An Educational Intervention for Type 2 Diabetes Patients (ACTIVet)

Tracking Information
First Submitted Date ICMJE	June 14, 2012
First Posted Date ICMJE	August 23, 2012
Last Update Posted Date	April 10, 2017
Actual Study Start Date ICMJE	November 27, 2013
Actual Primary Completion Date	November 30, 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 20, 2012)	patients active participatory communication behaviors [ Time Frame: visit 1 and 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; communicating concerns.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01671345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 20, 2012)	patients' perceived self-efficacy to communicate [ Time Frame: per visit outcome ]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; medication adherence [ Time Frame: 6 month ]; hemoglobin A1c [ Time Frame: 6 month ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	An Educational Intervention for Type 2 Diabetes Patients
Official Title ICMJE	A Randomized Trial of an Educational Intervention in Type 2 Diabetes Patients
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 IOM Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.
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 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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Health Services Research
Condition ICMJE	Diabetes Mellitus
Intervention ICMJE	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 Name: Speak UP; Behavioral: Control Attention control
Study Arms	Active Comparator: Intervention Patients randomized to the intervention will view the intervention video Intervention: Behavioral: Intervention Video; Placebo Comparator: Control Patients randomized to control will view an informative video about nutrition and exercise of similar length Intervention: Behavioral: Control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 6, 2017)	169
Original Estimated Enrollment ICMJE; (submitted: August 20, 2012)	160
Actual Study Completion Date	January 9, 2017
Actual Primary Completion Date	November 30, 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01671345
Other Study ID Numbers ICMJE	IIR 12-050
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	VA Office of Research and Development
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Howard S. Gordon, MD SB Jesse Brown VA Medical Center, Chicago, IL
PRS Account	VA Office of Research and Development
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP