Personal Health Libraries for Formerly Incarcerated Individuals

This is a randomized pilot study to test the acceptance and use of PerHL among formerly incarcerated individuals

Study Overview

• Status: Not yet recruiting
• Conditions: Personal Health Information; Incarcerated Individuals
• Intervention / Treatment: Device: Epic®MyChart; Device: Personal Health Library (PerHL) + MyChart

Detailed Description

Eligible participants will be enrolled after providing informed consent .Participants will then complete a baseline assessment. After the interview, eligible participants will be randomly assigned to the intervention or control group. The research assistant (RA) will be blinded to the randomization allocation until after the consent process. For the purposes of this study, permuted block randomization with random block sizes of 2, 4 and 6 will be used.

Intervention: Those randomized to the intervention arm will have access to PerHL. The intervention group will watch a demonstration by the RA and will practice using PerHL for 10-15 minutes, i.e. taking a picture of a document and uploading to PerHL, entering specific information, voice recording an appointment reminder. The RA will be responsible for providing technical support and assist with the need for initial support, e.g. phone-call or text-based support. At baseline, participants will be asked to provide a list of every organization they visited that may have health and health-related social information on them and receive consent to request their information to be sent to the participant and the study team on their behalf.

Control: Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart). The RA will give them an informational pamphlet outlining key features of the patient portal and guide them through the steps for signing up for a MyChart account, assist them to sign up, add the standard patient portal MyChart app to their phone, and provide them with the MyChart technical support hotline.

Study Procedures: During the intervention phase, all participants will meet with the RA at baseline, 1- and 3 months. During the study, each participant will be asked to provide at least 5 verified locators who are likely to have knowledge of their whereabouts throughout follow-up. Each participant will be provided with $50 payment to participants for each completion of surveys at baseline, 1, 3 months. In addition, participants will be given $10 each month to travel to a location with free wireless so their information can be uploaded to the cloud and a list of available locations. In total, each participant will receive $180 for participation.

For the 1- and 3-month follow-up period, the RA will ask participants to bring information collected and uploaded in PerHL and additional information that is important to the participant but was not uploaded.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marisol Credle, MA; Phone Number: 203-627-4050; Email: marisol.credle@yale.edu
• Study Contact Backup: Name: Kimberly Vasquez, MPH; Phone Number: 212-363-080; Email: Kimberly.vasquez@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
      • Contact: Marisol Foumakoye, MA; Phone Number: 203-627-4050; Email: marisol.credle@yale.edu
      • Principal Investigator: Karen Wang, MD, MHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• English-speaking
• have at least one chronic condition
• engaged in primary care in the community
• have been released from a correctional facility in the past year.

Exclusion Criteria:

• visual impairments
• cognitive impairments
• language barriers
• planned relocation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - MyChart; Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).	Device: Epic®MyChart; Participants randomized to the control arm will receive the standard of care patient portal (Epic®MyChart).
Experimental: Access to Personal Health Library (PerHL) + MyChart; Participants randomized to the PerHL arm will have access to PerHL and the standard of care patient portal (Epic®MyChart).	Device: Personal Health Library (PerHL) + MyChart; Participants randomized to the PerHL arm will have access to PerHL + the standard of care patient portal (Epic®MyChart).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance - Intention to use	Assess intention to use the app developed for the project. Intention to use will be assessed by a survey conducted in person. This survey item is in development.	1 month post enrollment
Acceptance - Intention to use	Assess intention to use the app developed for the project. Intention to use will be assessed by a survey conducted in person. This survey item is in development.	3 month post enrollment
Use of Personal health information technology	Assess the number of times the personal health information app was accessed each week and the duration of time on the system per week. This will be assessed using tracking functionality built into the app.	1 month post enrollment
Use of Personal health information technology	Assess the number of times the personal health information app was accessed each week and the duration of time on the system per week. This will be assessed using tracking functionality built into the app.	3 month post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived ease of use for the app	Assess how easy it was for the participant to use the app. Perceived ease of use will be assessed by self-report survey. This survey item is in development.	1 month post enrollment
Perceived ease of use for the app	Assess how easy it was for the participant to use the app. Perceived ease of use will be assessed by self-report survey. This survey item is in development.	3 month post enrollment
Perceived usefulness of the app	Assess how useful the participant found app to be. Perceived usefulness will be assessed by self-report survey. This survey item is in development.	1 month post enrollment
Perceived usefulness of the app	Assess how useful the participant found app to be. Perceived usefulness will be assessed by self-report survey. This survey item is in development.	3 month post enrollment
Attitude towards use of technology	Assess the participant's attitude towards using technology. Attitude towards technology will be assessed by self-report survey. This survey item is in development.	1 month post enrollment
Attitude towards use of technology	Assess the participant's attitude towards using technology. Attitude towards technology will be assessed by self-report survey. This survey item is in development.	3 month post enrollment
Completeness of data	Assess the proportion of health system data sources received by study team and/or patient (#organizational data received/ #organizational requests made), assess type of data received (# of medication list received/ requested or # of allergies received/requests made) to determine completeness of data.	1 month post enrollment
Completeness of data	Assess the proportion of health system data sources received by study team and/or patient (#organizational data received/ #organizational requests made), assess type of data received (# of medication list received/ requested or # of allergies received/requests made) to determine completeness of data.	3 month post enrollment
General self-efficacy	Assess participant self-efficacy. Self-efficacy will be assessed by self-report survey. This survey item is in development.	1 month post enrollment
General self-efficacy	Assess participant self-efficacy. Self-efficacy will be assessed by self-report survey. This survey item is in development.	3 month post enrollment
Medication adherence	Medication Adherence will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, medication adherence (as measured by ninety-day medication refill).	1 month post enrollment
Medication adherence	Medication Adherence will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, medication adherence (as measured by ninety-day medication refill).	3 month post enrollment
Engagement in primary care	Engagement in primary care will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, engagement in primary care (as measured by appointments made) via MyChart systems.	1 month post enrollment
Engagement in primary care	Engagement in primary care will be measured by personal health information technology use (MyChart) at Yale New Haven Hospital, engagement in primary care (as measured by appointments made) via MyChart systems.	3 month post enrollment

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Library of Medicine (NLM)
• Investigators: Principal Investigator: Karen Wang, MD, MHS, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2000028862; 1R01LM013477-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No