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Trial registered on ANZCTR

Registration number

ACTRN12621000554864p

Ethics application status

Not yet submitted

Date submitted

8/01/2021

Date registered

12/05/2021

Date last updated

12/05/2021

Date data sharing statement initially provided

12/05/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The impact of patient and family education on nutrition and exercise after serious illness (PIVOTAL)

Scientific title

Feasibility of a patient- and family-mediated nutrition and exercise-based intervention following recovery from critical illness (PIVOTAL)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PIVOTAL

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical Illness

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is premised on the OPTICS nutrition intervention, which has been systematically evaluated over the past 5 years. We have augmented the intervention to incorporate aspects of exercise and mobility throughout critical illness recovery because it is suggested that nutrition and exercise in combination may have the greatest impact on physical recovery of survivors of critical illness. The intervention is premised on developing capacity of patients and families to engage and partner with health professionals; thus our education focuses on capacitating the patient and family to interact with health care providers and encourage them to ask questions about the nutrition and exercise being received by the patient. We use a variety of dissemination methods including face-to-face education, written information and video clips, which reinforce information provided (exercise videos to be developed as part of this grant) and also provide an exemplar of engagement between patients/families and health care providers in the ICU and following transfer to the ward. These resources are designed specifically for this study. During face-to-face education the ‘teach back’ method will be used to allow for assessment of information comprehension.
Post randomisation, patients randomised to the intervention arm will be receiving the following:
Nutrition Care:
During ICU stay:
- Nutrition risk assessment performed by the dietitian with results communicated to the clinical team verbally and in the medical record
- Face-to-face education focusing on nutrition support strategies provided to the family (approx 15 min); verbal information is supplemented with summary sheets designed to reinforce the information provided. Video information reinforcing the information will also be made available (2 x 3 min videos).
- touch points during ICU admission by the dietitian to communicate nutrition goals and adequacy
In preparation for ICU discharge:
- provide patient (if able) and families with information about current nutrition status (nutrition support, eating by mouth, swallowing difficulty), nutrition the patient can expected on the ward. This information session will be approximately 15 min, and as described previously, will be supplemented with summary information sheets to reinforce the information provided.
- setting up nutrition related goals and monitoring/follow up plan for home
- Information reinforced through viewing of the ward-based video which is specific to nutrition after ICU discharge
In the ward:
- Nutrition care plan for the ward developed by the ICU and ward dietitians and communicated to the patient and family; this will take approximately 10 minutes, and will be reinforced with summary information sheets.
- Nutrition plan handed over to ward dietitian by the ICU dietitian
- provide 2 or more Oral Nutrition Supplements per day (approximately 400kCal/day)
Prior to hospital Discharge, ward dietitian will work with patient and family to develop a nutrition plan for implementation after hospital discharge which will be provided in writing.

Mobilisation
In the ICU:
- A preadmission level of function assessed by the Clinical Frailty Scale and the Pre-ICU baseline FSS-ICU with data obtained from the patient or family member
- face-to-face education focusing on progression of exercise and mobility in the ICU; duration is approximately 10 minutes with supplemental information sheets provided to reinforce the information provided. Video materials will also be provided (approximately 2 x 3 min each).
- touch points during the ICU admission by the physiotherapist to communicate exercise/mobility progression to the family as per the ICU Mobility Scale.
- Provide patient (if able) and families with information about the plan for exercise progression on the ward; this will take approximately 10 min duration and will be supplemented with summary information sheets
- setting of exercise goals and monitoring/follow-up plan for home
- information reinforced through viewing of the ward-based video which is specific to exercise and mobility on the ward (approximately 2 x 3 min each)
In the ward:
- exercise and rehabilitation plan for the ward developed by the ICU and ward physiotherapist and communicated to the patient and family (duration approximately 10 min with information supplemented with summary information sheets)
-handover between ICU/Ward physiotherapists

Prior to Hospital discharge:
Ward physiotherapist to work with patient and family to develop an exercise plan for implementation after hospital discharge which will be provided in writing (duration approximately 10 minutes)

Intervention code [1]

Prevention

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

Control patients:
Nutrition: Control patients received prescribed nutrition and ONS on the ward as prescribed at the discretion of the treating team with minimal interactions with the ICU dieititian.

Physiotherapy/Mobility: Control patients are mobilised at the discretion of the physiotherapist/treating team with minimal interactions and education from the physiotherapy team or other health care professionals

Control group

Active

Outcomes

Primary outcome [1]

Feasibility is the primary (composite) outcome measure. Feasibility will be assessed against the following criteria:
>80% of eligible participants recruited to the study, to be determined when patients are able to be consented into the study from study data
>70% of recruited participants remain in the study for 6 months follow up. This is determined via the phone based follow up from study data
>90% of recruited participants achieve compliance with intervention components determined from study data
>75% of patients are able to engage in the interventions will be determined from study data

Timepoint [1]

Time points for feasibility assessment are at
1) recruitment will be determined at hospital discharge
2) compliance and participation with study interventions will be determined at 6 month post hospital discharge
3) retention will be determined at 6 months post hospital discharge follow-up.

Primary outcome [2]

Acceptability of the study interventions and outcome measures will be determined by using the theoretical framework of acceptability (TFA) Questionnaire, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self efficacy.

Timepoint [2]

Within 48 hours of hospital discharge

Secondary outcome [1]

Nutritional adequacy in the ICU calculated as the proportion of prescribed nutrition received by the patient (information obtained from the patient's medical record).

Timepoint [1]

Daily during ICU admission

Secondary outcome [2]

Composite secondary outcome of Frequency and Duration of active mobilisation during hospitalisation

Timepoint [2]

In the ICU, Daily using ICU Mobility Scale, and ICU Exercise Milestone Form

In the ward, daily using extracts from the patient's medical record

Secondary outcome [3]

Nutrition adequacy in the ward and consumption of oral nutrition supplements, determined as the proportion of prescribed energy which was consumed.

Timepoint [3]

On ward: 3 day calorie count continues weekly until patient is discharged from hospital or for a maximum of 4 weeks, whichever comes first.

Secondary outcome [4]

ICU length of stay data extracted from medical chart

Timepoint [4]

Assessed once post hospital discharge

Secondary outcome [5]

Health related quality of life (QOL) will be measured using SF-36 version 2 (SF-36 v2) and EQ-5D-5L. The SF-36 is valid and reliable across a variety of patient groups, including ICU survivors. The EQ-5D-5L is included, in addition to SF-36 v2, because it is suitable for patients with inattention and fatigue recommended for use in ICU survivors

Timepoint [5]

6 month phone based follow up post hospital discharge.

Secondary outcome [6]

Physical functional status will be measured using Katz activities of daily living (ADL) scale

Timepoint [6]

6 months phone based follow up post hospital discharge

Secondary outcome [7]

Family satisfaction measured using the Family Satisfaction with the ICU Revised (FS24-ICU24R) which is a 24-item survey generated from conceptual frameworks of patient satisfaction, quality end-of-life care, research on needs of critically ill families, literature on family satisfaction with medical decision making, existing validated satisfaction surveys

Timepoint [7]

Within 48 hours of ICU Discharge

Eligibility

Key inclusion criteria

All patients greater than or equal to 18 years of age admitted to ICU with a projected duration of ICU dependency of >72 hours OR patients with two or more organ failures will be eligible to participate.

Family members of eligible patients will include both relatives and close friends who know the patient well and either live with, or are involved in, the ongoing care of the patient provide support and/or with whom the patient has a significant relationship.
Family members must be
1) greater than or equal to 18 years old, be expected to visit the patient regularly (approximately 3 times/week) and
2) be able to communicate in English (verbally and in writing).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients not expected to benefit will be excluded, including those who are:
1) expected to die or for whom life-sustaining treatments will be withdrawn in ICU;
2) not ambulating independently prior to ICU admission (use of a gait aid permitted);
3) have lower extremity injury or impairments (e.g. stroke) that prevent them walking prior to hospital discharge;
4) have pre-existing primary severe systemic neuromuscular disease resulting in severe weakness (e.g. Myasthenia Gravis); are hospitalised for >5 days before ICU admission;
5) expected to be transferred to another health care facility prior to hospital discharge.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated randomisation schedule, allocating patients 1:1 to either the intervention or control group by the method of permuted blocks of random, undisclosed size

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The feasibility outcomes (enrolment and consent rate, and compliance with outcome assessments) will be described by group as rates with 95% confidence intervals. As part of the screening procedures we will collect data on factors influencing recruitment and retention rates.

Prior to analysis, missing values will be described for all variables; all missing data and improbable values checked against source data. Nutritional adequacy at hospital discharge will be compared between the two groups using the rank-based Mann-Whitney U test, as we expect data to not be normally distributed. Secondary continuous outcomes will be analysed as described above. Categorical secondary outcomes will be analysed using Fisher’s exact tests. If >5% of outcome data are missing, multiple imputation will be used for the primary analysis and a ‘missing not at random’ sensitivity analysis will be performed using the tipping point approach of the pattern mixture model with multiple imputation.

Acceptability outcomes will be used to assess intervention acceptability, feasibility and to identify what factors helped or hindered adherence to intervention components. Qualitative data will be analysed using content analysis with an inductive approach.
Sample size and duration:
Given the main objective of the study related to feasibility, acceptability and intervention compliance we feel a sample size of 25 per group will allow us to assess these endpoints with reasonable precision and is consistent with the sample size of other Phase II studies. Based on the number of critically injured patients admitted to GCUH ICU each year (approx. 180 per year) we anticipate recruitment to take 2 years, with an anticipated consent rate of 50%.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/10/2021

Actual

Date of last participant enrolment

Anticipated

31/12/2022

Actual

Date of last data collection

Anticipated

1/07/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Gold Coast Health and Gold Coast Hospital Foundation Research Grant Scheme

Address [1]

1 Hospital Blvd, Southport, Queensland, QLD 4215

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gold Coast University Hospital

Address

1 Hospital Blvd, Southport, QLD 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Gold Coast Hospital and Health District Human Research Ethics Committee

Ethics committee address [1]

1 Hospital Blvd
Southport QLD 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The broad aim of the study is to demonstrate that supporting active patient and family engagement in nutrition and exercise (active mobilisation and rehabilitation) during recovery from critical illness will result in better patient- and family-centred outcomes compared with usual care. 
Before we can assess these long-term patient- and family-centred outcomes we need to evaluate, in a Phase II trial, the feasibility, intervention acceptability and short-term effectiveness, which is the specific aim of the study proposed here.
We hypothesise that the trial will be feasible (as determined by ability to recruit 80% of eligible participants, retain 70% of participants to 6-month follow-up, achieve 90% intervention fidelity and collect 75% of all outcome measures) and the intervention acceptable to patients, family members and health professionals as determined by the Theoretical Framework of Acceptability questionnaire.
We also hypothesise that the trial will result in improvements in short-term outcomes including nutrition adequacy and exercise throughout the hospital stay.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Andrea Marshall

Address

Gold Coast University Hospital
E 2 015, 1 Hospital Blvd, Southport QLD 4215

Country

Australia

Phone

+61 7 5687 3235

Fax

[email protected]

Contact person for public queries

Name

Julie Barker

Address

Gold Coast University Hospital
1 Hospital Blvd, Southport QLD 4215

Country

Australia

Phone

+61 7 5687 3254

Fax

[email protected]

Contact person for scientific queries

Name

Andrea Marshall

Address

Gold Coast University Hospital.
E 2 015, 1 Hospital Blvd, Southport QLD 4215

Country

Australia

Phone

+61 7 5687 3235

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data will be reported in a group manner to protect participant confidentiality, which is consistent with our conditions of ethical approval.

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
9930	Study protocol		380935-(Uploaded-02-12-2020-11-13-45)-Study-related document.docx
9931	Informed consent form	Multiple consent forms are available on request to... [More Details]
9932	Ethical approval	Ethical approval will be available once submitted ... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically