- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055429
Enhancing Care of the Aged and Dying in Prisons Ph II
February 2, 2023 updated by: Klein Buendel, Inc.
Enhancing Care of the Aged and Dying in Prisons Phase II
The mission of corrections is to provide custody, control and care for incarcerated individuals.
United States 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 II project focuses on the correct users accessing correct learning strategies in the correct setting (i.e., interdisciplinary prison staff accessing high quality products designed to educate and lead practice change initiatives within the walls of prisons), by continuing research and development of a learning system that promotes an integrated systems approach to enhancing the care of the aged and dying in prisons.
Study Overview
Detailed Description
The United States has the highest rate of incarceration in the world.
There are over 1,821 state and federal prisons housing over 2.3 million prisoners in the United States.
The demographics of the prison population are shifting.
Longer sentences and constrained options for early release compound this trend.
The older adult segment of prison populations has more than tripled since 1990.
The health status of aging inmates does not mirror the free-world population.
In fact, prisoners typically present with health issues common to free citizens who are 10-15 years their senior.
Prisoners are wards of that state, that is, the system is responsible for providing for not only custody and control of offenders, but also their care.
Collectively, these trends have had a profound impact on prison systems: U.S. prisons are facing sharply increased demands in caring for aged and dying inmates.
In response to this need, Phase I project Enhancing Care for the Aged and Dying in Prisons (ECAD-P) demonstrated that (1) there is a need and interest for products such as ECAD-P (i.e., corrections administrators and staff are interested in end-of-life (EOL) care training); (2) trainings should be short, intensive, engaging, interactive, and contextually sensitive to the specific environment; and (3) an interactive, media-rich prototype with high acceptability and usability could be developed.
The specification document and commercialization plan indicate it is possible to develop a full-scale ECAD-P learning system in Phase II and market potential exists.
The technological innovation proposed for the ECAD-P project is well-suited to the targeted market.
Technical merit, feasibility, and market potential of the ECAD-P Learning System were demonstrated in the Phase I project.
The purpose of this Phase II application is to continue research and development of the ECAD-P learning system with an emphasis on developing a scalable unit for commercialization and testing scale-up in a larger number of more diverse contexts.
More specifically, the aims of ECAD-P Phase II are to 1) Develop a full scale media-rich interactive computer-based learning system consisting of six modules addressing EOL and geriatric care issues in prisons; 2) Conduct in-person usability testing of the full scale ECAD-P Learning System in state and federal prisons to evaluate the user interface, ease of use, and perceived barriers in order to optimize the scalable unit for broader dissemination; and 3) Test scale-up of the full scale ECAD-P Learning System in 12 federal (n=6) and state (n=6) prisons across the nation to evaluate outcomes, usage patterns, and commercialization opportunities.
Continued research and development will permit the refinement the scalable unit for commercialization.
Expanded testing of the learning system will establish the effectiveness of the learning system and will provide critical insights relevant to dissemination of the commercial product.
Study Type
Interventional
Enrollment (Actual)
241
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
-
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Colorado
-
Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
-
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Pennsylvania
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Employed by a participating state or federal prison
- Able to speak English
- Able to consent
Exclusion Criteria:
- Under 18 years
- Not employed by a participating state or federal 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Full Scale Unit
Testing of 6 modules
|
Pre-test, usability, post-test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of knowledge from Baseline (pre-test) to post-test (4-months). (End-of-Life and geriatric-related knowledge)
Time Frame: Pre-test and Post-test (4-months)
|
A questionnaire will be developed using the content expertise of study personnel and consultants.
The questionnaire will evaluate the change in knowledge of geriatric-related and end-of-life prior to the training (pre-test) and at the end of the training (post-test @ 4 months)
|
Pre-test and Post-test (4-months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Environmental Survey via questionnaire
Time Frame: 6 months
|
Evaluation of support systems and prison environment.
|
6 months
|
Environmental Survey via Qualitative Interviews
Time Frame: 6 months
|
Evaluation of support systems and prison environment.
|
6 months
|
Survey of past users of the Toolkit for Enhancing End-of-Life Care in Prisons
Time Frame: 6 months
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Explore the experiences of early adopters of the original Toolkit.
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6 months
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System Usability Questionnaire
Time Frame: 6 months
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The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Janice Penrod, PhD, Penn State University
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
- Wagner P, Sakala L. Mass incarceration: the whole pie. Northampton, MA: Prison Policy Initiative. Available at: Retrieved from: http://www.prisonpolicy.org/reports/pie.html. Published 2014. Updated.
- Williams BA, Goodwin JS, Baillargeon J, Ahalt C, Walter LC. Addressing the aging crisis in U.S. criminal justice health care. J Am Geriatr Soc. 2012 Jun;60(6):1150-6. doi: 10.1111/j.1532-5415.2012.03962.x. Epub 2012 May 29.
- Aday RH. Aging prisoners : crisis in American corrections. Westport, Conn.: Praeger; 2003.
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)
April 1, 2017
Primary Completion (ACTUAL)
April 30, 2019
Study Completion (ACTUAL)
April 30, 2019
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
February 15, 2017
First Posted (ACTUAL)
February 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 2, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0314
- 2R42AG049570-02 (NIH)
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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