Juice Preference in the Emergency Department | NCT02506478

Studies
Juice Preference in the Emergency Department

NCT02506478

Sponsor

Hennepin Healthcare Research Institute

Status

Completed

Last Update Posted

Dec 28, 2016Estimated

Enrollment

385Actual

Phase

Not provided

Conditions

All Eligible ED Patients (Not Limited to a Particular Condition)

Interventions

Beverage procurement

Countries

United States

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

Dec 2016

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 2015

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jun 15, 2015

First Submission Date that Met QC Criteria

Jul 22, 2015

First Posted Date

Jul 23, 2015Estimated

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

Dec 23, 2016

Last Update Posted Date

Dec 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brian Driver, Associate Research Director, Hennepin Healthcare Research InstitutePrincipal Investigator

Lead Sponsor

Hennepin Healthcare Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

ED patients who are able to drink juice will be approached and asked their beverage preference.

Detailed Description

Once per week for 26 weeks, patients will be enrolled during a randomly selected 1-hour block. The random blocks will be assigned using STATA. During these enrollment periods, all current ED patients will be screened by the treating physicians and research associates, excluding patients in the "Special Care" unit, where most patients are intoxicated with alcohol.

Eligibility for oral consumption of water and juice will be determined by treating physicians. Patients who are deemed eligible to drink water or juice will be approached and asked their beverage preferences. Their response will be recorded, and the beverage will be procured for them.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

385Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ED patients		All ED patients who are able to drink water/juice, and be able to communicate juice preference.	Other: Beverage procurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beverage procurement	Other	All Emergency Department patients will be approached to ask their beverage preferences in a randomly permuted data collection form. If they would like juice, the flavor will be recorded and the juice (and/or water) will be procured by a research assistant if the patient would like that, though the actual procurement of the juice is not part of the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Juice preference	Cranberry, apple, orange, or grape	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Beverage preference	Water, juice, or both	1 hour
Ice preference	Yes or no (in any beverage)	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference. Patients are only enrolled during randomly selected 1-hour blocks once per week for 26 weeks.

Exclusion Criteria:

Previously enrolled in the study
Patients who are placed in the "special care" unit of the Emergency Department, which generally cares for intoxicated patients.

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

All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian E Driver, MD	Hennepin Healthcare Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hennepin County Medical Center		Minneapolis	Minnesota	55415	United States