Diabetes MellitusDM2GONCT03623607
Diabetes to Go: Inpatient Education Implementation
An observational study of Diabetes Mellitus, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The study used the Practical, Robust, Implementation and Sustainability Model (PRISM) with mixed methods to: redesign a diabetes survival skills education (DSSE) program (DM2Go) content and the processes for its inpatient delivery; and to evaluate the feasibility of integrating and implementing high-tech tablet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Survival Skills Education
- How many people
- 596 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diabetes on the selected units who meet the criteria above are eligible. Among 596 T2DM patients identified on three medical-surgical units, 415 (70%) were program eligible (mean age 64 years, 57% male, 51% Black). The criteria for inclusion were intentionally been kept broad to minimize disruption to unit workflow and to increase generalizability of findings. Where appropriate, the justification for each criteria is also presented, e.g. exclusion of minors.
Who may be able to join
- Age > 18 yrs (lower limit of age for admission to MWHC adult units. All of the Diabetes To Go content is designed for adult learners)
- English speaking (Diabetes To Go content is currently only available in English);
- Diagnosis of diabetes mellitus (ICD9 250.xx/ICD-10-CM E08-E11) documented in the EMR
- Admitted to one of the inpatient units (non-critical care adult medicine/surgery nursing units, including 1 psychiatry unit) where the study is being conducted
- Willing and able to participate in the program.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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
The study used the Practical, Robust, Implementation and Sustainability Model (PRISM) with mixed methods to: redesign a diabetes survival skills education (DSSE) program (DM2Go) content and the processes for its inpatient delivery; and to evaluate the feasibility of integrating and implementing high-tech tablet computer-enabled delivery of the DSSE program for hospital inpatients within usual workflow by staff on general medical/surgical units (MSUs) and a behavioral health unit. The four study phases were: I) Interviews and focus groups with stakeholders to identify perceived barriers and facilitators for implementation; II) Redesign of the D2Go program to address usability issues and potential barriers and to optimize perceived facilitators; III) Development of implementation processes and a D2Go toolkit; IV) Conduct of a prospective cohort pilot study on three MSUs and one BHU.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Survival Skills Education
- Keywords
- Diabetes Self-Management Education, Inpatient, Technology, Nursing, Diabetes Survival Skills Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Survival Skills EducationOther
Also called Diabetes To Go Inpatient, Inpatient Diabetes 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 explored
What is being measured
The primary outcome is the main question the study is designed to answer.
Integration of Diabetes Self Management Education and Support (DSMES) into nurses workflow
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.
Measured: July 2016-May 2017 (11 months)
Patient acceptance of diabetes self-management education delivered via an e-learning platform.
Rates of patient engagement with the DSMES program via the e-learning platform.
Measured: November 2017 to March 2018 months
Secondary outcomes (1)
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.
Measured: May 2017 to Oct 2017 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Apr 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle F Magee, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623607
- Sponsor's protocol ID
- 2016-019
- Other IDs
- 1R34DK109503-01
- Acronym
- DM2GO
- Status last verified
- Nov 2020
- First submitted
- 6 Aug 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data collected will be housed and maintained within the MedStar Health system on shared drives equipped with appropriate security measures behind the MedStar Health firewall. Data sharing will be housed within the MedStar Health Research Data Capture (RedCap) file server that provides HIPAA level protection of research data. Analytics on identifiable patient data will be maintained within MedStar Health's research servers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03623607
- Acronym / sponsor ID
- DM2GO / 2016-019
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Self-Management Education, Inpatient, Technology, Nursing, Diabetes Survival Skills Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study used the Practical, Robust, Implementation and Sustainability Model (PRISM) with mixed methods to: redesign a diabetes survival skills education (DSSE) program (DM2Go) content and the processes for its inpatient delivery; and to evaluate the feasibility of integrating and implementing high-tech tablet computer-enabled delivery of the DSSE program for hospital inpatients within usual workflow by staff on general medical/surgical units (MSUs) and a behavioral health unit. The four study phases were: I) Interviews and focus groups with stakeholders to identify perceived barriers and facilitators for implementation; II) Redesign of the D2Go program to address usability issues and potential barriers and to optimize perceived facilitators; III) Development of implementation processes and a D2Go toolkit; IV) Conduct of a prospective cohort pilot study on three MSUs and one BHU.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diabetes on the selected units who meet the criteria above are eligible. Among 596 T2DM patients identified on three medical-surgical units, 415 (70%) were program eligible (mean age 64 years, 57% male, 51% Black). The criteria for inclusion were intentionally been kept broad to minimize disruption to unit workflow and to increase generalizability of findings. Where appropriate, the justification for each criteria is also presented, e.g. exclusion of minors.
Key inclusion criteria (5 listed)
- Age > 18 yrs (lower limit of age for admission to MWHC adult units. All of the Diabetes To Go content is designed for adult learners)
- English speaking (Diabetes To Go content is currently only available in English);
- Diagnosis of diabetes mellitus (ICD9 250.xx/ICD-10-CM E08-E11) documented in the EMR
- Admitted to one of the inpatient units (non-critical care adult medicine/surgery nursing units, including 1 psychiatry unit) where the study is being conducted
- Willing and able to participate in the program.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Survival Skills EducationAlso: Diabetes To Go Inpatient, Inpatient Diabetes EducationApplication 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 explored | Other | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No. All data collected will be housed and maintained within the MedStar Health system on shared drives equipped with appropriate security measures behind the MedStar Health firewall. Data sharing will be housed within the MedStar Health Research Data Capture (RedCap) file server that provides HIPAA level protection of research data. Analytics on identifiable patient data will be maintained within MedStar Health's research servers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle F Magee, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integration of Diabetes Self Management Education and Support (DSMES) into nurses workflow (time frame: July 2016-May 2017 (11 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.