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Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients (OptiNAM)

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ClinicalTrials.gov Identifier: NCT03741283
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Clinical Research Centre
Region Hovedstaden
Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet
Region Capital Denmark
Regionernes Lægemiddelorganisation
Information provided by (Responsible Party):
Ove Andersen, Hvidovre University Hospital

Brief Summary:
Malnutrition and inappropriate medication prescribing are highly prevalent among acutely admitted older medical patients leading to re-admissions, frailty, poor physical, performance compromised quality of life and mortality. Thus, the aim of this study is to optimise the nutrition and medication in older medical patients admitted to an acute care department at admission and up to 16 weeks after discharge. Participants in the intervention group receives a medication review and participants with malnutrition or risk of malnutrition additionally receive a transitional multimodal intervention. The control group receives standard care.

Condition or disease Intervention/treatment Phase
Aging Malnutrition Drug Prescribing Other: Optimisation of nutrition and medication Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimisation of Nutrition and Medication for Acutely Admitted Older Medical Patients
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Optimisation of nutrition and medication

N=approx.

65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.

Other: Optimisation of nutrition and medication
  1. Inter-professional optimisation of medication prescribing:

    Study participants in the intervention group receives optimisation of medication prescribing at admission day (baseline) regardless of nutritional state. The intervention is performed in cooperation between a clinical pharmacist and a medical physician.

  2. Nutritional intervention:

If positive screening for malnutrition or risk of malnutrition a dietetic intervention is initiated and if positive screening below interventions are initiated:

  • Dysphagia: occupational therapy intervention.
  • Oral cavity problems: odontological intervention.
  • Depression: geriatric intervention.
  • Low ADL: occupational therapy intervention and if positive screening for poor muscle strength: physiotherapeutic intervention.

No Intervention: Standard care
N= approx. 65 acutely admitted older medical patients with undernutrition or risk of undernutrition, and 35 without undernutrition or risk of undernutrition.



Primary Outcome Measures :
  1. Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1) [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Patient administered quality of life scoring system with focus on mobility, daily activities, pain and discomfort and depression.

  2. Changes in Medication Appropriateness Index-score" (sub-study 2) [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Medical physician, geriatric or senior pharmacist perform the MAI-scoring to evaluate the appropriateness of the medication prescribing.

  3. Accuracy of renal function estimates (sub-study 3) - cystatin C [ Time Frame: Baseline (admission day) or no later than 14 days after admission ]
    Differences between GFR measured by a renally excreted radioactive labeled isotope (chromium 51-Cr-EDTA or 99mTc diethylenetriaminepentaacetic acid) and estimated GFR based on Creatinine and Cystatin C or a combination of the biomarkers.


Secondary Outcome Measures :
  1. Walking speed to evaluate the development in physical performance [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    4-Meter Walk Test

  2. Functional measurement to evaluate the development in physical performance [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    30-second chair stand test

  3. Functional measurement to evaluate the development in physical performance [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    handgrip strength test

  4. Functional measurement to evaluate the development in physical performance [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    The de morton mobility index

  5. Measure of physically active time and number of steps taken [ Time Frame: Week 1, week 8 and week 16 after discharge ]
    Assessed by applying an activPAL chip to the thigh for one week

  6. Frailty assessment [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Fried frailty phenotype

  7. Frailty assessment [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Morleys frail questionnaire

  8. Anthropometric measurement to monitor changes in bodyweight [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Bodyweight

  9. Cognitive test aiming to evaluate cognitive function [ Time Frame: Baseline (admission day), week 8 and week 16 ]
    Orientation Memory Concentration test

  10. Patient records [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Contacts related to the health care system, medication lists, use of municipal services

  11. Standard admission blood work [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    ALAT, albumin, alkaline phosphatase, bilirubin, CO2, CRP, haemoglobin, INR, K+, blood urea nitrogen, coagulation factors, leucocytes, neutrophils, MCH, MCV, Na+, thrombocytes, lactate-dehydrogenases, NGAL, β-trace protein and β-trace microglobulins.

  12. Quality of life score, WHO-5 [ Time Frame: Baseline (admission day), week 8 and week 16 ]
    Patient administered quality of life scoring system with focus on general well-being on a scale from 0-100.

  13. Cognitive performance [ Time Frame: Week 8 and week 16 ]
    Mini mental state examination

  14. Cognitive performance [ Time Frame: Week 8 and week 16 ]
    Hopkins verbal learning test

  15. Cognitive performance [ Time Frame: Week 8 and week 16 ]
    Trail making test

  16. Cognitive performance [ Time Frame: Week 8 and week 16 ]
    Digit Symbol Substitution test

  17. Assessment of dietary intake after admission [ Time Frame: Week 8 and week 16 ]
    24 hours dietary recall

  18. Evaluation of medication under-prescribing [ Time Frame: Baseline (admission day), week 8 and week 16 ]
    Assessment of underutilization Index (AOU)

  19. Inflammatory marker to evaluate the inflammatory state [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    SuPAR

  20. Polypharmacy [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    The number of patients in polypharmacy

  21. Potentially inappropriate medication to elderly [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    The number of potentially inappropriate medication prescriptions

  22. Acceptance of suggested changes in medications [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Frequency of physicians' acceptance of suggested changes in medications

  23. Accuracy of renal function estimates - all biomarkers [ Time Frame: Baseline (admission day) or no later than 14 days after admission. ]
    Differences between GFR measured by a renally excreted radioactive labeled isotope (chromium 51-Cr-EDTA or 99mTc diethylenetriaminepentaacetic acid) and estimated GFR based on Creatinine, Cystatin C, Beta-trace protein, Beta-2 microglobulin or a combination of the biomarkers.

  24. Dosing discrepancies of renal risk medication [ Time Frame: Baseline (admission day) or no later than 14 days after admission. ]
    Frequency of renal risk medication prescribed in disagreement to clinical recommendation guidelines based on measured GFR and the choice of eGFR biomarker.

  25. Nutritional status [ Time Frame: Baseline (admission day), week 8 and week 16. ]
    Screening scores for undernutrition with Mini Nutritional Assesment - Short Form, Eating validation scheme, Nutritional Risk Screening-2000


Other Outcome Measures:
  1. Number and types of actionable gene variants - Pharmacogenetic test [ Time Frame: Baseline (admission day) ]
    The number of actionable gene variants identified by the pharmacogenetic test

  2. Number and types of recommended therapy changes -Pharmacogenetic test [ Time Frame: Baseline (admission day) ]
    The number of actionable gene variants identified by the pharmacogenetic test

  3. Health economy related to Sub-study 1 [ Time Frame: Baseline (admission day), week 8 and week 16 and 1 year after discharge ]
    Health care costs will be evaluated in regards to changes in quality of life measured by EURO-Qol-5D-5L.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥65 years
  • Acutely admitted medical patients
  • Understand and speak Danish
  • Caucasian
  • Resident in Municipality: Brøndby, Hvidovre or Copenhagen

Exclusion Criteria:

  • Unable to cooperate cognitively
  • Terminal/suicidal patients
  • Patients in isolation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741283


Contacts
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Contact: Morten B. Houlind, MSc 38623184 ext 28838563 morten.baltzer.houlind@regionh.dk

Locations
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Denmark
Amager & Hvidovre Hospital Recruiting
Hvidovre, Region Hovedstaden, Denmark, 2650
Contact: Aino L Andersen, Msc    0045 24616108    Aino.leegaard.andersen@regionh.dk   
Contact: Morten B Houlind, Msc    0045 28 83 85 63    morten.baltzer.houlind@regionh.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Clinical Research Centre
Region Hovedstaden
Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet
Region Capital Denmark
Regionernes Lægemiddelorganisation
Investigators
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Study Chair: Ove Andersen, MD, PhD Hvidovre University Hospital
Principal Investigator: Aino L. Andersen, MSc Hvidovre University Hospital

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Responsible Party: Ove Andersen, Head of Clinical Research Centre, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03741283     History of Changes
Other Study ID Numbers: OptiNAM
VD-2018-390 -"optiNAM" ( Other Identifier: Danish Data Protection Agency )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ove Andersen, Hvidovre University Hospital:
Medicines optimisation
Multimodal interventions
Inflammation
Emergency Service, Hospital
Pharmacogenetics
Renal function
Food intake
Quality of life
Polypharmacy

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders