Evaluation of Mobile X-ray Within the Triple Aim Method | NCT04005040

Studies
Evaluation of Mobile X-ray Within the Triple Aim Method

NCT04005040

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 22, 2020Actual

Enrollment

374Actual

Phase

Not Applicable

Conditions

X-rays; Effects
Health Impairment
Patient Satisfaction

Interventions

Mobile X-ray

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Apr 17, 2019Actual

Completion Date

Apr 17, 2019Actual

First Submitted Date

Jun 28, 2019

First Submission Date that Met QC Criteria

Jun 28, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2020

Last Update Posted Date

Apr 22, 2020Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background:

In foreign countries, mobile x-ray already is being used where transfer to the radiology department at the hospital may be an obstacle. Using mobile x-ray, the x-ray examination is performed in the patients own home with transportable equipment that reminds of the transportable x-ray equipment that is being used in the intensive care units. At The Department of Radiology (DOR), Aarhus University Hospital there is an ongoing project mobile x-ray for patients living in nursing homes in Aarhus. The project will be evaluated inspired by the Triple Aim Approach in three sub studies.

Overall aim:

The overall aim is to conclude if mobile x-ray improves healthcare for fragile patients.

Hypotheses:

Patients examined with mobile x-ray have fewer number of hospital admissions compared with patients examined with x-ray at DOR.
Patients examined with mobile x-ray are more satisfied with their examination compared with patients examined with x-ray at DOR.

Sub study 1 - Population health

Aim:

The primary aim is to study if mobile x-ray improves the health of the defined population measured in hospital admission. Also to study challenges conducting a RCT.

The outcome measures:

The primary outcome is hospital admissions.

Sub study 2 - Experience of care

Aim:

The aim is to study the satisfaction with mobile x-ray compared the satisfaction to x-ray at DOR.

Methods:

Observations, interview and questionnaires.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

374Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mobile X-ray	Active Comparator	Intervention: X-ray examination in the patients own home	Procedure: Mobile X-ray
X-ray at the Hospital	Placebo Comparator	Control: X-ray at the hospital	Procedure: Mobile X-ray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobile X-ray	Procedure	Evaluating the effect of mobile x-ray compared to x-ray at the Hospital	Mobile X-ray X-ray at the Hospital

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital admissions	How many patients are hospitalized	one year

Secondary Outcomes

Measure	Description	Time Frame
patient satisfaction	Measuring satisfaction using questionnaires	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients referred to a mobile X-ray examination in Aarhus Municipality

Exclusion Criteria:

all other patients referred to an x-ray examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helene Nørrelund, Decan	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Central Region Denmark	8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28181756	Result	Vigeland E, Bohm RE, Rostad A, Lysdahl KB. Mobile X-ray service for nursing homes. Tidsskr Nor Laegeforen. 2017 Feb 7;137(3):198-202. doi: 10.4045/tidsskr.16.0035. eCollection 2017 Feb. English, Norwegian.

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior