Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469723
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-06
Brief Title:
Protocol for Inpatient Nursing Frailty Assessment INFA
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
Protocol for Inpatient Nursing Frailty Assessment INFA Comprehensive Geriatric Assessment and Multidisciplinary Intervention for Frail Hospitalised Older Adults
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Frailty confers greater risks of negative health outcomes in hospitalised older adults To improve care for this vulnerable population Comprehensive Geriatric Assessment CGA is recommended for frail older persons However implementing CGA outside of specialised geriatrician-led settings is limited and few care models use frailty to identify and target older persons for CGA in the hospital-wide context
The Inpatient Nursing Frailty Assessment INFA programme is a CGA-based care model that targets frail older adults acutely admitted to the hospital under non-geriatrician care The INFA collects information from routine admission assessments by ward nurses identifying CGA domains of functional decline delirium falls sensory impairment nutrition oral health and swallowing The CGA allows earlier identification of health issues and development of a personalised care plan which directs patients to resources that mitigate the risks of functional decline Resources include nurse-initiated interventions multidisciplinary team care discharge planning community care referrals and specialist geriatric medicine reviews
Methods
The investigators aim to evaluate the INFA programme over two phases pre-implementation and implementation The updated CFIR including its Outcomes Addendum is the framework guiding both phases in the evaluation of effectiveness and implementation The investigators hybrid type 2 effectiveness-implementation study design is anchored in this framework During pre-implementation the investigators will evaluate the determinants of implementation success and subsequently refine implementation strategies In the implementation phase the investigators apply a quasi-experimental approach with intervention and control groups to examine the effects of the INFA intervention compared to usual care Study participants are patients admitted to medical and surgical wards and are not receiving geriatric care Individuals are aged 65 years and above and mild to moderately frail CFS score 4-6 Implementation research in this phase aims to evaluate implementation outcomes The primary outcome is activities of daily living at six months post-discharge Secondary outcomes include length of stay healthcare utilisation including readmissions and ED visits quality-of-life and cost-effectiveness
Discussion
The studys overall goal is to enhance the quality of care for frail older adults during their hospital stay leading to improved functional outcomes
Frailty confers greater risks of negative health outcomes in hospitalised older adults To improve care for this vulnerable population Comprehensive Geriatric Assessment CGA is recommended for frail older persons However implementing CGA outside of specialised geriatrician-led settings is limited and few care models use frailty to identify and target older persons for CGA in the hospital-wide context
The Inpatient Nursing Frailty Assessment INFA programme is a CGA-based care model that targets frail older adults acutely admitted to the hospital under non-geriatrician care The INFA collects information from routine admission assessments by ward nurses identifying CGA domains of functional decline delirium falls sensory impairment nutrition oral health and swallowing The CGA allows earlier identification of health issues and development of a personalised care plan which directs patients to resources that mitigate the risks of functional decline Resources include nurse-initiated interventions multidisciplinary team care discharge planning community care referrals and specialist geriatric medicine reviews
Methods
The investigators aim to evaluate the INFA programme over two phases pre-implementation and implementation The updated CFIR including its Outcomes Addendum is the framework guiding both phases in the evaluation of effectiveness and implementation The investigators hybrid type 2 effectiveness-implementation study design is anchored in this framework During pre-implementation the investigators will evaluate the determinants of implementation success and subsequently refine implementation strategies In the implementation phase the investigators apply a quasi-experimental approach with intervention and control groups to examine the effects of the INFA intervention compared to usual care Study participants are patients admitted to medical and surgical wards and are not receiving geriatric care Individuals are aged 65 years and above and mild to moderately frail CFS score 4-6 Implementation research in this phase aims to evaluate implementation outcomes The primary outcome is activities of daily living at six months post-discharge Secondary outcomes include length of stay healthcare utilisation including readmissions and ED visits quality-of-life and cost-effectiveness
Discussion
The studys overall goal is to enhance the quality of care for frail older adults during their hospital stay leading to improved functional outcomes
Detailed Description:
The Inpatient Nursing Frailty Assessment INFA programme is a Comprehensive Geriatric Assessment CGA-based care model that targets frail older adults acutely admitted to the hospital under non-geriatrician care
Briefly the INFA programme includes 1 A comprehensive geriatric syndrome screening tool merging multiple assessment areas into a streamlined Epic template This unified system optimises patient data capture and monitoring promoting early detection of geriatric syndromes 2 Nurse-led intervention protocols offering detailed strategies for managing identified geriatric syndromes This development equips nurses with skills to address complex needs of frail adults through additional training and supervision 3 An improved referral process for complex cases to specialist Geriatric nursing and medical care and 4 Comprehensive early discharge planning and systematic follow-up procedures involving both internal hospital personnel and external community service teams
This study aims to use the updated Consolidated Framework for Implementation Research CFIR including its Outcomes Addendum to guide the evaluation of the effectiveness and implementation of the INFA programme over two phases pre-implementation and implementation
In the pre-implementation phase a detailed written description of the INFA care model will be produced We will also create a logic model to describe the activities outputs and outcomes of INFA will be constructed and a theory of change model to explain the causal pathways linking them will be developed The investigators will engage implementors healthcare professionals through focus group discussions FGDs and in-depth interviews IDIs to understand their perspectives on various contextual factors to implementing the INFA program thereby enhancing the chances of successful and sustained implementation
Each participant will attend either a FGD or IDI covering the barriers and facilitators framed as CFIR determinants that influence the acceptability feasibility and adoptability of the INFA programme prior to implementation
The investigators will identify strategies from the Expert Recommendations for Implementing Change compilation ERIC before using the CFIR-ERIC matching tool to select implementation strategies to address CFIR-identified contextual barriers based on the implementers views
In the implementation phase the investigators will apply a quasi-experimental pretest-posttest design with intervention and control groups to examine the effects of the INFA intervention compared to standard careIn the implementation phase the investigators will apply a quasi-experimental pretest-posttest design with intervention and control groups to examine the effects of the INFA intervention compared to standard care There will be one control and one intervention ward in General Medicine and General Surgery wards Evaluations on the primary outcome of interest - Functional status - will occur at baseline admission discharge and six months post-discharge Secondary outcomes and cost-effectiveness analysis will also be collected and analyzed during this study
Importantly the implementation phase involves implementation research The investigators will evaluate the degree of adoption and implementation outcomes of the INFA program and likelihood of these interventions being delivered long-term and scaled-up Secondly the investigators will evaluate the selected implementation strategies in action by examining adoption and fidelity and also identify the CFIR determinants that influence these implementation outcomes This will be done through FGDsIDIs with the nursing leadership programme implementers and older adults Additionally the logic model and theory of change will be refined
Briefly the INFA programme includes 1 A comprehensive geriatric syndrome screening tool merging multiple assessment areas into a streamlined Epic template This unified system optimises patient data capture and monitoring promoting early detection of geriatric syndromes 2 Nurse-led intervention protocols offering detailed strategies for managing identified geriatric syndromes This development equips nurses with skills to address complex needs of frail adults through additional training and supervision 3 An improved referral process for complex cases to specialist Geriatric nursing and medical care and 4 Comprehensive early discharge planning and systematic follow-up procedures involving both internal hospital personnel and external community service teams
This study aims to use the updated Consolidated Framework for Implementation Research CFIR including its Outcomes Addendum to guide the evaluation of the effectiveness and implementation of the INFA programme over two phases pre-implementation and implementation
In the pre-implementation phase a detailed written description of the INFA care model will be produced We will also create a logic model to describe the activities outputs and outcomes of INFA will be constructed and a theory of change model to explain the causal pathways linking them will be developed The investigators will engage implementors healthcare professionals through focus group discussions FGDs and in-depth interviews IDIs to understand their perspectives on various contextual factors to implementing the INFA program thereby enhancing the chances of successful and sustained implementation
Each participant will attend either a FGD or IDI covering the barriers and facilitators framed as CFIR determinants that influence the acceptability feasibility and adoptability of the INFA programme prior to implementation
The investigators will identify strategies from the Expert Recommendations for Implementing Change compilation ERIC before using the CFIR-ERIC matching tool to select implementation strategies to address CFIR-identified contextual barriers based on the implementers views
In the implementation phase the investigators will apply a quasi-experimental pretest-posttest design with intervention and control groups to examine the effects of the INFA intervention compared to standard careIn the implementation phase the investigators will apply a quasi-experimental pretest-posttest design with intervention and control groups to examine the effects of the INFA intervention compared to standard care There will be one control and one intervention ward in General Medicine and General Surgery wards Evaluations on the primary outcome of interest - Functional status - will occur at baseline admission discharge and six months post-discharge Secondary outcomes and cost-effectiveness analysis will also be collected and analyzed during this study
Importantly the implementation phase involves implementation research The investigators will evaluate the degree of adoption and implementation outcomes of the INFA program and likelihood of these interventions being delivered long-term and scaled-up Secondly the investigators will evaluate the selected implementation strategies in action by examining adoption and fidelity and also identify the CFIR determinants that influence these implementation outcomes This will be done through FGDsIDIs with the nursing leadership programme implementers and older adults Additionally the logic model and theory of change will be refined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None