Clinical trial NCT04944186: Effect of Structured Pressure Injury Patient Education
Official title: The Effect of Structured Pressure Injury Patient Education Program on Knowledge, Participation, Wound Healing Progress and Quality of Life Among Patient With Limited Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Limitation, Mobility
Keywords: patient education
structured patient education
wound healing
quality of life
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective quasi-experimental study
Primary purpose: PREVENTION

Brief summary: This study was planned as a prospective quasi-experimental study with the control group to determine the effect of structured pressure injury patient education (program on the knowledge, participation, wound healing progress, and quality of life among patients with limited mobility. We hypothesized that there would be a significant effect of structured pressure injury patient education on patient's knowledge, participation, wound healing rate, and quality of life between the control and intervention group over time.

Detailed description: Patients with limited mobility and pressure injury are always at higher risk of having multiple functional, social, psychological, and financial repercussions. Without intensive PI management and prevention, these populations continue to suffer from prolonged pain, infection, social isolation, and exacerbation of mental health conditions.

While many preventive strategies and management are available to ease patient burden due to pressure injury, involving patient to take part in their care make a huge difference in patient outcome. In Malaysia, nurses play an important role in providing patient education on pressure injury, usually delivered through informal routine care, by distributing information leaflet or via digital resources on the Ministry of Health's website. However, the existing pressure injury education content is too broad, only emphasizing pressure injury prevention and no information on pressure injury care.

Few pieces of evidence reported on the effectiveness of patient education were able to improve patient knowledge on PI, increase patient participation in PI care associate with wound healing and improve the quality of life. However, there is a content gap in pressure injury patient education, which is wound care. While there a lot of patient education on pressure injury had been conducted extensively in the literature review, the components of wound care in pressure injury patient education are still unclear. Thus the primary objective of this study is to identify the effect of structured pressure injury patient education on the knowledge, participation, wound healing progress, and quality of life among patients with limited mobility. We hypothesized that there would be a significant effect of structured pressure injury patient education compared to the standard patient education on patient's knowledge, participation, wound healing rate, and quality of life between control and intervention group over time.

To achieve this research objective, we opt to conduct a quasi-experimental study-calculation of sample size is by using STATA 12.0 program. To calculate the sample size, power at 80%, and alpha was pre-set at 0.05. Mean, and standard deviation (σ) were extracted from previous researcher. Based on the calculation, a total of 120 eligible samples will be recruited with 60 samples each arm.

The patients included in the study will be assigned to the experimental group (structured pressure injury patient education) and control group (standard patient education). Eight medical-surgical wards including rehabilitation ward with a high prevalence of pressure injury were identified and invited to participate. Four wards agreed (medical ward, two multidisciplinary wards, and orthopedic ward), and the rest unable to participates because allocated as active COVID-19 ward. Thus, potential participants for this study will be recruited in these four wards in this tertiary hospital. The process of data collection will be started with control group first and followed by intervention group. Considering the limited availability of the target population set in the inclusion criteria earlier, the researcher opts to use convenience sampling.

For the implementation of the study, permission was obtained from the Medical Research Ethical Committee of the Malaysian Ministry of Health. The patient included in the study sample will be informed before the study that the study's purpose and participation are voluntary, and the patient may withdraw at any time without penalties.

Data collection tools; In this study, a checklist and structured questionnaires will be used to measure the four outcomes of this research which are 1) knowledge, 2) participation, 3) wound healing progress, and 4) quality of life.

Personal Information Checklist:

Checklists consist of three parts: part I- patient health status, part II: Wound Healing Progress (PUSH Tool 3.0), and part III- Nutritional Assessment (MNA-SF). This checklist will be filled up by the wound care nurse at baseline (T0), week-4 (T1), and week-8 (T2). The wound care nurse will be given a briefing and manual on how to fill-up the form. The wound care nurse responsible for filling up the required checklist is not aware of the study hypothesis.

Part I: Patient health status - patient's registration ID, gender, ward, IC number, age, comorbidities, PI categories, and PI site.

Part II: Wound Healing Progress (PUSH Tools 3.0) - to measure PI healing progress. The total score will be ranging between 0 to 17, lower PUSH tools 3.0 indicate better-wound healing progress.

Part II: Nutritional Status (MNA-SF) - to determine the patient's current nutritional status. It is further be classified into three categories: normal nutritional status (12-14 points), at risk of malnutrition (8-11 points), and malnourished (0 - 7 points). Measure once at baseline.

Questionnaires Part I: Sociodemographic - sociodemographic characteristics, including seven components: age, socio-economic status, gender, level of education level, ethnicity, occupation, and marital status.

Part II: Knowledge on Prevention and Treatment on Pressure Injury - use to self-assess basic knowledge of the prevention and treatment of pressure injury using Skin-Management Needs Assessment Checklist. The total score is expressed as a percentage and interpreted as a higher score reflecting better knowledge.

Part III: Patient Participation - self-administered questionnaire by which patient will self-rate their active participation based on the given items. The total score is expressed as a percentage and interpreted as a higher score reflecting greater participation.

Part IV: Quality of Life - PU-QOL questionnaire is a PI-specific questionnaire that measuring how much does the occurrence of PI bothers their life. Scale scores are generated by summing items and then transforming them to a 0-100 scale. High scores indicate more excellent patient bother.

Descriptive analysis The sociodemographic data of the patient will be described as frequencies and percentages for categorical data; mean and standard deviation for continuous data. Descriptive analysis was used to estimate the score of each outcome (patient's knowledge, participation, wound healing progress, and quality of life). The Chi-square test was used to test the crude associations for categorical data. Comparison between two groups of continuous variables will be made using an independent t-test. All analysis will be conducted at a 5% significant level.

Analysis of efficacy The effectiveness of the intervention will be assessed using repeated measure analysis of covariance (ANCOVA), modeling the within-subject effects. Model fit will be determined using residual plots and lack-of-fit tests. The effect sizes of the ANCOVA will be interpreted according to Cohen (a partial η2 of .01 can be considered a small effect, a partial η2 of .06 can be considered a medium effect, and a partial η2 of .14 can be considered a significant effect).

Potential risk, benefit, and patient's safety All potential participants will be ensured that patient safety will be the priority upon conducting this study. Participation in this study will not affect their treatment, and the risk is very minimal. They are free to decline to answer any of the questions that they feel uncomfortable with. The benefit of the study may vary, as reported in previous research. However, the information obtained from this study will help the patient to gain more understanding on pressure injury, how to prevent pressure injury in the future from getting worse, and knowledge on pressure injury care. A booklet on pressure injury education as education material will also be provided to patients in both control and intervention groups for future references.

Eligibility criteria: Inclusion Criteria:

* Patient must be literate in either Malay or English language.
* Patients with PI stage II or stage III according to NPIAP staging of PI.
* PI located either at sacrococcygeal / greater trochanter/ischial tuberosities.
* Braden score 18 or less; with limited mobility
* Absence of any active malignant, hematological problem or psychiatric disease

Exclusion Criteria:

* Immunocompromised
* Having urinary/fecal incontinence
* Comatose patient or who are unable to respond verbally and cognitively impaired
* Patient who will undergo flap or skin graft surgery

Primary outcomes:
measure: Knowledge
timeFrame: 8 weeks
measure: Patient Participation
timeFrame: 8 weeks
measure: Wound-healing progress
timeFrame: 8 weeks
measure: Pressure ulcer-specific symptoms and functional outcomes
timeFrame: 8 weeks
Secondary outcomes:
measure: Effectiveness of mySPIPE on PI knowledge
timeFrame: 8 weeks
measure: Effectiveness of mySPIPE on Patient participation on PI prevention
timeFrame: 8 weeks
measure: Effectiveness of SPIPE on Wound Healing Progress
timeFrame: 8 weeks
measure: Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital
state: Sabah
Study officials:
affiliation: University of Malaya
name: Deena C Thomas, MNSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Chui Ping Lei, PhD
role: STUDY_DIRECTOR
affiliation: University of Malaya
name: Abqariyah Yahya, PhD
role: STUDY_CHAIR
affiliation: Ministry of Health
name: Alan Yap Jiann Wen, MSc; MD
role: STUDY_CHAIR
References:
citation: Chaboyer W, Bucknall T, Webster J, McInnes E, Banks M, Wallis M, Gillespie BM, Whitty JA, Thalib L, Roberts S, Cullum N. INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial. Int J Nurs Stud. 2015 Nov;52(11):1659-68. doi: 10.1016/j.ijnurstu.2015.04.018. Epub 2015 May 11.
citation: Chaboyer W, Bucknall T, Webster J, McInnes E, Gillespie BM, Banks M, Whitty JA, Thalib L, Roberts S, Tallott M, Cullum N, Wallis M. The effect of a patient centred care bundle intervention on pressure ulcer incidence (INTACT): A cluster randomised trial. Int J Nurs Stud. 2016 Dec;64:63-71. doi: 10.1016/j.ijnurstu.2016.09.015. Epub 2016 Sep 23.
citation: Robineau S, Nicolas B, Mathieu L, Durufle A, Leblong E, Fraudet B, Gelis A, Gallien P. Assessing the impact of a patient education programme on pressure ulcer prevention in patients with spinal cord injuries. J Tissue Viability. 2019 Nov;28(4):167-172. doi: 10.1016/j.jtv.2019.06.001. Epub 2019 Jun 22.
citation: Kim JY, Cho E. Evaluation of a self-efficacy enhancement program to prevent pressure ulcers in patients with a spinal cord injury. Jpn J Nurs Sci. 2017 Jan;14(1):76-86. doi: 10.1111/jjns.12136. Epub 2016 Jul 7.
citation: Arora M, Harvey LA, Glinsky JV, Chhabra HS, Hossain S, Arumugam N, Bedi PK, Lavrencic L, Hayes AJ, Cameron ID. Telephone-based management of pressure ulcers in people with spinal cord injury in low- and middle-income countries: a randomised controlled trial. Spinal Cord. 2017 Feb;55(2):141-147. doi: 10.1038/sc.2016.163. Epub 2016 Dec 20.