Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries.

Malnutrition Clinical Trial

— INCA  

Official title:

Individualized Nutritional Care Bundle for Home Nursing Patients With Pressure Injuries - A Cluster-Randomized, Pragmatic Clinical Trial and Economic Evaluation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078488
• Other study ID #: INCA
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Changi General Hospital
• Contact: Alvin Wong, MSc
• Phone: (65)64268775
• Email: alvin_wong[@]cgh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective:

To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore.

Study Design:

A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis.

Location/ Setting:

Community

Participants:

Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable).

190 subjects per arm

Intervention:

The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care.

The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation.

Outcome Measures:

Main outcomes of wound area reduction, and proportion of participants with >40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions.

Economic Evaluation:

The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year.

Statistical Analyses:

Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model.

Hypothesis:

This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.

Description:

Intervention:

• Individualized nutritional intervention

• receive an educational pamphlet on nutritional and wound care for patient/family based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline", with an in-depth explanation by trained nursing staff and research dietitian.

• reinforcement of nutritional education (adequate calories/ protein/fluid intake, and compliance to consumption of supplements) by nurses on visits without dietitian.

• A dietetic consultation at baseline, 30 days, 60 days and 90 days of the intervention will be done by an experienced and trained dietitian on optimizing nutritional intake to meet energy/protein requirements. The dietetic consultation will be done via face-to-face home visits and/or teleconsultation (depending on patient and caregiver preference).

• additional high protein high energy (HPHE) supplementation (commercial ready-to-drink oral nutritional supplements, which are available in hospitals, pharmacies and retail outlets) prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d).

• a specialized nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding for 12 weeks (14 serves per week).

• adjustment of enteral feeding regimen will be made for those patients who have not seen a dietitian previously in their last hospital admission.

• Compliance to supplementation will be determined by recording the amount of leftover products by individuals / caregivers and confirmation of intake with the caregiver / family member during the dietitian or nursing visit at 30-day, 60-day and 90-day period.

Control:

• protocolized nutritional intervention

• receive an educational pamphlet on nutritional and wound care for patient/family based on the latest nursing and nutritional guidelines, with an in-depth explanation by trained nursing staff. The trained nurses will provide reinforcement of nutritional education on planned visits as per usual practice over the 90 days.

• Standard care and follow-up as per hospital care plans with dietitian/home nursing foundation calling hospital dietitian-in-charge of subject if necessary, for verbal advice as per usual practice.

• HPHE supplementation (commercial standard ready-to-drink oral nutritional supplements available in pharmacy) / dietary advice to meet nutritional requirements will be based on previous recommendations from hospital dietitian-in-charge/clinician review of subject.

Primary Outcome Measurements

1. Change in Pressure Injury Area from Baseline: Measurement of the alteration in the surface area of the identified pressure injury (PI) at time points of 30, 60, 90 days, 6 months and 1 year post-intervention.

2. Proportion of Participants with 40% or Greater Area Reduction: Calculation of the percentage of participants who exhibit a reduction in the PI area by at least 40% at the same time points.

Secondary Outcome Measurements

1. Proportion with Increased Severity in Pressure Injury Stages

2. Proportion with Complete Pressure Injury Healing

3. Proportion with Improvement in Health-Related Quality of Life (HRQOL)

4. Proportion with Nutritional Status Improvement

5. Change in HRQOL (EQ-5D-5L Utility Values and VAS)

6. Incidence of New Pressure Injury

7. Incidence of Pressure Injury Wound Infections

8. Mortality Rate

9. Unplanned Hospital Admissions and Length of Stay

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Adult (age more than or equal to 21 years, any gender).

2. Stage II, III, IV, and unstageable pressure injuries. For patients with multiple wounds, we will include all the pressure injuries (stages II and above) in the investigation.

3. Able to provide written informed consent (patient or legal guardian).

4. Be on oral and/or enteral nutritional support.

Exclusion Criteria:

1. Known palliative care individuals with a lifespan of </= 3 months,

2. Known septicaemia,

3. Poorly controlled diabetes (glycated haemoglobin level > 8.5%17),

4. Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:

1. Advanced renal disease not on dialysis (KDIGO [21, 22] Stage G4 with an estimared Glomerular Filtration Rate (eGFR) of 15-29 ml/min/1.73m2 and Stage G5 with an eGFR less than 15 ml/min/1.73m2

2. Advanced decompensated alcoholic and non-alcoholic liver cirrhosis

3. Heart failure with reduced ejection fraction requiring fluid restriction less than 800ml per day,

6. Previous (last chemotherapy or radiotherapy less than one year ago) or current neoplastic disease 7. Currently on immunosuppressive therapy, 8. Known allergy reaction to L-arginine, phenylketonuria 9. Presence of an infected wound (if it is the only pressure injury present on the participant) 10. Presence of untreated diagnosed osteomyelitis.

Related Conditions & MeSH terms

• Crush Injuries
• Malnutrition
• Nurse's Role
• Nutritional Deficiency
• Wound Healing Delayed
• Wounds and Injuries

Intervention

Other:
• Individualized and Protocolized Nutritional Care Bundle
Education on nutritional and wound care for patient/family based on the latest guidelines based on the "The European Pressure Ulcer Advisory Panel, the National Pressure Injury Advisory Panel, and the Pan Pacific Pressure Injury Alliance Prevention and Treatment of Pressure Ulcers/Injuries: 2019 Clinical Practice Guideline". A dietetic consultation at baseline, week 4 and week 8 on optimizing nutritional intake to meet caloric/protein requirements, along with additional high protein high energy (HPHE) supplementation prescribed for those participants who do not meet nutritional requirements (25-35kcal/kg/d and 1.2-2.0g protein/kg/d). The dietetic consultation will be done via face-to-face home visits and/or telehealth. A specialised nutritional supplement containing 4.5 g Arginine, 156 mg Vitamin C, 40.9 mg alpha-tocopherol equivalents (Vitamin E), 30 kcal will be administered twice a day via oral ingestion or tube feeding (mixed in 100ml water) for 12 weeks.
• Optimized Standard Care
Only receiving education and management from specialized nurses trained in nutritional management , with or without supplementation

Locations

Country	Name	City	State
Singapore	Home Nursing Foundation	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Changi General Hospital	Duke-NUS Graduate Medical School, Home Nursing Foundation (HNF), Temasek Foundation

Country where clinical trial is conducted

Singapore, 

References & Publications (14)

Cereda E, Klersy C, Andreola M, Pisati R, Schols JM, Caccialanza R, D'Andrea F; OligoElement Sore Trial (OEST) Study Group. Cost-effectiveness of a disease-specific oral nutritional support for pressure ulcer healing. Clin Nutr. 2017 Feb;36(1):246-252. doi: 10.1016/j.clnu.2015.11.012. Epub 2015 Dec 2. — View Citation

Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964. — View 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. — View Citation

European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel, and Pan Pacific Pressure Injury Alliance, Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide., E. Haesler, Editor. 2019

Goh OQ, Ganesan G, Graves N, Ng YZ, Harding K, Tan KB. Incidence of chronic wounds in Singapore, a multiethnic Asian country, between 2000 and 2017: a retrospective cohort study using a nationwide claims database. BMJ Open. 2020 Sep 25;10(9):e039411. doi: 10.1136/bmjopen-2020-039411. — View Citation

Graves, N. and H. Zheng, The prevalence and incidence of chronic wounds: a literature review. Wound Practice & Research: Journal of the Australian Wound Management Association, 2014. 22(1): p. 4-12

Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S; CHEERS 2022 ISPOR Good Research Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations. Value Health. 2022 Jan;25(1):3-9. doi: 10.1016/j.jval.2021.11.1351. — View Citation

Langer G, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD003216. doi: 10.1002/14651858.CD003216.pub2. — View Citation

Lo ZJ, Lim X, Eng D, Car J, Hong Q, Yong E, Zhang L, Chandrasekar S, Tan GWL, Chan YM, Sim SC, Oei CW, Zhang X, Dharmawan A, Ng YZ, Harding K, Upton Z, Yap CW, Heng BH. Clinical and economic burden of wound care in the tropics: a 5-year institutional population health review. Int Wound J. 2020 Jun;17(3):790-803. doi: 10.1111/iwj.13333. Epub 2020 Mar 9. — View Citation

Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad. — View Citation

Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12195. Erratum In: JAMA. 2016 Nov 8;316(18):1924. — View Citation

Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259. — View Citation

Wong A, Goh G, Banks MD, Bauer JD. Economic Evaluation of Nutrition Support in the Prevention and Treatment of Pressure Ulcers in Acute and Chronic Care Settings: A Systematic Review. JPEN J Parenter Enteral Nutr. 2019 Mar;43(3):376-400. doi: 10.1002/jpen.1431. Epub 2018 Sep 12. — View Citation

Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003 Oct 8;290(14):1868-74. doi: 10.1001/jama.290.14.1868. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to Nutrition Supplementation Intake	Adherence to nutrition supplementation assessed by the number of participants with >75% consumption of oral nutritional supplements and Arginaid, where the servings of products consumed are counted w confirmation of intake during follow-up.	30 days, 60 days and 90 days
Other	Hospital Length of Stay	Hospital Length of Stay assessed by the number of days for each unplanned hospital admission.	1 year
Other	Wound Depth	Wound Depth measured (millimeters) using sterile forceps and ruler at follow-up.	30 days, 60 days, 90 days, 6 months and 1 year
Other	Wound Duration	Measured by days to complete heal for participants with complete wound healing.	1 year
Primary	Change in the area of pressure injury from baseline	Assessed by the change in wound area from baseline to the follow-up timepoints, measured with a 3D wound imaging device at the time of follow-up.	Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Primary	Percentage (%) of participants at time of follow-up with pressure injury wound area reduction of >/=40%	Percentage (%) of participants at time of follow-up with wound area reduction >/= 40%, at time of follow-up versus baseline, where the number of patients with wound area reduction >/= 40% at follow-up timeframe will be determined as a percentage of total number of participants in the study group.	Baseline, 30 days, 60 days, 90 days, 6 months and 1 year
Secondary	Proportion of participants with complete wound healing of the main wound	Proportion of participants with complete wound healing of the main wound. Assessed by the number of participants with complete healing of a wound, determined by clinical assessment and pressure injury staging.	30 days, 60 days, 90 days, 6 months and 1 year
Secondary	Proportion of participants with increased severity of pressure injury (PI stage)	Proportion of participants with increased severity of pressure injury (PI stage). Assessed by the number of participants with increased severity of wound at follow-up. Severity of pressure injury determined by the increase in pressure injury staging, or increase in area of wound if pressure injury staging remains the same at the follow-up time points	30 days, 60 days, 90 days, 6 months and 1 year
Secondary	Proportion of participants with new wound infection	Proportion of participants with New wound infection. Assessed by the number of participants with a new wound infection(s) at follow-up, that is clinically diagnosed with confirmation from blood tests (e.g., C-Reactive Protein (CRP), renal and liver function tests).	30 days, 60 days, 90 days, 6 months and 1 year
Secondary	Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.	Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) utility scores at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.	90 days, 6 months and 1 year
Secondary	Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.	Change in HRQOL assessed by the change in the EuroQOL 5-Dimensions 5-Levels (EQ5D-5L) Visual Analogue Scale (VAS) at follow-up from baseline for the overall population and age categories if appropriate, where change in scores expressed as mean differences or standardised mean differences.	90 days, 6 months and 1 year
Secondary	Change in Nutritional status.	Change in Nutritional status. Assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria, to determine the severity of malnutrition. Change in the nutritional status determined by direction of nutritional status shift from baseline to follow-up.	30 days, 60 days, 90 days and 1 year
Secondary	Change in Nutritional Intake.	Change in Nutritional Intake. Assessed by the change in average of energy, protein and selected micronutrient intake derived from 3day food records.	30 days and 60 days
Secondary	Mortality	Mortality assessed by the occurrence and time-to-event of all-cause mortality during the study period.	30 days, 60 days, 90 days, 6 months and 1 year
Secondary	Unplanned Hospital Admission	Unplanned hospital admission assessed by the occurrence and time-to-event of one or more admissions during the study period.	30 days, 60 days, 90 days, 6 months and 1 year