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
Contact information
Dr Simon Hammond
Scientific
Scientific
Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603 591460 |
|---|---|
| s.hammond@uea.ac.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN99336264_PIS_V4.0_03May2017.pdf |
| 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 |
| Study acronym | PERFECTED CRCT |
| Study objectives | 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(s) | 04/07/2016, ref: 16/LO/0621 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Feasibility outcomes: 1. Recruitment rate 2. Retention rate |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2016 |
| Completion date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 800; UK Sample Size: 800 |
| Total final enrolment | 282 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2016 |
| Date of final enrolment | 31/01/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Norwich
NR4 7UY
United Kingdom
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Victoria Hospital
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby
DE22 3NE
United Kingdom
Princess Royal University Hospital
Farnborough Common
Orpington
BR6 8ND
United Kingdom
Orpington
BR6 8ND
United Kingdom
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
London
SE5 9RS
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Wakefield
WF1 4DG
United Kingdom
The York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
York
YO31 8HE
United Kingdom
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Leicester
LE1 5WW
United Kingdom
Sponsor information
University of East Anglia
Hospital/treatment centre
Hospital/treatment centre
Norwich Research Park
Norwich
NR4 7TJ
England
United Kingdom
"ROR" |
https://ror.org/026k5mg93 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
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 share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not 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
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.
