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Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits

Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522494
Acronym
TELEHEALTH
Enrollment
102
Registered
2015-08-13
Start date
2016-07-01
Completion date
2020-03-31
Last updated
2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the prevalence of diabetes at almost 20 percent in VA patients. Poorly controlled diabetes leads to a number of complications including cardiovascular disease, blindness, amputation, and end stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care is related at least in part to effective communication in medical encounters. This project is designed to test a video intervention to improve patients' communication behaviors. Providers will also receive a pamphlet with specific recommendation to improve communication skills. The project will assess the impact of the training programs on communication and outcomes. The study is designed to help make patient care more patient-centered, which is one of the six aims for improvement in the IOM Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.

Detailed description

Background: Clinical video telehealth (CVT) offers the opportunity for more efficient access to high quality primary and specialist care for Veterans. Enthusiasm for CVT is especially high in the VA given geographical separation between many Veterans and their providers at VA Medical Centers. However, because CVT encounters are by nature less personal than in-person visits, communication during CVT visits may be more challenging for both patients and providers resulting in less patient-centered communication. Less personal visits may have less exchange of information, lower satisfaction, less trust, and poorer outcomes. Indeed, research comparing CVT with in-person consultations found that patients in CVT visits were more passive and that CVT interactions were dominated by providers when compared with in-person visits. This project will leverage prior work from two HSR&D-funded pilot projects to improve provider - patient communication for Veterans with type 2 diabetes mellitus. In a short-term project, SHP-08-182, the investigators conducted focus groups to elicit and understand patients' barriers to communicating with their providers. This qualitative work was used in a subsequent pilot project, PPO-08-402 to develop an educational video to encourage Veterans to use active participatory communication in their visits to providers. This work was successfully completed and the product is a 10-minute video that, in testing, was found to be acceptable and feasible to show to VA patients immediately preceding their medical encounters. Objectives: The investigators goal in this project is develop and test a video intervention and to also develop pamphlets for patients and providers to encourage active and positive communication in CVT medical interactions. The investigators goal was developed with and is supported by the project's operational partner the Office of Telehealth Services and is integral to the goal to ensure patient-centered care in new models of care. Patient-centered communication in medical interactions is critical and plays an important, but often overlooked, role in the delivery of health services. There are two aims. First, the investigators will develop educational interventions to encourage patients and providers to use active communication behaviors during CVT visits. Second, the investigators will conduct a randomized trial of the video and pamphlet (intervention) vs. pamphlet alone (comparison) in a two-arm randomized effectiveness trial. The investigators will evaluate for improvement in visit outcomes including patient and provider measures of patient-centered care and communication, reduction in several common barriers to clinical improvement, and improved medication adherence measures and hemoglobin A1c. In addition, the investigators will assess the mediators and moderators of the relationship of the intervention condition to outcomes. Methods: The project will have two phases. In the initial phase of the proposed project the investigators will develop the video intervention. Video development will include qualitative interviews with stakeholders and patients regarding CVT barriers and perceived benefits. The investigators will use several existing resources and an expert panel of co-investigators and consultants to bring these elements together and produce the intervention. In phase 2 the investigators will conduct a randomized trial of the intervention, evaluating for improvement in a number of outcomes. Impacts: The educational tools will be deliverables that could be used prior to CVT visits to improve communication and could serve as a paradigm for developing communication aids for other medical conditions and other clinical settings. The investigators will evaluate whether the educational intervention will help improve communication and will be associated with better visit and intermediate outcomes. Educational tools that encourage more patient-centered communication during CVT encounters may allow more rapid acceptance of CVT, thereby improving access to healthcare and enhancing the operational mission of the project's partner.

Interventions

BEHAVIORALPamphlet

An educational intervention delivered prior to patients' visits with primary care physicians.

BEHAVIORALVideo

An educational intervention delivered prior to patients' visits with primary care providers.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of type 2 diabetes mellitus, * Hemoglobin A1c not controlled, * Adults, * Age 18 or older

Exclusion criteria

* Dementia, * Lives in skilled nursing facility, * Terminal medical condition, * Drug-induced diabetes, * Blind or deaf.

Design outcomes

Primary

MeasureTime frameDescription
Resistance to Treatment Questionnaire (RTQ)4 weeks past CVT visitResistance 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).
Medication Adherence (MPR)6 monthsMedication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Consultation and Relational Empathy (CARE)Post-intervention (interview within one week past CVT visit)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.
Communication RatingsPost-intervention (interview within one week after CVT visit)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.
Human Connection ScaleAt the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)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.
Adherence at 1 Year1 yearMedication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
HgbA1cAt 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.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.
Communication Self-efficacyAt the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)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.
Consultation Care Measure (CCM)post-intervention (interview within 1 week after CVT visit)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.
Adherence (Self-reported)4 weeks after the CVT visitSelf-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.

Secondary

MeasureTime frameDescription
Patient Satisfactionfour weeks after CVT visitPatient 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.
Participatory Decision-MakingAt the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)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.
Diabetes Self-EfficacyAt the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)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.
Trust in Provider QuestionnaireAt the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)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.

Countries

United States

Participant flow

Recruitment details

Total number of patients enrolled in randomized trial - 102.

Participants by arm

ArmCount
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.
37
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.
48
Total85

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCVT visit cancelled or no-show for CVT visit62
Overall StudyDeath01
Overall StudyLost to Follow-up62
Overall StudyParticipant did not watch the video10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicInterventionPamphlet AloneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
24 Participants29 Participants53 Participants
Age, Categorical
Between 18 and 65 years
13 Participants19 Participants32 Participants
Age, Continuous65 years
STANDARD_DEVIATION 8.37
65 years
STANDARD_DEVIATION 9.38
65 years
STANDARD_DEVIATION 8.91
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants16 Participants28 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants31 Participants56 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants2 Participants6 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
32 Participants45 Participants77 Participants
Region of Enrollment
United States
37 Participants48 Participants85 Participants
Sex: Female, Male
Female
0 Participants2 Participants2 Participants
Sex: Female, Male
Male
37 Participants46 Participants83 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 371 / 48
other
Total, other adverse events
0 / 370 / 48
serious
Total, serious adverse events
0 / 371 / 48

Outcome results

Primary

Adherence at 1 Year

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

Time frame: 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.

Primary

Adherence (Self-reported)

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.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
InterventionAdherence (Self-reported)78.51 units on a scaleStandard Deviation 21.53
Pamphlet AloneAdherence (Self-reported)75.98 units on a scaleStandard Deviation 26.43
Primary

Communication Ratings

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
InterventionCommunication Ratings94.24 units on a scaleStandard Deviation 13.54
Pamphlet AloneCommunication Ratings88.67 units on a scaleStandard Deviation 18.55
Primary

Communication Self-efficacy

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionCommunication Self-efficacypre-CVT visit22.81 units on a scaleStandard Deviation 4.61
InterventionCommunication Self-efficacypost-CVT visit22.94 units on a scaleStandard Deviation 4.76
Pamphlet AloneCommunication Self-efficacypre-CVT visit21.64 units on a scaleStandard Deviation 5.94
Pamphlet AloneCommunication Self-efficacypost-CVT visit22.75 units on a scaleStandard Deviation 5.89
Primary

Consultation and Relational Empathy (CARE)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
InterventionConsultation and Relational Empathy (CARE)44.65 units on a scaleStandard Deviation 7.75
Pamphlet AloneConsultation and Relational Empathy (CARE)40.39 units on a scaleStandard Deviation 10.73
Primary

Consultation Care Measure (CCM)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
InterventionConsultation Care Measure (CCM)90.22 units on a scaleStandard Deviation 16.3
Pamphlet AloneConsultation Care Measure (CCM)84.08 units on a scaleStandard Deviation 21.43
Primary

HgbA1c

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionHgbA1cpre-CVT visit8.5 percentage of glycated hemoglobinStandard Deviation 1.76
InterventionHgbA1cpost-CVT visit7.99 percentage of glycated hemoglobinStandard Deviation 1.28
Pamphlet AloneHgbA1cpre-CVT visit8.5 percentage of glycated hemoglobinStandard Deviation 1.2
Pamphlet AloneHgbA1cpost-CVT visit8.2 percentage of glycated hemoglobinStandard Deviation 1.26
Primary

Human Connection Scale

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionHuman Connection Scalepre-CVT visit49.73 units on a scaleStandard Deviation 13.19
InterventionHuman Connection Scalepost-CVT visit52.44 units on a scaleStandard Deviation 10.63
Pamphlet AloneHuman Connection Scalepre-CVT visit49.28 units on a scaleStandard Deviation 12.05
Pamphlet AloneHuman Connection Scalepost-CVT visit49.35 units on a scaleStandard Deviation 12.77
Primary

Medication Adherence (MPR)

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

Time frame: 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.

Primary

Resistance to Treatment Questionnaire (RTQ)

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).

Time frame: 4 weeks past CVT visit

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

ArmMeasureValue (MEAN)Dispersion
InterventionResistance to Treatment Questionnaire (RTQ)42.59 units on a scaleStandard Deviation 11.06
Pamphlet AloneResistance to Treatment Questionnaire (RTQ)45.13 units on a scaleStandard Deviation 13.99
Secondary

Diabetes Self-Efficacy

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionDiabetes Self-Efficacypre-CVT visit22.81 units on a scaleStandard Deviation 4.61
InterventionDiabetes Self-Efficacypost-CVT visit22.94 units on a scaleStandard Deviation 4.76
Pamphlet AloneDiabetes Self-Efficacypre-CVT visit21.64 units on a scaleStandard Deviation 5.94
Pamphlet AloneDiabetes Self-Efficacypost-CVT visit22.75 units on a scaleStandard Deviation 5.89
Secondary

Participatory Decision-Making

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionParticipatory Decision-Makingpre-CVT visit16.68 units on a scaleStandard Deviation 4.45
InterventionParticipatory Decision-Makingpost-CVT visit17.15 units on a scaleStandard Deviation 4.76
Pamphlet AloneParticipatory Decision-Makingpre-CVT visit15.34 units on a scaleStandard Deviation 5.34
Pamphlet AloneParticipatory Decision-Makingpost-CVT visit15.06 units on a scaleStandard Deviation 5.1
Secondary

Patient Satisfaction

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.

Time frame: four weeks after CVT visit

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

ArmMeasureValue (MEAN)Dispersion
InterventionPatient Satisfaction24.19 units on a scaleStandard Deviation 3.98
Pamphlet AlonePatient Satisfaction23.35 units on a scaleStandard Deviation 5.45
Secondary

Trust in Provider Questionnaire

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
InterventionTrust in Provider Questionnairepre-CVT visit47.08 units on a scaleStandard Deviation 14.63
InterventionTrust in Provider Questionnairepost-CVT visit53.27 units on a scaleStandard Deviation 8.88
Pamphlet AloneTrust in Provider Questionnairepre-CVT visit45.00 units on a scaleStandard Deviation 15.16
Pamphlet AloneTrust in Provider Questionnairepost-CVT visit50.19 units on a scaleStandard Deviation 11.76

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026