Diabetes Mellitus, Type 2, Patient Education
Conditions
Brief summary
The purpose of the study is to develop and evaluate a multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
Detailed description
Prior to the clinical trial, qualitative methods were used to inform the intervention protocol. For the clinical trial, a pilot study will be conducted to evaluate the effect of the intervention on patient portal use, patient engagement with care, and clinical outcomes in adults with type 2 diabetes. The focus of this registration is the clinical trial. Using a within subjects, pre-post design the investigator will pilot MAP in an anticipated 30 adults with T2D who are not using the portal. Data will be collected at baseline, 3, and 6 months. The investigators will evaluate the feasibility of MAP using an established framework (acceptability, demand, implementation, adaptation, and integration. The intervention will consist of the following: 1. provide free access to tablets and internet (material circumstances); 2. technology training and ongoing support (psychosocial factors); 3. assess social determinants of health and refer to community resources (material circumstances); 4. support diabetes self-management behaviors and refer to clinic services (behavioral and biological factors). MAP will be delivered by community health workers (CHW) and nurses already embedded in CHCs (healthcare system). The 3-month intervention is thoughtfully sequenced to first have CHWs address patient portal access (tablet, home internet), and then move on to patient mastery of the tablet and portal functionality. Next, CHWs will assess social determinants of health using an established measure and connect the participant to relevant community resources (e.g., SNAP benefits). It is anticipated that participants will have 4-6 individual sessions with the CHW, approximately 30 minutes each, followed by ongoing technology support as needed. Next, the clinic nurse will proactively contact the participant via the portal to provide diabetes self-management support. The nurse will begin by assessing participant behaviors and will then work with the participant to co-create a plan to help with diabetes self-management. The plan will include referral to relevant ancillary clinic services as needed (e.g., DSM education \[DSME\], nutritionist, obtaining a glucose meter). Participants will be instructed and encouraged to upload blood glucose data and communicate with the nurse and their health care provider via the portal, both of which have been shown to improve glycemic control. The nurse will work with each patient to individualize DSMS behavioral targets, considering the following priorities: use of the portal, attendance at appointments, uploading of blood glucose data to the portal, medication refills and adherence, and lifestyle and emotional factors. It is anticipated that nurses will communicate with patients via the portal at least twice weekly during the first month followed by ongoing DSMS as needed. In-person or telehealth sessions will be scheduled as needed. However, the exact sequence, timing, and length of sessions will be participant driven. For example, a participant who learns the portal quickly may proceed at a faster rate, or a participant who already uploads glucose data may skip that step.
Interventions
A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
Sponsors
Study design
Eligibility
Inclusion criteria
* Established patient of one of the partner CHCs * Age \> 18 years * Diagnosed with T2D \>6 months * Able to read in English or Spanish * Not using the patient portal * A1c \>7.5%
Exclusion criteria
* Cognitive impairment (≥3 errors on the Six Item Screener for cognitive impairment in clinical research \[SIS\]) (Callahan et al. 2002) as they will have difficulty in completing the study requirements * Gestational diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of Portal | Monthly for 6 months | Frequency. Mean portal login days/per month will be calculated using the EMR system |
| Change in A1C Value | Baseline, 3 months and 6 months | The A1C value will be assessed via fingerprick point of care A1c kits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Self-Care in Diabetes Survey- Diet | Baseline, 3 months, and 6 months | Diet - following diabetes diet over past 7 days (score range 0-7, with higher scores indicating better self-care) |
| Diabetes Self-Efficacy | Baseline, 3 months, 6 months | Self-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy) |
| Health Care Climate Questionnaire | Baseline, 3 months, 6 months | Perception of support by health care providers with higher scores indicating more perceived support, scores range from 1-5 |
| Problem Areas in Diabetes (PAID) | Baseline, 3 and 6 months | Score ranges from 0-100 with higher scores indicating more distress |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two community health centers. Flyers were posted in the clinics. Clinic personnel identified potentially eligible participants and if interested, would refer to research team. A trained research assistant provided information about the study and obtained informed consent in the preferred language of participant (Spanish or English).
Participants by arm
| Arm | Count |
|---|---|
| Use of Patient Portal for Diabetes Management A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
1. Provision of table and 6 month data plan for internet
2. Technology training
3. Diabetes support
4. Text message/phone calls | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Use of Patient Portal for Diabetes Management |
|---|---|
| Age, Continuous | 56.32 Years STANDARD_DEVIATION 10.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Change in A1C Value
The A1C value will be assessed via fingerprick point of care A1c kits.
Time frame: Baseline, 3 months and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Change in A1C Value | Baseline | 8.31 percent | Standard Deviation 1.65 |
| Use of Patient Portal for Diabetes Management | Change in A1C Value | 3 months | 8.09 percent | Standard Deviation 1.64 |
| Use of Patient Portal for Diabetes Management | Change in A1C Value | 6 months | 8.23 percent | Standard Deviation 1.35 |
Usage of Portal
Frequency. Mean portal login days/per month will be calculated using the EMR system
Time frame: Monthly for 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Usage of Portal | Mean of first 3 months | 12.65 days per month | Standard Deviation 6.21 |
| Use of Patient Portal for Diabetes Management | Usage of Portal | Mean of 3- 6 months | 5.79 days per month | Standard Deviation 3.74 |
Diabetes Self-Efficacy
Self-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy)
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Diabetes Self-Efficacy | Baseline | 3.14 score on a scale | Standard Deviation 1.01 |
| Use of Patient Portal for Diabetes Management | Diabetes Self-Efficacy | 3 months | 3.44 score on a scale | Standard Deviation 1.17 |
| Use of Patient Portal for Diabetes Management | Diabetes Self-Efficacy | 6 months | 3.68 score on a scale | Standard Deviation 2.8 |
Health Care Climate Questionnaire
Perception of support by health care providers with higher scores indicating more perceived support, scores range from 1-5
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Health Care Climate Questionnaire | Baseline | 4.15 score on a scale | Standard Deviation 0.78 |
| Use of Patient Portal for Diabetes Management | Health Care Climate Questionnaire | 3 months | 4.14 score on a scale | Standard Deviation 0.83 |
| Use of Patient Portal for Diabetes Management | Health Care Climate Questionnaire | 6 months | 3.95 score on a scale | Standard Deviation 1.07 |
Problem Areas in Diabetes (PAID)
Score ranges from 0-100 with higher scores indicating more distress
Time frame: Baseline, 3 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Problem Areas in Diabetes (PAID) | Baseline | 43.58 score on a scale | Standard Deviation 30.51 |
| Use of Patient Portal for Diabetes Management | Problem Areas in Diabetes (PAID) | 3 months | 29.09 score on a scale | Standard Deviation 23.03 |
| Use of Patient Portal for Diabetes Management | Problem Areas in Diabetes (PAID) | 6 months | 25.45 score on a scale | Standard Deviation 24.88 |
Summary of Self-Care in Diabetes Survey- Diet
Diet - following diabetes diet over past 7 days (score range 0-7, with higher scores indicating better self-care)
Time frame: Baseline, 3 months, and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Use of Patient Portal for Diabetes Management | Summary of Self-Care in Diabetes Survey- Diet | Baseline | 2.82 score on a scale | Standard Deviation 2.91 |
| Use of Patient Portal for Diabetes Management | Summary of Self-Care in Diabetes Survey- Diet | 3 months | 4.00 score on a scale | Standard Deviation 2.54 |
| Use of Patient Portal for Diabetes Management | Summary of Self-Care in Diabetes Survey- Diet | 6 months | 3.68 score on a scale | Standard Deviation 2.8 |