Diabetes Mellitus, Type 2
Conditions
Keywords
Geriatrics
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMy Diabetes Goal Survey and Optional Care Management
The intervention is already described in the intervention arm description.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years and older * Diagnosis of Type 2 Diabetes * Enrolled in MyChart (University of Chicago Patient Portal) * Outpatient clinic visit in the prior year
Exclusion criteria
* Under 64 years of age * No type 2 diabetes * Not enrolled in MyChart * No outpatient clinic visit in the prior year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of Diabetes Goal | Baseline, 6 months | Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Personalized A1C Goals | Baseline, 6 months | 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. |
| Patient Ability to Reach Personalized Goals | Baseline, 6 month | Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Care Utilization | 1 year | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Intervention | Delayed Intervention |
|---|---|---|---|
| A1c | 7.1 % (percentage of A1c) STANDARD_DEVIATION 1.1 | 7.1 % (percentage of A1c) STANDARD_DEVIATION 0.8 | 7.2 % (percentage of A1c) STANDARD_DEVIATION 1.3 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 100 Participants | 50 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.5 years STANDARD_DEVIATION 5.2 | 72.4 years STANDARD_DEVIATION 5 | 72.7 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 48 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 31 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 100 participants | 50 participants | 50 participants |
| Sex: Female, Male Female | 68 Participants | 29 Participants | 39 Participants |
| Sex: Female, Male Male | 32 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Documentation of Diabetes Goal
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
Time frame: Baseline, 6 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Arm | Documentation of Diabetes Goal | Baseline | Documentation of Goals | 21 Participants |
| Intervention Arm | Documentation of Diabetes Goal | 6-month Trial | Documentation of Goals | 45 Participants |
| Intervention Arm | Documentation of Diabetes Goal | Baseline | No Documentation of Goals | 29 Participants |
| Intervention Arm | Documentation of Diabetes Goal | 6-month Trial | No Documentation of Goals | 5 Participants |
| Delayed Intervention Arm | Documentation of Diabetes Goal | Baseline | No Documentation of Goals | 23 Participants |
| Delayed Intervention Arm | Documentation of Diabetes Goal | Baseline | Documentation of Goals | 27 Participants |
| Delayed Intervention Arm | Documentation of Diabetes Goal | 6-month Trial | No Documentation of Goals | 28 Participants |
| Delayed Intervention Arm | Documentation of Diabetes Goal | 6-month Trial | Documentation of Goals | 22 Participants |
p-value: <0.01Chi-squared
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.
Time frame: Baseline, 6 month
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Arm | Patient Ability to Reach Personalized Goals | Baseline | Achieved Goal | 10 Participants |
| Intervention Arm | Patient Ability to Reach Personalized Goals | Baseline | Goal not achieved | 22 Participants |
| Intervention Arm | Patient Ability to Reach Personalized Goals | 6 month trial | Achieved Goal | 13 Participants |
| Intervention Arm | Patient Ability to Reach Personalized Goals | 6 month trial | Goal not achieved | 17 Participants |
| Delayed Intervention Arm | Patient Ability to Reach Personalized Goals | 6 month trial | Goal not achieved | 12 Participants |
| Delayed Intervention Arm | Patient Ability to Reach Personalized Goals | Baseline | Achieved Goal | 10 Participants |
| Delayed Intervention Arm | Patient Ability to Reach Personalized Goals | 6 month trial | Achieved Goal | 5 Participants |
| Delayed Intervention Arm | Patient Ability to Reach Personalized Goals | Baseline | Goal not achieved | 15 Participants |
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.
Time frame: Baseline, 6 months
Population: The number of participants analyzed is less than 50 because of incomplete collection of personalized A1c goals at the 6 month timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Personalized A1C Goals | Baseline | 6.6 % (percentage A1c) | Standard Deviation 0.7 |
| Intervention Arm | Personalized A1C Goals | 6 months | 7.0 % (percentage A1c) | Standard Deviation 0.9 |
| Delayed Intervention Arm | Personalized A1C Goals | Baseline | 6.9 % (percentage A1c) | Standard Deviation 1.6 |
| Delayed Intervention Arm | Personalized A1C Goals | 6 months | 6.7 % (percentage A1c) | Standard Deviation 0.6 |
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.
Time frame: 1 year