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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05180721
Collaborator
National Institutes of Health (NIH) (NIH)
36
2
1
21.5
18
0.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Use of patient portal for diabetes management
N/A

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 36 adults with T2D who are portal naive. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Multi-level Intervention to Increase Access and Use of the Patient Portal
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Jun 15, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

  1. Usage of Portal [Monthly for 6 months]

    Frequency. Mean portal login days/per month will be calculated using the EMR system

  2. Change in A1C value [Baseline, 3 months and 6 months]

    The A1C value will be extracted from the EMR system. The most proximal to date of study assessment (baseline, 3, 6 months) will be utilized

Secondary Outcome Measures

  1. Portal messaging [Monthly for 6 months]

    Number of messages sent/received total and per month

  2. Tracking biometric data [Monthly for 6 months]

    Number of views of test results, blood glucose uploads total and per month

  3. Health care engagement - positive [Baseline, 3 months, and 6 months]

    Number of medication refills, clinic appointments, use of community resources over previous 3 months

  4. Summary of Self-Care in Diabetes Survey [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)

  5. Diabetes Self-Efficacy [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)

  6. Health Care Climate Questionnaire [Baseline, 3 months, 6 months]

    Perception of support by health care providers (score range from 15-75 with higher scores indicating more perceived support)

  7. Health care engagement - negative [Baseline, 3 months, 6 months]

    Number of ER visits and hospitalizations over the previous 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fair Haven Community Health Center New Haven Connecticut United States 06510
2 Norwalk Community Health Center Norwalk Connecticut United States 06854

Sponsors and Collaborators

  • Yale University
  • National Institutes of Health (NIH)

Investigators

  • Study Chair: Robin Whittemore, PhD, APRN, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05180721
Other Study ID Numbers:
  • 2000031753
  • R21MD016949-01
First Posted:
Jan 6, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022