Hammond 2017.

Trial name or title	PERFECTED enhanced recovery (PERFECT‐ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomised controlled trial.
Methods	A feasibility cluster‐randomised controlled trial comparing PERFECTED enhanced recovery (PERFECTER‐ER) vs standard care.
Participants	Number: Will recruit 400 hip fracture patients identified as experiencing confusion (also suitable informants who will complete proxy measures). Eligibility criteria: Patient inclusion criteria: Patient must have had confirmed proximal hip fracture requiring an operation and be aged ≥ 60 years at the time of the operation Patient has a preoperative Abbreviated Mental Test Score (AMTS) ≤ 8 in England (including those with zero because of an inability to answer questions) or a 4A Test: screening instrument for cognitive impairment and delirium score ≥ 1 in Scotland Patient must have a “suitable informant” (e.g. relative, unpaid or paid carer, care home manager) who has a minimum of once‐a‐month face‐to‐face or telephone contact with the patient and is able, and consents to, provide information on proxy measures Patient and a suitable informant must be recruited into the trial within 7 days of the hip fracture operation Patient must spend a minimum of 5 days on the study ward Patient exclusion criteria: Decision taken not to undergo hip surgery Patient not expected to survive beyond 4 weeks Patient already enrolled in a clinical trial of an investigational medicinal product (CTIMP) Suitable informant inclusion criteria: Individual has a minimum of once‐a‐month face‐to face or telephone contact with the patient Individual is able, and consents to, provide information on proxy measure Suitable informant exclusion criteria: Individual not over 16 years of age. Group allocation: Cluster‐randomised across hospital wards in 10 NHS hospitals located in 5 different UK regions. Each hospital contributes 1 ward, and the unit of randomisation is the hospital site. An ad hoc programme will be written in SAS to carry out this procedure. 40 participants in 10 different sites. Diagnosis/cognitive status: The Abbreviated Mental Test Score (AMTS) and the 4A Test: screening instrument for cognitive impairment and delirium (4AT). Age: 60 years old and over Gender mix: Not specified Usual place of residence: Not specified Surgical management: Not specified Comorbidities: Not specified
Interventions	Intervention arm: PERFECT‐ER pathway. As the current paper is reporting the protocol for a feasibility study, the intervention is understandably not yet in the public domain. Control arm: Control is treatment as usual. Local practices in each site will differ. We will collect relevant site profile data (please see “Site profile data” for details).
Outcomes	Time points: 1 month +/‐ 5 days; 3 months +/‐ 5 days; 6 months +/‐ 5 days Outcomes: MMSE‐2 (participant); Dementia Quality of Life (DEMQOL) (participant and informant); EQ‐5D‐5L (participant and informant); howRwe (participant); howRthey (informant); Clinical Dementia Rating (CDR) (participant and informant); patient care profile (participant); timed up and go (participant); Bristol Activities of Daily Living Scale (informant); EQ‐5D‐5L carer self‐report (informant); client service receipt inventory (CSRI) (informant); number of days in institutional care (informant); participant place of residence (informant); Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) (informant); length of hospital stay; discharge destination; mortality; hospital readmission; hospital service use; 4AT; Charlson Comorbidity Index (CCI).
Starting date	1 November 2016
Contact information	Professor Chris Fox ‐ Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ. Email: chris.fox@uea.ac.uk
Notes	Proposed end date: August 2018 ISRCTN registration: ISRCTN99336264 Trial registration last updated: 20 February 2018 ‐ completed Site inclusion criteria: Sites have an average monthly admission of at least 12 individuals who sustain proximal hip fracture requiring an operation and have a preoperative AMTS ≤ 8 (England) or a 4AT ≥ 1 (Scotland) in the last 12 available calendar months. Sites are able to provide the PERFECTED trial team with contextual ward‐level data (comprising BPT scores, number of falls, pressure ulcers, deaths, and safeguarding incidents) in the last 12 available calendar months. Sites that have participated in the 'PERFECTED WP2: Implementing optimised hospital care' research programme leading to the development and refinement of PERFECT‐ER will be excluded.

ADLs: Activities of Daily Living

BPT: Best Practice Tariff

CTIMP: Clinical Trial of an Investigational Medicinal Product
 MMSE: Mini‐Mental State Examination