- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03323008
E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons (P2P)
December 9, 2019 updated by: Klein Buendel, Inc.
The mission of corrections is to provide care, custody, and control for incarcerated individuals.
United State prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison.
This Phase I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in prisons.
Study Overview
Detailed Description
The US has the highest incarceration rate in the world-imprisoning 693 people per 100,000.
The older adult segment of the prison population has more than tripled since 1990 and their health issues are common to free people who are 10-15 years their senior.
Inmates over the age of 55 have a death rate that is 10 times that of prisoners aged 25-34.
US prison systems are facing sharply increased demands in caring for aged and dying inmates.
A recent systematic review revealed that inmate peer caregivers can figure prominently in delivery of end-of-life (EOL) care in prison.
However, the degree of training received by inmate peer caregivers varies widely.
The lack of consistent training, both in content and duration points to a need for evidence based, current, and readily accessible training for this abundant human resource for meeting a growing need in US prisons.
In response to this need, this Phase I STTR project, titled E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-Life Care in Prisons, will demonstrate the scientific merit and feasibility of developing cutting edge, media rich learning modules to train inmate peer caregivers in geriatric and EOL care.
The specific aims of the project are to (1) transform best practices in inmate peer caregiving into a comprehensive training program that consists of media-rich and highly interactive computer-based learning modules for providing geriatric and EOL care to their peers; and (2) conduct in-person usability testing of the media-rich and highly interactive web-based prototypes with inmates who are currently Mental Health Peer Support Specialists (i.e., prisoners who are experienced caregivers, but naïve to geriatric and EOL care) to evaluate the user interface, ease of use, and perceived barriers in order to refine and optimize the product.
In collaboration with an advisory board of experts in prison healthcare, geriatrics, ethics, palliative/hospice care, and oversight of an inmate peer support program, the investigators plan and develop discussion guides and then conduct focus groups with three groups of prison stakeholders: inmates who serve as peer caregivers for aged or dying peers; interdisciplinary staff who care for, or oversee care of aged and dying inmates; and training and information technology staff.
One focus group with each of the above three constituent groups will be held at a men's and a women's prison.
Focus groups will permit investigators to ensure that the design and technology plans match what is allowable for inmate training and will allow us to isolate essential geriatric and EOL content for specification in the development of the comprehensive training program.
Finally, the investigators will create and evaluate prototypes of media rich, interactive computer-based learning modules for inmates serving as peer caregivers.
At the end of Phase I, the investigators will have a specifications document for the design of modules that: fit with the technology available in corrections settings; is permissible to be used by inmates; represents the critical learning needs of inmate peer caregivers for assisting with geriatric and EOL care; and further develops the collaborative relationships in preparation for commercialization of the product.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16801
- Penn State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inmate Inclusion Criteria:
- Be a Mental Health Peer Support Specialist
- Be 18 years or older
- Able to speak, understand, and read English
- Able to consent.
Inmate Exclusion Criteria:
- Not be a Mental Health Peer Support Specialist
- Under 18 years of age
- Unable to speak, understand, and read English
- Unable to consent.
Prison Employee Inclusion Criteria:
- 18 years or older
- Employed by a participating at a participating prison
- Able to speak, understand, and read English
- Able to consent
Prison Employee Exclusion Criteria:
- Under 18 years
- Not employed by a participating prison
- Unable to speak English
- Unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Training Prototype
Testing of 3 modules
|
Usability testing and System Usability Scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale
Time Frame: 2 months
|
The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products.
It contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100."
A score of 68 is considered "above average."
Anything below a 68 is considered "below average."
The higher the score, the higher the usability of the product.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Loeb SJ, Steffensmeier D, Lawrence F. Comparing incarcerated and community-dwelling older men's health. West J Nurs Res. 2008 Mar;30(2):234-49; discussion 250-8. doi: 10.1177/0193945907302981. Epub 2007 Jul 13.
- Noonan M, Ginder S. Mortality in local jails and state prisons, 2000-2012-statistical table. Washington, DC: US Department of Justice, Office of Justice Programs, Bureau of Justice Statistics. October 2014.
- Wion RK, Loeb SJ. CE: Original Research: End-of-Life Care Behind Bars: A Systematic Review. Am J Nurs. 2016 Mar;116(3):24-36; quiz 37. doi: 10.1097/01.NAJ.0000481277.99686.82.
- Cloyes KG, Rosenkranz SJ, Berry PH, Supiano KP, Routt M, Shannon-Dorcy K, Llanque SM. Essential Elements of an Effective Prison Hospice Program. Am J Hosp Palliat Care. 2016 May;33(4):390-402. doi: 10.1177/1049909115574491. Epub 2015 Mar 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R41AG057239-01 (U.S. NIH Grant/Contract)
- 03017 (Klein Buendel, Inc.)
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
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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