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Functional StatusNCT06469723

Protocol for Inpatient Nursing Frailty Assessment (INFA)

A study testing INFA Program in people with Functional Status and Frailty, run by Tan Tock Seng Hospital at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Functional Status, Frailty
What is being tested?
INFA Program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSingapore
Study dates
3 Mar 2024to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participants are 65 years or older
  • Has a Clinical Frailty Scale (CFS) rating of 4-6
  • Admitted to surgical and general medical wards

Who cannot join

  • They do not consent to participating.
  • All elective admissions
  • Individuals admitted from nursing or sheltered homes
  • Patients who are admitted for less than 48 hours.

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Tan Tock Seng Hospital

    Singapore, Singpaore, S308433

Other trials in Singapore

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
INFA Program
Keywords
INFA, Inpatient Nursing Frailty Assessment, Consolidated Framework for Implementation Research, CFIR, Functional Status, Healthcare utilization, Cost Effectiveness Analysis
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INFA ProgramOther

    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.

Study groups in NCT06469723
Study groupRoleWhat they receive
INFA InterventionExperimentalParticipants 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.
Receives: Other: INFA Program
Standard Care - ControlNo interventionParticipants sorted into this arm will continue to receive standard care in the wards.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Implementation phase] Effectiveness of INFA Program - Functional status

    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.

    Measured: Upon discharge and 6-months post-discharge

  2. [Implementation phase] Effectiveness of INFA Program - Implementation Strategies

    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.

    Measured: Within 6 months post discharge

Secondary outcomes (3)
  1. [Implementation phase] Participant healthcare utilization

    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.

    Measured: Upon discharge and 6-months post-discharge

  2. [Implementation phase] Health-Related Quality of Life (HRQoL)

    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.

    Measured: Upon discharge and 6 months post-discharge.

  3. [Implementation phase] Cost Effectiveness Analysis

    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.

    Measured: 6 months prior to index admission and 6 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start3 Mar 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two General Medicine (GM) wards and two General Surgery (GS) wards will be used for the study. One GM and one GS ward will be designated as INFA intervention wards while the remaining two wards will be designated as control. Participants will be randomly sorted into either of the wards and outcome data will be collected from the participants at three timepoints: Baseline (Admission), discharge, and 6-months post discharge.
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06469723
Sponsor's protocol ID
2023/00937
Other IDs
2023
Status last verified
Jul 2025
First submitted
6 May 2024
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36309746
  • 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.

    PubMed 35065675
  • 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.

    PubMed 31036028
  • 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.

    PubMed 33272208
  • Lim C, Ginting ML, Subramaniam A, Tang JY, Rodrigues EE, Chia JQ, Chua SY, Tan WS, Lim WS, Ding YY, Chew J, Sum G; INFA group. Nurse-led geriatric syndrome screening and intervention program for frail older inpatients in Singapore: a study protocol on implementation research and program evaluation. BMC Geriatr. 2025 Dec 22;26(1):131. doi: 10.1186/s12877-025-06861-1.

    PubMed 41430113

Questions about this trial

What is this clinical trial studying?

A study testing INFA Program in people with Functional Status and Frailty, run by Tan Tock Seng Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Implementation phase] Effectiveness of INFA Program - Functional status (time frame: Upon discharge and 6-months post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06469723, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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