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Fast-track Discharge With Telemedicine

Primary Purpose

Emergencies

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Telemedicine

About this trial

This is an interventional supportive care trial for Emergencies focused on measuring telemedicine, patient satisfaction, randomization

Eligibility Criteria

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

Inclusion Criteria:

municipal home care at admittance
admitted to medical emergency care unit at Kolding Hospital

Exclusion Criteria:

ketoacidosis,
hyperosmolar diabetic coma,
serious hypercalcemia,
acute renal insufficiency with serum-creatinin > 175 mmol/l,
serious cardiac failure
septicemia
acute coronary disease
apoplexia cerebri
neuroinfection
progressive or active cancer
hepatic disease
serious psychiatric disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Telemedicine

Control

Arm Description

Discharge with telemedicine contact to emergency nurse, doctor, and municipality

Standard care with 24-48 h observation at emergency unit

Outcomes

Primary Outcome Measures

Walking distance

Measurement of walking distance regularly by home care nurse (in meters)

Secondary Outcome Measures

Days of admittance

Days in hospital according t hospital charts

Fall in home

No. of falls in home recorded by home care nurse

Full Information

NCT ID

NCT03730285

First Posted

February 28, 2016

Last Updated

November 1, 2018

Sponsor

Kolding Sygehus

1. Study Identification

Unique Protocol Identification Number

NCT03730285

Brief Title

Fast-track Discharge With Telemedicine

Official Title

Fast-track Discharge Combined With Treatment and Rehabilitation at Home With Telemedicine

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2019 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kolding Sygehus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluation of discharge after arrival at emergency unit, Kolding Hospital combined with treatment and rehabilitation in the home either by telemedicine or the usual treatment

Detailed Description

Participants are acute in-patients at the Medical Department, Kolding Hospital. Participants shall be informed about the project, and all screened initially within 30 minutes. After 3-4 hours adjusted treatment and possible need for new investigations are conducted. Patients are randomized at discharge to home treatment with rounds via telemedicine with support of emergency team of nurses or hospitalization in emergency unit. Observations, treatment and rehabilitation follow the same standards and guidelines for all patients. The cohort of patients is recruited between Oct 1, 2015 until January 1, 2016. The study is a randomized quality evaluation study of patient satisfaction, of the emergency team at Kolding Municipality, re-admittance rate, use of other health services, and new services from the municipality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emergencies

Keywords

telemedicine, patient satisfaction, randomization

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telemedicine

Arm Type

Active Comparator

Arm Description

Discharge with telemedicine contact to emergency nurse, doctor, and municipality

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard care with 24-48 h observation at emergency unit

Intervention Type

Device

Intervention Name(s)

Telemedicine

Intervention Description

Installation of videotelephone with broadband in patient's home

Primary Outcome Measure Information:

Title

Walking distance

Description

Measurement of walking distance regularly by home care nurse (in meters)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Days of admittance

Description

Days in hospital according t hospital charts

Time Frame

3 months

Title

Fall in home

Description

No. of falls in home recorded by home care nurse

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: municipal home care at admittance admitted to medical emergency care unit at Kolding Hospital Exclusion Criteria: ketoacidosis, hyperosmolar diabetic coma, serious hypercalcemia, acute renal insufficiency with serum-creatinin > 175 mmol/l, serious cardiac failure septicemia acute coronary disease apoplexia cerebri neuroinfection progressive or active cancer hepatic disease serious psychiatric disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ole W Rasmussen, Dr Med Scie

Phone

004576362000

Ole.Winther.Rasmussen@rsyd.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Finn F Lauszus, PhD

Phone

004578430999

finlau@rm.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole W Rasmussen, DrMedScie

Organizational Affiliation

Kolding Sygehs, Medical Department

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

publication planned

Citations:

PubMed Identifier

20340049

Citation

van Mastrigt GA, Joore MA, Nieman FH, Severens JL, Maessen JG. Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial. Qual Life Res. 2010 Jun;19(5):631-42. doi: 10.1007/s11136-010-9625-5. Epub 2010 Mar 26.

Results Reference

background

PubMed Identifier

19390093

Citation

Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.

Results Reference

background

PubMed Identifier

20406123

Citation

Mayes PA, Silvers A, Prendergast JJ. New direction for enhancing quality in diabetes care: utilizing telecommunications and paraprofessional outreach workers backed by an expert medical team. Telemed J E Health. 2010 Apr;16(3):358-63. doi: 10.1089/tmj.2009.0110.

Results Reference

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Fast-track Discharge With Telemedicine

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