- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469723
Protocol for Inpatient Nursing Frailty Assessment (INFA)
Protocol for Inpatient Nursing Frailty Assessment (INFA): Comprehensive Geriatric Assessment and Multidisciplinary Intervention for Frail Hospitalised Older Adults
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 investigator's 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 study's overall goal is to enhance the quality of care for frail older adults during their hospital stay, leading to improved functional outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
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 implementer's 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 care.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 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 FGDs/IDIs with the nursing leadership, programme implementers, and older adults. Additionally, the logic model and theory of change will be refined.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Singpaore
-
Singapore, Singpaore, Singapore, S308433
- Tan Tock Seng Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria [Pre-implementation]:
- Participants are healthcare professionals (nurses, doctors, allied health workers, nursing/clinical leadership) who are involved in the conceptualisation, implementation and/or delivery of the INFA programme.
- They are able to share their views on the anticipated barriers and facilitators of implementing and delivering the INFA programme.
- They consent to participating in the focus group discussion or in-depth interview.
Exclusion Criteria [Pre-implementation]:
- They do not consent to participating.
Inclusion Criteria [Implementation]:
- Participants are 65 years or older
- Has a Clinical Frailty Scale (CFS) rating of 4-6
- Admitted to surgical and general medical wards
Exclusion Criteria [Implementation]:
- All elective admissions
- Individuals admitted from nursing or sheltered homes
- Patients who are admitted for less than 48 hours.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INFA Intervention
Participants sorted into this arm will receive care under the INFA program, which includes standard care, along with early detection of geriatric syndromes or symptoms using the INFA screening tool.
This will include potential early referrals to allied health professionals, care plans, and comprehensive early discharge planning and systematic follow-ups.
|
Participants will be screened using the INFA Screening tool, comprising of assessments for multiple domains that are part of existing routine admission nursing assessments, including functional decline, delirium, recurrent falls, self-reported hearing and visual impairment questionnaires, malnutrition risk, oral health, and dysphagia screening. Nurse-led protocols will be done to address each identified geriatric syndrome. Participants with complex cases (defined as delirium and/or high-risk falls) will be referred to the GeriCARE service, with capabilities for performing comprehensive geriatric assessment (CGA) guiding discharge planning. Referrals to geriatricians can be initiated whenever necessary, facilitating access to specialised geriatric medical expertise. Participants will also receive comprehensive discharge planning and systematic follow-up procedures, done by ward resource nurses. |
|
No Intervention: Standard Care - Control
Participants sorted into this arm will continue to receive standard care in the wards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[Implementation phase] Effectiveness of INFA Program - Implementation Strategies
Time Frame: Within 6 months post discharge
|
To understand the effectiveness of the selected implementation strategies from the pre-implementation phase, qualitative interviews will be conducted on INFA implementors to understand the adoption, feasibility, sustainability, and scalability of the INFA program.
|
Within 6 months post discharge
|
|
[Implementation phase] Effectiveness of INFA Program - Functional status
Time Frame: Upon discharge and 6-months post-discharge
|
It is hypothesized that with the implementation of the INFA program will lead to improved ADL functions. Changes in functional status will be measured using the modified Barthel Index of Activities of Daily Living (ADL) functional ability by comparing participants receiving INFA intervention on top of standard care, compared to participants who received only standard care. |
Upon discharge and 6-months post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[Implementation phase] Participant healthcare utilization
Time Frame: Upon discharge and 6-months post-discharge
|
To compare the effectiveness of the INFA programme by analyzing data on participant's healthcare utilization such as number of unplanned hospital readmissions, Emergency Department visits and length-of-stay. Where possible, hospital data will be accessed to obtain the relevant data for analysis. |
Upon discharge and 6-months post-discharge
|
|
[Implementation phase] Health-Related Quality of Life (HRQoL)
Time Frame: Upon discharge and 6 months post-discharge.
|
HRQoL will be measured using the five-level version of the EuroQoL 5 dimensions (EQ-5D-5L) instrument. Quality-Adjusted Life Years (QALYs) will be the primary measure of health benefits gained. Where possible, hospital data will be accessed to obtain the relevant data for analysis. Else, surveying of the participant's caregiver would be done. |
Upon discharge and 6 months post-discharge.
|
|
[Implementation phase] Cost Effectiveness Analysis
Time Frame: 6 months prior to index admission and 6 months post-discharge
|
The cost of providing the entire programme at a per patient level will be determined. This will include the cost of providing (1) INFA, (2) Nurse-led protocols, (3) GeriCARE and geriatricians referrals, (4) Discharge and follow-up planning. Where possible, hospital data will be accessed to obtain the relevant data for analysis. Else, surveying of the participant's caregiver would be done. |
6 months prior to index admission and 6 months post-discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[Implementation phase] INFA Process Indicators
Time Frame: Regular 1-month intervals after implementation phase have begun
|
Guided by the developed logic model, relevant process indicators such as percentage of INFA assessments completed, proportion (%n) of eligible patients with nursing care plans initiated for applicable INFA domains, number of (actualized) referrals for each INFA domain, etc., will be collected to identify the implementation effectiveness of INFA program. Where possible, hospital data will be accessed to obtain the relevant data for analysis. |
Regular 1-month intervals after implementation phase have begun
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Justin Chew, Tan Tock Seng Hospital
Publications and helpful links
General Publications
- Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
- Damschroder LJ, Reardon CM, Opra Widerquist MA, Lowery J. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum. Implement Sci. 2022 Jan 22;17(1):7. doi: 10.1186/s13012-021-01181-5.
- Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
- Rezaei-Shahsavarloo Z, Atashzadeh-Shoorideh F, Gobbens RJJ, Ebadi A, Ghaedamini Harouni G. The impact of interventions on management of frailty in hospitalized frail older adults: a systematic review and meta-analysis. BMC Geriatr. 2020 Dec 3;20(1):526. doi: 10.1186/s12877-020-01935-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/00937
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
University of IcelandLandspitali University HospitalRecruitingFrailty Syndrome | Elective Surgery | Frailty in Adult SurgeryIceland
-
University of NottinghamRecruitingFrailty | Diet | Systemic Inflammatory Response | Dietary Fiber | Frailty at Older Adults | Pre-FrailtyUnited Kingdom
-
Ji Yan Biomedical Co., Ltd.YC Biotech Co., Ltd.Not yet recruiting
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Maximilian KönigNot yet recruiting
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
Clinical Trials on INFA Program
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
National Yang Ming Chiao Tung UniversityCompletedBreast Cancer | Weight LossTaiwan
-
National Taiwan University HospitalCompleted
-
Kafrelsheikh UniversityRecruitingLow Back Pain | Pilates Exercises | Nonspecific | Postnatal WomenEgypt
-
University of Illinois at ChicagoActive, not recruitingMultiple Sclerosis | Cognitive Impairment | Older Adults | Walking ImpairmentUnited States
-
Linkoeping UniversityThe Swedish Research Council; Swedish Research Council for Sport ScienceCompleted
-
Linnaeus UniversityNot yet recruitingAnterior Cruciate Ligament ReconstructionSweden
-
Children's Hospital Medical Center, CincinnatiSeattle Children's Hospital; St. Jude Children's Research Hospital; University...CompletedCancer | Adherence, MedicationUnited States
-
Istanbul Medipol University HospitalCompletedInvestigation of the Effect of Online Yoga Based Exercise Program on Women With Primary DysmenorrheaPrimary DysmenorrheaTurkey
-
EpicentreMedecins Sans Frontieres, Spain; Direction de la Nutrition du Niger; District... and other collaboratorsCompleted