Protocol for Inpatient Nursing Frailty Assessment (INFA)
NCT Number: NCT06469723
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Status|Frailty
Interventions: OTHER: INFA Program
Sponsor: Tan Tock Seng Hospital
Collaborators: Geriatric Education and Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-04-30
Completion Date: 2026-03
Locations: Tan Tock Seng Hospital, Singapore, Singpaore, S308433, Singapore

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.

Primary Outcome Measures: [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., 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 Outcome Measures: [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, length-of-stay and health-related quality of life (HRQoL).

HRQoL will be measured using the five-level version of the EuroQoL 5 dimensions (EQ-5D-5L) instrument.

Where possible, hospital data will be accessed to obtain the relevant data for analysis., Upon discharge and 6-months post-discharge|[Implementation phase] Quality of Life, 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, 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. The investigators hypothesized a better quality of life in this time-limited programme.

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.
Other Outcome Measures: [Implementation phase] INFA Process Indicators, 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