Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing

Study Overview
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Brief Summary
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The Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long term care (LTC) setting comparing an intervention group with a control group receiving standard oral care, to prevent respiratory infections.

Detailed Description
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The investigators will recruit a convenience sample of 36 participants from a single long-term care facility. Participants will be randomly assigned into control or intervention groups. Both groups will be assessed at study onset for swallowing and oral health and continue with agreed upon diet texture and fluid modifications. The intervention group (FFWP and improved oral hygiene) will receive a dental hygienist cleaning at onset of the study and have supervised tooth brushing before thin water between meals. The control group will continue with standard oral care and offered the full dental hygienist cleaning at the end of the study. If findings indicate no difference between groups on outcome measures (eg. respiratory illness, hydration, nutrition) then the intervention is considered efficacious in long-term care residents. If improvements in outcome measures are evident for the treatment relative to the control group, then this intervention may provide opportunity for improved healthcare and cost-savings.

Official Title
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Implementing the Frazier Free Water Protocol to Improve Hydration and Quality of Life in Long Term Care Residents

Conditions
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Dysphagia, Respiratory Tract Infections

Intervention / Treatment
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* Other: FFWP and Improved Oral Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long Term Care Residents with moderate to severe swallowing difficulty and modified texture diet; or have a dry mouth and thirsty most of the time by report of patient participant, family or staff. Exclusion Criteria: Participant Resident taking part in another study; participant finished another study in last 30 days prior to this study; Participant has dental pain or waiting to see a dentist for pain and discomfort; Participant has current chest infection including pneumonia or is prone to chest infections with more than one episode per year; Participant is unable to tolerate assessments and oral care.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All study participants will have assessments for swallowing and oral hygiene. The intervention group will have a dental hygiene cleaning and supervised tooth brushing before taking plain, thin (unmodified) water and between meals. The control group will continue with standard oral care and the agreed upon diet texture and fluid modifications.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FFWP and Improved Oral Care<br>Receiving dental hygienist cleaning with supervised tooth brushing and FFWP (plain, unmodified water). | Other: FFWP and Improved Oral Care<br>* The FFWP with dental hygiene participants will have assessments for swallowing and oral health then proceed to have a dental hygienist cleaning. This intervention group will have supervised and assisted tooth brushing by nursing staff before taking plain (thin) unmodified water and between meals.<br>* Other names: Dental hygienist intervention and supervised tooth brushing;|
| No Intervention: Standard Care<br>This group has assessments and standard oral care with no dental hygienist cleaning, no FFWP or supervised tooth brushing and continuing with agreed upon diet texture and fluid modification. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Chest Infections | To determine whether the Frazier Free Water Protocol (FFWP) with improved oral care will decrease risk of respiratory illness events (eg. chest congestion, fever, etc.) for long term care residents by numbers of documented cases of upper and lower respiratory illnesses and hospital admissions over a 90-day duration. | Change from baseline (Day-0 to 90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of positive experience with FFWP intervention. | Analysis of participant experience with FFWP intervention over the 90-day study period by scaled responses to feedback question: Did you feel this was a positive experience? Responses range from Strongly Agree, Agree, Disagree, Strongly Disagree and Neither Agree or Disagree. | Change from baseline (Day 0-90 days) | 
| Change in Hydration | To assess change in hydration associated with FFWP intervention measured by lab values for electrolytes, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period. | Change from baseline (Day-0 to 90 days) | 
| Change in Nutrition. | To assess change in nutrition associated with FFWP intervention measured by lab values for albumin, BUN (Blood, Urea, Nitrogen) and Creatinine obtained over the 90-day study period. | Change from baseline (Day 0 to 180 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspiration pneumonia, Dementia, Dysphagia, Oral hygiene, Long-term care, Frazier Free Water