NCT02212353

Brief Summary

This small observational study is a contractual component of a 5-year (2013-18) NIHR funded programme called PERFECTED (Peri-operative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia) whose overall aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients with dementia suffering a fractured hip. The findings from this particular observational study will support other PERFECTED work-packages in establishing current care practices in acute hospital settings for older people in general with hip fractures. Observation is a well-established qualitative technique widely used to understand cultures, processes and interactions in defined locations including hospitals. In this study, researchers will observe day-to-day practices on specific ortho-geriatric wards and Emergency Departments in three English hospitals (Norfolk and Norwich University Hospital, Bradford Royal Infirmary and Queen's Medical Centre in Nottingham). Observations will occur intermittently over a 4-week period, covering the full 24h cycle. The prime objective of the study is to describe delivery of care to older patients with a hip fracture including an assessment of cost consequences. Crucially, the observations will focus exclusively upon the hospital personnel that routinely provide care in the designated locations being observed. Other individuals who frequent the locations (patients, visitors and other more peripheral health care professionals) are NOT the focus of the research and will be regarded as "incidental others" rather than "participants". This approach is common in observational research. Observations will be conducted by experienced qualitative researchers and assisted by specifically trained lay researchers to provide a valuable service-user dimension to the study. Field-notes and contextual information will be collected and thematically analysed, again in partnership with trained 'lay' researchers. Resulting data will address the pre-defined aims of the observational study and feed into the findings reported across the whole of work package 1 of PERFECTED.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2014

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2014

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 6, 2014

Last Update Submit

August 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • To observe and describe the general day-to-day practices and routines in three English acute hospitals for treating older patients with hip fracture.

    The overall aim of this study (phase 3, WP1 of PERFECTED) is to observe and describe the general day-to-day practices and routines in three English acute hospitals for treating older patients with hip fracture. The influence on care practices of significant co-morbidities, particularly dementia, will especially be noted. Observations will take place in defined areas on specified ortho-geriatric wards and in EDs. The study's aims and objectives focus on the delivery of care. As such, the focus of the observations is solely upon those health professionals who routinely deliver care in the designated spaces.

    Observations in each of the 3 sites will take place for a 4 week period.

Study Arms (3)

Site 1 Health Care Professionals

Observational research. This is a cohort of health care professionals working in site 1 in delivering to care to neck of femur patients.

Other: Observational study, not interventional

Site 2 Health Care Professionals

Observational research. This is a cohort of health care professionals working in site 2 in delivering to care to neck of femur patients.

Other: Observational study, not interventional

Site 3 Health Care Professionals

Observational research. This is a cohort of health care professionals working in site 3 in delivering to care to neck of femur patients.

Other: Observational study, not interventional

Interventions

Site 1 Health Care ProfessionalsSite 2 Health Care ProfessionalsSite 3 Health Care Professionals

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondry Care

You may qualify if:

  • Health Care Professioanls delivering care in the observational environments

You may not qualify if:

  • Those who are not Health Care Professioanls delivering care in the observational environments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaHip Fractures

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • George C Fox

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 8, 2014

Study Start

September 1, 2014

Primary Completion

December 12, 2014

Study Completion

December 16, 2014

Last Updated

August 11, 2017

Record last verified: 2017-08