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

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03741283
Collaborator
Clinical Research Centre (Other), Region Hovedstadens Apotek (Other), Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet (Other), Region Capital Denmark (Other), Regionernes Lægemiddelorganisation (Other)
193
1
2
45
4.3

Study Details

Study Description

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
  • Other: Optimisation of nutrition and medication
N/A

Detailed Description

The OptiNAM study is designed as a single-blinded randomised controlled trial starting upon admission and continues till 16 weeks after discharge. The trial has five sub-studies with three independent primary endpoints, all with individual sample size calculations.

The study consists of an intervention group and a control group. The control group receives standard care.

Patients that meet all inclusion criteria and none of the exclusion criteria are invited to participate. After signing a written informed consent, the participants are block randomised to either the intervention or control group.

The intervention group receives a personalised rehabilitation program, which is described below. Outcome measures are performed at baseline, week 8 and week 16 after after discharge, cf. section regarding outcome measures.

Sub study 1, Malnutrition:

As malnutrition among older patients has multifactorial etiology sub-study 1 investigates the effects of a multimodal transitional intervention on quality of life in acutely admitted older patients with malnutrition or risk of malnutrition (according to the Mini Nutritional Assessment - Short Form) from baseline (admission day) and 16 weeks after discharge compared to standard care. The intervention includes a medication review (cf. sub-study 2), a dietetic intervention and if clinical relevant physiotherapeutic-, occupational-, geriatric- and/or odontological intervention. It is secondary hypothesised that a multimodal intervention compared to standard care may improve the quality of life, nutritional status, energy- and protein intake, symptoms which compromise nutritional intake, physical performance, cognitive function, frailty, re-admissions, inflammation and biomarkers. A cost-benefit analysis will be conducted.

Dietetic intervention: The study subjects receives a personal diet plan during admission. The diet plan is reviewed at discharge by a dietician. To ensure optimal energy- and protein intake after discharge, a community-based dietician visit the participants for one hour in week 1, 2, 4 and 8.

Physiotherapeutic intervention: Participants with low ability to perform groceries shopping, cooking and/or eating are offered a community-based strength, balance and endurance training after discharge if they also have low muscle strength in the lower extremities. The training sessions are based on algorithms, have a duration of one hour, and are offered twice a week for 16 weeks after discharge.

Occupational intervention, Dysphagia: If relevant (EAT-10 score >=3), a hospital-based occupational therapist review and treat the dysphagia based on the Facial Oral Tract Therapy (FOTT) principle during admission. During the first week after discharge a community-based occupational therapist continues with the treatment. A maximum of two weekly visits of one hour throughout the interventions period is offered.

Occupational Intervention, low Ability to perform Activities of Daily Living (ADL): If the participant has low ability to perform grocery shopping, cooking and eating (evaluated by Functional Recovery Score <=2) then a community-based occupational therapist visit the participant during the first two weeks after discharge to evaluate the quality of activities of daily living. If relevant, and if there is a rehabilitation potential, seven visits of one hour is offered during the 16 weeks after discharge.

Geriatric intervention: If relevant (a Mini Geriatric Depression Score >=2), a geriatric physician conducts a clinical assessment of depression during admission and initiate treatment if necessary.

Odontological intervention: If relevant (participant reported pain in mouth, difficulties chewing or xerostomia), a dentist evaluate the dental status and oral health during admission, and if necessary encourage the participant to consult a dentist after discharge. If a participant shows insufficient oral hygiene a dental hygienist visits the participant after discharge twice during after discharge.

Sub-study 2, Medication optimisation:

Medication prescription for older patients is challenging and may be attributed to marked inter-individual variations in general health, comorbidities, organ function, pharmacokinetic and pharmacodynamic properties, biological age and physical performance. Thus, the "one size fits all" approach is probably inappropriate in older patients. The aim of sub-study 2 is to investigate the investigate the effect of an inter-professional conducted medication review during admission in an acute care department regardless of the nutritional status in the study participant, thus all subjects in the intervention group receive a medication review. It is hypothesized that inter-professional conducted medication reviews reduce the Medication Appropriateness Index score (MAI score) in the intervention group eight weeks after discharge compared to the control group. It is secondary hypothesized that inter-professional conducted medication reviews improve: lack of medication prescribing for a condition/disease, inappropriate polypharmacy and suboptimal medication prescribing of high risk medications.

Sub-study 3, Accuracy of renal function estimates and the consequence for prescribing recommendations guidelines:

Accuracy in renal function estimates is essential for optimization of medication prescribing since 40 % of all medication or their active metabolites is renally excreted. Lack of medication prescribing and dose adjustment according to the renal function is common in older patients with renal impairment and can result in overdosing, adverse drug reactions, hospital admissions, reduced quality of life and mortality. The gold standard for measuring glomerular filtration rate (GFR) is an exogenous filtration marker. However, this method is costly, time consuming and thus impractical in a clinical setting. Therefore, GFR is often estimated on serum concentrations of an endogen biomarker. Sub-study 3 aim to investigate which biomarker(s) and equation most accurately estimate the GFR in older medical patients who have been acutely admitted.

Sub-study 4, Pharmacogenetic test on cytochrome 450 variations and its potential for optimization of medication prescribing:

Cytochrome 450 enzymes are responsible for metabolism of up to 80% of all medications. The enzyme complex is mainly found in liver but are also present in intestinal mucosa, skin, lungs, brain and kidneys. There are major genetic inter-individual differences in the activity of the CYP 450 complex, resulting in lack of therapeutic effects, lack of effect or adverse drug reactions. Insight into these genetic inter-individual differences via pharmacogenetic tests possess a potential in optimization of medication prescribing with regard to therapeutic effects, compliance and risk of side effects. Thus, sub-study 4 wish to descriptively investigate the potential of pharmacogenetic test on cytochrome 450 variations.

Sub-study 5, Assessment of Frailty:

Frailty is a common clinical syndrome in older adults and defined as state of increased vulnerability resulting from decline in reserve capacity and function across multiple physiologic systems. Frailty affects the person's ability to cope with everyday life and leads to high risk for falls, disability, hospitalization and mortality. The frailty assessment is based on two different frailty scoring systems, Frieds "Frailty Phenotype" and Morley's "Frail Scale", examined at admission and 8 and 16 weeks after discharge. The purpose of the assessment is to evaluate which frailty measure is the best applicable in describing the patients and changes in their functional level. As there is no gold standard we use FI-Outref as an independent measure of frailty. FI-OutRef is a Frailty Index, based on standard admission laboratory test results Outside of the Reference interval.

Study Design

Study Type:
Interventional
Actual Enrollment :
193 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 :
Oct 15, 2018
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

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
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. 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in quality of life score EuroQol- 5 Dimensions- 5 Levels (sub-study 1) [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) [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 [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 [Baseline (admission day), week 8 and week 16.]

    4-Meter Walk Test

  2. Functional measurement to evaluate the development in physical performance [Baseline (admission day), week 8 and week 16.]

    30-second chair stand test

  3. Functional measurement to evaluate the development in physical performance [Baseline (admission day), week 8 and week 16.]

    handgrip strength test

  4. Functional measurement to evaluate the development in physical performance [Baseline (admission day), week 8 and week 16.]

    The de morton mobility index

  5. Measure of physically active time and number of steps taken [Week 1, week 8 and week 16 after discharge]

    Assessed by applying an activPAL chip to the thigh for one week

  6. Frailty assessment [Baseline (admission day), week 8 and week 16.]

    Fried frailty phenotype

  7. Frailty assessment [Baseline (admission day), week 8 and week 16.]

    Morleys frail questionnaire

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

    Bodyweight

  9. Cognitive test aiming to evaluate cognitive function [Baseline (admission day), week 8 and week 16]

    Orientation Memory Concentration test

  10. Patient records [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 [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 [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 [Week 8 and week 16]

    Mini mental state examination

  14. Cognitive performance [Week 8 and week 16]

    Hopkins verbal learning test

  15. Cognitive performance [Week 8 and week 16]

    Trail making test

  16. Cognitive performance [Week 8 and week 16]

    Digit Symbol Substitution test

  17. Assessment of dietary intake after admission [Week 8 and week 16]

    24 hours dietary recall

  18. Evaluation of medication under-prescribing [Baseline (admission day), week 8 and week 16]

    Assessment of underutilization Index (AOU)

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

    SuPAR

  20. Polypharmacy [Baseline (admission day), week 8 and week 16.]

    The number of patients in polypharmacy

  21. Potentially inappropriate medication to elderly [Baseline (admission day), week 8 and week 16.]

    The number of potentially inappropriate medication prescriptions

  22. Acceptance of suggested changes in medications [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 [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 [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 [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

  26. Intestinal microbiome composition [Baseline (admission day), week 8 and week 16 after discharge.]

    Composition and changes in the intestinal microbiome.

  27. Body composition [Baseline (admission day), daily through out admission, up to three weeks after admission during kidney function measurement, week 8 and week 16 after discharge.]

    Description and changes in body composition, assessed by bioelectric impedance analysis (InBodyS10).

  28. Body composition [Up to three weeks after admission during kidney function measurement]

    Assessed by dual x-ray absorptiometry (DXA)

Other Outcome Measures

  1. Number and types of actionable gene variants - Pharmacogenetic test [Baseline (admission day)]

    The number of actionable gene variants identified by the pharmacogenetic test

  2. Number and types of recommended therapy changes -Pharmacogenetic test [Baseline (admission day)]

    The number of actionable gene variants identified by the pharmacogenetic test

  3. Health economy related to Sub-study 1 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amager & Hvidovre Hospital Hvidovre Region Hovedstaden Denmark 2650

Sponsors and Collaborators

  • Hvidovre University Hospital
  • Clinical Research Centre
  • Region Hovedstadens Apotek
  • Udviklings- og forskningspuljen, Danske Regioner og Sundhedskartellet
  • Region Capital Denmark
  • Regionernes Lægemiddelorganisation

Investigators

  • Study Chair: Ove Andersen, MD, PhD, Hvidovre University Hospital
  • Principal Investigator: Aino L. Andersen, MSc, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ove Andersen, Head of Clinical Research Centre, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT03741283
Other Study ID Numbers:
  • OptiNAM
  • VD-2018-390 -"optiNAM"
First Posted:
Nov 14, 2018
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ove Andersen, Head of Clinical Research Centre, Hvidovre University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2021