Effect of Structured Pressure Injury Patient Education (SPIPE)

The Effect of Structured Pressure Injury Patient Education Program on Knowledge, Participation, Wound Healing Progress and Quality of Life Among Patient With Limited Mobility

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury; Limitation, Mobility
• Intervention / Treatment: Other: Structured Pressure Injury Patient Education (mySPIPE); Other: Standard Patient Education

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deena C Thomas, MNSc; RN; Phone Number: +60138750362; Email: dnaclare@ums.edu.my

Study Locations

• Malaysia
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Patients in the experimental group will receive structured pressure injury patient education. It is consists of 2 sessions followed by biweekly follow-up for 8-week. The first session lasts for two days; the duration is 80 minutes (40 minutes /day for two days). Method of delivery is face to face, one to one with the aid of PowerPoint presentation and booklet. In the second session, the duration remains the same (80 minutes; 40 minutes/day for 2 days). The method of delivery also the same but teaching aid video presentation will be used. Three videos with a duration of approximately 2 - 3 minutes. In the second session, participants will be given a task to perform and document in the booklet given to monitoring its adherence. Upon completion of the two sessions, the patient will be follow-up biweekly and monitored their progress.	Other: Structured Pressure Injury Patient Education (mySPIPE); It consists of PI education topics which include four main topics; 1) Pressure Injury: Why Me, which will be covering the basic information that patient need to know about PI; 2) Look After Your Skin, in this topics, patient will be thought about how skin checking was done and why it need to be done; 3) Preventing pressure injury, in this topic, patient will be emphasized on the suitable repositioning for them and the benefit of support surfaces and preventive wound dressing; 4) Help your PI heal, in this topic patient will be guided on what are condition that help PI healing and dietary needs to support wound healing
Other: Control group; Patients in this group shall continue with the standard patient education in the ward. Standard patient education routinely delivers through an informal verbal method after wound dressing is done.	Other: Standard Patient Education; No fixed content/ duration of patient education. Basically, patient repositioning emphasized verbally after wound dressing completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge	Pressure Injury Knowledge (%)	8 weeks
Patient Participation	Patient Participation on Pressure Injury Prevention (%)	8 weeks
Wound-healing progress	Pressure injury condition includes size, exudate and tissue type (Score 0 -17). 0 minimum points indicate wound completely heal. Increasing number of score indicate wound condition is worsening. 17 maximum points represents a serious PI with wound area more than 24cm2 of of size, heavy exudate, and non-viable tissue.	8 weeks
Pressure ulcer-specific symptoms and functional outcomes	Pressure ulcer-specific symptoms and functional outcomes is assessed by the Pressure Ulcer Quality of Life (PU-QOL)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of SPIPE on Wound Healing Progress	Effectiveness of SPIPE on Wound Healing Progress at week 4 and week 12. NAME OF MEASUREMENT : Wound Healing Progress; MEASUREMENT TOOL - Checklist : Pressure Ulcer Scale of Healing (PUSH 3.0); UNIT OF MEASURE: Mean difference of PUSH score at baseline (T0) to week 4 (T1), and Mean difference of PUSH score from week 4 (T1) to week 8 (T2). Minimum value = 0, Maximum value = 17; Lower score better outcome.	8 weeks
Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes	Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes at week 4 and week 8. NAME OF MEASUREMENT: Quality of Life; MEASUREMENT TOOL - Questionnaire: Pressure Ulcer Quality of Life (PUQOL); UNIT OF MEASURE: Mean difference of PUQOL at baseline (T0) to week 4 (T1), and Mean difference of PUQOL score from week 4 (T1) to week 8 (T2). Minimum value = 0, Maximum value = 100; Higher score better outcome.	8 weeks
Effectiveness of mySPIPE on PI knowledge	Effectiveness of mySPIPE on PI knowledge at week 4 and week 8. NAME OF MEASUREMENT : PI knowledge; MEASUREMENT TOOL - Questionnaire: Revised Skin-Management Needs Assessment Checklist (Revised SMNaC) ; UNIT OF MEASURE: Mean difference of PI knowledge at baseline (T0) to week 4 (T1), and Mean difference of PI knowledge from week 4 (T1) to week 8 (T2). Minimum value = 10, Maximum value = 100; Higher score better outcome.	8 weeks
Effectiveness of mySPIPE on Patient participation on PI prevention	Effectiveness of mySPIPE on patient participation on PI prevention at week 4 and week 8. NAME OF MEASUREMENT : Patient participation on PI prevention; MEASUREMENT TOOL - Questionnaire: Patient Participation on PI prevention (PPPIP); UNIT OF MEASURE: Mean difference of PPPIP at baseline (T0) to week 4 (T1), and Mean difference of PPPIP from week 4 (T1) to week 8(T2). Minimum value = 12.5, Maximum value = 100; Higher score better outcome.	8 weeks

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Deena C Thomas, MNSc, University of Malaya; Study Director: Chui Ping Lei, PhD, University of Malaya; Study Chair: Abqariyah Yahya, PhD, University of Malaya; Study Chair: Alan Yap Jiann Wen, MSc; MD, Ministry of Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): September 17, 2022
• Study Completion (Actual): September 25, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; patient education; wound healing; structured patient education
• Additional Relevant MeSH Terms: Wounds and Injuries; Crush Injuries; Mobility Limitation
• Other Study ID Numbers: 17033704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IDP sharing plan include a study protocol, statistical analysis plan, and informed consent form
• IPD Sharing Time Frame: October 2021 for 12 months
• IPD Sharing Access Criteria: Access granted upon request via direct email dnaclare@ums.edu.my
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No