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Protocol for a Hybrid Implementation-effectiveness Feasibility Study of a Transdisciplinary ICU-to-home Recovery Model

ConditionPost ICU Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTan Tock Seng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Received invasive mechanical ventilation for ≥ 48 hours;

Aged ≥ 21 years;

Premorbidly independent in basic activities of daily living;

Had decision-making capacity before the acute illness and are expected to regain capacity before acute hospital discharge;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • THRIVE@TTSH follow up program

    Other intervention

    1. Structured post-ICU screening 2. Comprehensive multidomain assessment 3. Personalised ICU recovery summary 4. Multidisciplinary review and closed-loop care coordination 5. Volunteer-supported home follow-up and multidisciplinary meetings

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single arm feasibility studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
2

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.

Time frame
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment
3

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.

Time frame
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)
4

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

Time frame
From recruitment to 6 months post hospital discharge, or death by any cause, up to 24 months from recruitment

Secondary outcomes

1

Feasibility of program

proportion of eligible patients successfully recruited out (screened at ICU discharge)

Time frame
From start of screening to 12 months post hospital discharge for the last patient recruited (approximately 24 months from start of study)
2

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.

Time frame
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
3

Grip strength

Handgrip strength with dynamometer

Time frame
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)
4

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.

Time frame
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

Other outcomes

1

life-space

Life space at month 3, 6, 12 post hospital discharge

Time frame
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)
2

Clinical Frailty Scale

trajectory of CFS over time. Scores will be summarized descriptively across assessment time points.

Time frame
From hospital admission up to 24 months from recruitment (Time points: pre-ICU baseline , hospital discharge, 3, 6, 12 months post hospital)
3

User acceptability

acceptability of the program and free text comments

Time frame
From recruitment up till 24 months from recruitment or date of death from any cause (Time points: 6 and 12 month post hospital discharge )

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tan Tock Seng Hospital

Lead sponsor

Source ClinicalTrials.gov

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