Inpatients who exhibited a degree of pharyngeal dysphagia characterized by aspiration of thin liquids as observed by instrumental swallow studies (Modified Barium Swallow Study or Fiberoptic Endoscopic Evaluation of Swallowing) were referred to the study by their primary treating SLP. Patients referred were either on a nil-per-os (NPO) diet with alternate means of nutrition, or on a PO diet with drink and food texture modifications as aligned with the National Dysphagia Diet (NDD) .
After referral, the principal investigator used the predefined inclusion and exclusion criteria to further determine candidacy (Table 1). To be considered, patients needed to be 18 years of age or older, capable of ambulation with a physical or occupational therapist, have overall medical stability, and show no overt signs of discomfort (i.e. excessive coughing or gagging) when drinking thin liquids. The attending physician for each patient was consulted to determine medical stability, which was primarily constituted by the patient being afebrile, hemodynamically stable, having a stable respiratory status, and no known active infection. Excluded from the study were patients with a compromised pulmonary system, including both tracheostomy and ventilator needs, patients with poor oral hygiene status, patients with an absent pharyngeal swallow reflex, and patients with a Montreal Cognitive Assessment (MoCA) score less than 17 . Conveniently, the Occupational Therapy department was already collecting MoCA scores for all patients at admission. We used these scores to ensure the cognitive capacity of candidates to adequately understand the rules of the protocol and give informed consent. If a patient was unable to complete the MoCA due to communication deficits, cognitive status was determined by consultation with the patient’s primary therapists, family, and analysis of etiology for hospitalization. All participants enrolled in the study provided informed consent.
The study was comprised of participants with a wide range of admitting diagnoses as listed in Table 2. Consistent with an inpatient rehabilitation program, all participants were transferred to [removed for blinding] from an acute care hospital. They all received daily occupational, physical, and speech therapy 5 to 6 days a week as appropriate. Per standard procedures, either a physiatrist or a hospitalist was assigned to the patient for daily rounds and medical monitoring.
After providing informed consent, ten participants were then enrolled in the study. One participant who was originally enrolled, was excluded from data analysis. Due to unrelated medical issues, which ultimately required a transfer from our facility, we were uncertain of the validity and quality of the data collected from this individual. All data are representative of these 9 individuals.
Research Design and Setting
This was a feasibility study completed at the inpatient level of care at [removed for blinding] in [removed for blinding]. [Removed for blinding] is an LTACH focused on medical rehabilitation across a variety of diagnoses, including: brain injury, acute and chronic pulmonary conditions, and spinal cord injuries. The average inpatient length of stay (LOS) is 24 days. Prior to participant recruitment, the study was reviewed and approved by the Institutional Review Board to ensure ethical standards. As this was a feasibility study intended to investigate the implementation of this protocol at our institution and did not use an FDA regulated device or medication, this study was not registered with clinicaltrials.gov as it was determined to not meet the criteria for an applicable clinical trial [22,23]
Similar to prior implementation strategies , this study consisted of 3 phases, including: a Staff Education/Preparation phase, an Implementation phase, and a Conclusion phase.
Staff Education and Preparation
As our institution only had a protocol related to ice chips at this time, the importance of staff education was quickly realized as most hospital staff were either hesitant or unfamiliar with the concept of free water. During the education/preparation phase, a comprehensive interdisciplinary research committee was formed consisting of three SLPs, one occupational therapist, one physician, two registered dieticians, and one registered nurse. Committee members assisted in providing education to hospital staff in the form of in-service presentations, provision of written handouts, and establishing the protocols necessary for implementation.
Additionally, SLP committee members created a PowerPoint Presentation that was presented at the monthly medical team meeting preceding participant recruitment. This presentation contained information related to the rationale behind using a FWP and a review of related research. The medical team then provided initial verbal consent to implement the FWP in the context of research. Specific team member duties were also assigned during this time. The physician was available to address medical questions or concerns as they arose. The occupational therapist was to monitor daily oral care interventions. The two registered dieticians tracked hydration status, including overall daily fluid intake. The hospital’s chief nursing officer was contacted to discuss the study and potential impact on nursing responsibilities (e.g., providing participants with water, recording daily fluid intake) and was agreeable to implementation. Nursing staff were requested to initial the oral care form each time oral care was completed and to record fluid intake for all drinks consumed by the participant each day during the tracking periods. A new order for “Free Water Protocol” was requested of the clinical informatics manager and placed in the electronic medical record system. This order contained the written rules of the protocol within it.
Concurrently, contact was made with clinicians and researchers in similar hospital settings to obtain permission to use or recreate applicable handouts for this study. Specifically, a brochure outlining a brief history of the free water protocol in addition to an oral care plan were adapted from research previously published by the G.F. Strong Rehab Centre , an inpatient rehabilitation setting similarly structured to our LTACH setting. The brochure, a simple fluid tracking form, and the oral care plan were assembled in two-pocket folders. These were reviewed with staff and left in participants’ rooms upon the study start.
The Implementation phase of the study used a modified Free Water Protocol based on previously published protocols [6,9,10,13,15,24]. To ensure a complete dataset could be collected given the potential for a shortened LOS for some patients, we implemented a 7 day study scheme consisting of two distinct periods: a baseline period and a FWP period (Figure 1). During the baseline period, days 1 to 3, baseline data related to hydration status and fluid intake were collected (Table 3 and 4). During this time, fluid consisted of any form of thickened liquid bolus placed in the patient’s mouth or via alternate means (i.e. PEG tube). The amount of liquid provided by tube feeding remained constant throughout the tracking period and did not impact results of fluid intake.
Day 4 was a transition day used to introduce the FWP. At this time, the attending physician was requested to put in the FWP order in the electronic medical record. Participants were given a green arm bracelet reading “Free Water Protocol” as a visual cue for staff to be aware of free water diet orders. Once initiated, participants could have thin-liquid water in between meals (at least 30 minutes after meals), and in the absence of any other food or beverage. Any other food or snacks outside of meals required a minimum of a mouth rinse with water or the use of low or alcohol-free mouthwash before free water could be again consumed. Additionally, participants were provided with a new, fully filled, 32oz plastic water container. To accurately track the amount of free water intake, only water poured from this measured container would be permitted and calculated. Prescribed thickened liquids were also provided according to normal routines (e.g., on meal trays) or upon patient request. During the FWP period, data related to fluid intake and hydration were collected days 5 to 7.
During the study and throughout the participants’ stay, a strict oral care regimen was followed. This consisted of teeth brushing and a Chlorhexidine rinse at least three times a day as aligned with the [removed for blinding] “Oral Care Protocol” for high-pneumonia-risk patients. Signs related to oral care and free water rules were reviewed and hung above the participants’ beds to reinforce education and compliance across staff, families, and participants.
After day 7, participants remained on the FWP until they were: discharged from the facility; advanced to thin liquids by their primary SLP; or were required to discontinue free water intake due to medical instability. In order to monitor for adverse events, we continued to track participants until the FWP was discontinued.
Outcome Measures and Data Collection
The study focused on several independent and dependent variables for analysis. Independent variables collected included: participant age, diagnosis, and gender. Dependent variables also collected included: incidence of adverse reaction seemingly related to thin liquid water consumption; hydration status; quality of life; and functional swallow ability. To track incidence of adverse reaction, a participant’s medical chart and clinical presentation were monitored daily. This included review of documentation for abnormal lung sounds, white blood cell count, temperatures, and chest x-ray results if requested by the treating physician. Together, these would aggregately suggest aspiration PNA and be written as such in the physician’s daily note.
Hydration status was uniquely tracked by the registered dieticians using several measures over the course of the seven day study period. These consisted of pre- and post-ratings of oral hygiene status (moist, dry, or cracked), urine color (dark or yellow/clear), and laboratory findings for BUN/Cr (either within normal range or not). An overall impression of “dehydrated” would be given if 2 out of 3 measures were deviant from the norm. Fluid intake was also tracked to assess for any substantial changes when on the protocol.
To assess for quality of life changes, we requested each participant fill out the SWAL-QOL scale (Table 5) upon study enrollment, and again when the study ended . The SWAL-QOL is a 44-item questionnaire designed to assess a patient’s perceived satisfaction and challenges in regard to eating using a five point ordinal scale. The lower the sum of scores, the more impactful or difficult swallowing was perceived. If a participant exhibited any visual, reading, or writing deficits that may impact authenticity of responses, the form was read aloud to the participant and responses recorded by the investigator.
The final dependent variable in this study was functional eating ability. We used the FOIS (Table 6), a psychometric tool that assigns numeric values based on an individual’s means and type of nutritional intake . Clinicians gave participants a baseline FOIS score upon study enrollment, a second score upon FWP discontinuation, and a third at LTACH discharge. The FOIS was already being used by the inpatient Speech Therapy department and was available for electronic documentation.
As this was a feasibility study, a power analysis and sample size estimation were not conducted. Collected data was analyzed using GraphPad Prism version 9.1.1 (GraphPad Software, San Diego, CA). Shapiro-Wilk Test was first used to test for normality; if one or both of the datasets in the group failed (p<0.05), nonparametric testing was used. The only normally distributed collected dataset was the total fluid intake volume; paired two-tailed Student’s t-test was used to determine if differences existed between baseline and FWP periods. The rest of the datasets were abnormally distributed and included BUN/Cr, SWAL-QOL, and FOIS. BUN/Cr and SWAL-QOL were analyzed using a Wilcoxon matched-pairs signed rank test to determine if differences existed baseline and FWP periods. The three measurements collected for FOIS were compared using a Kruskal-Wallis analysis of variance (ANOVA) and Dunn’s multiple comparisons test.