In order for proper implementation of the project, study participants, volunteers, and public representatives would have to be identified and recruited. The purpose of recruiting representatives/volunteers are to educate and promote the concept and importance of treatment and prevention of IAD among elderly women in acute care settings. The education and training of these volunteers should be kept as priority before the commencement of the project and the recruitment of study participants.
The volunteers would also act as a mediator between the study team and the scientific committee involved in the conduct of the study. Each volunteer and representative would be provided vital information on the ethical and regulatory aspects of the study. The treatment, assessment, and care of patients in accordance with ethical conduct of research would be communicated with volunteers and representatives.
The primary objective of the volunteers would be to assist the scientific committee and public representatives in enrolling participants and organizing programs, seminars, and social activities for patients affected with IAD. The public representatives would interact with scientific committee team and organize meetings and reviews in order to strategize the enrolment of participants. Thus, the volunteers, public representatives, scientific committee and the study team would work in-line to educate, promote, and conduct the research in an ethical and scientific manner to serve elderly patients affected with IAD.
Analysis
In the past decade, there has been inconsistent evidence on the use of acidic based-pH foam for the treatment of IAD in acute care settings. The most recent evidence on the treatment, management, and prevention of IAD was reviewed and published in 2010. Based on the proceedings of the Global IAD Expert Panel in 2014, a soap cleanser with a pH range similar to that of skin in the form of liquid or foam is recommended for skin protection and moisturisation in IAD patients. A recently published paper also stated the use of zelaic acid foam 15% in the treatment of papulopustular rosacea often observed in patients with IAD. A randomized controlled trial also confirmed the usefulness of an improved absorbent pad for elderly women with IAD. Many scientific proceedings and reviews have confirmed the usefulness of creams, ointments, pastes, lotions, and films in patients with IAD in acute care settings. Based on the current scenario on the treatment and management of IAD among elderly women, only a small number of participants would be recruited for the current study setting.
A randomized controlled trial (RCT) is one of the best methods to derive a conclusive statement for an intervention in comparison to a placebo or standard/conventional intervention (Peduzzi P, et al. 2004). The outcomes of this study would be based on the severity of IAD, quality of life improvement, safety and efficacy of treatment intervention, and the consistency of intervention in terms of improvement. Not more than 30 participants would be recruited for the current study and only 1 study centre would be in-charge for the overall conduct of the study. A hypothesis-driven analysis would be utilized along with student’s t-test for the study. Biostatisticians and a physician would be involved in designing the protocol for the RCT in terms with local regulatory authorities.
Resource Requirement
The resources involving educational grant, investigator compensation, and staff recruitment would be borne by the Leeds teaching Hospital Trust. The research and development department in conjunction with the scientific committee of this study would provide major resources for the study. The major costs associated with the conceptualizing, strategizing, and implementation of the study have been outlined here below:
Capital Equipment: One of the major resources to conduct the study would include (a) Laboratory supplies such as assessment tools, vials, tubes, and other pathological materials (b) Medical record organizer (electronic preferred) (c) SPSS or other high-end statistical software (d) Photograph and external support for image production and storage and (e) Disinfectant and cleansing appliance such as washing machine and dryer
Staff Time: (a) Part-time trained and experienced nurse in catering to elderly women patients with IAD (b) Volunteers and public representatives to coordinate the overall study along with an experienced clinical research coordinator (CRC) (c) Full-time pathologists and examiner to assess all samples of patients at all stages of the study (d) Trial management team for the conduct of the study along with statistician and committee and (e) Principal investigator and photographer along with study team coordinators
Professions of staff support: All staff will undergo good clinical practice training in line with the latest clinical practice/research guidelines as laid by regulatory health authorities. The photographer involved will also be trained and educated on the confidentiality of participants and that under no circumstances would patient identity or visuals be disclosed to a third party.
Treatment costs: In case participants would react to the treatment intervention, the treatment costs would increase due to follow-up and other clinical activities. All expenses would be borne by the sponsor (Leeds Teaching Hospital)
Project running costs: A full-time salary would have to be provided to the primary investigator along with other study team members and professional photographer. Other running costs would include expenses towards IT, data storage, participant reimbursement, administrative support, and dissemination costs such as publications, reports, etc. Additional costs may also be involved with print, photograph, and digital expenses.
Potential sources of funding
The major source for funding would come from the medical research council or any supporting institute/university interested in IAS research.
Medical Research Council: To primarily provide a novel treatment approach for IAD across various healthcare settings
The funding from both parties are dependent on the dissemination strategies such as publication, acknowledgement, authorship, compensation and staff involvement and conflict of interest (if any) during and after the course of the study
Management and research governance
The principal investigator (PI) would be in-charge of the overall study with respect to ethical conduct and overview of clinical operations. The PI would coordinate with the study team in order to communicate and assess activities of the study. The primary duties of each team member involved in the study would be overlooked by the PI including the safety of patients throughout the study. The PI would be solely responsible for any misconduct during or after the study completion.
The nursing staff and other healthcare professional involved in the care and assessment of participants would be trained, educated and overlooked by the PI. A trial management file would be maintained in order to assess and supervise the task of each member involved in the study. The research study group would also take into account the IT infrastructure involved in the study such as digital platforms, photographs, and print with respect to patient confidentiality and (HIPPA) Health Insurance Portability and Accountability Act of 1996.
The overall study would not take more than 2 years including post-assessment and follow-up visits based on the current protocol for the treatment and management of IAD in elderly women in acute care settings with acidic based-pH foam cleanser. The overall study would compromise of the following stages:
Figure 1: Gannt Chart for proposed project
Dissemination and implementation
The study completion results would be disclosed for public on the institutional website and the grant or main funder’s website. The results would be acknowledged by an autonomous scientific expert committee and reviewed for publication in a journal of repute. The same paper would also be reviewed by the medical council for research in accordance with fair publication and non-biased clinical information.
Both interventions would be closely assessed and identified for any potential intra-study bias or discrepancies. Prior to publication of the paper, a review of current research and publications would be made in order to assess the similarity or potential use of the scientific research conducted. The authorship of the publication would be given to the PI and other subordinate staff involved directly from implementation to dissemination of the results of the study. All study participants would also be assessed 6 months and 9 months after the study to assess any long-term effects of the intervention. The results of the study would also be showcased in scientific meetings, seminars, consensus meets, expert panel reviews, hospital-based training institutes, and scientific bodies. Some of the key barriers identified upon literature search include poor to fair recommendations for acidic-based pH foam cleansers for IAD. Furthermore, many conventional and proven treatment interventions are available compared to acidic skin-safe foam for IAD.
Upon successful publication and study participant follow-up, the results of the study would help researchers further investigate on the treatment intervention. Large scale studies would be conducted in the future in order to assess the potential value of the acidic based pH foam for IAD in elderly women.
References
Doughty D, et al. Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012 May-Jun;39(3):303-15; quiz 316-7.
Draelos ZD, et al. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015 Jul;96(1):54-61.
Sugama, Junko et al. Efficacy of an Improved Absorbent Pad on Incontinence-Associated Dermatitis in Older Women: Cluster Randomized Controlled Trial. BMC Geriatrics 12 (2012): 22.
Beeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence associated dermatitis: moving prevention forward. Wounds International 2015.
Peduzzi P, et al. Analysis of randomized controlled trials. Epidemiol Rev. 2002;24(1):26-38.
