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COVID-19 Outbreak Consequences for Outpatients Followed in PRM (Handicall)

20 mei 2020 bijgewerkt door: University Hospital, Montpellier

Assessment of the Consequences of the Abrupt Interruption of Physical and Rehabilitation Medicine Consultations During the Quarantine Period in France Between 2020 March 17th and May 11th

Objectives This survey aims at reporting the immediate impact of the COVID-19 epidemic on outpatients followed in Physical and Rehabilitation Medicine (PRM). It focuses on the disruption of PRM healthcare services during the quarantine period in France between 2020 March 17th and May 11th and on its medical consequences.

Method This observational study was conducted in the PRM department of a French University Hospital. Outpatients whose PRM medical consultation had been cancelled were contacted by phone between April 9th, 2020 and May 7th, 2020. A structured questionnaire was fulfilled for each patient.

Demographical and medical data were recorded, including the disabling diseases motivating the PRM outpatients' follow-up. The necessity to perform an immediate phone consultation or to schedule an urgent consultation within the next 3 weeks constituted the main judgment criterion. Other recorded criteria were: the reason for this urgent need of a medical consultation, the access to other medical services during the quarantine period, the interruption of home-based rehabilitation services and its perceived consequences for the patients.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

The PRM Department of Montpellier University Hospital usually provides between 8500 and 9500 medical consultations/year. A total of 830 medical consultations have been cancelled during the lockdown for COVID-19 between March 17th, 2020, and May 11th, 2020. This survey was approved by the local Institutional Review Board (IRB accreditation number: 19871).

Procedure Phone calls were performed by residents. These young doctors worked in the PRM Department for 4 months before the beginning of the outbreak and were used to the PRM medical practices of the senior practitioners. They received a special dedicated education before they start calling the patients. They fulfilled a structured questionnaire for each patient. Each resident was supervised by a senior MD. A personalized daily appointment was organized with the group of residents to check for difficulties in recording the data and to answer any question from them. Questionnaires were collected each day and data were daily implemented in a dedicated database.

Data recorded Descriptive data concerning age, description of the underlying disease, and delay from the cancelled consultation were recorded at the beginning of the call.

The main Judgment criterion is the necessity to schedule a medical consultation within the next 3 weeks: immediate telephone consultation for urgent but easy situations (like refilling a prescription or advising the patient), or short-term consultation within the next three weeks. Other patients have been proposed for a delayed consultation within the next 3 months.

Secondary objectives are: 1/ the reason for this urgent need of a medical consultation within the next 3 weeks, 2/ the category of patients for whom this need was the most prevalent, 3/the relationship between the date of the cancelled consultation and the feeling of emergency for reprogramming it, 4/ the disruption of home-based or community-based rehabilitation and its consequences for patients, and 5/ the access to other medical services for those patients during the quarantine period.

Studietype

Observationeel

Inschrijving (Werkelijk)

467

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Montpellier, Frankrijk, 34295
        • Uh Montpellier

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Outpatients from an university hospital PRM Department

Beschrijving

Inclusion criteria:

- All outpatients whose medical appointment had been cancelled between March 17th and May 11th 2020 were contacted by phone between April 9th and May 7th 2020.

Exclusion criteria:

  • Patients who had spontaneously called the hospital to ask for reprogramming the cancelled consultation before being contacted
  • Patients followed by the three senior MD who preferred to call patients by themselves and who didn't want to fulfill the questionnaires for personnel reasons
  • Patient who didn't answer after three phone calls

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Retrospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of patients necessitating the scheduling of a medical consultation
Tijdsspanne: 1 day (Time of the phone call)
Proportion of patients necessitating the scheduling of a medical consultation within the next 3 weeks
1 day (Time of the phone call)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
the reason for this urgent need of a medical consultation
Tijdsspanne: 1 day (Time of the phone call)
the reason for this urgent need of a medical consultation
1 day (Time of the phone call)
the access to other medical services during the quarantine period
Tijdsspanne: 1 day (Time of the phone call)
the access to other medical services during the quarantine period
1 day (Time of the phone call)
the interruption of home-based rehabilitation services
Tijdsspanne: 1 day (Time of the phone call)
the interruption of home-based rehabilitation services and its perceived consequences for the patients
1 day (Time of the phone call)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Isabelle LAFFONT, Professor, University Hospital, Montpellier

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2020

Primaire voltooiing (Werkelijk)

1 mei 2020

Studie voltooiing (Werkelijk)

9 mei 2020

Studieregistratiedata

Eerst ingediend

10 mei 2020

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2020

Eerst geplaatst (Werkelijk)

12 mei 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 mei 2020

Laatste update ingediend die voldeed aan QC-criteria

20 mei 2020

Laatst geverifieerd

1 mei 2020

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Onbeslist

Beschrijving IPD-plan

NC

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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