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

• ClinicalTrials.gov Identifier: NCT02836015
• Recruitment Status: Completed
• First Posted: July 18, 2016
• Last Update Posted: October 27, 2017
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Leslie Eiland MD, University of Nebraska

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2	Behavioral: Shared Medical Visit	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• 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
• Study Start Date: May 2016
• Actual Primary Completion Date: June 30, 2017
• Actual Study Completion Date: June 30, 2017

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 75 Years (Adult, Older Adult)
• 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

Locations

United States, Nebraska

Midtown Clinic

Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

University of Nebraska

Investigators

• Principal Investigator: Leslie A Eiland, MD; University of Nebraska

More Information

Additional Information:

American Association of Diabetes Educators. 

Overview of race and Hispanic origin: 2010. 2010 Census Briefs. US Department of Commerce Economics and Statistics Administration, US Census Bureau 

The Potential of Group Visits in Diabetes Care 

Implementing Group Visits: Are They Effective to Improve Diabetes Self-Management Outcomes? 

Diabetes Initiative: a National Program of The Robert Wood Johnson Foundation 

Publications of Results:

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.

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. Review.

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.

Other Publications:

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. Review.

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.

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.

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.

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.

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.

• Responsible Party: Leslie Eiland MD, MD, University of Nebraska
• ClinicalTrials.gov Identifier: NCT02836015
• Other Study ID Numbers: 146-16-EP
• First Posted: July 18, 2016
• Last Update Posted: October 27, 2017
• Last Verified: October 2017

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