Short ‘n Sweet Review – Frazier Free Water Protocol (FFWP)

It’s been a quencher for most places already this summer☀️🥵, so why not learn more about all the benefits (and cons) to drinking more *clear* water for our patients💧🧊😎?!


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Obviously, the first thing we gotta do is to share the backstory and actual description of FFWP (sometimes referred to as FWP when modified😉):

“The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes (while they continue with any thickened fluid recommendations at mealtimes/snacktimes).”

“This protocol identifies patients who are at risk of aspiration on thin fluids and have been deemed safe to consume only thickened fluids or to remain ‘nil by mouth’, following a swallow assessment..are excluded if they are impulsive, have an excessive cough reflex to water or cannot maintain alertness. Water should be deemed ‘safe’ for drinking by each organisation’s national water quality standards.” p.2

So, why is this so important to consider for our patients?

As clinicians, we’re obviously all aware of aspiration, aspiration pneumonia, and all the other horrorsSitting On The Fence GIFs | Tenor that are threatened into our brains as we enter the field😱. But there are some concerning factors on the other side of the fence as well:

  • “Dehydration can impact a patient’s overall general health and result in medical complications such as chronic renal insufficiency, sepsis, impaired cognition, venous thromboembolism acutely post-stroke, and death”
  • Just because someone aspirates, does not automatically = pneumonia infection (let’s all say it together: Langmore, 1998º😁)
  • The obvious dislike of thickened fluids resulting in low adherence to recommendations (then resulting in the first bullet☝️☝️) or increasing risks for more fatal consequences

And because we’re not talking about your energy drinks, alcoholic beverages, or sweet teas which are highly excluded from the protocol,

“The risk of developing aspiration pneumonia is deemed to be lesser through the aspiration of thin pure water than the aspiration of thickened fluids. The aspiration of small amounts of pure water is considered relatively benign because pure water contains less pathogenic bacteria than other fluids, and because a small amount of aspirated water can be absorbed into the blood stream via the lungs’ aquaporins (permeable ‘water conducting channels’) without causing an infection.” p.2

Seriously, the citations (here, and here) that are referenced in that quote (including a perspective from Langmore herself!) are pretty awesome to bookmark, I know I did!!👍

One last thing about the protocol can’t be emphasized enough:

AGGRESSIVE ORAL HYGIENE IS CRITICAL!!!!!!!!!!!!!!!!!!!! (or as Karen Sheffler admirably defines here, ‘oral infection control‘ 👏👏)º


Okay, now that we’re all on the same clean, clear liquid page, the actual systematic review focused on gathering allll the peer-reviewed studies and results for FFWP (up to 2016), of all qualities and design types, to really give clinicians a better understanding of all the who, what, when, where, and why questions we might have regarding the FFWP and our patients.

They looked at studies with the following inclusion criteria:

  • Population
    • Oropharyngeal dysphagia patient population at risk of aspiration on thin liquids (adults/children) (be sure to keep reading for more on this😉)
    • Patients with NPO recommendations
    • Patients with thickened liquid recommendations
  • Intervention
    • A FFWP/FWP
  • Outcomes
    • Any (wowzers can you say free-range!!😯)

And left out all the studies for the following exclusion criteria:

  • non-English studies
  • non-peer-reviewed
  • conference/abstracts, systematic reviews

As you can see, there’s a LOT that can be included in the mix, and after narrowing their search down from 2,792 to only 8 studies, if you really think about it, that means that all the other studies couldn’t be included (even if they were good quality) because they failed to include any one of those specific measures above😕. (BUT- doesn’t mean you can’t skim their reference list for all those discards😉)


Ok, so what does all this evidence about FWWP say????

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Well my to-the-point friends, if you’ve got questions, this review found you some answers, sort of🙃😏. . .

WHAT kind of studies were found and what quality were they?

The final 8 studies included:

  • 5= randomized control trials (whoah!😱)
  • 1= retrospective chart review with a retrospectively matched cohortº
  • 1= retrospective study with a retrospective matched cohortº
      • all above control groups remained NPO (with enteral feeding) and never participated in FFWP
  • 1= single group pre/post-intervention prospective case studyº

All 8 studies ranged from 13-29 out of a total score of 31 for risk of bias, and “Six of the studies were classified as good quality,” including all RCTs and the single group pre/post-intervention, however also had a lack of blinding. Parks and Recreation | GIFGlobe

 

WHO can we (or shouldn’t we) implement FFWP with??

“At present, candidates should be considered only if they are adult inpatients in rehabilitation and if they do not have degenerative neurological conditions. There is currently an insufficient volume of evidence for implementing the Free Water Protocol with medically unwell patients.”

“Patients must have sufficient cognitive functioning to safely and independently (or with strict supervision/assistance) implement the Free Water Protocol, as well as an adequate level of mobility to maximise their respiratory support.” p.14

A big caveat to that is that there was either absent definitions of what “cognitive impairment” meant or inconsistent and vague descriptions, meaning some studies only included patients with “good cognition,” while others excluded patients with “severely impaired” or “very impaired cognition” unlessOr Idk GIFs - Get the best GIF on GIPHY they could adhere to the protocol with supervision/assistance. So, there’s no standardized way to know exactly what level of cognition may be most beneficial or required, and another thing to be mindful of is there likely wasn’t any defined description of exactly what counted as “assistance/supervision” and how much was permissible or not.🤨

Along with “medical stability, oral status, respiratory status, absent swallow reflex, and strong uncomfortable reflex to thickened water,” mobility status was considered important by some studies, although some studies still lacked some consistency across descriptions or what this could be defined as, with some stating “participants should not be immobile or of low mobility status,” and others not excluding those who were “bedbound or predominantly sitting.” Now as far as exactly what that means, your guess is as good as mine.🤷‍♀️

 

WHERE might be the best settings to implement FFWP???

“The Free Water Protocol was mostly implemented across inpatient rehabilitation settings. These included stroke rehabilitation units, an acute neurologic rehabilitation setting and programs for acquired brain injury, neuromusculoskeletal and spinal cord injuries. One study took place in a regional hospital..One study was conducted in a respiratory care unit.” p.6-7

Unfortunately for all you acute SLPs (me included🙋‍♀️), some studies originally wanted to include acute patients but ultimately had to disregard the data due to poor recruitment and data collection (story of our lives, right?!). Now does this mean you CAN’T implement FFWP anywhere else? Nope! This really is gonna depend on YOUR specific patient, YOUR specific department, and YOUR specific facility, staffing, and supportive culture.

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WHEN might be the best time to start/stop FFWP????

In other words, when and for how long?

“The duration of treatment ranged from 5 days to 17 weeks between studies but both intervention and usual care comparison groups were evaluated over the same duration within each study.” p.10

Unfortunately,

Ring Dings and Pepsi“the treatment lengths varied significantly across studies, without any follow-up and, as a result, it may not be possible to rule out the acquisition of lung complications after the cessation of the shorter treatments.” p.14

Something that could possibly be an advantage for more long-term settings, no? Again, specific to YOUR specific patient and circumstances and what is needed.😉😉

 

WHAT are the outcomes found from the research?????

When it came to Volume of Fluid Intake and FFWP:

“Meta-analysis of 148 patients from these 5 studies demonstrated low-quality evidence of an observed increase in fluid intake with the Free Water Protocol” 

“A second review finding was that there was low level of evidence that fluid intake levels may have increased, which suggests that implementing the Free Water Protocol may potentially have a positive effect on patients who are consuming thickened fluids or are ‘nil by mouth’, who have health complications associated with reduced fluid intake.” p.13

In other words, there’s some evidence from the data to suggest that FFWP may improve patients’ hydration levels for the populations looked at, however, it’s not the best quality. (Always gotta read that fine print right!🧐)

When it comes to the Impact on Swallow-Related Quality of Life with FFWP:

“A third review finding was that the majority of the studies that assessed quality of life reported more favourable outcomes post implementation of the Free Water Protocol, suggesting acceptance of the protocol by patients.” p.13

Overall, 2 studies used standardized assessments (i.e. SWAL-QOL, SWAL-CARE), some used “purpose-built multiple question surveys,” and 1 lone control patient in a study even reported being satisfied with thickened liquids (hey, to each-their-own, right?👍).

And the big one, when it comes to the Impact of FFWP on Lung Status:

“Meta-analysis of 206 patients from six studies in a rehabilitation setting demonstrated low-quality evidence that there was no significant increase in the odds of having lung complications with the Free Water Protocol.” p.10

I feel like this could be stated a bunch of different ways depending on your current mood (or at least how my SLP mind is interpreting it🙃):

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“We have low-quality evidence that says FFWP doesn’t significantly increase the odds of having lung complications”

 

“We have some evidence that shows your odds of developing lung complications with FFWP is low, although the evidence is poor-quality”

Yay? Nay? Either way you slice it, it’s ‘something‘ (just not the best)😒🤷‍♀️.

 

BUT before you jump too high outta your chair to let your patient guzzle some water. . .

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WHY might we not consider FWWP and what are the limitations of the gathered evidence????? 

First and foremost:

“There is, as of yet, a relatively small body of evidence-based on 8 studies and less than 250 participants.”

“Further limitations are that the clinical populations across the studies varied, the oral care provided to patients varied and limited information was provided by authors on the severity of participants’ dysphagia and on the timing of the dysphagia assessment in relation to their admission.” p.14

While the above limitations along with consistently small sample sizesºdon’t necessarily yield the highest confidence😓, what they did conclude can be useful in our clinical decision-making process:

“There is low-quality evidence indicating that carefully selected adult rehabilitation inpatients, who do not have degenerative neurological conditions and who are relatively mobile with reasonably intact cognition (or access to supervision to compensate for a cognitive deficit), should be given the choice to implement the Free Water Protocol, and that this may increase their fluid intake levels. Swallow-related quality of life may also improve.” p.14

There’s still a lot to consider and unpack, including the question that might be on every SLP’s mind, “how was it confirmed they had dysphagia/aspiration?” Well, I’m incredibly sad and sorry to say that not all patients were assessed using instrumental swallow study evaluation (i.e. VFSS/FEES)😩😥.

It is, therefore, not possible to determine the total number of participants who were confirmed aspirators versus those who may have been ‘at risk’ of aspiration. This may suggest that not all patients in the treatment group aspirated on thin fluids.” p.13

Another HUGE issue to keep at the forefront of your mind is the incredibly inconsistent clarity and descriptions of just what constitutes a ‘lung complicationº/aspiration pneumonia,’ as many studies didn’t state if this only included aspiration pneumonia or if other types of pulmonary complications were or were not included in their outcome measures??? Who really knows?🤷‍♀️🤷‍♀️ (not to mention any other kind of complications???)

Finally, something that literally 🤯‍BLEW MY SLP MIND🤯‍ was that while almost every study described their “aggressive oral hygiene program” differently, it seemed there wasn’t any way to assess and appraise the “best quality” type of oral hygiene program?! In real-life terms, I guess this does make more sense because even today we still can’t agree on what exactly this needs to look like given all the different settings and needs of each patient and staffing!

Some had a simple “swish and spit” rinsing method, some included an actual description of teeth brushing and Chlorhexidine mouthwash “thoroughly”, and others had specific times for oral hygiene from “3-5 times a day” to “morning, before oral intake, and bedtime” (some even included mere mouth swabs to do the job😳😬😓🤢).

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Well folks, all this to say in the end, just like in everything else in our field when it comes to dysphagia (and most other things too):

“It is expected that clinicians continue to use their best clinical judgement, in conjunction with the interdisciplinary team, to carefully select appropriate candidates for the Free Water Protocol…Thorough pre-planning and education of the interdisciplinary team of doctors, nurses, and relevant allied health staff are recommended to ensure that the protocol is closely adhered to.” p.14

And don’t even *think* about tossing out the exclusion criteria that were established from these studies and review:

“The exclusion criteria to be considered include medical instability, impaired respiratory functioning, degenerative neurological conditions, impaired mobility, impaired cognition, an oral/dental infection and a severe cough reflex to thin fluids.” p.14

And as always, to keep pushing our field forward:

“Further research is recommended to determine specifically what populations the protocol can be implemented with, for example, which degenerative neurological conditions are inappropriate, what levels of mobility and cognition are inadequate, and whether it can be implemented with children.”

“Further research is also required to identify an appropriate oral hygiene program and to determine if this protocol can be implemented within other settings such as the acute, out-patient and residential care settings.” p.14

Leaving you with,

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(for your patients)

Because

💖

 

“To summarise, the developers of the Frazier Free Water Protocol hypothesised that when water is aspirated, the likelihood of a pneumonia developing is reduced if the risk factors of aspiration pneumonia, as discussed above, are managed” p.2


Article Referenced: [Free Access for DRS members🤓]

Gillman, A., Winkler, R. & Taylor, N.F. Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. Dysphagia 32,345–361 (2017). doi: 10.1007/s00455-016-9761-3

 

Some more resources of FFWP for ya’ll:

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