Clinical trial NCT05441306: Personal Health Libraries for Formerly Incarcerated Individuals
Official title: Personal Health Libraries for Formerly Incarcerated Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Personal Health Information
Incarcerated Individuals
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2022-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptance - Intention to use
timeFrame: 1 month post enrollment
measure: Acceptance - Intention to use
timeFrame: 3 month post enrollment
measure: Use of Personal health information technology
timeFrame: 1 month post enrollment
measure: Use of Personal health information technology
timeFrame: 3 month post enrollment
Secondary outcomes:
measure: Perceived ease of use for the app
timeFrame: 1 month post enrollment
measure: Perceived ease of use for the app
timeFrame: 3 month post enrollment
measure: Perceived usefulness of the app
timeFrame: 1 month post enrollment
measure: Perceived usefulness of the app
timeFrame: 3 month post enrollment
measure: Attitude towards use of technology
timeFrame: 1 month post enrollment
measure: Attitude towards use of technology
timeFrame: 3 month post enrollment
measure: Completeness of data
timeFrame: 1 month post enrollment
measure: Completeness of data
timeFrame: 3 month post enrollment
measure: General self-efficacy
timeFrame: 1 month post enrollment
measure: General self-efficacy
timeFrame: 3 month post enrollment
measure: Medication adherence
timeFrame: 1 month post enrollment
measure: Medication adherence
timeFrame: 3 month post enrollment
measure: Engagement in primary care
timeFrame: 1 month post enrollment
measure: Engagement in primary care
timeFrame: 3 month post enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Karen Wang, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: