Investigation of a Free Water Protocol
1 other identifier
interventional
136
1 country
2
Brief Summary
Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
June 5, 2025
May 1, 2025
3.2 years
November 2, 2023
May 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dysphagia Handicap Index
Quality of life survey
Through study completion, an average of 5 days
Oral Assessment Guide
8-point visual assessment of oral hygiene
Through study completion, an average of 5 days
Qualitative data
Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking
Through study completion, an average of 5 days
Secondary Outcomes (2)
Adverse events: Aspiration pneumonia/pneumonitis
Through study completion, an average of 5 days
Liquid intake
Through study completion, an average of 5 days
Study Arms (2)
Control / Standard Care
OTHERStandard care provided for patients with orders for thickened liquids.
Free Water Protocol
EXPERIMENTALStandard care provided for patients with orders for thickened liquids. Additionally, participant will be allowed to have plain, un-thickened water after the following have taken place: 1) Wait 30 minutes after meal or medication administration; 2) Complete oral care according to instructions posted at bedside.
Interventions
Intake of plain, un-thickened water is allowed even when a patient has orders for thickened liquids. Risks of pulmonary complications are decreased with use of a strict oral care regimen and timed intake of water related to meals. Patient satisfaction and comfort is increased with ingestion of plain water.
Standard care will be given to patients with orders for thickened liquids. This will include oral care twice a day and implementation of swallowing strategies and precautions as prescribed by the treating speech-language pathologist. Only fluids thickened to the recommended viscosity will be available to the patient.
Eligibility Criteria
You may qualify if:
- Stroke diagnosis or trauma patients being cared for by Trauma \& Acute Care Surgery (TACS) providers
- Current orders for restricted or thickened liquids
- Ability to control their own airway (i.e. airway adjuncts not needed)
You may not qualify if:
- Individuals who are medically fragile, as determined by treating physician, to include diagnosis of sepsis, need for vasopressors, or high oxygenation needs (requiring high-flow nasal cannula, Airvo, or oximask)
- Individuals who refuse oral care, have any decayed teeth or dental disease, or have a documented active oral infection
- Individuals with an advanced progressive neurological condition, active head/neck cancer, or those who are immunosuppressed
- Individuals who are on bed-rest orders
- Individuals who are lethargic or sedated
- Individuals with suspected pre-hospital aspiration event and/or aspiration pneumonitis
- Individuals with a fever of unknown origin
- Individuals with a history of recurrent aspiration pneumonia/pneumonitis
- Individuals whose primary language is one that the questionnaires are not available in a validated format
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2023
First Posted
March 13, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
June 5, 2025
Record last verified: 2025-05