An interventional study of Pamphlet and Video in Diabetes Mellitus, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
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Exclusion Criteria:
Patients randomized to the intervention will view the video
Behavioral: Pamphlet · Behavioral: Video
Patients randomized to the pamphlet alone will only receive the pamphlet
Behavioral: Pamphlet
An educational intervention delivered prior to patients' visits with primary care physicians.
Also known as: Speak Up for Telehealth
An educational intervention delivered prior to patients' visits with primary care providers.
Also known as: Speak Up Video for Telehealth
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.
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)
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)
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
Medication Adherence (MPR)
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Time frame: 6 months
Adherence at 1 Year
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Time frame: 1 year
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)
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)
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)
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
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)
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
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)
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)
Total number of patients enrolled in randomized trial - 102.
| Milestone | Intervention | Pamphlet Alone |
|---|---|---|
| Started | 51 | 51 |
| Post-cvt visit interview | 37 | 48 |
| 4-week follow up | 37 | 46 |
| Completed | 37 | 46 |
| Not completed | 14 | 5 |
| Withdrew: Lost to follow-up | 6 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Cvt visit cancelled or no-show for cvt visit | 6 | 2 |
| Withdrew: Participant did not watch the video | 1 | 0 |
| Withdrew: Death | 0 | 1 |
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.
| percentage of glycated hemoglobin | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 8.5 ± 1.76 | 8.5 ± 1.20 |
| post-CVT visit | 7.99 ± 1.28 | 8.2 ± 1.26 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 22.81 ± 4.61 | 21.64 ± 5.94 |
| post-CVT visit | 22.94 ± 4.76 | 22.75 ± 5.89 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Consultation Care Measure (CCM) | 90.22 ± 16.30 | 84.08 ± 21.43 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Adherence (Self-reported) | 78.51 ± 21.53 | 75.98 ± 26.43 |
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
No measurements were reported for this outcome.
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
No measurements were reported for this outcome.
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Consultation and Relational Empathy (CARE) | 44.65 ± 7.75 | 40.39 ± 10.73 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Communication Ratings | 94.24 ± 13.54 | 88.67 ± 18.55 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 49.73 ± 13.19 | 49.28 ± 12.05 |
| post-CVT visit | 52.44 ± 10.63 | 49.35 ± 12.77 |
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).
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Resistance to Treatment Questionnaire (RTQ) | 42.59 ± 11.06 | 45.13 ± 13.99 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 47.08 ± 14.63 | 45.00 ± 15.16 |
| post-CVT visit | 53.27 ± 8.88 | 50.19 ± 11.76 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| Patient Satisfaction | 24.19 ± 3.98 | 23.35 ± 5.45 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 16.68 ± 4.45 | 15.34 ± 5.34 |
| post-CVT visit | 17.15 ± 4.76 | 15.06 ± 5.10 |
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.
| units on a scale | Intervention | Pamphlet Alone |
|---|---|---|
| pre-CVT visit | 22.81 ± 4.61 | 21.64 ± 5.94 |
| post-CVT visit | 22.94 ± 4.76 | 22.75 ± 5.89 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Pamphlet Alone | 1/48 (2.1%) | 1/48 (2.1%) | 0/48 (0%) |
| Event | Intervention | Pamphlet Alone |
|---|---|---|
| deathGeneral disorders | — | 1/48 |
Veterans with diabetes mellitus whose HbA1c ≥7 and whose primary care includes CVT visits at ECHCS or JBVAMC.
| Age, Categorical(Participants) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 19 | 32 |
| >=65 years | 24 | 29 | 53 |
| Age, Continuous(years) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| Mean | 65 ± 8.37 | 65 ± 9.38 | 65 ± 8.91 |
| Sex: Female, Male(Participants) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 37 | 46 | 83 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 16 | 28 |
| Not Hispanic or Latino | 25 | 31 | 56 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 2 | 6 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 32 | 45 | 77 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention | Pamphlet Alone | Total |
|---|---|---|---|
| United States | 37 | 48 | 85 |
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