Bamberg Diabetes Transitional Care Pilot Study

Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients

Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions.

The purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods:

1. standard of care,
2. a nurse telephone intervention (care coordination and education), and
3. an in-home community health worker intervention (care coordination and education).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Surveys; Behavioral: Telephonic Nurse Intervention; Behavioral: In-person Community Health Worker

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • The Regional Medical Center of Orangeburg and Calhoun Counties

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bamberg County resident
• between 18 and 75 years of age
• a patient discharged from the Regional Medical Center emergency department or Regional Medical Center hospital within 72 hours prior to consent
• diagnosed with diabetes or at high risk for diabetes
• will be a Regional Medical Center patient for follow-up care
• speaks English
• has access to a phone

Stage 2 Recruitment:

• If recruitment at 3 weeks after the first patient is enrolled is < 15 or the recruitment at 12 weeks is < 45, additional inclusion criteria will include the following: Regional Medical Center outpatient or unassigned community member with uncontrolled diabetes (defined as A1C >8 or blood pressure >140/90) is uninsured or who self-reports problems with obtaining medications.

Exclusion Criteria:

• end-stage renal disease
• terminal illness (e.g., advanced cancer, end-stage chronic obstructive pulmonary disease, advanced dementia)
• incarceration
• resident in a skilled nursing home.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Survey assessments as well as collection of medical records and billing information.	Behavioral: Surveys; The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.
Active Comparator: Telephonic Nurse Intervention; Survey assessments as well as collection of medical records and billing information. A nurse will communicate with participants via telephone to support diabetes self-management practices.	Behavioral: Surveys; The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.; Behavioral: Telephonic Nurse Intervention; A nurse will contact patients by phone at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.
Active Comparator: In-person Community Health Worker Intervention; Survey assessments as well as collection of medical records and billing information. A community health worker will work with participants in person to support diabetes self-management practices.	Behavioral: Surveys; The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.; Behavioral: In-person Community Health Worker; An in-person Community Health Worker will contact patients in-person at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion	Hospital data will be obtained from Revenue and Financial Affairs South Carolina Data Oversight Council. These data come from the health organization where patients receive care and include components such as age, health care facility type, dates of admission/ discharge, length of stay, charges, payment source, primary and secondary procedure codes.	Retrospective billing collection 2 years prior to study enrollment and 1 year after study completion
Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study Completion	Diabetes self-management assessment tool administered to participant over the phone or in-person	Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Health Goal Progress Captured by Field Notes to Track Intervention Activities from Baseline to Study Completion	Field Notes are completed after each interventionist's interaction with the participant to track progress to addressing health goals	Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)
Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study Completion	The 24-item Introduction to the Lifestyle Survey will be used to assess diet (fats, protein, fruits and vegetables) and at enrollment, week 4 and 12	Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: University of North Carolina, Chapel Hill; North Carolina Translational and Clinical Sciences Institute; South Carolina Department of Health and Human Services; The Regional Medical Center of Orangeburg and Calhoun Counties
• Investigators: Principal Investigator: Carolyn Jenkins, DrPh, MSN, Medical University of South Carolina; Principal Investigator: Samuel Cykert, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Pro00038334