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A Multi-level Intervention to Increase Access and Use of the Patient Portal

A Multi-level Intervention to Increase Access and Use of the Patient Portal

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05180721
Enrollment
26
Registered
2022-01-06
Start date
2022-10-03
Completion date
2024-07-02
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Patient Education

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

BEHAVIORALUse 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).

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Usage of PortalMonthly for 6 monthsFrequency. Mean portal login days/per month will be calculated using the EMR system
Change in A1C ValueBaseline, 3 months and 6 monthsThe A1C value will be assessed via fingerprick point of care A1c kits.

Secondary

MeasureTime frameDescription
Summary of Self-Care in Diabetes Survey- DietBaseline, 3 months, and 6 monthsDiet - following diabetes diet over past 7 days (score range 0-7, with higher scores indicating better self-care)
Diabetes Self-EfficacyBaseline, 3 months, 6 monthsSelf-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy)
Health Care Climate QuestionnaireBaseline, 3 months, 6 monthsPerception 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 monthsScore 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

ArmCount
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
Total22

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up4

Baseline characteristics

CharacteristicUse of Patient Portal for Diabetes Management
Age, Continuous56.32 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 typeEG000
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

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementChange in A1C ValueBaseline8.31 percentStandard Deviation 1.65
Use of Patient Portal for Diabetes ManagementChange in A1C Value3 months8.09 percentStandard Deviation 1.64
Use of Patient Portal for Diabetes ManagementChange in A1C Value6 months8.23 percentStandard Deviation 1.35
Primary

Usage of Portal

Frequency. Mean portal login days/per month will be calculated using the EMR system

Time frame: Monthly for 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementUsage of PortalMean of first 3 months12.65 days per monthStandard Deviation 6.21
Use of Patient Portal for Diabetes ManagementUsage of PortalMean of 3- 6 months5.79 days per monthStandard Deviation 3.74
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementDiabetes Self-EfficacyBaseline3.14 score on a scaleStandard Deviation 1.01
Use of Patient Portal for Diabetes ManagementDiabetes Self-Efficacy3 months3.44 score on a scaleStandard Deviation 1.17
Use of Patient Portal for Diabetes ManagementDiabetes Self-Efficacy6 months3.68 score on a scaleStandard Deviation 2.8
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementHealth Care Climate QuestionnaireBaseline4.15 score on a scaleStandard Deviation 0.78
Use of Patient Portal for Diabetes ManagementHealth Care Climate Questionnaire3 months4.14 score on a scaleStandard Deviation 0.83
Use of Patient Portal for Diabetes ManagementHealth Care Climate Questionnaire6 months3.95 score on a scaleStandard Deviation 1.07
Secondary

Problem Areas in Diabetes (PAID)

Score ranges from 0-100 with higher scores indicating more distress

Time frame: Baseline, 3 and 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementProblem Areas in Diabetes (PAID)Baseline43.58 score on a scaleStandard Deviation 30.51
Use of Patient Portal for Diabetes ManagementProblem Areas in Diabetes (PAID)3 months29.09 score on a scaleStandard Deviation 23.03
Use of Patient Portal for Diabetes ManagementProblem Areas in Diabetes (PAID)6 months25.45 score on a scaleStandard Deviation 24.88
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Use of Patient Portal for Diabetes ManagementSummary of Self-Care in Diabetes Survey- DietBaseline2.82 score on a scaleStandard Deviation 2.91
Use of Patient Portal for Diabetes ManagementSummary of Self-Care in Diabetes Survey- Diet3 months4.00 score on a scaleStandard Deviation 2.54
Use of Patient Portal for Diabetes ManagementSummary of Self-Care in Diabetes Survey- Diet6 months3.68 score on a scaleStandard Deviation 2.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026