Bamberg Diabetes Transitional Care Pilot Study

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560090
• Other study ID #: Pro00038334
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: March 21, 2018
• Start date: June 1, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: March 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Regional Medical Center of Orangeburg and Calhoun Counties	Orangeburg	South Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of South Carolina	North Carolina Translational and Clinical Sciences Institute, South Carolina Department of Health and Human Services, The Regional Medical Center of Orangeburg and Calhoun Counties, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)