Investigation of a Free Water Protocol

Part of paid clinical trials in Loveland, Colorado.

Sponsor
Poudre Valley Health System
Study ID
NCT06309602
Status
Recruiting
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Conditions

  • Oropharyngeal Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Free Water Protocol — OTHER
    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.
  • Control / Standard Care — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
May 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Control / Standard Care
    Standard care provided for patients with orders for thickened liquids.
  • Experimental: Free Water Protocol
    Standard 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.

Primary Outcome Measure

Dysphagia Handicap Index [ Time Frame: Through study completion, an average of 5 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Medical Center of the RockiesLovelandColorado80538
Emily Main, MS, CCC-SLP
[email protected]
970-624-4369
Brian Daily, MD (SUB_INVESTIGATOR)
Cordelie Witt, MD (SUB_INVESTIGATOR)
Lucie Uncapher, MD (SUB_INVESTIGATOR)
Brandon Petrun, MD (SUB_INVESTIGATOR)
Medical Center of the RockiesLovelandColorado80538
Emily Main, MS
[email protected]
970-624-4369

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By research site
Medical Center of the Rockies· Loveland, CO

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