Clinical trial NCT02560090: Bamberg Diabetes Transitional Care Pilot Study
Official title: Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: South Carolina Department of Health and Human Services
name: North Carolina Translational and Clinical Sciences Institute
name: The Regional Medical Center of Orangeburg and Calhoun Counties
First posted: 2015-09-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion
timeFrame: Retrospective billing collection 2 years prior to study enrollment and 1 year after study completion
measure: Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study Completion
timeFrame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)
Secondary outcomes:
measure: Change of Health Goal Progress Captured by Field Notes to Track Intervention Activities from Baseline to Study Completion
timeFrame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)
measure: Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study Completion
timeFrame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: The Regional Medical Center of Orangeburg and Calhoun Counties
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Carolyn Jenkins, DrPh, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Samuel Cykert, MD
role: PRINCIPAL_INVESTIGATOR
References: