PERFECTED CRCT: Care of patients experiencing hip fracture & confusion

ISRCTN ISRCTN99336264
DOI https://doi.org/10.1186/ISRCTN99336264
Secondary identifying numbers 31290
Submission date
05/09/2016
Registration date
05/09/2016
Last edited
28/02/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Plain English summary under review

Study website

Contact information

Dr Simon Hammond
Scientific

Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Phone +44 (0)1603 591460
Email s.hammond@uea.ac.uk

Study information

Study designRandomised; Interventional; Design type: Process of Care, Education or Self-Management, Management of Care, Rehabilitation
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN99336264_PIS_V4.0_03May2017.pdf
Scientific titleEnhancing 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
Study acronymPERFECTED CRCT
Study objectivesThe 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(s)04/07/2016, ref: 16/LO/0621
Health condition(s) or problem(s) studiedSpecialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system
InterventionTen 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 typeOther
Primary outcome measureFeasibility outcomes:
1. Recruitment rate
2. Retention rate
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2016
Completion date31/07/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 800; UK Sample Size: 800
Total final enrolment282
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2016
Date of final enrolment31/01/2018

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom

Study participating centres

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Victoria Hospital
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Princess Royal University Hospital
Farnborough Common
Orpington
BR6 8ND
United Kingdom
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
The York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor information

University of East Anglia
Hospital/treatment centre

Norwich Research Park
Norwich
NR4 7TJ
England
United Kingdom

ROR logo "ROR" https://ror.org/026k5mg93

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 04/12/2017 Yes No
Results article 28/02/2022 28/10/2022 Yes No
Other publications Process evaluation 03/02/2023 06/02/2023 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet version 4.0 03/05/2017 03/12/2024 No Yes

Additional files

ISRCTN99336264_PIS_V4.0_03May2017.pdf

Editorial Notes

03/12/2024: Participant information sheet added.
06/02/2023: Publication reference added.
28/10/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
20/02/2018: The overall trial end date has been updated from 28/02/2018 to 31/07/2018.
15/02/2018: Publication reference added.
23/10/2017: The recruitment end date was changed from 01/09/2017 to 31/01/2018.