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Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes (SMV)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Leslie Eiland MD, University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Leslie Eiland MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02836015
First received: May 23, 2016
Last updated: July 15, 2016
Last verified: July 2016
  Purpose
The investigators seek to apply a shared medical visit model and interdisciplinary approach to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c as a marker of glycemic control and evaluate their mood with PHQ screening tools. The investigators seek to improve diabetes care for this group of underserved patients. Potential participants will be selected from the UNMC diabetes registry. Eligibility criteria includes adult patients over the age of eighteen years old with Type 2 diabetes, HgbA1c greater than 8%, whose preferred language is Spanish. Exclusion criteria include pregnancy, residency at a nursing home or other facility, substance abuse, and physician recommendation that study is not appropriate for the patient.

Condition Intervention
Diabetes Mellitus Type 2 Behavioral: Shared Medical Visit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes

Further study details as provided by Leslie Eiland MD, University of Nebraska:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Every three months, up to 1 year ]
    Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.


Secondary Outcome Measures:
  • Improvement in self care behaviors [ Time Frame: Every three months, up to 1 year ]
    See improvement in self care behaviors as defined by American Association of Diabetes Educators1: healthy eating, being active, monitoring, taking medication, problem solving, reducing risks, and healthy coping

  • Barriers to care for Spanish-speaking patients with diabetes [ Time Frame: Every 3 months, up to 1 year ]
    Identify barriers to care for Spanish-speaking patients with diabetes, which are specific to this minority group, in order to improve care of this specific population.

  • Screening for complications of diabetes [ Time Frame: Once annually, up to 1 year ]
    Urine microalbumin/creatinine ratio, low density lipoprotein, yearly dilated eye exam, yearly flu shot, and yearly diabetic foot exam.

  • PHQ-2 and PHQ-0 Depression screening tool [ Time Frame: Every three months, up to 1 year ]
    Evaluate change in the overall mood of patients with diabetes, as measured by reduced scores on the validated depression screening assessments. Each patient will always be administered the PHQ-2, a 2 question survey, and if they screen positive for depression on that they will be administered a PHQ-9, 9 question depression screening tool.

  • Blood pressure [ Time Frame: Every 3 months, up to 1 year ]
    Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.

  • BMI [ Time Frame: Every 3 months, up to 1 year ]
    Participants will have height and weight measured at each visit which allows for calculation of BMI


Estimated Enrollment: 16
Study Start Date: May 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shared Medical Visit Groups
All patients will be enrolled in the experimental group and will be involved in shared medical visits.
Behavioral: Shared Medical Visit
The Shared Medical Visits are a replacement for standard diabetic visits with PCP, and will occur completely in Spanish, the patients' preferred primary language. An interdisciplinary group including behavioral health, social work, pharmacy, MD, and diabetic educator will be involved in the visit. The focal point of the meeting is a 30 minute session in which all members are seated around a large table in the Midtown SMV area and each patient's blood sugars, labs, and medications are discussed in front of the entire group. Pertinent labs and vaccines are drawn/administered.
Other Name: SMV

Detailed Description:

Type 2 diabetes is an expanding epidemic, which is particularly pervasive in the Hispanic community. In 2014, the CDC reported that 21.9 million adults have been diagnosed with diabetes, a number which has nearly quadrupled since 1980.

Diabetes is a particularly challenging chronic disease due to the need for self-management. This research study plans to explore how shared medical visits with Spanish-speaking patients with diabetes can improve their control of diabetes, develop self-management behaviors, and enhance overall perspective of having a chronic disease.

The investigators will model this project after an ongoing with English speakers and they have demonstrated improvements in hemoglobin A1c levels and quality of life, and will now apply this model to Spanish-speaking patients.

Eligibility and exclusion criteria are detailed in the brief summary. Eligible participants will be recruited for the study through use of phone call in Spanish, letter writing in Spanish, word of mouth, and direct referral from their providers throughout UNMC. Once the list of potential subjects is compiled, those patients will be contacted and the details of the study will be explained in Spanish. All the participating staff in the study speak Spanish. The participants, at any time, can withdraw from the study.

Participants will receive education in diabetes health and lifestyle education. This will be a quantitative study using pre- and post-intervention measures to evaluate the outcomes of HgbA1c levels, scores on the validated 2-item and 9-item Patient Health Questionnaires (PHQ-2 and PHQ-9), and questionnaire which measures improvements in self-management behaviors.

Researchers will to follow-up with the participants in the week following the visit to discuss lab results. At the end of the study, researcher will send a detailed letter to the patient's primary care provider regarding progress and management in shared medical visits.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients over the age of eighteen years old with Type 2 diabetes
  • HgbA1c greater than 8%
  • Preferred language is Spanish

Exclusion Criteria:

  • Pregnancy
  • Residency at a nursing home or other facility
  • Substance abuse
  • Physician recommendation that study is not appropriate for the patient
  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: NCT02836015

Contacts
Contact: Meredith F Ross, MD 402-559-6036 meredith.ross@unmc.edu
Contact: Leslie A Eiland, MD 402-559-6876 leslie.eiland@unmc.edu

Locations
United States, Nebraska
Midtown Clinic Recruiting
Omaha, Nebraska, United States, 68131
Contact: Susan Burbach, CDE    402-595-3939    suburbach@nebraskamed.com   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Leslie A Eiland, MD University of Nebraska
  More Information

Additional Information:
Publications:

Responsible Party: Leslie Eiland MD, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT02836015     History of Changes
Other Study ID Numbers: 146-16-EP
Study First Received: May 23, 2016
Last Updated: July 15, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Leslie Eiland MD, University of Nebraska:
Shared Medical Visits
Spanish-speaking

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

ClinicalTrials.gov processed this record on September 25, 2017