An Educational Intervention for Type 2 Diabetes Patients (ACTIVet)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01671345
First received: June 14, 2012
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Intervention Video
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of an Educational Intervention in Type 2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • patients active participatory communication behaviors [ Time Frame: visit 1 and visit 2 ] [ Designated as safety issue: No ]

    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:

    1. telling a medical history;
    2. asking questions,
    3. being assertive or making requests, and
    4. communicating concerns.


Secondary Outcome Measures:
  • patients' perceived self-efficacy to communicate [ Time Frame: per visit outcome ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • hemoglobin A1c [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Speak UP
Placebo Comparator: Control
Patients randomized to control will view an informative video about nutrition and exercise of similar length
Behavioral: Control
Attention control

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 we build upon our 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, we 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 we propose to test the effectiveness of the video as an intervention to improved patients' communication. Our 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: We will conduct a two group, pre-post, randomized controlled, single-site trial of the intervention in patients with T2DM. We 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. Our 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671345

Contacts
Contact: Valencia E Burton, AS BA (312) 569-7473 valencia.burton@va.gov
Contact: Howard S Gordon, MD SB (312) 569-6129 howard.gordon2@va.gov

Locations
United States, Illinois
Jesse Brown VAMC (WestSide Division) Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen M Lenehan    312-569-6343    Karen.Lenehan@va.gov   
Principal Investigator: Howard S. Gordon, MD SB         
Sponsors and Collaborators
Investigators
Principal Investigator: Howard S. Gordon, MD SB Jesse Brown VAMC (WestSide Division)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01671345     History of Changes
Other Study ID Numbers: IIR 12-050
Study First Received: June 14, 2012
Last Updated: October 1, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014