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Pilot Study of Video and Telephone Primary Care Visits

8. Februar 2022 aktualisiert von: Johns Hopkins University

Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits

The inability to access and use smartphones or camera-outfitted internet-connected devices during the COVID-19 pandemic relegates certain patients to receive audio-only telemedicine instead of audio/video-based telemedicine. The investigators are conducting a randomized controlled trial in order to characterize patient and provider attitudes towards these two modalities of care and to test the feasibility of a new model to make tablets for video-based care accessible to those who need that. The investigators hypothesize that patient and provider satisfaction will be higher with video-based telehealth when compared to phone-based telehealth.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Johns Hopkins Outpatient Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City

Exclusion Criteria:

  • Patients with significant visual or hearing impairment
  • Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity
  • Patients that have not selected English as their preferred language

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Telemedicine - Phone
Patients will continue with their telephone-based telemedicine visit as scheduled. There will be no change to their care. Patients will receive a survey by mail about the visit.
Experimental: Telemedicine - Audio/Video
Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video. A survey can be completed on the tablet. The devices will be sent back to the research time after their single use.
Sonstiges: Internet-connected computer tablet
An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Zeitfenster: Within 2 weeks of the study visit
Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.
Within 2 weeks of the study visit

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Zeitfenster: Within 2 weeks of the study visit

Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction.

Satisfaction (1=strongly disagree to 5=strongly agree).

  1. In general, I was satisfied with using a video or phone call for this visit
  2. I could explain my medical problems well enough
  3. Talking to the doctor was as satisfying as talking in person

Overall score 3 to 15 with higher scores signifying better satisfaction.
Within 2 weeks of the study visit
Satisfaction with telemedicine visit for provider as assessed by a Likert scale
Zeitfenster: Within 2 weeks of the study visit

Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction.

[1=Strongly Disagree. 5=Strongly Agree].

  1. In general, I was satisfied with using telemedicine for this visit
  2. Talking to the patient was as satisfying as talking in person.

Overall score 2 to 10 with higher scores signifying better satisfaction.
Within 2 weeks of the study visit
Efficacy of telemedicine visit for provider as assessed by a Likert scale
Zeitfenster: Within 2 weeks of the study visit

Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy.

[1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough.

c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management
Within 2 weeks of the study visit
Provider communication as assessed by yes/no question
Zeitfenster: Within 2 weeks of the study visit

The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication.

Did this provider explain things in a way that was easy to understand? Yes/No
Within 2 weeks of the study visit
Provider listening as assessed by yes/no question
Zeitfenster: Within 2 weeks of the study visit

Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening.

Did this provider listen carefully to you? Yes/No
Within 2 weeks of the study visit
Provider respect as assessed by yes/no question
Zeitfenster: Within 2 weeks of the study visit

Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect.

Did this provider show respect for what you had to say? Yes/No
Within 2 weeks of the study visit
Provider time spent as assessed by yes/no question
Zeitfenster: Within 2 weeks of the study visit

Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter.

Did this provider spend enough time with you? Yes/No
Within 2 weeks of the study visit
Patient health rating as assessed by a likert scale
Zeitfenster: Within 2 weeks of the study visit

Patient health will be assessed with Likert-scale questions related to patient health.

In general, how would you rate your overall health?

  1. Excellent
  2. Very good
  3. Good
  4. Fair
  5. Poor

In general, how would you rate your overall mental or emotional health?

  1. Excellent
  2. Very good
  3. Good
  4. Fair
  5. Poor

Overall score 2 to 10 with lower scores signifying better health.
Within 2 weeks of the study visit

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Johns Hopkins University

Ermittler

  • Hauptermittler: Jeremy A Epstein, MD, Johns Hopkins University
  • Hauptermittler: Casey Overby Taylor, PhD, Johns Hopkins University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Januar 2021

Primärer Abschluss (Tatsächlich)

24. November 2021

Studienabschluss (Tatsächlich)

30. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2020

Zuerst gepostet (Tatsächlich)

3. August 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Februar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Februar 2022

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • IRB00257994

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Protocol and analysis plan, without any protected health information (PHI), can be shared on request via email.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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