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

Not Applicable

Completed

• Conditions: Patient Education; Diabetes Mellitus, Type 2

• Registration Number: NCT05180721
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Study Start: 2022-10-03
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Results First Submitted: 2025-05-28
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-21
• Last Update Submitted: 2025-06-21
• Results First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Problem Areas in Diabetes (PAID)	Baseline, 3 and 6 months	Score ranges from 0-100 with higher scores indicating more distress
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

Trial Locations

Locations (2)

Fair Haven Community Health Center; 🇺🇸 New Haven, Connecticut, United States

Norwalk Community Health Center; 🇺🇸 Norwalk, Connecticut, United States