None listed
Conditions
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.
Interventions
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
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)
Sponsors
Gold Coast University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed