Clinical trial NCT02864160: Integrated Second Language Learning for Chronic Care
Official title: Integrated Second Language Learning for Chronic Care: A Model to Improve Primary Care for Hispanics With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Language Concordance
Diabetes Self-Management
Health Coaching
Latinos
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-08-11
Enrollment: 64
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group study with concurrrent random assignment to intervention or control group using random assignment list that was pre-generated
Primary purpose: TREATMENT

Brief summary: Language barriers continue to impede access to quality care for limited English proficient populations. Recent research has demonstrated that access to language concordant providers increases quality of care. This project evaluates the efficacy and acceptability of a model intervention to improve second language proficiency, patient-centered communication, and clinical competency of nurse practitioner students who care for Spanish-speaking patients with diabetes.

Detailed description: The purpose of this randomized controlled 2-group study is to test the effect of an innovative educational intervention called Integrated Language Learning for Chronic Care (IL2L) on successful self-management of diabetes. It pursues an integrated development of second language and interpersonal communication skills that will facilitate productive interactions between Spanish-speaking nurse practitioners (NP) and limited English proficiency Hispanic patients with diabetes. The intervention targets the acquisition of language skills that facilitate communicative functions known to be effective in engaging chronically ill patients. It accelerates acquisition of these skills by adding a longitudinal clinical instruction dimension. Further, the investigators propose that the efficacy of the intervention can be demonstrated at the provider level through improved linguistic and interpersonal performance and at the patient level through improved diabetes outcomes in response to language concordance. In support of these claims, the investigators seek to achieve the following specific aims:

Aim 1: To determine the efficacy of the IL2L for Chronic Care intervention on physical and mental health outcomes for Spanish-speaking patients with diabetes. Our hypothesis is: H1: Patients in the IL2L care group will report better physical health (HbA1C, lipids, and weight), mental health (depression and anxiety) and satisfaction with their healthcare than patients in the non-IL2L care group.

Aim 2: To determine the efficacy of the IL2L for Chronic Care intervention on provider language proficiency and interpersonal communication skills. Our hypothesis is:H2: Providers exposed to the IL2L intervention will demonstrate improved Spanish language skills and interpersonal communication skills upon completion of the intervention.Specific Aim 3: To assess the acceptability of the IL2L for Chronic Care model within a graduate level nurse practitioner curriculum in a leading College of Nursing.

The study will employ a mixed-methods model to assess the efficacy and accessibility of the IL2L for Chronic Care educational intervention in The Ohio State University's College of Nursing nurse practitioner program. To achieve Aim 1, the investigators will use a randomized control trial to demonstrate efficacy of the IL2L for Chronic Care model at the patient level. The investigators will compare a group of patients exposed to providers who underwent the IL2L intervention (intervention group) and a group of patients who are undergoing standard care (comparison group). To achieve Aim 2, the investigators will use a qualitative data interaction analysis system to demonstrate improvement in Spanish language proficiency and interpersonal communication skills. To achieve Aim 3, the investigators will use a combination of quantitative and qualitative measures within the RE-AIM model to assess the acceptability of the IL2L for chronic care model at the program level in a nurse practitioner program in a leading College of Nursing. The study has been approved by the institutional review boards of both universities prior to implementation and patients and student providers provide written informed consent.

Eligibility criteria: INCLUSION CRITERIA

Students:

Enrolled in nurse practitioner programs at Ohio State University or University of Arizona Minimum intermediate Spanish language fluency by Oral Proficiency testing Patients Self identify as Hispanic/Latino Self identify preference for health care interaction in Spanish Clinical diagnosis of Type 2 diabetes Hemoglobin A1C of 7 or higher 22 years or older Must have access to land line or mobile phone

EXCLUSION CRITERIA

Students:

Distinguished Spanish language fluency by Oral Proficiency testing Received professional training for a health-related profession in a Spanish-speaking country

Patients:

Clinic diagnosis of diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy Clinical diagnosis of major depression Clinical diagnosis of other psychiatric disorder

Primary outcomes:
measure: Change in Patient Hemoglobin A1C from Baseline to 6 Months
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change in Patient Self-Efficacy from Baseline to 6 Months as Assessed by the DSES
timeFrame: From baseline to 6 months
measure: Change in Patient Depression from Baseline to 6 Months as Assessed by the PHQ-9
timeFrame: From baseline to 6 months
measure: Change in Patient Anxiety from Baseline to 6 Months as Assessed by the GAD-7
timeFrame: From baseline to 6 months
measure: Change in Patient Blood Pressure from Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Patient Weight from Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Patient Body Mass Index from Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Patient Waist Circumference from Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Patient Total Cholesterol from Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Health Coach Spanish Language Proficiency from Baseline to 6 Months as Assessed by the ACTFL
timeFrame: From baseline to 6 months
measure: Change in Health Coach Interpersonal Communication from Baseline to 6 Months as Assessed by the RIAS
timeFrame: From baseline to 6 months
Other outcomes:
measure: Change in Program Acceptability from Baseline to End of Year 5
timeFrame: From baseline to end of Year 5
measure: Change in Program Reach to End of Year 5
timeFrame: From baseline to end of Year 5
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Nursing
state: Arizona
city: Columbus
country: United States
facility: The Ohio State University College of Arts and Sciences
state: Ohio
Study officials:
affiliation: University of South Florida College of Nursing
name: Usha Menon, PhD, RN,
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at San Antonio
name: Glenn A Martinez, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menon U, Szalacha LA, Martinez GA, Graham MC, Pares-Avila JA, Rechenberg K, Stauber LS. Efficacy of a language-concordant health coaching intervention for latinx with diabetes. Patient Educ Couns. 2022 Jul;105(7):2174-2182. doi: 10.1016/j.pec.2021.11.024. Epub 2021 Nov 28.