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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

6 months

Results posted on

2024-08-22

Participant Flow

Participant milestones

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

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 months

Population: 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

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 checklist

Population: 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

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 visit

Population: 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

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 visit

Population: 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

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 after

Population: 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

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

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 after

Population: 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

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 after

Population: 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

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 visit

Population: 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

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 visit

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Companions

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Unaccompanied Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 919-445-6783

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place