Clinical trial NCT05180721: A Multi-level Intervention to Increase Access and Use of the Patient Portal
Official title: A Multi-level Intervention to Increase Access and Use of the Patient Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Education
Diabetes Mellitus, Type 2
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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: There are 2 phases in this study, developing and optimizing the intervention in Phase 1 using qualitative methods. In Phase 2, a pilot study will be conducted at two CHCs to evaluate the effect of the intervention on patient portal use, patient engagement with care, and clinical outcomes in adults with type 2 diabetes. For the purpose of this registration, Phase 2 of the study will be described.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usage of Portal
timeFrame: Monthly for 6 months
measure: Change in A1C value
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Portal messaging
timeFrame: Monthly for 6 months
measure: Tracking biometric data
timeFrame: Monthly for 6 months
measure: Health care engagement - positive
timeFrame: Baseline, 3 months, and 6 months
measure: Summary of Self-Care in Diabetes Survey
timeFrame: Baseline, 3 months, and 6 months
measure: Diabetes Self-Efficacy
timeFrame: Baseline, 3 months, 6 months
measure: Health Care Climate Questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Health care engagement - negative
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Fair Haven Community Health Center
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Community Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Robin Whittemore, PhD, APRN
role: STUDY_CHAIR
References: