Enhancing Care of the Aged and Dying in Prisons Ph II

Aging Problems Clinical Trial

Official title:

Enhancing Care of the Aged and Dying in Prisons Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055429
• Other study ID #: 0314
• Secondary ID: 2R42AG049570-02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2023
• Source: Klein Buendel, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging Problems

Intervention

Other:
• Full Scale Unit
Pre-test, usability, post-test

Locations

Country	Name	City	State
United States	Klein Buendel, Inc.	Golden	Colorado
United States	Penn State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Klein Buendel, Inc.	National Institute on Aging (NIA), Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aday RH. Aging prisoners : crisis in American corrections. Westport, Conn.: Praeger; 2003.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of knowledge from Baseline (pre-test) to post-test (4-months). (End-of-Life and geriatric-related knowledge)	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	Environmental Survey via questionnaire	Evaluation of support systems and prison environment.	6 months
Secondary	Environmental Survey via Qualitative Interviews	Evaluation of support systems and prison environment.	6 months
Secondary	Survey of past users of the Toolkit for Enhancing End-of-Life Care in Prisons	Explore the experiences of early adopters of the original Toolkit.	6 months
Secondary	System Usability Questionnaire	The System Usability Scale (SUS) is a validated tool for assessing the usability and acceptability of technology-based products	6 months