Trial Outcomes & Findings for Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits (NCT NCT02522494)

NCT ID: NCT02522494

Last Updated: 2022-08-04

Results Overview

HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.
• Results posted on: 2022-08-04

Participant Flow

Total number of patients enrolled in randomized trial - 102.

Participant milestones

Measure	Intervention Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Overall Study STARTED	51	51
Overall Study Post-CVT Visit Interview	37	48
Overall Study 4-Week Follow Up	37	46
Overall Study COMPLETED	37	46
Overall Study NOT COMPLETED	14	5

Reasons for withdrawal

Measure	Intervention Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Overall Study Lost to Follow-up	6	2
Overall Study Withdrawal by Subject	1	0
Overall Study CVT visit cancelled or no-show for CVT visit	6	2
Overall Study Participant did not watch the video	1	0
Overall Study Death	0	1

Baseline Characteristics

Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits

Baseline characteristics by cohort

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 8.37 • n=5 Participants	65 years STANDARD_DEVIATION 9.38 • n=7 Participants	65 years STANDARD_DEVIATION 8.91 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	46 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	45 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	48 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC

HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
HgbA1c pre-CVT visit	8.5 percentage of glycated hemoglobin Standard Deviation 1.76	8.5 percentage of glycated hemoglobin Standard Deviation 1.20
HgbA1c post-CVT visit	7.99 percentage of glycated hemoglobin Standard Deviation 1.28	8.2 percentage of glycated hemoglobin Standard Deviation 1.26

PRIMARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Communication Self-efficacy pre-CVT visit	22.81 units on a scale Standard Deviation 4.61	21.64 units on a scale Standard Deviation 5.94
Communication Self-efficacy post-CVT visit	22.94 units on a scale Standard Deviation 4.76	22.75 units on a scale Standard Deviation 5.89

PRIMARY outcome

Timeframe: post-intervention (interview within 1 week after CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Consultation Care Measure (CCM) assesses patient-centered care and patient-centered communication. Patients rate such factors as their providers' (1) communication and partnership, (2) personal relationship, (3) health promotion, (4) positive and clear approach to problem, (5) interest in effect on life on a 21-item scale, each item scores from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 21 to 105. The higher scores mean a better patients' experiences with their provider.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Consultation Care Measure (CCM)	90.22 units on a scale Standard Deviation 16.30	84.08 units on a scale Standard Deviation 21.43

PRIMARY outcome

Timeframe: 4 weeks after the CVT visit

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC

Self-reported adherence is measured using a brief questionnaire - a general measure of adherence to providers' recommendations and includes 5 items and is scored on a 6-level Likert-type scale ranging from "none of the time" to "all of the time". Scores range from 0-100 (after normalizing the standard 6-30 range) with higher numbers reflecting better adherence. Adherence using this measure is assessed with a brief telephone survey 4 weeks following the visit.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Adherence (Self-reported)	78.51 units on a scale Standard Deviation 21.53	75.98 units on a scale Standard Deviation 26.43

PRIMARY outcome

Timeframe: 6 months

Population: The data was not collected because it was not possible to calculate useful medication possession ratios. Many patients in our study were on insulin which is a liquid and is not a unit dose. Further many patients take insulin on a sliding scale. Calculating the MPR was therefore not a useful measure in this study.

Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: The data was not collected because it was not possible to calculate useful medication possession ratios. Many patients in our study were on insulin which is a liquid and is not a unit dose. Further many patients take insulin on a sliding scale. Calculating the MPR was therefore not a useful measure in this study.

Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Post-intervention (interview within one week past CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Consultation and Relational Empathy (CARE) Measure - is a tool for measuring patients' perceptions of relational empathy in the consultation. In this 10-item questionnaire patients rate the statements about their doctor's understanding their concern, showing care, and etc. during the recent CVT visit on a scale from 1 to 5 where 1 is "poor" and 5 is "excellent". Scores can range from 10 to 50. The higher score means a better patient's perception of empathy in consultation.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Consultation and Relational Empathy (CARE)	44.65 units on a scale Standard Deviation 7.75	40.39 units on a scale Standard Deviation 10.73

PRIMARY outcome

Timeframe: Post-intervention (interview within one week after CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

The questionnaire assesses patients' ratings of their own participatory communication behavior and patients' ratings of their providers' communication. It is a 15-item scale with 3 sub-scales. Patients' ratings of their (1) providers' informativeness and the extent to which the patient understands that information (information sub-scale) are measured with 5-items; (2) patients' ratings that the provider values and respects them is measured with 5-items; and (3) patients' ratings of their own communication is measured with 5-items. This questionnaire has high internal consistency. The scale is scored from 1 (completely disagree) to 7 (completely agree). The total scores range from 15 to 105. The higher scores indicate a better quality of communication.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Communication Ratings	94.24 units on a scale Standard Deviation 13.54	88.67 units on a scale Standard Deviation 18.55

PRIMARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Human Connection Scale is a 15-item questionnaire that measures the extent to which patient feel a sense of mutual understanding, caring, and trust with their physicians. The scale is a valid and reliable measure of therapeutic alliance between patients and their physicians. The score from 1 to 4 is used where 1 is "not at all" and 4 is "extremely". The scores range from 15 to 60. The higher scores indicate higher therapeutic alliance between patients and physicians.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Human Connection Scale pre-CVT visit	49.73 units on a scale Standard Deviation 13.19	49.28 units on a scale Standard Deviation 12.05
Human Connection Scale post-CVT visit	52.44 units on a scale Standard Deviation 10.63	49.35 units on a scale Standard Deviation 12.77

PRIMARY outcome

Timeframe: 4 weeks past CVT visit

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Resistance to Treatment Questionnaire (RTQ) identifies the reasons for resistance to treatment and its intensity among patients with diabetes. 20-item questionnaire consists of four themes (lack of faith or dissatisfaction, emotional reasons, specific problems, factors connected to despair or failure) containing 5 items each; each item is scored from 1 (strongly disagree) to 5 (strongly agree). The scores range from 20 to 100. The higher scores mean more barriers to treatment (a worse outcome).

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Resistance to Treatment Questionnaire (RTQ)	42.59 units on a scale Standard Deviation 11.06	45.13 units on a scale Standard Deviation 13.99

SECONDARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC

Trust in Provider is an important characteristic of provider-patient relationships and is assessed with a questionnaire. Trust is measured pre- and post-CVT visit using a 9-item measure. The scale is scored on a 7-point Likert scale using the anchors "strongly disagree" and "strongly agree". The scores range from 9 to 63. The higher scores mean a better trust in provider.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Trust in Provider Questionnaire pre-CVT visit	47.08 units on a scale Standard Deviation 14.63	45.00 units on a scale Standard Deviation 15.16
Trust in Provider Questionnaire post-CVT visit	53.27 units on a scale Standard Deviation 8.88	50.19 units on a scale Standard Deviation 11.76

SECONDARY outcome

Timeframe: four weeks after CVT visit

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Patient Satisfaction is assessed as the extent to which the patient is content with the relationship with her/his provider, in terms of the quality of information exchanged during medical encounters, and in terms of the demeanor of the provider toward the patient (courtesy, respectfulness, sensitivity, taking time and not being rushed). This is a 4-item survey, patient's satisfaction is scored from 1 (not at all satisfied) to 7 (extremely satisfied). The scores range from 5 to 35. The higher score indicates a better patient satisfaction.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Patient Satisfaction	24.19 units on a scale Standard Deviation 3.98	23.35 units on a scale Standard Deviation 5.45

SECONDARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

Participatory Decision-Making Style represents the degree to which providers involve patients in decision making. We measure patients' ratings of providers' participatory decision-making style using a 4-item scale evaluated by Heisler et al. in a study of veterans with diabetes. The authors found it to be associated with better patient understanding of diabetes and self-management practices. The survey scores how often provider involves patient in decision-making on a scale from 1 to 5, where 1 is "none of the time" and 5 is "all of the time". Scores range from 4 to 20. Higher scores mean a better outcome.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Participatory Decision-Making pre-CVT visit	16.68 units on a scale Standard Deviation 4.45	15.34 units on a scale Standard Deviation 5.34
Participatory Decision-Making post-CVT visit	17.15 units on a scale Standard Deviation 4.76	15.06 units on a scale Standard Deviation 5.10

SECONDARY outcome

Timeframe: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)

Population: Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.

The investigators used a 4-item scale to measure patients' confidence in their ability to manage their diabetes. The survey scores patients' perception of how well they can handle their diabetes on a scale from 1 to 7, where 1 is "not at all true" and 7 is "very true". The scores range from 4 to 28. The higher score is validated as a predictor of better glycemic control. The higher scores mean a better confidence in managing diabetes.

Outcome measures

Measure	Intervention n=37 Participants Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 Participants Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
Diabetes Self-Efficacy pre-CVT visit	22.81 units on a scale Standard Deviation 4.61	21.64 units on a scale Standard Deviation 5.94
Diabetes Self-Efficacy post-CVT visit	22.94 units on a scale Standard Deviation 4.76	22.75 units on a scale Standard Deviation 5.89

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pamphlet Alone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Intervention n=37 participants at risk Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit.	Pamphlet Alone n=48 participants at risk Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit.
General disorders death	0.00% 0/37 • From the baseline (Pre-CVT visit interview Visit 1) to the follow-up telephone interview (four weeks past Post-CVT visit), an average of 3 months per participant. Time frame varies depending on occurrence of patients' Clinical Video Telehealth visits with their physicians in routine clinical practice.	2.1% 1/48 • From the baseline (Pre-CVT visit interview Visit 1) to the follow-up telephone interview (four weeks past Post-CVT visit), an average of 3 months per participant. Time frame varies depending on occurrence of patients' Clinical Video Telehealth visits with their physicians in routine clinical practice.

Other adverse events

Adverse event data not reported

Additional Information

Howard S. Gordon, MD

Jesse Brown VA Medical Center

Phone: (312) 569-7331

Email: howard.gordon2@va.gov

Results disclosure agreements

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