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Washington, District of Columbia 20010


Purpose:

This is a study to examine if it is possible to fit a diabetes education program into the workflow of hospital nursing units for delivery at the bedside to individual diabetes patients and, if so, the best design for implementation without increasing the burden of work of staff on the nursing unit. The study will refine and test the Diabetes 2 Go education program content and processes to establish Diabetes 2 Go program toolkit for use in additional hospital settings and hospitals.


Study summary:

The investigators seek to determine the feasibility of integrating the Diabetes To Go program's sustainability into ongoing hospital nursing unit processes for patient education and discharge planning. If successful, preliminary data generated will be used to develop a randomized controlled trial which will further assess program outcomes, including clinical and economic measures and potential for widespread dissemination. The objectives of the present R34 Diabetes To Go Inpatient proposal are to refine the Diabetes To Go program content based on user feedback and experience, as well as to design and develop processes to enhance the feasibility of integrated implementation within usual nursing unit workflow within a large health system. A mixed-methods approach is used to leverage implementation science frameworks and human factors principles to make DM survival skills education and discharge support more accessible, interactive and engaging for patients. The long-term goal of this research is to optimize scalable and sustainable solutions for DSME and for DM-related discharge support. This personalized approach leverages e-health technologies to pursue the following Specific Aims: Aim 1: To refine and optimize the Diabetes To Go program content and implementation processes. This will be achieved by applying user-centered interface design principles, content development in partnership with patients and providers, detailed process mapping for program integration into existing processes and workflow, and integrating mobile and e-health technology to support care transitions. The Practical, Robust, Implementation and Sustainability Model will guide implementation planning and evaluation. Hypothesis 1. Diabetes To Go: will be optimized for patient and provider usability and integration into nursing unit workflow; will enhance patient self-care knowledge and skills; and will support the discharge transition process. Aim 2: To conduct iterative rapid-cycle usability testing of the enhanced Diabetes To Go program content and processes and establish a Diabetes To Go program toolkit for widespread implementation. This will be achieved by a series of intervention-evaluation cycles of field testing, refinement, retesting of the Diabetes To Go program and evaluation through: direct observation; patient, provider and system leadership stakeholder interviews and focus groups; and evaluation of changes in early patient outcomes. Hypothesis 2. The Diabetes To Go program will be perceived favorably by stakeholders yielding a high-quality toolkit for implementation and delivery of the program for further evaluation and testing. Preliminary data gathered during this study will be used to design an R18 pragmatic trial in response to PAR 15-157 which will examine outcomes of implementation of the Diabetes To Go program when delivered on hospital nursing units to adult patients with diabetes across hospitals and health systems. The model has the potential to cause a paradigm shift in sustainable and generalizable approaches for delivery of patient-centered education and medication adherence and discharge transition support in the hospital


Criteria:

Inclusion Criteria: 1. Age > 18 yrs (lower limit of age for admission to MWHC adult units 2. English speaking (Diabetes To Go content is currently only available in English); 3. Diagnosis of diabetes mellitus (ICD9 250.xx/ICD-10-CM E08-E11) documented in the EMR 4. Admitted to one of the inpatient units (non-critical care adult medicine nursing units, including 1 psychiatry unit) where the study is being conducted 5. Willing and able to participate in the program. Exclusion criteria: 1. Age < 18 years (MWHC does not admit minors to its Medicine units and Diabetes To Go content has been prepared for adult learners) 2. Pregnancy or anticipated conception within 3 mos (Diabetes To Go content does not address gestational diabetes or diabetes in pregnancy where management and glycemic targets differ considerably from those for non-pregnant adults ); 3. Admission to an intensive-care unit, diabetic ketoacidosis, hyperglycemic hyperosmolar state - conditions in which the acuity level would likely preclude participation in DSME; 4. Patient declines participation in the education program for any reason; and any medical condition or cognitive dysfunction that, in the opinion of unit staff, would preclude participation in the education program. Exclusion Criteria:


NCT ID:

NCT03623607


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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