Protocol for Inpatient Nursing Frailty Assessment (INFA)

NCT06469723 | Active Not Recruiting

• 1 other identifier: 2023/00937
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Functional Status; Frailty

Keywords

INFA; Inpatient Nursing Frailty Assessment; Consolidated Framework for Implementation Research; CFIR; Functional Status; Healthcare utilization; Cost Effectiveness Analysis

Outcome Measures

Primary Outcomes (2)

• [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.

  Upon discharge and 6-months post-discharge

• [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.

  Within 6 months post discharge

Secondary Outcomes (3)

• [Implementation phase] Participant healthcare utilization

  Upon discharge and 6-months post-discharge

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

  Upon discharge and 6 months post-discharge.

• [Implementation phase] Cost Effectiveness Analysis

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

Other Outcomes (1)

• [Implementation phase] INFA Process Indicators

  Regular 1-month intervals after implementation phase have begun

Study Arms (2)

INFA Intervention

EXPERIMENTAL

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.

Other: INFA Program

Standard Care - Control

NO INTERVENTION

Participants sorted into this arm will continue to receive standard care in the wards.

Interventions

INFA Program OTHER

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.

INFA Intervention

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• They do not consent to participating.
• Participants are 65 years or older
• Has a Clinical Frailty Scale (CFS) rating of 4-6
• Admitted to surgical and general medical wards
• All elective admissions
• Individuals admitted from nursing or sheltered homes
• Patients who are admitted for less than 48 hours.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Geriatric Education and Research Institute: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singpaore, S308433, Singapore

Location

Related Publications (4)

• 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.

  PMID: 36309746 BACKGROUND

• 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.

  PMID: 35065675 BACKGROUND

• 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.

  PMID: 31036028 BACKGROUND

• 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.

  PMID: 33272208 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Chew

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 24, 2024
• Study Start: March 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)