- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04496713
Pilot Study of Video and Telephone Primary Care Visits
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins Outpatient Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Časové okno: 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
Časové okno: 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].
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jeremy A Epstein, MD, Johns Hopkins University
- Vrchní vyšetřovatel: Casey Overby Taylor, PhD, Johns Hopkins University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IRB00257994
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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