An Educational Intervention for Type 2 Diabetes Patients

Diabetes Mellitus Clinical Trial

— ACTIVet  

Official title:

A Randomized Trial of an Educational Intervention in Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671345
• Other study ID #: IIR 12-050
• Status: Completed
• Phase: N/A
• Start date: November 27, 2013
• Est. completion date: January 9, 2017

Study information

• Verified date: November 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: January 9, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• Control
Attention control

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2016 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	at the baseline ( Visit 1) and post-intervention (Visit 2)
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: 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.	at the baseline ( Visit 1) and post-intervention (Visit 2)
Secondary	Medication Adherence	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.	Four weeks post-intervention (i.e. four weeks after Visit 2).
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.	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.