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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Medical Visit
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Shared Medical Visits, Spanish-speaking

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nebraska Medicine, Midtown Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shared Medical Visit Groups

Arm Description

All patients will be enrolled in the experimental group and will be involved in shared medical visits.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.

Secondary Outcome Measures

Improvement in self care behaviors
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
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
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
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
Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
BMI
Participants will have height and weight measured at each visit which allows for calculation of BMI

Full Information

First Posted
May 23, 2016
Last Updated
September 2, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT02836015
Brief Title
Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes
Acronym
SMV
Official Title
Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Shared Medical Visits, Spanish-speaking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Medical Visit Groups
Arm Type
Experimental
Arm Description
All patients will be enrolled in the experimental group and will be involved in shared medical visits.
Intervention Type
Behavioral
Intervention Name(s)
Shared Medical Visit
Other Intervention Name(s)
SMV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Every 3 months we will measure hemoglobin A1c to assess for improvement in glycemic control.
Time Frame
Every three months, up to 1 year
Secondary Outcome Measure Information:
Title
Improvement in self care behaviors
Description
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
Time Frame
Every three months, up to 1 year
Title
Barriers to care for Spanish-speaking patients with diabetes
Description
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.
Time Frame
Every 3 months, up to 1 year
Title
Screening for complications of diabetes
Description
Urine microalbumin/creatinine ratio, low density lipoprotein, yearly dilated eye exam, yearly flu shot, and yearly diabetic foot exam.
Time Frame
Once annually, up to 1 year
Title
PHQ-2 and PHQ-0 Depression screening tool
Description
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.
Time Frame
Every three months, up to 1 year
Title
Blood pressure
Description
Assessment of blood pressure at each visit, with goal for improvement in blood pressure control.
Time Frame
Every 3 months, up to 1 year
Title
BMI
Description
Participants will have height and weight measured at each visit which allows for calculation of BMI
Time Frame
Every 3 months, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Eiland, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nebraska Medicine, Midtown Health Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25107290
Citation
Edelman D, Gierisch JM, McDuffie JR, Oddone E, Williams JW Jr. Shared medical appointments for patients with diabetes mellitus: a systematic review. J Gen Intern Med. 2015 Jan;30(1):99-106. doi: 10.1007/s11606-014-2978-7. Epub 2014 Aug 9.
Results Reference
background
PubMed Identifier
11375359
Citation
Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M. Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. Diabetes Care. 2001 Jun;24(6):995-1000. doi: 10.2337/diacare.24.6.995.
Results Reference
background
PubMed Identifier
20860336
Citation
McCloskey J, Flenniken D. Overcoming cultural barriers to diabetes control: a qualitative study of southwestern New Mexico Hispanics. J Cult Divers. 2010 Fall;17(3):110-5.
Results Reference
background
PubMed Identifier
22427108
Citation
Ramal E, Petersen AB, Ingram KM, Champlin AM. Factors that influence diabetes self-management in Hispanics living in low socioeconomic neighborhoods in San Bernardino, California. J Immigr Minor Health. 2012 Dec;14(6):1090-6. doi: 10.1007/s10903-012-9601-y.
Results Reference
background
PubMed Identifier
24867918
Citation
Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. "We are all gonna get diabetic these days": the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.
Results Reference
background
PubMed Identifier
20097780
Citation
Ell K, Katon W, Xie B, Lee PJ, Kapetanovic S, Guterman J, Chou CP. Collaborative care management of major depression among low-income, predominantly Hispanic subjects with diabetes: a randomized controlled trial. Diabetes Care. 2010 Apr;33(4):706-13. doi: 10.2337/dc09-1711. Epub 2010 Jan 22.
Results Reference
background
PubMed Identifier
20128205
Citation
Bohn J, Burrowes N, Pinkston L, Riddett M, Chalmers S. Diabetes care for Hispanic patients: honoring culture while promoting glycemic control. Adv Nurse Pract. 2010 Jan;18(1):46-8. No abstract available.
Results Reference
result
PubMed Identifier
16672681
Citation
Jaber R, Braksmajer A, Trilling JS. Group visits: a qualitative review of current research. J Am Board Fam Med. 2006 May-Jun;19(3):276-90. doi: 10.3122/jabfm.19.3.276.
Results Reference
result
PubMed Identifier
21756014
Citation
Gutierrez N, Gimple NE, Dallo FJ, Foster BM, Ohagi EJ. Shared medical appointments in a residency clinic: an exploratory study among Hispanics with diabetes. Am J Manag Care. 2011 Jun 1;17(6 Spec No.):e212-4.
Results Reference
result
Links:
URL
https://www.diabeteseducator.org/patient-resources/aade7-self-care-behaviors
Description
American Association of Diabetes Educators.
URL
http://www.diabetesinitiative.org
Description
Diabetes Initiative: a National Program of The Robert Wood Johnson Foundation

Learn more about this trial

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

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