NCT01098916

Brief Summary

Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
Last Updated

April 5, 2010

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

March 10, 2010

Last Update Submit

April 2, 2010

Conditions

Keywords

hospital at homeradiology at homefrail elderly

Outcome Measures

Primary Outcomes (1)

  • Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM)

    Frail patients, especially old ones,often develop delirium or confusion when moved from their usual environment. In home-hospitalized patients with the same risk of developing delirium, according to the Inouye's criteria, we evaluated the onset of a confusional status after X-rays performed at home or in hospital

    24 hours after the radiological procedure

Secondary Outcomes (2)

  • Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital

    1 year

  • Satisfaction of patients and/or families

    within 1 month after the procedure

Study Arms (2)

X-rays at home

EXPERIMENTAL

Home hospitalized elderly patients undergo X-rays at home

Radiation: Home X-rays

Hospital X-rays

ACTIVE COMPARATOR

Home hospitalized elderly patients undergo X-rays examinations in hospital

Radiation: X-rays in hospital

Interventions

Home X-raysRADIATION

X-rays examinations performed at home

X-rays at home
Hospital X-rays

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • immobilization or chairbound,
  • need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
  • absence of definite delirium at enrollment according to the Confusion Assessment Method, and
  • intermediate or high risk of delirium according to the criteria of Inouye.

You may not qualify if:

  • need of urgent examination (within 24 hours),
  • need of X-ray examinations not suitable at home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Battista Hospital

Torino, 10126, Italy

Location

Related Publications (1)

  • Ricauda NA, Tibaldi V, Bertone P, Quagliotti E, Tizzani A, Zanocchi M, Isaia GC, Grosso M, Cammarota T, Davini O. The RAD-HOME project: a pilot study of home delivery of radiology services. Arch Intern Med. 2011 Oct 10;171(18):1678-80. doi: 10.1001/archinternmed.2011.336. Epub 2011 Aug 8. No abstract available.

MeSH Terms

Conditions

PneumoniaFractures, BoneOsteomyelitis

Interventions

X-RaysHospitals

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesWounds and InjuriesBone Diseases, InfectiousBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Teresa Cammarota, MD

    Fifth Radiology Department, San Giovanni Battista Hospital of Torino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

April 5, 2010

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 5, 2010

Record last verified: 2008-05

Locations