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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK127961-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.
The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. |
|
| Delayed Intervention/Control | Active Comparator | Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Diabetes Goal Survey and Optional Care Management | Behavioral | The intervention is already described in the intervention arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Documentation of Diabetes Goal | Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no). | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Personalized A1C Goals | The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. The number of analyzed A1C goal results is therefore dependent on the number of survey respondents. | Baseline, 6 months |
| Patient Ability to Reach Personalized Goals |
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Utilization | We will utilize the EHR to determine the frequency of referrals to telephone care management, the source of referrals (population management, physician), the patient predictors of referrals, and to characterize frequency and content of telephonic management. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elbert S Huang, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38915356 | Derived | Zhu M, Cui M, Nathan AG, Press VG, Wan W, Miles C, Ali R, Pusinelli M, Huisingh-Scheetz M, Huang ES. A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management. Health Sci Rep. 2024 Jun 23;7(6):e2208. doi: 10.1002/hsr2.2208. eCollection 2024 Jun. |
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110 Participants were randomized to either intervention or delayed intervention, but only 75 participants completed the initial survey immediately after randomization that was a required element to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. |
| FG001 | Delayed Intervention/Control | Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above. My Diabetes Goal Survey and Optional Care Management: The intervention is already described in the intervention arm description. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Does not include 7 participants in the intervention arm and 3 from the delayed intervention arm who withdrew from the study prior to receiving the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. |
| 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 | Documentation of Diabetes Goal | Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no). | We reviewed the electronic health records to assess how many participants of the total sample of 100 participants had a documented goal in the EHR at baseline and at months. | Posted | Count of Participants | Participants | Baseline, 6 months |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. The data collection period was 23 months.
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Experimental: Intervention Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elbert Huang | The University of Chicago | (773) 834-9143 | ehuang@medicine.bsd.uchicago.edu |
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| 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 | Jul 9, 2018 | Sep 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey. |
| Baseline, 6 month |
| BG001 | Delayed Intervention | Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| A1c | There are missing baseline A1C values for both study arms. | Mean | Standard Deviation | % (percentage of A1c) |
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| OG001 | Delayed Intervention Arm | Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated. |
|
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| Secondary | Personalized A1C Goals | The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. The number of analyzed A1C goal results is therefore dependent on the number of survey respondents. | The number of participants analyzed is less than 50 because of incomplete collection of personalized A1c goals at the 6 month timepoint. | Posted | Mean | Standard Deviation | % (percentage A1c) | Baseline, 6 months |
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| Secondary | Patient Ability to Reach Personalized Goals | Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey. | We reviewed the electronic health records to assess how many participants of the Intervention Arm reached their documented goals at baseline and at 6 months. The denominator is limited to participants with survey responses and lab values. | Posted | Count of Participants | Participants | Baseline, 6 month |
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| Other Pre-specified | Health Care Utilization | We will utilize the EHR to determine the frequency of referrals to telephone care management, the source of referrals (population management, physician), the patient predictors of referrals, and to characterize frequency and content of telephonic management. | Not Posted | 1 year | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6 months |
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| Goal not achieved |
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| 6 month trial |
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