Andersen 2021.

Study name	Optimization of Nutrition And Medication (OptiNAM) for acutely admitted older patients: protocol for a randomized single blinded controlled trial
Methods	Randomised controlled trial
Participants	Setting: Hvidovre Hospital, Denmark Inclusion criteria: ≥ 65 years Acutely admitted to the ED Community‐dwelling and residing in one of the following municipalities: Hvidovre, Copenhagen (Districts of West and South Western Copenhagen) or Brøndby Exclusion criteria: Inability to understand Danish Inability to co‐operate physically (e.g. hearing or speech impairment) or cognitively (e.g. dementia or unconsciousness) Isolation room stay Not Caucasian Admission due to suicide attempt or terminal illness
Interventions	Intervention group: optimisation of nutrition and medication (1) Inter‐professional optimisation of medication prescribing: Study participants in the intervention group receive optimisation of medication prescribing at admission day (baseline) regardless of nutritional state. The intervention is performed in co‐operation 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 is initiated: dysphagia: occupational therapy intervention; oral cavity problems: odontological intervention; depression: geriatric intervention; low ADL: occupational therapy intervention; if positive screening for poor muscle strength: physiotherapeutic intervention Control group: the control group receives standard care
Outcomes	Primary outcomes: Changes in quality of life score EuroQol‐5 Dimensions‐ 5 Levels (sub‐study 1) (time frame: baseline, week 8 and week 16) Changes in Medication Appropriateness Index score (sub‐study 2) (time frame: baseline, week 8 and week 16) Accuracy of renal function estimates (sub‐study 3) ‐ cystatin C (time frame: baseline or no later than 14 days after admission). Differences between GFR measured by a renally excreted radioactive labelled 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 outcomes: (All secondary outcomes are assessed at baseline (admission day), week 8 and week 16): Walking speed to evaluate the development in physical performance (4‐Metre Walk Test) Functional measurement to evaluate the development in physical performance (30‐second chair stand test) Functional measurement to evaluate the development in physical performance (handgrip strength test) Functional measurement to evaluate the development in physical performance (De Morton Mobility Index) The measure of physically active time and number of steps taken assessed by applying an activPAL chip to the thigh for 1 week Frailty assessment (Fried frailty phenotype) Frailty assessment (Morley's FRAIL questionnaire) Anthropometric measurement to monitor changes in body weight Cognitive test aiming to evaluate cognitive function (Orientation Memory Concentration test) Patient records (contacts related to the healthcare system, medication lists, use of municipal services) Standard admission blood work (ALT, 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) Quality of life score, WHO‐5 (patient‐administered quality of life scoring system with a focus on general well‐being on a scale from 0 to 100) Cognitive performance ‐ Mini Mental State Examination Cognitive performance ‐ Hopkins verbal learning test Cognitive performance ‐ trail making test Cognitive performance ‐ Digit Symbol Substitution test Assessment of dietary intake after admission (24 hours dietary recall) Evaluation of medication under‐prescribing (assessment of under‐utilisation index (AOU)) Inflammatory marker to evaluate the inflammatory state (SuPAR) Polypharmacy (the number of patients in polypharmacy) Potentially inappropriate medication to elderly (the number of potentially inappropriate medication prescriptions) Acceptance of suggested changes in medications (frequency of physicians' acceptance of suggested changes in medications) 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 labelled 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) 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 with clinical recommendation guidelines based on measured GFR and the choice of eGFR biomarker.) Nutritional status (screening scores for undernutrition with Mini Nutritional Assessment ‐ Short Form, Eating validation scheme, Nutritional Risk Screening‐2000) Other outcome measures: Number and types of actionable gene variants ‐ pharmacogenetic test (admission day); the number of actionable gene variants identified by the pharmacogenetic test Number and types of recommended therapy changes ‐ pharmacogenetic test (admission day); the number of actionable gene variants identified by the pharmacogenetic test Health economy related to Sub‐study 1 (time frame: baseline, week 8 and week 16 and 1 year after discharge). Healthcare costs will be evaluated in regards to changes in quality of life measured by EURO‐Qol‐5D‐5L.
Starting date	15 October 2018
Contact information	Ove Andersen, Department of Clinical Research, Copenhagen University Hospital Amager and Hvidovre, Denmark. Email: Ove.Andersen@regionh.dk
Notes	Funding: The Capital Region’s strategic funds (2,000,000 DKK); Capital Region’s fund for transitional research (2,011,807 DKK); Danish Regions (1,000,000 DKK); The Danish Research Unit for Hospital Pharmacy, Amgros I/S, Copenhagen (1,000,000 DKK)), Denmark; and the Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat (190,000 DKK) Trial ID: ClinicalTrials.gov NTC03741283