NCT02836015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

May 23, 2016

Last Update Submit

December 21, 2023

Conditions

Diabetes Mellitus Type 2

Keywords

Shared Medical VisitsSpanish-speaking

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

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

    Every three months, up to 1 year

Secondary Outcomes (6)

  • Improvement in self care behaviors

    Every three months, up to 1 year

  • Barriers to care for Spanish-speaking patients with diabetes

    Every 3 months, up to 1 year

  • Screening for complications of diabetes

    Once annually, up to 1 year

  • PHQ-2 and PHQ-0 Depression screening tool

    Every three months, up to 1 year

  • Blood pressure

    Every 3 months, up to 1 year

  • +1 more secondary outcomes

Study Arms (1)

Shared Medical Visit Groups

EXPERIMENTAL

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

Behavioral: Shared Medical Visit

Interventions

Shared Medical VisitBEHAVIORAL

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.

Also known as: SMV
Shared Medical Visit Groups

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nebraska Medicine, Midtown Health Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (9)

  • 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.

    PMID: 25107290BACKGROUND

  • 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.

    PMID: 11375359BACKGROUND

  • 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.

    PMID: 20860336BACKGROUND

  • 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.

    PMID: 22427108BACKGROUND

  • 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.

    PMID: 24867918BACKGROUND

  • 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.

    PMID: 20097780BACKGROUND

  • 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.

    PMID: 20128205RESULT

  • 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.

    PMID: 16672681RESULT

  • 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.

    PMID: 21756014RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leslie A Eiland, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

July 18, 2016

Study Start

May 13, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)