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

Primary Purpose

Patient Education, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of patient portal for diabetes management
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patient Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Fair Haven Community Health CenterRecruiting
  • Norwalk Community Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of patient portal for diabetes management

Arm Description

A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).

Outcomes

Primary Outcome Measures

Usage of Portal
Frequency. Mean portal login days/per month will be calculated using the EMR system
Change in A1C value
The A1C value will be assessed via fingerprick point of care A1c kits.

Secondary Outcome Measures

Portal messaging
Number of messages sent/received total and per month
Tracking biometric data
Number of views of test results, blood glucose uploads total and per month
Health care engagement - positive
Number of medication refills, clinic appointments, use of community resources over previous 3 months
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)
Diabetes Self-Efficacy
Self-confidence in diabetes self-management tasks (score range from 0-10 with higher scores indicating better diabetes self-efficacy)
Health Care Climate Questionnaire
Perception of support by health care providers with higher scores indicating more perceived support
Health care engagement - negative
Number of ER visits and hospitalizations over the previous 3 months

Full Information

First Posted
December 14, 2021
Last Updated
March 13, 2023
Sponsor
Yale University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05180721
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Education, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Whittemore, PhD, APRN
Phone
203-737-2351
Email
robin.whittemore@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Wagner
Email
juwagner@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Whittemore, PhD, APRN
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Fair Haven Community Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Norwalk Community Health Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06854
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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