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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 and the prevalence of diabetes in the VA is higher among racial and ethnic minorities. 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. Doctors will also receive a communication skills training program. 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 Institute Of Medicine report, Crossing the Quality Chasm and is a goal of VA transformation efforts.
Background: Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4 racial/ethnic minority patients. Patients with low health literacy and minority groups have more difficulty communicating with physicians, report lower adherence to physicians' recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use more effective communication with physicians' can lead to better adherence to treatment and to better biomedical outcomes. In this project the investigators build upon their prior work from two Health Services Research & Development (HSRD) funded pilot projects to improve doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a previously funded short-term project, #SHP-08-182, the investigators conducted focus groups with patients with T2DM to elicit and understand from the patient perspective, barriers to communicating with their physician. This qualitative work was used in a subsequent pilot project, #PPO-08-402 to refine and pilot test an educational video to encourage patients to use active participatory communication in their visits to physicians. This work was successfully completed and the product is a 10 minute video that in testing was found to be acceptable to patients and feasible for patients to view immediately preceding their medical encounter.
Objectives: In this project the investigators propose to test the effectiveness of the video as an intervention to improved patients' communication. The primary aim is to conduct a randomized controlled trial of an intervention testing whether the intervention increases patients' active participatory communication behaviors, patients' post-visit ratings of self efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four secondary aims which include assessments of the (1) mediators, and (2) moderators of the relationship of the intervention condition to outcomes, (3) costs of the intervention, and (4) an evaluation of the feasibility of using the video for pre-visit preparation.
Methods: The investigators will conduct a two group, pre-post, randomized controlled, single-site trial of the intervention in patients with T2DM. The investigators will recruit 156 patients and their physicians for a pre and post-intervention visit. Physicians will be trained with the agenda setting module from the Four Habits model. Patients will be randomized to view a 10 minute intervention or control video prior to their second visit. Visits will be audio recorded and analyzed for patients' and physicians' communication behaviors. Self-efficacy to communicate will be collected by self report. Adherence will be collected by self-report and by medication possession ratio. Diabetic control is collected by chart review. Analyses will evaluate the relationship of the intervention condition to outcomes, mediators and moderators of that relationship, and will estimate costs of the intervention and feasibility of using the video in a busy clinic.
Impacts: VA transformation efforts including interprofessional Patient Aligned Care Teams (PACT) are focusing attention on patient-centered care. Improved communication is a central feature of patient centered care. Communication in medical interactions is critical and plays an important, but often overlooked role in health-care decision making and quality of care. Patients who have difficulty communicating are less involved in consultations with their physician, receive less information and support, and are less satisfied with their care. In turn, these patients may not understand their treatment options, may have less knowledge, less positive beliefs about treatment and less trust in physician, and may experience poorer health outcomes. Teaching patients to communicate more effectively is patient-centered because it inherently supports a patient-driven approach to delivering healthcare. The investigators' intervention is designed to encourage patients' active communication. Improving patients' communication is a unique focus that may supplement and add to the VA efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not disease specific and may be a paradigm for improvement in other conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Patients randomized to the intervention will view the intervention video |
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| Control | Placebo Comparator | Patients randomized to control will view an informative video about nutrition and exercise of similar length |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Video | Behavioral | A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Perceived Self-efficacy to Communicate | Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians. | at the baseline ( Visit 1) and post-intervention (Visit 2) |
| Patients Active Participatory Communication Behaviors | Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits. Active participatory communication behaviors include four essential elements:
| at the baseline ( Visit 1) and post-intervention (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard S. Gordon, MD SB | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26755527 | Result | Gordon HS, Street RL. How Physicians, Patients, and Observers Compare on the Use of Qualitative and Quantitative Measures of Physician-Patient Communication. Eval Health Prof. 2016 Dec;39(4):496-511. doi: 10.1177/0163278715625737. Epub 2016 Jan 10. |
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794 patients were screened; 625 were excluded (not meeting inclusion criteria -188, declined participation/did not respond to invite - 437). 169 patients were enrolled.
Eligible patients (active diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥ 7.5) were identified and recruited from the Primary Care clinic and Women's clinics at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago. Recruitment period lasted from 11/27/13 to 11/30/16.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients randomized to the intervention view the intervention video. Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence. |
| FG001 | Control | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients randomized to the intervention view the intervention video. Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients' Perceived Self-efficacy to Communicate | Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians. | Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5 | Posted | Mean | Standard Deviation | units on a scale | at the baseline ( Visit 1) and post-intervention (Visit 2) |
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From the baseline (Visit 1) to the follow-up telephone interview that was conducted four weeks post-intervention (i.e. four weeks after Visit 2). As this is a pragmatic study, we could not enforce the same specific time interval on each patient. Time frame varies depending on occurrence of patients' appointments with their physicians in routine clinical practice.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients randomized to the intervention view the intervention video. Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence. |
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The analysis of communication outcomes is not yet complete because of delays in coding of transcribed audio-recordings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard S. Gordon, MD | Jesse Brown VA Medical Center | 312-569-7331 | howard.gordon2@va.gov |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
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| Control | Behavioral | Attention control |
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| Four weeks post-intervention (i.e. four weeks after Visit 2). |
| Hemoglobin A1c | Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5. | At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2. |
| BG001 |
| Control |
Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control |
|
|
| Primary | Patients Active Participatory Communication Behaviors | Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits. Active participatory communication behaviors include four essential elements:
| Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5 | Posted | Mean | Standard Deviation | utterances | at the baseline ( Visit 1) and post-intervention (Visit 2) |
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|
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| Secondary | Medication Adherence | Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.
| Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5 | Posted | Mean | Standard Deviation | units on a scale | Four weeks post-intervention (i.e. four weeks after Visit 2). |
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| Secondary | Hemoglobin A1c | Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5. | Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5 | Posted | Mean | Standard Deviation | percent | At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2. |
|
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| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Control | Patients randomized to control will view an informative video about diet and nutrition of similar length. Control: Attention control. | 0 | 92 | 0 | 92 | 0 | 92 |
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| Morisky scale |
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