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

This study has been completed.
Sponsor:
Collaborator:
FondazioneCRT
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT01098916
First received: March 10, 2010
Last updated: April 2, 2010
Last verified: May 2008
  Purpose

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.


Condition Intervention
Acute Congestive Heart Failure
Exacerbation of COPD
Pneumonia
Fractures
Osteomyelitis
Radiation: Home X-rays
Radiation: X-rays in hospital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM) [ Time Frame: 24 hours after the radiological procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 1 month after the procedure ] [ Designated as safety issue: No ]
    Customer satisfaction is evaluated using an ad hoc questionnaire


Enrollment: 69
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X-rays at home
Home hospitalized elderly patients undergo X-rays at home
Radiation: Home X-rays
X-rays examinations performed at home
Active Comparator: Hospital X-rays
Home hospitalized elderly patients undergo X-rays examinations in hospital
Radiation: X-rays in hospital

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098916

Locations
Italy
San Giovanni Battista Hospital
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
FondazioneCRT
Investigators
Principal Investigator: Teresa Cammarota, MD Fifth Radiology Department, San Giovanni Battista Hospital of Torino
  More Information

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01098916     History of Changes
Other Study ID Numbers: 0078572
Study First Received: March 10, 2010
Last Updated: April 2, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
hospital at home
radiology at home
frail elderly

Additional relevant MeSH terms:
Heart Failure
Osteomyelitis
Bone Diseases
Bone Diseases, Infectious
Cardiovascular Diseases
Heart Diseases
Infection
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 20, 2014