Diabetes to Go: Inpatient Education Implementation (DM2GO)
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|ClinicalTrials.gov Identifier: NCT03623607|
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Other: Diabetes Survival Skills Education|
The investigators sought to determine the feasibility of integrating the Diabetes To Go inpatient DSSE program sustainably into ongoing hospital nursing unit processes for diabetes 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 R34 Diabetes To Go Inpatient proposal were 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 one hospital belonging to a regional health system. A mixed-methods approach is used to leverage implementation science frameworks and human factors principles to make DSSE 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 DSSE delivery 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 multiple hospitals in a regional health system. 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.
|Study Type :||Observational|
|Actual Enrollment :||596 participants|
|Official Title:||Diabetes to Go Inpatient: A Study of the Implementation of a Technology-enabled Diabetes Survival Skills Education Program Within Medical-Surgical Nursing Unit Workflow|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2019|
- Other: Diabetes Survival Skills Education
Application of human factors and education principles to refine and optimize an DSSE program for delivery to inpatients with type 2 diabetes (D2Go - IN) using a table-based e-learning platform ; utilization of implementation science to inform design of implementation processes for delivery within nursing unit workflow; establishment of a D2Go program toolkit; and evaluation of the feasibility and preliminary impact of the program when delivered by nursing unit staff on medical-surgical units (MSUs) to adults with type 2 diabetes. Barriers and facilitators of the D2Go - Inpatient program's reach, effectiveness, adoption, implementation and maintenance (RE-AIM)(31) were exploredOther Names:
- Diabetes To Go Inpatient
- Inpatient Diabetes Education
- Integration of Diabetes Self Management Education and Support (DSMES) into nurses workflow [ Time Frame: July 2016-May 2017 (11 months) ]
To identify and validate barriers and facilitators of reach, effectiveness, adoption, implementation and maintenance of a diabetes survival skills education program which is delivered at the bedside using a web-based e-learning platform by nursing unit staff to adult patients with type 2 diabetes prior to discharge from the hospital.
Nursing unit staff (RN, patient care technician, clerical, leadership) provided input via focus groups and key informant interviews to inform intervention design.
- Patient acceptance of diabetes self-management education delivered via an e-learning platform. [ Time Frame: November 2017 to March 2018 months ]Rates of patient engagement with the DSMES program via the e-learning platform.
- 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 [ Time Frame: May 2017 to Oct 2017 months ]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.
- Implementation effectiveness evaluation [ Time Frame: February 2018 - October 2018 (6 months) ]Implementation effectiveness evaluation will be guided by the RE-AIM framework. Our approach considers differences in hospital and nursing workflow, patient characteristics and is sensitive to differences in patient culture, knowledge and beliefs. Our mixed methods approach to operationalizing the RE-AIM framework used both qualitative and quantitative outcomes at the setting, staff, and patient levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623607
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Michelle F Magee, MD||Medstar Health Research Institute|