Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model (THRIVE@TTSH)

Transition Support and Holistic Recovery Interventions for Vulnerable Ex-ICU Patients @ Tan Tock Seng Hospital (THRIVE@TTSH): Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model

This is a prospective, single-centre study which will recruit 50 adult ICU survivors over 12 months. Assessments will occur during hospitalisation and at Months 3 and 6 after hospital discharge, with a final phone follow-up at Month 12. There will be volunteer-supported home visits for 6 months post hospital discharge.

Study Overview

• Status: Not yet recruiting
• Conditions: Post ICU Syndrome
• Intervention / Treatment: Other: THRIVE@TTSH follow up program

Detailed Description

This is a prospective, single-centre hybrid implementation-effectiveness feasibility study which will recruit 50 adult ICU survivors over 12 months. Assessments will occur during hospitalisation and at Months 3 and 6 after hospital discharge, with a final phone follow-up at Month 12. There will be volunteer-supported home visits for 6 months post hospital discharge. The primary feasibility outcome is the proportion of enrolled participants alive at Month 6 who complete outcome assessment.

Secondary implementation outcomes include recruitment, retention, home-visit completion and acceptability. Exploratory outcomes include Post ICU Syndrome (PICS) recovery trajectories, healthcare utilisation and mortality through 12 months post discharge from the acute hospital.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yie Hui Lau; Phone Number: +65 63577771; Email: yie.hui.lau@nhghealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Received invasive mechanical ventilation for ≥ 48 hours;
2. Aged ≥ 21 years;
3. Premorbidly independent in basic activities of daily living;
4. Had decision-making capacity before the acute illness and are expected to regain capacity before acute hospital discharge;
5. Have evidence of new or worsening physical, cognitive, mental-health or swallowing impairment compared with their premorbid state; and
6. Are ultimately planned for discharge to the community/home setting. Worsening in PICS domains is defined as an increase in CFS score compared with premorbid status, newly acquired swallowing dysfunction, new cognitive impairment after exclusion of delirium, suspected anxiety or depressive symptoms, or clinically important deterioration in physical or functional performance.

Mental-health screening will not be interpreted as diagnostic criteria for anxiety or depressive disorders.

Exclusion criteria

• cognitive or psychiatric impairment that precludes meaningful participation in the study;
• are already enrolled in, or expected to enter, a structured follow-up pathway that substantially duplicates the rehabilitation intervention; or
• have treatment primarily directed towards palliation or end-of-life care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm feasibility study	Other: THRIVE@TTSH follow up program; Structured post-ICU screening; Comprehensive multidomain assessment; Personalised ICU recovery summary; Multidisciplinary review and closed-loop care coordination; Volunteer-supported home follow-up and multidisciplinary meetings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
completion of the Month-6 PICS physical assessment	Physical :5 Times Sit-to-Stand Time in seconds required to complete five sit-to-stand repetitions. Values will be summarized at each assessment time point and change over time described.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
completion of the Month 6 physical domain assessment	Handgrip strength measured in kilograms using a standardized dynamometer procedure. Values will be summarized at each assessment time point and longitudinal change described.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
completion of Month 6 Cognitive domain assessment	Cognitive function measured using the Mini Mental State examination. Scores will be summarized at each assessment time point and longitudinal change described. MoCA may be used where clinically indicated and will be reported separately rather than treated as equivalent to MMSE.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
Completion of Month 6 Mental Domain assessment	Depressive symptoms screened using the Patient Health Questionnaire-9(PHQ-9). Total scores will be summarized at each assessment time point	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
Completion of Month 6 Mental Domain Assessment	Anxiety symptoms screened using the GAD-7. Total scores will be summarized at each assessment time point	From recruitment to 6 months post hospital discharge, or death by any cause, up toFrom recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
Health related quality of life	Health-related quality of life assessed using the EQ-5D-5L. EQ-5D-5L health-state/index values and EQ visual analogue scale scores will be summarized as applicable at each assessment time point.	from recruitment to 12 months post hospital discharge, or date of death from any cause (time points: 3,6 and 12 months post hospital discharge), up to 24 months from recruitment
Modified Barthel Index	Functional independence measured using the Modified Barthel Index. Higher scores indicate greater independence in activities of daily living. Scores will be summarized at each assessment time point	From recruitment to 12 months post hospital discharge, or death by any cause up to 24 months from recruitment
Return to work status	Employment status prior to ICU admission and post hospital discharge will be assessed. Among participants employed before critical illness, the number and percentage who have returned to work will be reported.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of program	proportion of eligible patients successfully recruited out (screened at ICU discharge)	From start of screening to 12 months post hospital discharge for the last patient recruited (approximately 24 months from start of study)
Five Times Sit to Stand	Time in seconds required to complete five sit-to-stand repetitions. Values will be summarized at each assessment time point and change over time described.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (time points :at hospital discharge, 3 and 6 months post hospital discharge
Grip strength	Handgrip strength with dynamometer	From recruitment to 6 months post hospital discharge or date of death from any cause, up to 24 months from recruitment (Time points: ICU discharge, hospital discharge, 3 and 6 months post hospital discharge)
Modified Barthel Index	Functional independence measured using the Modified Barthel Index. Higher scores indicate greater independence in activities of daily living. Scores will be summarized at each assessment time point and longitudinal change described.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points: hospital discharge, 3,6, 12 month post hospital discharge
Mini-mental state examination	Cognitive function measured using the MMSE. Scores will be summarized at each assessment time point and longitudinal change described. MoCA may be used where clinically indicated and will be reported separately rather than treated as equivalent to MMSE.	From recruitment to 6 months post hospital discharge, up to 24 months from recruitment Time points: (Hospital discharge, 3, 6 month post hospital discharge)
Patient health questionnaire -9	Depressive symptoms measured using the PHQ-9. Total scores will be summarized at each assessment time point and longitudinal change described.	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment (Time points :Hospital discharge, 3, 6 month post hospital discharge)
General anxiety scale-7	Anxiety symptoms measured using the GAD-7. Total scores will be summarized at each assessment time point and longitudinal change described.	From recruitment up to 24 months from recruitment (time points: hospital discharge, 3,6 month post hospital discharge)
Retention at 6 months	Number of ICU survivors who have not withdrawn/ lost to follow up compared to original recruited number (excluding deaths)	From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
Completion of planned home visits	Monthly home visits x6 are planned per ICU survivor Number of planned home visits declined/ lost to follow up amongst survivors (excluding deaths) 3 and 6 month home visits converted to telehealth/ hospital visits	6 months post hospital discharge, up to 24 months from recruitment
UCLA loneliness scale-3	University of California Los Angeles loneliness scale-3	from recruitment up to 24 months post recruitment (time points 1,4 12 months post hospital discharge)
Caregiver burden	Caregiver burden will be measured using the shortened 9-item Zarit Burden Interview (ZBI-9), with scores summarized over follow-up.	From recruitment to 6 months post hospital discharge, or patient death by any cause , up to 24 hours post recruitment (Time points :1 and 6 months post hospital discharge)
reasons for non-participation or declining home visits	reasons for non-participation of home visits	at the point of enrolment into home visits at hospital discharge up to 6 months post hospital discharge, or death from any cause, whichever comes first , up to 24 months from recruitment
Medication or follow-up appointment reconciliation events	number of medication or follow up appointment reconciliation events done during home visits, per home visit	6 months post hospital discharge, from recruitment up to 24 months from recruitment
Swallowing status	In- hospital, oral intake and swallowing status assessed using the Functional Oral Intake Scale. EAT-10 questionnaire post hospital discharge; Scores will be summarized descriptively over follow-up.	From recruitment into study, up 24 months from recruitment, or death by any cause, whichever first (time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
Body weight	Contributes to nutritional assessment Body weight measured in kilograms and summarized at each assessment time point and longitudinally.	From recruitment into study, up to 24 months from recruitment, or death from any cause, whichever comes first (time points: pre ICU, at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge
arm and leg circumference	arm and leg circumference as a surrogate for nutritional status and muscle bulk. Excludes patients who have contraindications e.g. loss of limb, abnormal BMI, edema	From recruitment into study, up to 24months from recruitment or death from any cause, whichever comes first (Time points: at the Icu discharge, hospital discharge, 2 and 5 months post hospital discharge)
Chelsea Critical Care Physical Assessment tool	CPax	From recruitment into study, up to death from any cause or 24 months from recruitment, whichever comes first.
Montreal Cognitive Assessment Tool	MoCA assessment for patients screened with MMSE and have high suspicion of cognitive impairment	From recruitment into study, 6 months post hospital discharge, or date of death from any cause, whichever comes first (if applicable)
healthcare utilisation	number of unplanned clinic visits, emergency department visits, unplanned admissions with reference from point of hospital discharge	12 months post hospital discharge
mortality	mortality	From recruitment to 12 months post hospital discharge, up till 24 months from recruitment, or death by any cause, whichever comes first
return to work status	for survivors who were working pre ICU admission, the number who returned to work	From recruitment until 24 months from recruitment (time points: 3,6 12 months post hospital discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
life-space	Life space at month 3, 6, 12 post hospital discharge	From recruitment to 24 months from recruitment, or death from any cause, whichever comes first (Time points: Pre ICU admission, 3,6 and 12 months)
Clinical Frailty Scale	trajectory of CFS over time. Scores will be summarized descriptively across assessment time points.	From hospital admission up to 24 months from recruitment (Time points: pre-ICU baseline , hospital discharge, 3, 6, 12 months post hospital)
User acceptability	acceptability of the program and free text comments	From recruitment up till 24 months from recruitment or date of death from any cause (Time points: 6 and 12 month post hospital discharge )

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Yie Hui Lau, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 21, 2026
• First Submitted That Met QC Criteria: September 30, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: September 30, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: critical care; rehabilitation; implementation study; post icu syndrome
• Other Study ID Numbers: NTF_FY25_T1C1_17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No