Clinical trial NCT03464812: Evaluating Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Diabetes Education Program
Official title: Evaluating Patient Engagement and Other Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Structured, Physician Supported, Patient-centered Diabetes Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Diabetes education
Psychosocial management of diabetes
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.

Detailed description: Diabetes is a chronic and a progressive metabolic disorder which necessitates active patient involvement to effectively manage nutrition, physical activity, and medication for optimal outcomes. Self-management is a critical aspect of diabetes care and a variety of studies have established the need for people with diabetes to be knowledgeable about their condition and be actively involved in its management to effectively reduce the risk of future health complications and improve other outcomes. Diabetes self-management education and support (DSMES) can help patients effectively engage in and perform their diabetes-related self-care activities. However, only a small number of patients with diabetes participate in DSMES. A few studies in this area have highlighted both physician and patient-related factors that could affect the receipt of DSMES. Patients' involvement in a DSMES program continues to be largely prompted by a physician referral and it has been suggested that improving physician involvement in the DSMES process could enhance overall patient engagement and adherence to such programs.

As part of the proposed mixed methods study, in Phase 1, in-depth surveys (or interviews) will be undertaken with: (a) physicians caring for people with type 2 diabetes, (b) DSMES providers (e.g., certified diabetes educators, diabetes nurses, dietitians), and (b) patients with type 2 diabetes regarding their perception of diabetes education programs, barriers, and facilitators to engagement. Findings from Phase 1 will be shared with the education team at a diabetes center in a community hospital in Orange County, California to inform changes to their currently existing diabetes education curriculum to make it more patient-centered and improve physician engagement and support. As part of Phase 2, the newly developed program will be implemented with a diverse cohort of 90 patients with type 2 diabetes. Patient participation (attendance) in the DSMES process will be documented as a primary marker of patient engagement while their clinical and psycho-social outcomes will serve as secondary indicators. Among other outcomes, physician, educator, and patient satisfaction with the newly developed referral process will also be assessed as a measure of intervention acceptability and success.

Eligibility criteria: Inclusion Criteria:

Patients of White, Asian, or Hispanic origin (30 in each group) Fluent in English (for the White and Asian group) Fluent in Spanish (for the Hispanic group) Age \> 18 years Physician referral for DSME/S Formal diagnosis of type 2 diabetes

Exclusion Criteria:

Current or planned pregnancy. Any medical or other condition that the investigator feels would interfere with study participation.

Mental incapacity precluding adequate understanding or cooperation. Potential participants who are imprisoned or hospitalized

Primary outcomes:
measure: Program completion
timeFrame: Approximately at 4 months from the start of the study.
Secondary outcomes:
measure: Glycemic control
timeFrame: At baseline and repeated after approximately 4 months
measure: Diabetes-specific quality of life
timeFrame: At baseline and repeated after approximately 4 months
measure: Diabetes-related distress
timeFrame: At baseline and repeated after approximately 4 months
measure: Diabetes self-care
timeFrame: At baseline and repeated after approximately 4 months
measure: Diabetes-related self efficacy
timeFrame: At baseline and repeated after approximately 4 months
measure: Patient and referring provider satisfaction
timeFrame: Approximately at 4 months from the start of the study.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Mary & Dick Allen Diabetes Center, Hoag Hospital
state: California
Study officials:
affiliation: Hoag Hospital
name: Harsimran Harsimran, PhD
role: PRINCIPAL_INVESTIGATOR
References: