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

NCT06078488 | Unknown DMC

• 1 other identifier: INCA
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pressure Injury; Nutritional Support; Community Nursing; Clinical Nutrition; Malnutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Proportion of participants with complete wound healing of the main wound

  30 days, 60 days, 90 days, 6 months and 1 year

• Proportion of participants with increased severity of pressure injury (PI stage)

  30 days, 60 days, 90 days, 6 months and 1 year

• Proportion of participants with new wound infection

  30 days, 60 days, 90 days, 6 months and 1 year

• Change in Health-Related Quality of Life (HRQOL) utility scores from baseline to time of follow-up.

  90 days, 6 months and 1 year

• Change in Health-Related Quality of Life (HRQOL) Visual Analogue Scale (VAS) scores from baseline to time of follow-up.

  90 days, 6 months and 1 year

Other Outcomes (4)

• Adherence to Nutrition Supplementation Intake

  30 days, 60 days and 90 days

• Hospital Length of Stay

  1 year

• Wound Depth

  30 days, 60 days, 90 days, 6 months and 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Individualized and Protocolized Nutrition Care Bundle with Nutritional Supplementation, Education and Support by Nurses trained in Nutritional Management and Dietitians.

Other: Individualized and Protocolized Nutritional Care Bundle

Control

EXPERIMENTAL

Nursing Care by Nurses trained in Nutritional Management, with or without Supplements.

Other: Optimized Standard Care

Interventions

Individualized and Protocolized Nutritional Care Bundle OTHER

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.

Intervention

Optimized Standard Care OTHER

Only receiving education and management from specialized nurses trained in nutritional management , with or without supplementation

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age more than or equal to 21 years, any gender).
• 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.
• Able to provide written informed consent (patient or legal guardian).
• Be on oral and/or enteral nutritional support.

You may not qualify if:

• Known palliative care individuals with a lifespan of \</= 3 months,
• Known septicaemia,
• Poorly controlled diabetes (glycated haemoglobin level \> 8.5%17),
• Individuals on strict fluid restriction if the provision of additional oral or enteral nutrition supplements leads to excess intake, for the following conditions:
• 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
• Advanced decompensated alcoholic and non-alcoholic liver cirrhosis
• Heart failure with reduced ejection fraction requiring fluid restriction less than 800ml per day,
• \. 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.

Sponsors & Collaborators

• Changi General Hospital: lead
• Home Nursing Foundation (HNF): collaborator
• Duke-NUS Graduate Medical School: collaborator
• Temasek Foundation: collaborator

Study Sites (1)

Home Nursing Foundation

Singapore, Singapore

RECRUITING

Related Publications (14)

• 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.

  PMID: 32058438 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32978205 BACKGROUND

• 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.

  PMID: 14532315 BACKGROUND

• 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.

  PMID: 32149471 BACKGROUND

• 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.

  PMID: 24919719 BACKGROUND

• 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.

  PMID: 27693836 BACKGROUND

• 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.

  PMID: 26703983 BACKGROUND

• 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.

  PMID: 25643304 BACKGROUND

• 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.

  PMID: 24810310 BACKGROUND

• 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.

  PMID: 30207386 BACKGROUND

• 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.

  PMID: 35031096 BACKGROUND

• 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.

  PMID: 27623463 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Malnutrition; Pressure Ulcer

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alvin Wong, MSc

  SingHealth Duke NUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvin Wong, MSc

CONTACT

(65)64268775; alvin_wong@cgh.com.sg

Precilla Lai, MSc

CONTACT

precilla.lai@hnf.org.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will not be blinded to group allocations due to the nature of the study, which is not a placebo-controlled trial, but rather, a real-world pragmatic study. Subjects, research dietitian and nursing staff will be aware that they are in a study to examine the effects of nutritional intervention on pressure injury healing rates. The nursing personnel responsible for measuring wounds and gathering data will not be blinded, given their role in conducting follow-up with the participants as a component of clinical care. However, they will be randomized to ensure that they do not attend to both the intervention and control groups. The research dietitian will be blinded to the measurement and health outcomes. The trial statistician will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: October 11, 2023
• Study Start: October 23, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)