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Evaluation a of Patient Portal Intervention to Address Diabetes Care Gaps

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ClinicalTrials.gov Identifier: NCT04728620
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
William Martinez, MD, MS, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., patient activation).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Diabetes Care Gaps Patient Portal Intervention Not Applicable

Detailed Description:

Up to 65 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care.

Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and two-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Intervention
Participants will have access to a new feature within an established patient portal native app on mobile devices. The new feature aims to address diabetes care gaps.
Other: Diabetes Care Gaps Patient Portal Intervention
The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, pneumonia vaccination, or influenza vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.




Primary Outcome Measures :
  1. Usability [ Time Frame: Immediately After First Use T(1) ]
    The System Usability Scale (SUS) is a validated measure of usability. The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). A score of above 68 indicative of "above average" usability.

  2. User Experience [ Time Frame: 2-month follow up (T2) ]
    User experience will be assessed by study-specific survey items administered to all participants at the end of the study period (T2). The survey items will inquire about participants' perspectives on the acceptability of the intervention and on particular components of the intervention such as notifications.


Secondary Outcome Measures :
  1. Changes in Patient Activation [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]
    The Patient Activation Measure® (PAM-13) is a validated measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care) and consists of 13 items. Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree to elicit endorsement of a particular statement. PAM® survey item responses result in total raw scores ranging from 13 to 52, which is converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation).

  2. Change in Diabetes Distress [ Time Frame: Enrollment (T0) and 2-month follow up (T2) ]
    The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress.

  3. Change in Diabetes Self-Efficacy [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]
    The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy. Eight items are scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.

  4. Change in Understanding of Diabetes Health Measures [ Time Frame: Enrollment (T0), Immediately After First Use (T1) and 2-month follow up (T2) ]
    Unique study specific items to assess participants' understanding of measures of diabetes health status (e.g., Hemoglobin A1C) will be administered to all study participants.

  5. Patient Initiated Orders [ Time Frame: 2-month follow up (T2) ]
    The investigators will collect data on the number of patient-initiated orders for evidence-based diabetes monitoring and preventative services (e.g., A1c).

  6. Order Completion [ Time Frame: 2-month follow up (T2) ]
    The investigators will collect data on the number of completed (i.e., care received) patient-initiated orders for evidence-based diabetes monitoring and preventative services.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Established patient at participating primary care clinic
  • Type 1 or 2 diabetes mellitus
  • Able to speak and read in English
  • Age 18 to 75 years old
  • Smartphone with internet access
  • Active MHAV account and willing and able to use the MHAV native app on a smartphone
  • Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, pneumococcal vaccination (PPSV-23), and/or influenza vaccination

Exclusion Criteria:

  • End Stage Renal Disease
  • Known cognitive deficits or functional impairment preventing the use of a mobile device
  • Pregnant or planning to become pregnant during the study period
  • Receiving treatment for cancer
  • Receiving hospice care
  • Residing in a long term care facility

Information from the National Library of Medicine

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): NCT04728620


Contacts
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Contact: William Martinez, MD, MS 615-936-1010 william.martinez@vumc.org

Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: William Martinez, MD, MS Vanderbilt University Medical Center
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Responsible Party: William Martinez, MD, MS, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04728620    
Other Study ID Numbers: 202281
R18DK123373-01 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Deidentified individual participant data that underlie the results reported will be available after publication in a peer reviewed journal and posted on clinical trials and ending after 36 months after publication.
Access Criteria: Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William Martinez, MD, MS, Vanderbilt University Medical Center:
Diabetes Mellitus
Medical Informatics
Preventative Care
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases