed by Accompanied and Unaccompanied Patients only. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient and all companions.
|
|
Mean Score on the CC-SCHFI - Maintenance Subscale
|
—
|
57.72 units on a scale
STANDARD_DEVIATION 23.37 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
—
|
57.72 units on a scale
STANDARD_DEVIATION 23.37 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
|
Mean Score on the CC-SCHFI - Management Subscale
|
—
|
75.56 units on a scale
STANDARD_DEVIATION 14.46 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
—
|
75.56 units on a scale
STANDARD_DEVIATION 14.46 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
|
Mean Score on the CC-SCHFI - Confidence Subscale
|
—
|
68.24 units on a scale
STANDARD_DEVIATION 25.98 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
—
|
68.24 units on a scale
STANDARD_DEVIATION 25.98 • n=22 Participants • This measure is completed by Companions only. Data are missing for 1 Companion and all accompanied and unaccompanied patients.
|
|
Mean Score on the PEPPI
|
3.68 units on a scale
STANDARD_DEVIATION 0.32 • n=22 Participants • Row total differs from overall total due to missing data on the questionnaire
|
3.83 units on a scale
STANDARD_DEVIATION 0.31 • n=22 Participants • Row total differs from overall total due to missing data on the questionnaire
|
3.52 units on a scale
STANDARD_DEVIATION 0.56 • n=7 Participants • Row total differs from overall total due to missing data on the questionnaire
|
3.72 units on a scale
STANDARD_DEVIATION 0.38 • n=51 Participants • Row total differs from overall total due to missing data on the questionnaire
|
|
Mean Score on Communication With Physicians Measure
|
3.35 units on a scale
STANDARD_DEVIATION 1.31 • n=22 Participants • The Communication with Physicians measure was not completed by companions. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient
|
—
|
3.00 units on a scale
STANDARD_DEVIATION 1.66 • n=6 Participants • The Communication with Physicians measure was not completed by companions. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient
|
3.27 units on a scale
STANDARD_DEVIATION 1.40 • n=28 Participants • The Communication with Physicians measure was not completed by companions. Data are missing for 1 Accompanied patient and 1 Unaccompanied patient
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes all participants screened for enrollment into the study
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.
Outcome measures
| Measure |
Patient and Companions
n=120 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Percent of Eligible Participants Who Enroll
|
44 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 days after receiving checklistPopulation: Data were reported when present and applicable.
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.
Outcome measures
| Measure |
Patient and Companions
n=23 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
n=23 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=7 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Acceptability Checklist Score
Easier to talk to doctor
|
5.09 score on a scale
Standard Deviation 1.16
|
5.04 score on a scale
Standard Deviation 1.36
|
4.86 score on a scale
Standard Deviation 1.46
|
|
Mean Acceptability Checklist Score
Existing questions matched what I wanted to ask
|
5.35 score on a scale
Standard Deviation 1.30
|
5.13 score on a scale
Standard Deviation 1.42
|
5.14 score on a scale
Standard Deviation 0.69
|
|
Mean Acceptability Checklist Score
Adequate time in waiting room to finish checklist
|
5.48 score on a scale
Standard Deviation 1.20
|
5.52 score on a scale
Standard Deviation 1.20
|
5.29 score on a scale
Standard Deviation 1.89
|
|
Mean Acceptability Checklist Score
Easy to fill out
|
5.86 score on a scale
Standard Deviation 0.35
|
5.95 score on a scale
Standard Deviation 0.21
|
6.00 score on a scale
Standard Deviation 0.00
|
|
Mean Acceptability Checklist Score
Instructions clear and understandable
|
5.95 score on a scale
Standard Deviation 0.21
|
5.91 score on a scale
Standard Deviation 0.29
|
5.29 score on a scale
Standard Deviation 1.89
|
|
Mean Acceptability Checklist Score
Easy to use during discussion with Dr
|
5.89 score on a scale
Standard Deviation 0.32
|
5.94 score on a scale
Standard Deviation 0.24
|
5.50 score on a scale
Standard Deviation 1.23
|
|
Mean Acceptability Checklist Score
Would use checklist at next appt
|
5.00 score on a scale
Standard Deviation 1.75
|
5.12 score on a scale
Standard Deviation 1.58
|
4.33 score on a scale
Standard Deviation 1.86
|
|
Mean Acceptability Checklist Score
Checklist helped to get more questions asked
|
5.39 score on a scale
Standard Deviation 1.34
|
5.35 score on a scale
Standard Deviation 1.27
|
4.83 score on a scale
Standard Deviation 1.60
|
|
Mean Acceptability Checklist Score
Able to learn more from Dr using checklist
|
5.28 score on a scale
Standard Deviation 1.36
|
5.24 score on a scale
Standard Deviation 1.39
|
4.50 score on a scale
Standard Deviation 1.64
|
|
Mean Acceptability Checklist Score
Clearer understanding of companion's concerns
|
4.75 score on a scale
Standard Deviation 1.94
|
5.53 score on a scale
Standard Deviation 1.23
|
—
|
|
Mean Acceptability Checklist Score
Felt supported by companion due to checklist
|
5.25 score on a scale
Standard Deviation 1.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 month after clinic visitPopulation: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 11 Accompanied patients and 3 Unaccompanied patients.
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.
Outcome measures
| Measure |
Patient and Companions
n=12 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=4 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale
Baseline
|
69.17 score on a scale
Standard Deviation 14.43
|
—
|
66.25 score on a scale
Standard Deviation 6.29
|
|
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Management Subscale
1 Month Follow-Up
|
61.67 score on a scale
Standard Deviation 31.72
|
—
|
62.50 score on a scale
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: Up to 1 month after clinic visitPopulation: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
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.
Outcome measures
| Measure |
Patient and Companions
n=22 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=6 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale
Baseline
|
76.20 score on a scale
Standard Deviation 9.72
|
—
|
81.10 score on a scale
Standard Deviation 12.76
|
|
Mean Score on the Self-Care of Heart Failure Index (SCHFI) - Maintenance Subscale
1 Month Follow-Up
|
76.51 score on a scale
Standard Deviation 12.70
|
—
|
76.66 score on a scale
Standard Deviation 9.43
|
SECONDARY outcome
Timeframe: Up to 1 month afterPopulation: This measure is completed by Accompanied and Unaccompanied patients only. Companion responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
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.
Outcome measures
| Measure |
Patient and Companions
n=22 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=6 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale
Baseline
|
67.48 score on a scale
Standard Deviation 19.44
|
—
|
60.23 score on a scale
Standard Deviation 12.39
|
|
Mean Score Self-Care of Heart Failure Index (SCHFI) F-Up Month 1 - Confidence Subscale
1 Month Follow-Up
|
70.51 score on a scale
Standard Deviation 15.67
|
—
|
61.16 score on a scale
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: Up to 1 month after.Population: This measure is completed by Companions only. Data are missing for 1 Companion
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.
Outcome measures
| Measure |
Patient and Companions
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
n=22 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale
Baseline
|
—
|
68.24 score on a scale
Standard Deviation 25.98
|
—
|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Confidence Subscale
1 Month Follow-Up
|
—
|
73.29 score on a scale
Standard Deviation 22.02
|
—
|
SECONDARY outcome
Timeframe: Up to 1 month afterPopulation: This measure is completed by Companions only. Patient responses are not applicable here and are captured in a separate outcome measure. Data are missing for 1 Companion.
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.
Outcome measures
| Measure |
Patient and Companions
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
n=22 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale
Baseline
|
—
|
57.72 score on a scale
Standard Deviation 23.37
|
—
|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Maintenance Subscale
1 Month Follow-Up
|
—
|
57.42 score on a scale
Standard Deviation 26.18
|
—
|
SECONDARY outcome
Timeframe: Up to 1 month afterPopulation: This measure is completed by Companions only. Accompanied and Unaccompanied responses are not applicable here and are captured in a separate outcome measure. Data are missing for 14 Companions.
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.
Outcome measures
| Measure |
Patient and Companions
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
n=9 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale
Baseline
|
—
|
75.56 score on a scale
Standard Deviation 14.46
|
—
|
|
Mean Score on Caregiver Contribution to Self-Care of Heart Failure Index (CC-SCHFI) - Management Subscale
1 Month Follow-Up
|
—
|
72.22 score on a scale
Standard Deviation 14.81
|
—
|
SECONDARY outcome
Timeframe: Up to 1 month after clinic visitPopulation: Reported data are less than the total number of participants who completed each arm due to participants not responding to questions for this measure. Data are missing for 1 Accompanied, 1 Unaccompanied, and 1 Companion.
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.
Outcome measures
| Measure |
Patient and Companions
n=22 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
n=22 Participants
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=6 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)
Baseline
|
3.68 score on a scale
Standard Deviation 0.32
|
3.83 score on a scale
Standard Deviation 0.31
|
3.52 score on a scale
Standard Deviation 0.56
|
|
Mean Score on Perceived Efficacy in Patient-Physician Interactions (PEPPI)
1 Month Follow-Up
|
3.76 score on a scale
Standard Deviation 0.29
|
3.81 score on a scale
Standard Deviation 0.33
|
3.78 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Up to 1 month after clinic visitPopulation: This measure was only answered by patients. Companion responses are not applicable here. Data are missing for 1 Accompanied patients and 1 Unaccompanied patients.
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.
Outcome measures
| Measure |
Patient and Companions
n=22 Participants
All patients and companions who were screened for eligibility and contacted by telephone for possible study participation
|
Companions
Family members who accompanied enrolled patient participants to a visit and participated in the study with the patient.
|
Unaccompanied Patients
n=6 Participants
The Question/Topic Prompt List is provided to individual, unaccompanied HF patient participants for completion prior to being seen by the doctor.
|
|---|---|---|---|
|
Mean Score on Communication With Physicians Measure
Baseline
|
3.35 score on a scale
Standard Deviation 1.31
|
—
|
3.00 score on a scale
Standard Deviation 1.66
|
|
Mean Score on Communication With Physicians Measure
1 Month Follow-Up
|
3.45 score on a scale
Standard Deviation 0.99
|
—
|
2.72 score on a scale
Standard Deviation 0.98
|
Adverse Events
Accompanied Patients
Companions
Unaccompanied Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Crystal Wiley Cené, MD, MPH, FAHA
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place