- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180721
A Multi-level Intervention to Increase Access and Use of the Patient Portal
Study Overview
Status
Conditions
Intervention / Treatment
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:
- provide free access to tablets and internet (material circumstances);
- technology training and ongoing support (psychosocial factors);
- assess social determinants of health and refer to community resources (material circumstances);
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robin Whittemore, PhD, APRN
- Phone Number: 203-737-2351
- Email: robin.whittemore@yale.edu
Study Contact Backup
- Name: Julie Wagner
- Email: juwagner@uchc.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Recruiting
- Fair Haven Community Health Center
-
Norwalk, Connecticut, United States, 06854
- Recruiting
- Norwalk Community Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usage of Portal
Time Frame: Monthly for 6 months
|
Frequency.
Mean portal login days/per month will be calculated using the EMR system
|
Monthly for 6 months
|
Change in A1C value
Time Frame: Baseline, 3 months and 6 months
|
The A1C value will be assessed via fingerprick point of care A1c kits.
|
Baseline, 3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Portal messaging
Time Frame: Monthly for 6 months
|
Number of messages sent/received total and per month
|
Monthly for 6 months
|
Tracking biometric data
Time Frame: Monthly for 6 months
|
Number of views of test results, blood glucose uploads total and per month
|
Monthly for 6 months
|
Health care engagement - positive
Time Frame: Baseline, 3 months, and 6 months
|
Number of medication refills, clinic appointments, use of community resources over previous 3 months
|
Baseline, 3 months, and 6 months
|
Summary of Self-Care in Diabetes Survey
Time Frame: Baseline, 3 months, and 6 months
|
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
|
Diabetes Self-Efficacy
Time Frame: Baseline, 3 months, 6 months
|
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
|
Health care engagement - negative
Time Frame: Baseline, 3 months, 6 months
|
Number of ER visits and hospitalizations over the previous 3 months
|
Baseline, 3 months, 6 months
|
Health Care Climate Questionnaire
Time Frame: Baseline, 3 months, 6 months
|
Perception of support by health care providers with higher scores indicating more perceived support
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robin Whittemore, PhD, APRN, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000031753
- R21MD016949-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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