- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04496713
Pilot Study of Video and Telephone Primary Care Visits
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21287
- Johns Hopkins Outpatient Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Ei väliintuloa: 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.
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Kokeellinen: 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.
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An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Aikaikkuna: Within 2 weeks of the study visit
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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.
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Within 2 weeks of the study visit
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Aikaikkuna: Within 2 weeks of the study visit
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Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction. Satisfaction (1=strongly disagree to 5=strongly agree).
Overall score 3 to 15 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
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Satisfaction with telemedicine visit for provider as assessed by a Likert scale
Aikaikkuna: Within 2 weeks of the study visit
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Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction. [1=Strongly Disagree. 5=Strongly Agree].
Overall score 2 to 10 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
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Efficacy of telemedicine visit for provider as assessed by a Likert scale
Aikaikkuna: Within 2 weeks of the study visit
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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
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Provider communication as assessed by yes/no question
Aikaikkuna: Within 2 weeks of the study visit
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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
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Provider listening as assessed by yes/no question
Aikaikkuna: Within 2 weeks of the study visit
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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
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Provider respect as assessed by yes/no question
Aikaikkuna: Within 2 weeks of the study visit
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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
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Provider time spent as assessed by yes/no question
Aikaikkuna: Within 2 weeks of the study visit
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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
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Patient health rating as assessed by a likert scale
Aikaikkuna: Within 2 weeks of the study visit
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Patient health will be assessed with Likert-scale questions related to patient health. In general, how would you rate your overall health?
In general, how would you rate your overall mental or emotional health?
Overall score 2 to 10 with lower scores signifying better health. |
Within 2 weeks of the study visit
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Jeremy A Epstein, MD, Johns Hopkins University
- Päätutkija: Casey Overby Taylor, PhD, Johns Hopkins University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- IRB00257994
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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