ACQ Vol 11 No 1 2009

MULTICULTURALISM AND DYSPHAGIA

reduced cost, as well as the posited health outcomes. We did not want to change clinical practice, however, without the evidence to support these changes. To determine which of two treatments implemented by speech pathologists results in the best outcomes for dysphagic stroke patients who aspirate thin liquids, and to obtain evidence for the relative influence of dysphagia versus thickened fluids on fluid intake and hydration, a randomised control trial (RCT) was designed and ethics approval was sought and granted. Research design and methodology The study was designed as a randomised control trial. This design comprised a treatment group with two treatment conditions and a control group. 1 The treatment group would comprise stroke patients aspirating thin fluids, as determined by clinical assessment and flexible endoscopic evaluation of swallowing (FEES) (Langmore, 2001). The participants in the treatment group would be randomly allocated to one of two treatment conditions, thickened fluids only or thickened fluids plus access to water, as discussed in more detail below. 2 The control group would comprise stroke patients with no evidence of dysphagia experiencing the same institutional and stroke-related conditions. This group was included to allow comparison to the fluid intake and hydration of non-dysphagic stroke patients, a unique feature of this study’s design. This would allow us to determine if the dysphagia rather than other conditions would influence the amount of fluid intake as there is currently no evidence that this population meets average fluid requirements. Participant selection criteria and initial assessment For inclusion in the study, the patient had to have experienced an acute stroke event and be medically stable. Exclusion criteria were specific medical conditions, i.e., neurode­ generative process, neurosurgery, previous head and neck cancer or surgery, tracheostomy, COPD, pneumonia or com­ promised immune status; factors compromising fluid intake or measurement i.e., supplementary non-oral fluid provision or renal failure; and known aspiration of pureed food or thickened fluids. “Aphasia friendly” information sheets and consent forms were used for communication impaired patients (Braunack-Mayer & Hersh, 2001; Kagan & Kimelman, 1995). Presence or absence of aspiration would be confirmed by FEES. All participants would also undergo an initial clinical assessment of swallowing, a 100ml water test (Wu, Chang, Wang, & Lin, 2004) and an oral health assessment (Chalmers, King, Spencer, Wright, & Carter, 2005). Treatment Participants in the treatment group would be prescribed the appropriate thickened fluid consistency and would be randomly allocated to one of two treatment groups. Treatment group 1 would receive traditional management and would be permitted to drink only thickened fluids. They would have free access to these thickened fluids, with a jug at bedside and in the dining room, and staff assistance as necessary. Treatment group 2 would receive thickened fluid plus access to water according to the RAH Free Water Protocol (please contact authors for a copy) which is similar but not identical to the Frazier Water Protocol. Key features of this protocol include access to water but not to any other thin liquids, and preclusion of water at meal times or when taking medication in order to prevent aspiration of food and tablets along with the water. With these restrictions, free access to water and thickened fluids is permitted, with jugs of water and thickened fluids at bedside, thickened fluids in the dining room, and staff assistance or supervision as necessary. One point of difference between the RAH Free Water Protocol and the original Frazier Water Protocol is that the latter explicitly outlines the need for routine oral care.

Procedure For all participants, fluid intake would be recorded daily by nursing and allied health staff on standard daily fluid balance charts, with thin and thickened fluid consumption recorded separately. Chest status would be checked weekly by medical officers. Diagnosis of pneumonia would be based on medical diagnosis confirmed by X-ray. Weekly blood tests would provide urea:creatinine ratio, as an indicator of hydration (Institute of Medicine of the National Academies, 2004). Oral health examinations would also be conducted weekly. Dysphagic participants would complete drink satisfaction surveys when discharged from the study, rating both thick fluids and water. The survey tool is a 5-point Likert scale, and rates factors such as taste, feel in the mouth, thirst, and coughing. All participants would be asked to follow an oral hygiene protocol and record their compliance with this, with nursing support as necessary. The protocol is based on the oral health protocols for residential aged care facilities developed by the South Australian Dental Service and Australian Dental Association (South Australian Dental Service, 2004). Please contact the authors for a copy. Participants without dysphagia would be discharged from the study after 21 days or on discharge from the hospital, whichever occurred earlier. Participants with dysphagia would be discharged from the study when dysphagia for thin fluids resolved or on discharge from the hospital, whichever occurred earlier. Education would be provided to all staff assisting with data collection including nursing, medical and allied health staff. This would be supplemented with written information sheets Consecutive admissions (97 in total) to the Medical Rehabilitation Unit at HRC were screened across a 9-month period. Of these, 31 (32%) did not satisfy the inclusion criteria, 44 (45%) did not consent and 4 (4%) consented but were unable to participate in the FEES. Eighteen (19%) participants were recruited and completed the study. Of these 18 participants, 15 were non-dysphagic controls and 3 were dysphagic. However, on FEES, the three dysphagic par­ ticipants demonstrated airway penetration of thin fluids, but not aspiration. Therefore, none of the recruited participants met the eligibility requirements for the treatment groups. Another 103 stroke admissions were screened at the Royal Adelaide Hospital over 7 months. Of the 28 eligible patients, none were recruited into the study: Patients were too unwell, or overwhelmed by their recent stroke, or excluded because they were receiving non-oral fluid supplements. In summary, recruiting participants was a challenge. Of the 200 patients screened across the two stroke units, only 22 were recruited, and 4 of these withdrew. Many refused consent either because of the invasive nature of the FEES or because they wanted to concentrate on their recovery and rehabilitation without distraction. No recruited patients were eligible for the treatment group, because none were found to be aspirating on objective assessment. Future directions Our intention in embarking on this study was to determine the best outcomes for dysphagic stroke patients who aspirate thin liquids, and to obtain evidence for the relative influence of dysphagia versus thickened fluids on fluid intake and hydration. Unfortunately, because of recruiting difficulties, we have not succeeded in gathering sufficient data to date to draw any conclusive results. We have not given up. We have found the research process rewarding, and we consider the question we are attempting to answer a vital one in our clinical practice. Our study differs from the outcome data collection being conducted elsewhere in Australia in that it is a randomised control trial that will and protocols. The reality

S p eech P athology A ustralia

44