Clinical trial NCT06469723: Protocol for Inpatient Nursing Frailty Assessment (INFA)
Official title: Protocol for Inpatient Nursing Frailty Assessment (INFA): Comprehensive Geriatric Assessment and Multidisciplinary Intervention for Frail Hospitalised Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Status
Frailty
Keywords: INFA
Inpatient Nursing Frailty Assessment
Consolidated Framework for Implementation Research
CFIR
Functional Status
Healthcare utilization
Cost Effectiveness Analysis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Geriatric Education and Research Institute
First posted: 2024-06-24
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria \[Pre-implementation\]:

1. 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.
2. They are able to share their views on the anticipated barriers and facilitators of implementing and delivering the INFA programme.
3. 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 \[Implementation\]:

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

Exclusion Criteria \[Implementation\]:

1. All elective admissions
2. Individuals admitted from nursing or sheltered homes
3. Patients who are admitted for less than 48 hours.

Primary outcomes:
measure: [Implementation phase] Effectiveness of INFA Program - Functional status
timeFrame: 6 months post discharge
measure: [Implementation phase] Effectiveness of INFA Program - Implementation Strategies
timeFrame: Within 6 months post discharge
Secondary outcomes:
measure: [Implementation phase] Participant healthcare utilization
timeFrame: Upon discharge and 6-months post-discharge
measure: [Implementation phase] Quality of Life
timeFrame: Upon discharge and 6 months post-discharge.
measure: [Implementation phase] Cost Effectiveness Analysis
timeFrame: Upon discharge and 6 months post-discharge.
Other outcomes:
measure: [Implementation phase] INFA Process Indicators
timeFrame: Regular 1-month intervals after implementation phase have begun
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
state: Singpaore
Study officials:
affiliation: Tan Tock Seng Hospital
name: Justin Chew
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.