Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol
Background: Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fract...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000523 |
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| author | Nancy A. Hodgson Miranda V. McPhillips Karen B. Hirschman Emily Summerhayes Catherine Verrier Piersol Laura N. Gitlin |
| author_facet | Nancy A. Hodgson Miranda V. McPhillips Karen B. Hirschman Emily Summerhayes Catherine Verrier Piersol Laura N. Gitlin |
| author_sort | Nancy A. Hodgson |
| collection | DOAJ |
| description | Background: Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fraction of the many individuals living with dementia and their caregivers within in the US have access to evidence-based programs. A leading barrier to implementation of evidence-based dementia caregiver support programs into long-term care settings is the lack of streamlined, scalable, user-friendly, and tested training modalities. Objective: To describe the protocol for a study evaluating the implementation of the Care of Persons in their Environment (COPE) in Programs of All-Inclusive Care for the Elderly (PACE) setting. The COPE in PACE study aims to determine if self-paced, online training in the evidence-based dementia care program COPE is non-inferior to the traditional, in-person, instructor-led training for improving clinician knowledge and competence, patient symptoms, function, caregiver confidence and burden, and therapeutic alliance between clinicians and caregivers.Methods/Design: Pragmatic, multisite randomized controlled non-inferiority trial is being used to assess the implementation of COPE into PACE. The study utilizes a type III hybrid effectiveness design with a primary focus on measuring implementation factors and a secondary focus on measuring COPE effectiveness through caregiver and patient outcomes and therapeutic alliance. The ‘COPE in PACE’ study is an ongoing trial being conducted in 10 PACE settings throughout the US (NCT04165213). Discussion: This study design has potential to guide future translational efforts by providing program adaptation, fidelity monitoring and implementation details to enhance scalability of evidence-based programs. Clinical trial registration: NCT04165213. |
| format | Article |
| id | doaj-art-9ac9aa3b205d4e57834eb907186e0307 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-9ac9aa3b205d4e57834eb907186e03072025-08-20T03:25:05ZengElsevierContemporary Clinical Trials Communications2451-86542025-06-014510147810.1016/j.conctc.2025.101478Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocolNancy A. Hodgson0Miranda V. McPhillips1Karen B. Hirschman2Emily Summerhayes3Catherine Verrier Piersol4Laura N. Gitlin5School of Nursing, University of Pennsylvania, Philadelphia, PA, USA; Corresponding author. University of Pennsylvania's School of Nursing, Claire M. Fagin Hall, 418 Curie Boulevard, Philadelphia, PA, 19104, USA.M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, PA, USASchool of Nursing, University of Pennsylvania, Philadelphia, PA, USA; M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, PA, USASchool of Nursing, University of Pennsylvania, Philadelphia, PA, USADepartment of Occupational Therapy, Jefferson College of Rehabilitation Sciences, Thomas Jefferson University, Philadelphia, PA, USACollege of Nursing and Health Professions, Drexel University, Philadelphia, PA, USABackground: Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fraction of the many individuals living with dementia and their caregivers within in the US have access to evidence-based programs. A leading barrier to implementation of evidence-based dementia caregiver support programs into long-term care settings is the lack of streamlined, scalable, user-friendly, and tested training modalities. Objective: To describe the protocol for a study evaluating the implementation of the Care of Persons in their Environment (COPE) in Programs of All-Inclusive Care for the Elderly (PACE) setting. The COPE in PACE study aims to determine if self-paced, online training in the evidence-based dementia care program COPE is non-inferior to the traditional, in-person, instructor-led training for improving clinician knowledge and competence, patient symptoms, function, caregiver confidence and burden, and therapeutic alliance between clinicians and caregivers.Methods/Design: Pragmatic, multisite randomized controlled non-inferiority trial is being used to assess the implementation of COPE into PACE. The study utilizes a type III hybrid effectiveness design with a primary focus on measuring implementation factors and a secondary focus on measuring COPE effectiveness through caregiver and patient outcomes and therapeutic alliance. The ‘COPE in PACE’ study is an ongoing trial being conducted in 10 PACE settings throughout the US (NCT04165213). Discussion: This study design has potential to guide future translational efforts by providing program adaptation, fidelity monitoring and implementation details to enhance scalability of evidence-based programs. Clinical trial registration: NCT04165213.http://www.sciencedirect.com/science/article/pii/S2451865425000523(3–7) implementationCaregivingDementiaOnline trainingFidelity monitoring |
| spellingShingle | Nancy A. Hodgson Miranda V. McPhillips Karen B. Hirschman Emily Summerhayes Catherine Verrier Piersol Laura N. Gitlin Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol Contemporary Clinical Trials Communications (3–7) implementation Caregiving Dementia Online training Fidelity monitoring |
| title | Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol |
| title_full | Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol |
| title_fullStr | Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol |
| title_full_unstemmed | Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol |
| title_short | Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol |
| title_sort | training to move an evidence based dementia caregiver support program into practice a pragmatic randomized non inferiority trial protocol |
| topic | (3–7) implementation Caregiving Dementia Online training Fidelity monitoring |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000523 |
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