BackBone Turning Wedge – A new design to support a person in a 30 degree side turned position Effectiveness Trial Proposal
1. Trial Abstract.
This Trial is to evaluate the effectiveness of an alternative wedge design for the support of a supine laying person in a 30 degrees turned position. The goal of the support wedge is to alleviate direct pressure to the sacral/coccyx area of a patient in a 30 degree turned position while supporting the patient comfortably in an ergonomically correct position. The wedge will also be evaluated for its effectiveness in maintaining correct position and support for an extended period of at least 1 hour, without slipping out of position or bottoming out.
The hypothesis for this study is that, when compared to a typical and standard turning wedge, this new turning wedge has unique design elements that make it more effective at alleviating pressure, including direct contact pressure, from the spinal column, especially the sacral/coccyx area. The wedge is also more effective at maintaining correct position and support for an extended period of time and is less likely to slip out of place than a standard wedge design. The wedge design is such that it is also less likely to bottom out than standard pillows, which are another device currently being used for this purpose as standard nursing practice.
The wedge design will be tested under a comparative case study design, in where a specified group of patients in an acute or long term care setting who present with low mobility scores, and therefore are at higher risk for pressure ulcer development as defined by low braden score, will be supported by both the standard wedge and the backbone turning wedge.
To test the hypothesis, the investigator will evaluate performance of the wedge compared device(s) currently being used as standard of practice; standard pillows and a straight angled wedge. Each device will be measured for is ability to;
1. Minimize direct contact with the sacral/coccyx area
2. Support the subject in a side turned position for an extended period of time
3. Stay in position without slipping out of place or bottoming out such that the subjects sacral/coccyx area receives direct contact.
Potential benefits from this study include the identification of a superior design for supporting a person in a side lying turned position. A device that is more effective in supporting a person without direct contact to the sacral/coccyx area can significantly reduce pressure, and therefore can make a significant contribution to efforts to reduce incidence and prevalence of pressure ulcers, both by reducing pain and suffering and also by helping to significantly reduce healthcare costs.
Since the wedge is designed using similar materials and methods as existing equipment used for the same purpose, there is minimal risk to the patient. Risks associated with incorrect device(s) placement or the device(s) being ineffective at maintaining correct position or pressure relief as hypothesized is equivalent to each device(s) being tested, thus there is minimal direct risk, and no new risk identifiable. Participation is voluntary as outlined below. The investigator is a registered nurse and is therefore qualified to identify potential harm and is ethically and professionally bound by the credentials of her license to intervene to prevent any potential harm. If an unforeseen risk to subject safety related to this study becomes apparent, the study will be discontinued.
2. Statement of Purpose and Background.
Approximately 45% of all pressure ulcers occur at the sacral/coccyx area. There is wide variability of reported incidence and prevalence rates depending on facility type and region. Although occurrence is related to numerous risk factors and variables, all pressure ulcers have in common that they occur where there is excessive, unrelieved pressure to the affected area.
The process of alleviating pressure to the sacral/coccyx area has proven particularly problematic for the healthcare industry. Current best practice protocols dictate that an at risk patient should be “turned” 30 degrees from side to side while in bed in order to alleviate pressure to the vulnerable sacral/coccyx area. Although sound in principle, this protocol is difficult to achieve in practice. The turning process itself is labor intensive and ergonomically risky for healthcare workers, often requiring at least 2 caregivers at a time to move the patient at the recommended 2 to 4 hour intervals. The most common device used to achieve support at 30 degrees to the side is the standard pillow, a device not specifically designed for this purpose. Although adequate for a short period, pillows tend to “bottom out” or fail to provide adequate “lift” off the sensitive sacral/coccyx area, and little or no true pressure relief is actually achieved. A foam wedge is designed for this purpose and is angled specially to 30 degrees on one side per protocol. But although it is possible to set a foam wedge to support at 30 degrees, it comes with the significant challenge of staying in place. As the wedge is placed to the patients’ side, her body weight places a constant lateral force to the wedge, and it does eventually (and often quickly) slip out to the side, causing the patient to return to the vulnerable pressure area. Additionally, the industry standard wedge designed for this purpose can apply direct contact pressure to the sacral area when placed correctly under the patient, without providing support under the hip. Additional costs are incurred by the healthcare facility when, despite excessive labor effort and time expenditure, a patient is unable to recover from, or worse, develops a costly pressure ulcer. Although pressure ulcer treatment methods may vary from clinician to clinician, all will agree that pressure alleviation is foremost to any prevention strategy.
The purpose of the study is to test a modified support wedge design for its effectiveness as a pressure relief and support device. The wedge has a particular contoured shape designed to avoid direct contact with the sacral/coccyx area and is angled so as to stay under a patient and not slip out of place. This study will test if this design and angle can result in a more comfortable, ergonomically correct support without slipping out of place and is able support for extended periods of time without direct contact pressure to the sacral/coccyx area.
- Subject characteristics: The participants in the study will include patients with a low Braden score of < 12 or with mobility impairment score of 2 or less who require frequent turning as a pressure ulcer preventative measure. Subjects may or may not currently present with a sacral or coccyx pressure ulcer.
- Selection Criteria: The subjects of this study will be purposefully chosen based on the subject characteristics as described above. The investigator will assess criteria for inclusion on the day of study.
- Recruitment Methods: The subjects of this study will be identified and recruited by the investigator specifically because they meet the selection criteria as outlined above. Subjects will be asked directly to participate. Subjects will receive a complete explanation of the wedge and compared the differences between the two prior to participation. Subject will be informed that they are not obligated to participate, that is, they are not obligated to let us use the trial wedge to support them to a turned position, and may opt for the standard, typical wedge instead. Subjects will also be that medical care treatment or decisions will not be affected in any way by this study.
- Informed Consent Process: Informed consent will be obtained verbally. All participants will be informed that they have the right to refuse use of the trail turning wedge without consequence, and that they may choose to remove themselves from participation at any time. If participants are unable to provide verbal consent, the legal guardian may provide verbal consent under the same criteria. Participants may be informed that the activity of turning is an essential medical intervention and is not itself the subject of study, only the device being used to support them. They will be informed that the cushion is not considered or claim to be a medical device, nor can it, or any one wedge or pillow, serve in and of itself only to be a definitive prevention or cure for pressure ulcers.
- Subject Privacy and Confidentiality: No patient identification data will be recorded. Medical record number will not be recorded. Each participating subject will be assigned a random subject number for the purposes of data collection. All data results will be recorded on separate documents by subject number only.
- Study Location: Subjects will participate in this research on the specified unit only. Data collection will be done at the bedside by a nurse investigator. Data storage and processing will be conducted off site using only subject code number as identifier. Participants outside the study will not have access to study data. Electronic data collection records must not contain any PHI.
- Potential Problems: Problems involving subject identification and recruitment are not expected. Subjects or persons involved in subjects’ healthcare (other than assigned nurse) may choose to withdrawal from the study at any time. In all such cases if/when subject or persons involved in subjects’ healthcare perceive suboptimal care or wish to withdrawal from participation, the investigator will immediately cease testing and remove the subject from the study. All records of participation of said subject will be destroyed. Problems with data collection may occur related to variables outside of investigator control.
4. Research Design and Method.
Research Design: To test the hypothesis that the wedge successfully achieves minimal direct contact with the sacral/coccyx area and can maintain positional support in a turned to 30 degree position more effectively for a longer period of time than devices currently being employed without slipping out of place, bottoming out or patient shifting off the device. The following process will be employed.
Performance data will be collected by the primary RN investigator. In addition, caregivers who participate in using the wedge will be asked to complete a satisfaction survey. Performance and satisfaction scores will be charted.
Effectiveness of the wedge design will measured by comparison to the turning wedge devices that are currently routinely used for the purpose of turning and supporting a subject at a 30 degree angle. The current standard foam wedge designed for this purpose and cut at an angle of 90 x 60 x 30 degrees, and has a friction bottom on the cover. The new turning wedge and the standard wedge devices will be evaluated for effectiveness and scored against each other for comparison.
Per standard best practice protocols and procedures, each device(s) will be employed under the subject for the period of 4 hours. Testing will be done in succession and will be declared complete for that subject after both device(s) have been tested for 4 hours. Data will be collected with each device at start, and each 1/2 hour afterward as described below. After completion of the testing interval, the subject will be turned to the alternating side, using the next support.
The investigator must initiate the start of device testing by requesting that the caregiver(s) assigned to the patients care assist to turn and support the subject using only the device being tested. The investigator may not assist or make any placement recommendations to the caregiver(s) in any way with initial placement or subsequent positioning manipulation of the subject or the device during the testing period. In no way may the investigator discuss the subjects’ nursing care with any caregiver during the testing period, unless a safety hazard to the patient occurs. The investigator must observe the patient at all times during the testing period, but will stand outside of the subjects’ view so as to minimize subject and caregiver behavior bias. The investigator is ethically obligated and committed to intervene if she perceives any situation that poses a threat to the subjects’ safety. Any intervention by the investigator constitutes an end to the testing period.
Testing will continue during natural patient movement and caregiver interventions. Any adjustments or manipulation of the support wedges, whether done by the patient, family or caregiver, will be recorded. The device being moved in order to provide nursing care does not constitute a rejection of the device unless it is not re-employed after care is completed. Assisted adjustments to patients position may include but is not limited to boost, re-turn, movement in order to provide pericare and assisting to sitting or standing position. Raising or lowering the head of the bed will not constitute an end to the test period. Caregiver assisted movement of the lower extremities will not constitute an end to the testing period. If the testing period must be ended before the 4 hour interval has transpired for some reason, the investigator may choose to start another test period using the same device(s) or begin with another device per her discretion.
b. Data collection
There will be 3 primary measures for data collection. i. Subject position, ii Direct contact between the sacral/coccyx area and the bed, and iii Direct contact between the sacral/coccyx area and the device(s). Each data point will be measured at initial placement and at 30 minute intervals thereafter up to 4 hours or end of test period, whichever comes first. Each primary measurement point will be rated with a score ranging from a score of 3 being the highest possible score, to 0 being the lowest possible score. Two photographic images will be taken at each interval for the purpose of documentation and evaluation. The photograph images will be taken from the foot of the bed and the side of bed depicting the device(s) relevant to the sacral/coccyx area. All photographs will not include the subjects head or any other PHI detail that may compromise subject confidentiality..
Sample size plans 10 subjects initially. Results may be evaluated and used to modify the new design for any needed and appropriate improvements to study design. Additional subjects may be necessary.
i. Subject position: The device(s) ability to maintain the subject in the intended position will be evaluated by approximating the tilt angle caused by and supported by the device(s) being tested. That is; does the device(s) support the subject at an angle so that neither the sacral/coccyx area nor the greater trochanter area are in direct contact with the bed (approx 30 degrees). Since exact tilt angle measurement is not feasible, tilt angle will be approximated based on the subjects’ hip position relevant to the bed. The closer the hips are to flat on the bed, the less effective the device is at maintaining intended position. The device(s) effectiveness will be scored as follows; Effective position will exist when the hips are at 30 degrees’ angle from the bed (score of 3), partially effective position will exist when angles are less than 30 degrees but greater than 15 degrees (score of 2), minimally effective position will exist when hip angles are between 15 and 5 degrees (score of 1) and ineffective position will exist when the hip (and thus sacral/coccyx area) is flat on the bed (score of 0).
ii. Direct contact between the sacral/coccyx area and the bed: The device(s) effectiveness at avoiding direct contact between the sacral/coccyx area and the bed will be assessed at each interval. Assessment of direct contact between the sacral/coccyx area and the bed is likely possible at initial placement. When visibility of the sacral/coccyx area is not possible, direct contact with be deduced based on the subjects’ hip position relevant to the bed. The closer the hips are to flat on the bed, the more direct contact exists between the sacral/coccyx area and the bed. The device(s) effectiveness at preventing direct contact between the sacral/coccyx area and the bed will be scored as follows: No direct contact will exist when the hips are at 30 degrees’ angle from the bed (score of 3), partial contact will exist when angles are less than 30 degrees but greater than 15 degrees (score of 2), most contact will exist at hip angles less than 15 degrees but not flat (score of 1), and total contact will exist when hips are flat upon the bed (score of 0).
iii. Direct contact between the sacral/coccyx area and the device(s). Any direct contact of a device(s) to the sacral/coccyx area constitutes direct pressure. Assessment of direct contact between the sacral/coccyx area and the device(s) is likely possible at initial placement. When visibility of the device and sacral/coccyx area is not possible, direct contact with be deduced based on the subjects’ sacral/coccyx area relevant to the device(s). The device(s) effectiveness at preventing direct contact between the sacral/coccyx area and the device will be scored as follows: 1. No direct contact between sacral/coccyx area and device (Score of 3). Minimal contact between sacral/coccyx area and device less than 50% (Score of 2). Direct contact of entire sacral/coccyx area by device (Score of 1). with device and 3. If the device(s) have shifted or bottomed out such that positional support is no longer maintained the score will be 0.
c. Post test evaluations:
Subjects: A post trial interview of each subject will be conducted where possible. The subject will be asked for feedback regarding what they like or don’t like about each device (s). Subject opinion will be solicited regarding which device (s) they found the most comfortable overall and especially if they can perceive which device relieved the pressure to the sacral/coccyx area most effectively.
Caregivers: Caregivers will be asked to complete a voluntary and anonymous satisfaction survey. Any caregiver who has used the new device will be welcomed to complete the survey. will be asked to evaluate the new wedge device based on the above criteria and if he/she has an opinion about which device (s) provided the best ease and convenience of use, and which device(s) in the caregivers’ opinion is most effective overall.
5. Potential Benefits.
Initially, there is a direct benefit to subjects in that they will receive turn therapy at regular intervals. The more frequent than standard of practice and will result in improved pressure relief, at least for the duration of testing period. Going forward, the study will raise caregiver awareness of correct application of support devices and clarify criteria for effective positioning, especially reduced contact to the sacral/coccyx area. The improved awareness and knowledge will serve to enhance the skills and the practice of pressure ulcer prevention.
The most significant benefit of this study is to identify and create a support design that is more effective for supporting a person in a side lying turned position without direct contact to the sacral/coccyx area. A device that is more effective in supporting a person without direct contact to the sacral/coccyx area could make a significant contribution to efforts to reduce incidence and prevalence of pressure ulcers, both by reducing pain and suffering and also by helping to significantly reduce healthcare costs.
The research involves no more than minimal risk to the subjects. Testing is non-invasive and standard bedside care protocols are not compromised. In no way does this trial adversely affect the rights and welfare of the subjects.Since the wedge is designed using similar materials and methods as existing equipment used for the same purpose, there is minimal risk to the subject. Risks associated with incorrect device(s) placement or the device(s) being ineffective at maintaining correct position or pressure relief as hypothesized is equivalent with each device(s) being tested. Participation is voluntary. Participation is non-invasive. The investigator will be present during the entire study period and is legally responsible to intervene immediately if subject safety appears compromised. If an unforeseen risk to subject safety becomes apparent, the study will be discontinued.
The investigator plans to report results in the form of case study and poster presentations. Data may be used in lectures or training composed by the investigator. All subject information will remain confidential.
The subjects of this study will not incur any costs as a result of their participation. The participating facility will not incur any of the costs associated with production of materials , supplies or labor associated with this study. Caregiver labor and time is not affected by this study as there is no change in practice protocol, only the equipment being used.
8. Compensation and Incentives.
There will be no compensation or incentives offered to subjects for participation in this study. There will be no compensation or incentives offered to the participating facility for involvement in this research project. There are no rights or privileges to the new device design granted to participating subject or facility.