Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R18DK123373 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.
Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. . |
|
| Usual Care | No Intervention | Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Care Gaps Patient Portal Intervention | Other | The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Number of diabetes care gaps per patient out of four possible:
| Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Initiated Orders | The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c). | 12-month follow-up |
| Change in Understanding of Diabetes Monitoring and Preventative Care |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Martinez, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38941148 | Derived | Hackstadt AJ, Elasy TA, Gangaputra S, Harper KJ, Mayberry LS, Nelson LA, Peterson NB, Rosenbloom ST, Yu Z, Martinez W. Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e56123. doi: 10.2196/56123. |
Not provided
Not provided
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.
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.
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.
Not provided
440 patients were enrolled and sent the baseline survey. 433 patients completed the baseline survey. Completion of the baseline survey was required prior randomization and assignment to a study arm.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). |
| FG001 | Intervention | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the study analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). |
| BG001 | Intervention | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months | Number of diabetes care gaps per patient out of four possible:
| Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the mixed effects regression analysis. | Posted | Count of Participants | Participants | Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Vascular disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Martinez, MD, MS | Vanderbilt University Medical Center | 615-936-1010 | william.martinez@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2023 | Feb 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2022 | Mar 22, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly. |
| Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
| Change in Confidence Toward Managing Diabetes in General | The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of the confidence a person has in managing their own health and health care and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general. | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
| Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants. | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
| Satisfaction/Usability of My Health at Vanderbilt | The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale [0 (Strongly disagree) to 4 (strongly agree)] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91). | Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up |
| Change in Blood Glucose Control | Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record. | Baseline to 12-month follow-up |
| Treatment Intensification | The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction. | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
| Change in Diabetes Self-efficacy | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is 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. | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
| Reported Services Completed Outside Vanderbilt System | The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention. | 12-month follow-up |
| Withdrawal by Subject |
|
| moved or exited health system |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| eHealth Literacy | The eHealth Literacy Scale (eHEALS) was used to assess eHealth literacy. The eHEALS is an 8-item survey that uses a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The eHEALS is scored on a scale of 8-40, with higher scores indicating greater eHealth literacy. | Mean | Standard Deviation | units on a scale |
|
| Usual Care |
Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). |
| OG001 | Intervention | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. |
|
|
|
| Secondary | Patient Initiated Orders | The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c). | This analysis is limited to the intervention arm only because only patients in the intervention arm were able to initiate orders via the study intervention. | Posted | Number | orders initiated | 12-month follow-up |
|
|
|
| Secondary | Change in Understanding of Diabetes Monitoring and Preventative Care | Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly. | Number analyzed varies because not all participants answered all items at each timepoint. | Posted | Count of Participants | Participants | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
|
|
|
|
| Secondary | Change in Confidence Toward Managing Diabetes in General | The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of the confidence a person has in managing their own health and health care and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general. | Number analyzed varies because not all participants answered all items at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
|
|
|
|
| Secondary | Change in Diabetes Distress | The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants. | Number analyzed varies because not all participants answered all items at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
|
|
|
|
| Secondary | Satisfaction/Usability of My Health at Vanderbilt | The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale [0 (Strongly disagree) to 4 (strongly agree)] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91). | Number analyzed varies because not all participants answered all items at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up |
|
|
|
|
| Secondary | Change in Blood Glucose Control | Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record. | Number analyzed differs because not all patients had a qualifying A1c value in the EHR for the timepoint. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Baseline to 12-month follow-up |
|
|
|
| Secondary | Treatment Intensification | The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction. | Posted | Count of Participants | Participants | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
|
|
|
| Secondary | Change in Diabetes Self-efficacy | The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is 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. | Number analyzed varies because not all participants answered all items at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up |
|
|
|
|
| Secondary | Reported Services Completed Outside Vanderbilt System | The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention. | This analysis is limited to the intervention arm only because only patients in the intervention arm were able to report diabetes eye exams received outside the Vanderbilt University Medical Center health system using the study intervention. | Posted | Number | reports | 12-month follow-up |
|
|
|
| 1 |
| 217 |
| 7 |
| 217 |
| 0 |
| 217 |
| EG001 | Intervention | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. | 0 | 216 | 7 | 216 | 0 | 216 |
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Hospitalization | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Death | Injury, poisoning and procedural complications | Non-systematic Assessment | motor vehicle accident |
|
| Hospitalization | General disorders | Non-systematic Assessment |
|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Two Care Gaps |
|
| Three Care Gaps |
|
| Four Care Gaps |
|
| Two Care Gaps |
|
| Three Care Gaps |
|
| Four Care Gaps |
|
| Two Care Gaps |
|
| Three Care Gaps |
|
| Four Care Gaps |
|
| Title | Measurements |
|---|---|
|
| Diabetes eye exam |
|
| No Change |
|
| Wrong to Correct |
|
| Baseline to 6-months: Recommended frequency of hemoglobin A1C testing |
|
|
| Baseline to 12-months: Recommended frequency of hemoglobin A1C testing |
|
|
| Baseline to 3-months: Recommended frequency of urine microalbumin testing |
|
|
| Baseline to 6-months: Recommended frequency of urine microalbumin testing |
|
|
| Baseline to 12-months: Recommended frequency of urine microalbumin testing |
|
|
| Baseline to 3-months: Recommended frequency of pneumococcal vaccination |
|
|
| Baseline to 6-months: Recommended frequency of pneumococcal vaccination |
|
|
| Baseline to 12-months: Recommended frequency of pneumococcal vaccination |
|
|
| Baseline to 3-months: Recommended frequency of diabetes eye exam |
|
|
| Baseline to 6-months: Recommended frequency of diabetes eye exam |
|
|
| Baseline to 12-months: Recommended frequency of diabetes eye exam |
|
|
| 3-month follow-up |
|
|
| 6-month follow-up |
|
|
| 12-month follow-up |
|
|
| Change baseline to 3-month follow-up |
|
|
| Change baseline to 6-month follow-up |
|
|
| Change baseline to 12-month follow-up |
|
|
| 3-month follow-up |
|
|
| 6-month follow-up |
|
|
| 12-month follow-up |
|
|
| Change baseline to 3-month follow-up |
|
|
| Change baseline to 6-month follow-up |
|
|
| Change baseline to 12-month follow-up |
|
|
| 3-month follow-up |
|
|
| 6-month follow-up |
|
|
| 12-month follow-up |
|
|
| Change baseline to 3-month follow-up |
|
|
| Change baseline to 6-month follow-up |
|
|
| Change baseline to 12-month follow-up |
|
|
| 12-month follow-up |
|
|
| Change in Hemoglobin A1C: Baseline to 12-month follow-up |
|
|
| Increase in the number of medications |
|
| Unknown |
|
| Antihyperglycemic medications: baseline to 6-month follow-up |
|
| Antihyperglycemic medications: baseline to 12-month follow-up |
|
| Antihypertensive medications: baseline to 3-month follow-up |
|
| Antihypertensive medications: baseline to 6-month follow-up |
|
| Antihypertensive medications: baseline to 12-month follow-up |
|
| 3-month follow-up |
|
|
| 6-month follow-up |
|
|
| 12-month follow-up |
|
|
| Change baseline to 3-month follow-up |
|
|
| Change baseline to 6-month follow-up |
|
|
| Change baseline to 12-month follow-up |
|
|