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Pilot Study of Video and Telephone Primary Care Visits

8. februar 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins Outpatient Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. januar 2021

Primær fullføring (Faktiske)

24. november 2021

Studiet fullført (Faktiske)

30. desember 2021

Datoer for studieregistrering

Først innsendt

29. juli 2020

Først innsendt som oppfylte QC-kriteriene

29. juli 2020

Først lagt ut (Faktiske)

3. august 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2022

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • IRB00257994

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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