Contact information
Type
Scientific
Primary contact
Dr Simon Hammond
ORCID ID
Contact details
Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 591460
s.hammond@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
31290
Study information
Scientific title
Enhancing recovery of patients admitted to acute settings with hip fracture who are identified as experiencing confusion: a multi-centre, cluster-randomised controlled, feasibility trial of the PERFECTED Enhanced Recovery (PERFECT-ER) care versus standard acute care
Acronym
PERFECTED CRCT
Study hypothesis
The aim of this study is to investigate the feasibility of conducting a large scale trial to evaluate the reliability, effectiveness and cost of delivering care via the processes and initiatives set out by the PERFECT-ER intervention.
Ethics approval
04/07/2016, ref: 16/LO/0621
Study design
Randomised; Interventional; Design type: Process of Care, Education or Self-Management, Management of Care, Rehabilitation
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system
Intervention
Ten hospitals from five regions will be assigned either active or control status (five hospitals per arm). Each region will have two hospitals, one active and one control. Active arm study hospitals will implement the PERFECT-ER intervention on a single acute trauma ward. Control arm study hospitals will select a single acute trauma ward and deliver treatment as usual in that setting.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility outcomes:
1. Recruitment rate
2. Retention rate
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2016
Overall trial end date
31/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient must have had a confirmed proximal hip fracture requiring an operation and be aged 60 or older at time of operation
2. Patient has a pre-op AMTS of 8 or below (including those with 0 because of an inability to answer questions)
3. Patient must have a ‘suitable informant’ (e.g. relative, unpaid or paid carer, care home manager) who has a minimum of once a week face-to-face contact with the patient and is able, and consents to, provide information on proxy measures
4. Patient and a ‘suitable informant’ must be recruited into the trial within 5 days of the hip fracture operation
5. Patient must spend a minimum of 5 days on the study ward
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 800; UK Sample Size: 800
Participant exclusion criteria
1. Decision taken not to have hip surgery
2. Patient not expected to survive beyond 4 weeks and therefore it is unlikely that follow-up data will be collected
Recruitment start date
01/11/2016
Recruitment end date
31/01/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Trial participating centre
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Victoria Hospital
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Trial participating centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Trial participating centre
Princess Royal University Hospital
Farnborough Common
Orpington
BR6 8ND
United Kingdom
Trial participating centre
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Trial participating centre
The York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29202786