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Advanced Point-of-care Technology During In-home Assessment Among Older Adults

Primary Purpose

Acute Respiratory Disease, Acute Illness

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Advanced point-of-care technology
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Disease focused on measuring acute illness, older adults, acute home care, pre-hospital care, point-of-care technology, geriatric, acute community nurse, focused lung ultrasound scan, FLUS

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • referred to the ACHCS in Kolding Municipality for in-home assessment
  • dyspnoea
  • cough
  • fever
  • fall
  • functional decline defined as either subjective (not able to perform normal daily activities as usual) or objective functional decline (increased need of home care)

Exclusion Criteria:

  • moderate to severe cognitive impairment
  • antibiotic treatment

Sites / Locations

  • Siri SmedemarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control - Usual Care

Intervention - Advanced point-of-care technology

Arm Description

Participants in the control-arm will undergo usual care. This covers clinical inspection, vital parameters (respiratory rate(breaths/min), saturation (%), blood pressure (mmHg), heart rate (beats/min), body temperature (celsius), and Glasgow Coma Scale) , and point-of-care blood-test for CRP and haemoglobin

Participants in the intervention-arm will undergo usual care as well as advanced point-of-care technology.

Outcomes

Primary Outcome Measures

Admission ≤ 30-days
Proportion of Admissions during 30 days follow-up

Secondary Outcome Measures

Mortality ≤ 30-days
Proportion of diseased participants in the intervention group and control group after inclusion during 30 days follow-up
Acute admissions at day 0
Proportion of acute admissions on visit day (day 0)
Length of hospital admission
Number of days admitted to acute-care hospital, long-term acute-care hospital or in an emergency department.
Hospital-free days ≤ 30-days
Number of days alive that is spend outside of an acute-care hospital, long-term acute-care hospital or in an emergency department, including days spent wholly or in part under "observation" status
Complications during hospital admission
Number of complications registered in the electronic patient journal during admission including delirium and fall
Treatment initiations or changes at day 0
Number of treatment initiation or changed at day 0 including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics
Treatment initiation or changes ≤ 30-day
Number of treatment initiation or changed during 30 days follow-up including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics
Functional level
Measured by proxy assessment of functional level: Change in amount of home care during 30 days follow-up number of change of dwelling
Re-referrals to the Acute Community Health Care Service
Number of re-referrals to the ACHCS
Contact to the PCP ≤ 30-days
Number of contact to the PCP during 30 days follow-up

Full Information

First Posted
September 14, 2022
Last Updated
January 10, 2023
Sponsor
University of Southern Denmark
Collaborators
Odense Patient Data Explorative Network, Region of Southern Denmark, Kolding Municipality, Denmark, Karen Elise Jensen Foundation, AP Moeller Foundation, Hartmann Fonden, Merchant L. F. Foghts Foundation, Director Emil C Hertz and wife Inger Hertz Foundation, Gangsted Foundation, Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05546073
Brief Title
Advanced Point-of-care Technology During In-home Assessment Among Older Adults
Official Title
Advanced Use of Point-of-care Technology Versus Usual Care During In-home-assessment by Acute Community Nurses in Older Adults for Reducing Acute Hospital Admissions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense Patient Data Explorative Network, Region of Southern Denmark, Kolding Municipality, Denmark, Karen Elise Jensen Foundation, AP Moeller Foundation, Hartmann Fonden, Merchant L. F. Foghts Foundation, Director Emil C Hertz and wife Inger Hertz Foundation, Gangsted Foundation, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Due to ageing-related physiological changes, diagnosing older adults is challenging. Delayed disease recognition lead to adverse health outcomes and increased hospitalisation, which is why there is a need to develop new procedures for timely diagnosis and treatment of older adults. Point-of-care technology, e.g. focused lung ultrasound scan and bedside analysis of blood samples (leucocytes with differential count, electrolytes and creatinine) carried out in the patients' home may support clinical decision-making, and potentially reduce acute hospital admissions. The trial's overall aim is to investigate whether increased point-of-care technology, i.e. focused lung ultrasound scan and bedside blood analysis, used as in-home diagnostics in older adults with acute respiratory symptoms, can qualify the general practitioner's clinical decision-making for early treatment initiation and eventually reduce acute hospital admission.
Detailed Description
The trial is conducted in Kolding municipality in Denmark. Participants eligible for this study are people aged 65 years or older, referred to the Acute Community Health Care Service (ACHCS) in Kolding municipality for an in-home assessment. Data collection: In the control group, the Acute Community Nurses (ANC) will carry out usual care that involves a clinical inspection, measurements of vital signs (respiratory rate(breaths/min), saturation (%), blood pressure (mmHg), heart rate (beats/min), body temperature (celsius), and Glasgow Coma Scale), and point-of-care tests (POCT) for C-reactive protein (CRP) and haemoglobin. In the intervention group, the ACN will carry out extended POCT besides usual care. Extended POCT covers a focused lung ultrasound scan (FLUS) and biochemical blood analyses. FLUS examination follows a standardized protocol (21). Biochemical analyses include sodium, potassium, creatinine, urea, and leucocytes with differential count. In both control and intervention groups the ACN communicates the examination results to the participants' primary care physician (PCP) by telephone as well as an electronic written documentation. The findings will support the PCP in the clinical decision-making. The communication to the PCP is part of the usual care and is carried out in both groups. Training of ACNs: Prior to the study initiation, all ACNs are trained in FLUS examination, technical procedure of POCT biochemical blood-analysis, as well as in research methods with specific focus on study procedures to increase their adherence to and respect for to the randomization procedure and protocol. Point-of-care technology used in the study: FLUS is carried out using Lumify® C5-2 Curved Array Transducer (Philips Medical Systems, Bothell, WA), with a bandwidth of 5-2 megahertz (MHz) and scan depth up to 30 cm. POCT on blood samples for creatinine and electrolytes are carried out using venous blood samples (collected in lithium/heparin vacutainers) and analysed immediately on the POCT instrument i-STAT® (Abbott, Inc., NJ, U.S.A.) using CHEM8 cassette. POCT blood analysis for leucocyte differential count is carried out using venous blood samples (collected in EDTA-vacutainers) and analysed immediately on the POCT instrument HemoCue® WBF DIFF System (HemoCue AB, Ängelholm, Sweden) with dedicated micro-cuvettes. POCT blood-analysis for CRP is carried out using blood samples obtained by finger-prick and analysed on the POCT instrument QuickRead go® (Orion Diagnostica, Oy). Data-sources: To assess co-morbidity, disabilities, utilization of primary care and health care services, death, and medical history external data sources will be applied for permission to access. The Danish Health Data Authority is responsible for the national health registers containing data related to the health of the entire Danish population and services of the healthcare system. A unique personal identification number for all people living in Denmark makes it possible to link data across national health registers. The Danish Health Data Authority will be applied to get access to the Danish National Patient Registry, the Danish Register of Causes of Death, The Danish National Prescription Registry, and the Danish National Health Service Register. The registers contain information about diseases, treatments, deaths, and health care utilization, and are needed to access information on comorbidity, time of death, medical history, treatment initiations or changes, and number of consultations at PCPs. The Electronic Municipal Care Records (EOJ - Elektronisk Omsorgsjournal) registers the amount of home care the participants receive, and will be obtained at day 0 and at day 30 to investigate possible changes as a proxy of changes in functional level. The hospital Electronic Patient Journal (EPJ) will be accessed by the primary investigator to register admissions, reason for admission and any complications during admission. The EPJ will be accessed at day 30 after the acute visit to register admissions, reasons for admission, length of admission, treatment during admission, functional decline during admission, and discharge diagnosis. Data monitoring: During the study, several checkpoints will be established to ensure adherence to protocol. Number of kits used will be noted every month to ensure no extra kits for POCT on biochemistry on blood samples are used as a violation to protocol. Time and date logging on each POCT device will be carried out each month to ensure adherence to protocol. Sample size: A clinically significant reduction of acute hospital admission is set to a 10% reduction. However, it is unknown how many patients are acutely admitted after the first visit of ACNs. Preliminary results from a pilot-study of the intervention (not yet published) showed that 21% of included participants were acutely admitted. We then assume to reduce hospital admissions by 10%, and to detect a reduction from 31% to 21% at a significance level 0.05 with a power of 80, a total of 602 participants are required (301 in each arm). Allowing for a 5 % drop out after randomisation, 316 in each arm are required (a total of 632 participants).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Disease, Acute Illness
Keywords
acute illness, older adults, acute home care, pre-hospital care, point-of-care technology, geriatric, acute community nurse, focused lung ultrasound scan, FLUS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
632 participants referred to the acute community health care service for in-home assessment due to acute disease will be enrolled and randomized 1:1 to receive usual care or advanced point-of-care technology
Masking
None (Open Label)
Allocation
Randomized
Enrollment
632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control - Usual Care
Arm Type
No Intervention
Arm Description
Participants in the control-arm will undergo usual care. This covers clinical inspection, vital parameters (respiratory rate(breaths/min), saturation (%), blood pressure (mmHg), heart rate (beats/min), body temperature (celsius), and Glasgow Coma Scale) , and point-of-care blood-test for CRP and haemoglobin
Arm Title
Intervention - Advanced point-of-care technology
Arm Type
Experimental
Arm Description
Participants in the intervention-arm will undergo usual care as well as advanced point-of-care technology.
Intervention Type
Other
Intervention Name(s)
Advanced point-of-care technology
Intervention Description
The intervention consists of: focused lung ultrasound scan(FLUS) venous blood samples for leucocytes with 5-part differential count, creatinin, sodium, potassium, urea
Primary Outcome Measure Information:
Title
Admission ≤ 30-days
Description
Proportion of Admissions during 30 days follow-up
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality ≤ 30-days
Description
Proportion of diseased participants in the intervention group and control group after inclusion during 30 days follow-up
Time Frame
30 days
Title
Acute admissions at day 0
Description
Proportion of acute admissions on visit day (day 0)
Time Frame
Day 0
Title
Length of hospital admission
Description
Number of days admitted to acute-care hospital, long-term acute-care hospital or in an emergency department.
Time Frame
30 days
Title
Hospital-free days ≤ 30-days
Description
Number of days alive that is spend outside of an acute-care hospital, long-term acute-care hospital or in an emergency department, including days spent wholly or in part under "observation" status
Time Frame
30 days
Title
Complications during hospital admission
Description
Number of complications registered in the electronic patient journal during admission including delirium and fall
Time Frame
30 days
Title
Treatment initiations or changes at day 0
Description
Number of treatment initiation or changed at day 0 including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics
Time Frame
Day 0
Title
Treatment initiation or changes ≤ 30-day
Description
Number of treatment initiation or changed during 30 days follow-up including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics
Time Frame
30 days
Title
Functional level
Description
Measured by proxy assessment of functional level: Change in amount of home care during 30 days follow-up number of change of dwelling
Time Frame
30 days
Title
Re-referrals to the Acute Community Health Care Service
Description
Number of re-referrals to the ACHCS
Time Frame
30 days
Title
Contact to the PCP ≤ 30-days
Description
Number of contact to the PCP during 30 days follow-up
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
The diagnostic accuracy of FLUS conducted by ACNs
Description
ACNs conclusions are index test and FLUS-specialist conclusions used as reference test.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: referred to the ACHCS in Kolding Municipality for in-home assessment dyspnoea cough fever fall functional decline defined as either subjective (not able to perform normal daily activities as usual) or objective functional decline (increased need of home care) Exclusion Criteria: moderate to severe cognitive impairment antibiotic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siri A Smedemark, MD
Phone
+4551557546
Email
siri.aas.smedemark@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri A Smedemark, MD
Organizational Affiliation
Department of Clinical Reasearch, University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Andersen-Ranberg, Prof, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Siri Smedemark
City
Kolding
State/Province
Region Syddanmark
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siri Smedemark
Phone
+45 51 55 75 46
Email
siri.aas.smedemark@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Siri A Smedemark, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Advanced Point-of-care Technology During In-home Assessment Among Older Adults

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