ACTIVet: An Educational Intervention for Type 2 Diabetes Patients
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Patients randomized to the intervention will view the intervention video |
Behavioral: 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
Other Names:
|
| Placebo Comparator: Control Patients randomized to control will view an informative video about nutrition and exercise of similar length |
Behavioral: Control
Attention control
|
Outcome Measures
Primary Outcome Measures
- Patients' Perceived Self-efficacy to Communicate [at the baseline ( Visit 1) and post-intervention (Visit 2)]
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 Active Participatory Communication Behaviors [at the baseline ( Visit 1) and post-intervention (Visit 2)]
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: telling a medical history; asking questions; being assertive or making requests, and communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.
Secondary Outcome Measures
- Medication Adherence [Four weeks post-intervention (i.e. four weeks after Visit 2).]
Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale. The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence. The Morisky scale (4-item version) assesses self-reported medication adherence using "yes" or "no" questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.
- Hemoglobin A1c [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.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of type 2 diabetes mellitus
-
Hemoglobin A1c (HgbA1c) greater than or equal to 8
-
Adults, age 18 or older
Exclusion Criteria:
-
Lives in skilled nursing facility
-
Dementia (abnormal score on Mini-COG)
-
Terminal medical condition
-
Drug- (e.g., steroid) induced diabetes.
-
Blind or deaf (e.g., unable to view/hear video)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Howard S. Gordon, MD SB, Jesse Brown VA Medical Center, Chicago, IL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 12-050
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 794 patients were screened; 625 were excluded (not meeting inclusion criteria -188, declined participation/did not respond to invite - 437). 169 patients were enrolled. |
| Arm/Group Title | Intervention | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control. |
| Period Title: Overall Study | ||
| STARTED | 77 | 92 |
| COMPLETED | 64 | 83 |
| NOT COMPLETED | 13 | 9 |
Baseline Characteristics
| Arm/Group Title | Intervention | Control | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control. | Total of all reporting groups |
| Overall Participants | 64 | 83 | 147 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
43
67.2%
|
57
68.7%
|
100
68%
|
| >=65 years |
21
32.8%
|
26
31.3%
|
47
32%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.19
(7.78)
|
59.50
(8.21)
|
59.89
(7.95)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
15.6%
|
12
14.5%
|
22
15%
|
| Male |
54
84.4%
|
71
85.5%
|
125
85%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
64
100%
|
83
100%
|
147
100%
|
Outcome Measures
| Title | Patients' Perceived Self-efficacy to Communicate |
|---|---|
| Description | 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. |
| Time Frame | at the baseline ( Visit 1) and post-intervention (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5 |
| Arm/Group Title | Intervention | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control |
| Measure Participants | 64 | 83 |
| Visit 1 |
22.11
(3.24)
|
22.14
(3.06)
|
| Visit 2 |
23.44
(2.40)
|
22.63
(2.99)
|
| Title | Patients Active Participatory Communication Behaviors |
|---|---|
| Description | 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: telling a medical history; asking questions; being assertive or making requests, and communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication. |
| Time Frame | at the baseline ( Visit 1) and post-intervention (Visit 2) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5 |
| Arm/Group Title | Intervention | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control |
| Measure Participants | 64 | 83 |
| Visit 1 |
41.96
(25.89)
|
44.32
(29.25)
|
| Visit 2 |
43.02
(30.95)
|
42.92
(26.52)
|
| Title | Medication Adherence |
|---|---|
| Description | Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale. The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence. The Morisky scale (4-item version) assesses self-reported medication adherence using "yes" or "no" questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence. |
| Time Frame | Four weeks post-intervention (i.e. four weeks after Visit 2). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5 |
| Arm/Group Title | Intervention | Control |
|---|---|---|
| Arm/Group Description | Patients randomized to the intervention view the intervention video Intervention Video: A video intervention delivered prior to patients' visit 2 with primary care physician designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence | Patients randomized to control view an informative video about diet and nutrition of similar length. Control: Attention control |
| Measure Participants | 64 | 83 |
| Measure of Outcome study |
82.66
(14.31)
|
78.78
(18.80)
|
| Morisky scale |
3.26
(1.03)
|
3.23
(0.92)
|
| Title | Hemoglobin A1c |
|---|---|
| Description | 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. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5 |
| Arm/Group Title | Intervention | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to control view an informative video about diet and nutrition of similar length Control: Attention control |
| Measure Participants | 64 | 83 |
| baseline |
10.07
(1.93)
|
9.53
(1.31)
|
| post-visit 2 |
9.07
(1.68)
|
9.27
(1.73)
|
Adverse Events
| Time Frame | 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. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Intervention | Control | ||
| Arm/Group Description | 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. | Patients randomized to control will view an informative video about diet and nutrition of similar length. Control: Attention control. | ||
All Cause Mortality |
||||
| Intervention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/77 (0%) | 0/92 (0%) | ||
Serious Adverse Events |
||||
| Intervention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/77 (0%) | 0/92 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intervention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/77 (0%) | 0/92 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Howard S. Gordon, MD |
|---|---|
| Organization | Jesse Brown VA Medical Center |
| Phone | 312-569-7331 |
| howard.gordon2@va.gov |
- IIR 12-050