None listed
Conditions
Brief summary
FORTRESS is a three-year research study which will take a validated frailty screening tool and an evidence-based intervention for frailty, and operationalise them together in the acute hospital setting, with follow up in the community and general practice setting in partnership with the local Primary Health Networks. It will use a randomised stepped wedge design to measure the effectiveness over 12 months of the frailty intervention on hospital readmissions (primary outcome), frailty status, and quality of life. A hybrid type III trial approach will allow us to test the implementation strategy (Implementation Facilitation) at the same time as observing the outcomes of the intervention (screening for frailty and use of appropriate interventions). Participants (n=732) will be people aged 75 years and over admitted to six acute wards in two hospitals, one in Northern Sydney and one in Southern Adelaide. It will use the FRAIL Scale as a screening tool, and the Asia Pacific Clinical Practice Guidelines for the Management of Frailty to direct the interventions. Cost-effectiveness of the intervention will also be measured. This research study aligns with Objectives 4 and 5 of the NHMRC Initiative Frailty in Hospital Care: Complex Health Care requirements. It addresses the impact of the frailty intervention on older people presenting to hospital with an acute illness, accident or trauma, and how integrated and coordinated in-hospital and post-hospital interventions can support frail older people to achieve the best possible health recovery outcomes.
Interventions
A frailty management plan will be devised while the participant is in hospital based on the FRAIL scale score. It will be a personalised intervention strategy that may include targeted physical exercises, dietary supplements and de-prescribing of poly-pharmacy. It will differ from participant to participant according to individual need. There will be facilitation and support of this intervention upon discharge from hospital by a community implementation facilitator. Participants will be dis
A frailty management plan will be devised while the participant is in hospital based on the FRAIL scale score. It will be a personalised intervention strategy that may include targeted physical exercises, dietary supplements and de-prescribing of poly-pharmacy. It will differ from participant to participant according to individual need. There will be facilitation and support of this intervention upon discharge from hospital by a community implementation facilitator. Participants will be discharged home with a set of exercises tailored to their needs. Some will have supplements or have been prescribed a high energy/high protein diet. They will be asked to do the exercises daily (or as often as possible) and to document when they have done so on a calendar. Similarly they will be asked to self report on their adherence to any dietary recommendations. The community facilitator will visit the participant only once or twice, but will also engage with the GP as it is expected the GP will encourage and support the participant with the frailty management plan in the community going forward. The intervention strategy is prescribed on the ward (jointly) by the Physiotherapist (exercise program), the Dietician (appropriate dietary intervention) and the Pharmacist (poly pharmacy) dependent on the participant needs as highlighted in the FRAIL Scale. The Implementation Clinician, assists with ensuring adherence to the intervention while the participant is in hospital and the Community Implementation Facilitator will engages with the participant and the GP in the community. The overall duration of the intervention is 12 months from date of recruitment with outcome assessments at 3 months and at 12 months. The first community facilitator visit will occur as soon as practicable following discharge at a date and time mutually agreed upon between the facilitator and the participant. There may be up to two further visits, depending on need. If a subsequent visit or visits are required these will occur at a time deemed most appropriate by the facilitator (ie - it may be based on a request by the participant, the GP or a significant other, or it may be arranged at the time of the first visit). There is flexibility around this, as it is thought that some participants will require more support than others to adhere to the management plan, and some participants have less home support than others. The nature of these visits will also depend on the individual but are about ensuring the management plan is transitioned smoothly into the community and participants are able to adhere to it at home. The facilitator will ensure exercises and dietary recommendations are being followed as prescribed and liaise back to the Implementation Clinicians (at the hospital) for adjustments or advice if necessary. They also will liaise with the GP to encourage support for the plan.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in the FORTRESS study people must: 1) be aged 75 years and over, with an estimated life expectancy of more than 12 months, estimated by a score 1 or 2 on a modified version of the Illness Severity Rating 2) have been admitted to an acute medical or rehabilitation ward in Hornsby Ku-ring-gai Hospital in northern Sydney, or Flinders Medical Centre in southern Adelaide 3) have been assessed as frail (using the FRAIL Scale Risk Assessment Tool) by the FORTRESS study Implementation Clinician (scored equal to or greater than 3 on this scale). 4) be living at home in the community prior to hospitalisation (ie they did not reside in an Aged Care Facility) 5) be able to cooperate with suggested interventions as assessed by the Implementation Clinician or other allied health staff (attain a score of 18 or more on the Mini Mental State Examination (MMSE)
Exclusion criteria
Exclusion criteria for FORTRESS include: 1) People admitted to hospital with stroke. (People with acute stroke are admitted to specialised units in both participating hospitals). 2) People who are not frail or screen as pre-frail (a score of less than 3 on the FRAIL Scale) 3) People who are unable to cooperate with intervention program (cognitive impairment per se is not an exclusion criteria but older people with moderately severe dementia or a score of less than 18 in the Mini Mental State Examination (MMSE) may not be able to participate) 4) People aged less than 75 years of age 5) People who were not mobile prior to admission (unable to walk without the assistance of another person) 6) People with a life expectancy of less than 12 months, estimated by a score of 3 or more on a modified version of the Illness Severity Scale 7) People who reside in a residential aged care facility 8) People who have already been recruited into the study when admitted to another participating ward
Outcome results
None listed