Condition category
Mental and Behavioural Disorders
Date applied
05/09/2016
Date assigned
05/09/2016
Last edited
05/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Plain English summary under review

Trial website

http://www.perfected.ac.uk/

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 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

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

28/02/2018

Reason abandoned

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

01/09/2017

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

Sponsor information

Organisation

University of East Anglia

Sponsor details

Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes