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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180721
• Other study ID #: 2000031753
• Secondary ID: R21MD016949-01
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: Robin Whittemore, PhD, APRN
• Phone: 203-737-2351
• Email: robin.whittemore[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Patient Education

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Fair Haven Community Health Center	New Haven	Connecticut
United States	Norwalk Community Health Center	Norwalk	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of Portal	Frequency. Mean portal login days/per month will be calculated using the EMR system	Monthly for 6 months
Primary	Change in A1C value	The A1C value will be assessed via fingerprick point of care A1c kits.	Baseline, 3 months and 6 months
Secondary	Portal messaging	Number of messages sent/received total and per month	Monthly for 6 months
Secondary	Tracking biometric data	Number of views of test results, blood glucose uploads total and per month	Monthly for 6 months
Secondary	Health care engagement - positive	Number of medication refills, clinic appointments, use of community resources over previous 3 months	Baseline, 3 months, and 6 months
Secondary	Summary of Self-Care in Diabetes Survey	Diet, exercise, medication, and blood glucose self-management over past 7 days (score range 0-7, with higher scores indicating better self-care)	Baseline, 3 months, and 6 months
Secondary	Diabetes Self-Efficacy	Self-confidence in diabetes self-management tasks (score range from 0-10 with higher scores indicating better diabetes self-efficacy)	Baseline, 3 months, 6 months
Secondary	Health Care Climate Questionnaire	Perception of support by health care providers with higher scores indicating more perceived support	Baseline, 3 months, 6 months
Secondary	Health care engagement - negative	Number of ER visits and hospitalizations over the previous 3 months	Baseline, 3 months, 6 months