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The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology (RHP)

Primary Purpose

Acute Congestive Heart Failure, Exacerbation of COPD, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Home X-rays
X-rays in hospital
Sponsored by
Azienda Ospedaliera San Giovanni Battista
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Congestive Heart Failure focused on measuring hospital at home, radiology at home, frail elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • San Giovanni Battista Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

X-rays at home

Hospital X-rays

Arm Description

Home hospitalized elderly patients undergo X-rays at home

Home hospitalized elderly patients undergo X-rays examinations in hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
Evaluation of costs includes: costs for transportation, ambulance, equipment (eg, processing costs), materials (eg, CD), technical staff (eg, radiographers, radiologists); for the control group: costs for working time employed by family members and health staff to bring patients to hospital for X.ray examination
Satisfaction of patients and/or families
Customer satisfaction is evaluated using an ad hoc questionnaire

Full Information

First Posted
March 10, 2010
Last Updated
April 2, 2010
Sponsor
Azienda Ospedaliera San Giovanni Battista
Collaborators
FondazioneCRT
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1. Study Identification

Unique Protocol Identification Number
NCT01098916
Brief Title
The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology
Acronym
RHP
Official Title
The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
Collaborators
FondazioneCRT

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Congestive Heart Failure, Exacerbation of COPD, Pneumonia, Fractures, Osteomyelitis
Keywords
hospital at home, radiology at home, frail elderly

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
X-rays at home
Arm Type
Experimental
Arm Description
Home hospitalized elderly patients undergo X-rays at home
Arm Title
Hospital X-rays
Arm Type
Active Comparator
Arm Description
Home hospitalized elderly patients undergo X-rays examinations in hospital
Intervention Type
Radiation
Intervention Name(s)
Home X-rays
Intervention Description
X-rays examinations performed at home
Intervention Type
Radiation
Intervention Name(s)
X-rays in hospital
Primary Outcome Measure Information:
Title
Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM)
Description
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
Time Frame
24 hours after the radiological procedure
Secondary Outcome Measure Information:
Title
Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
Description
Evaluation of costs includes: costs for transportation, ambulance, equipment (eg, processing costs), materials (eg, CD), technical staff (eg, radiographers, radiologists); for the control group: costs for working time employed by family members and health staff to bring patients to hospital for X.ray examination
Time Frame
1 year
Title
Satisfaction of patients and/or families
Description
Customer satisfaction is evaluated using an ad hoc questionnaire
Time Frame
within 1 month after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: need of urgent examination (within 24 hours), need of X-ray examinations not suitable at home.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Cammarota, MD
Organizational Affiliation
Fifth Radiology Department, San Giovanni Battista Hospital of Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Giovanni Battista Hospital
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21824941
Citation
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.
Results Reference
derived

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The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology

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