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出境医 / 临床实验 / Virtual and Physical Health Assessments and Treatment Plans (VHAT)
Virtual and Physical Health Assessments and Treatment Plans (VHAT)
Study Description
Brief Summary:
The aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. After both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. It is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. That is, virtual visit classifications will be as good as those made after physical visits.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vascular Diseases | Procedure: Virtual visit | Not Applicable |
Detailed Description:
Patient dissatisfaction can increase because of the complexities associated with navigating modern health care systems. It is easy to speculate that some of this dissatisfaction is associated with travel, wait times and other issues that arise during routine clinic visits. The authors of recent studies have demonstrated that it is possible and feasible to conduct many routine visits remotely. It is our belief that virtual health assessments and treatment plans (VHAT) conducted remotely can be as effective, perhaps be more efficient and increase patient satisfaction when compared to regular physical health assessments and treatment plans (PHAT). Physicians want to provide optimal health care; however, in geographically isolated areas such as some locations in West Virginia that can be a challenge. It seems reasonable to believe that monitoring patients with telehealth technology, collecting on-going real time data and conducting VHAT can provide high quality health care for patients. It can also help to classify health risk, increase patient and medical staff satisfaction, decrease staff time for visits, while at the same time increase the efficiency of the follow-up process. The investigators plan to compare the physician assessments and future treatment plans made using VHAT to those made after PHAT. It is believed that VHAT assessments will be in agreement with those made with PHAT.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Single arm crossover design where all participants receive both types of visits (Virtual and Physical visits). |
| Masking: | None (Open Label) |
| Masking Description: | Open label |
| Primary Purpose: | Health Services Research |
| Official Title: | Comparison of Virtual to Physical Health Assessments and Treatment Plans for Patients Presenting for Initial Vascular Clinic Visits |
| Estimated Study Start Date : | July 2020 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | July 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Type of visit
Single arm, non-randomized crossover design. All patients will receive both types of visits virtual and physical, and after assessments are made, participants will be classified by physicians into low, moderate or high risk for intervention.
|
Procedure: Virtual visit
Type of visit
Other Name: Physical visit
|
Outcome Measures
Primary Outcome Measures :
- Categorization of physician treatment plans. (Physicians will classify treatment plans as low, moderate or high need for vascular intervention) [ Time Frame: 1 week ]Comparison of virtual visit treatment plans to physical treatment plans. After assessments, physicians will classify patients' treatment plans into low (treat medically), moderate (vascular intervention in the future, but not immediately) or high (needs immediately, within 2 weeks). The distribution of low, moderate and high among the two types of visits (Virtual and Physical) will be compared.
Secondary Outcome Measures :
- Patient satisfaction [ Time Frame: 1 week ]Comparison of patient satisfaction after virtual and physical visits. Satisfaction will be measured by two survey questions based on a 1 to 5 Likert scale.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE).
Exclusion Criteria:
- Patients that are deemed urgent cases by the VCOE, and scheduled within two weeks for the initial clinic visit.
- Patients who are scheduled to have the placement of an arteriovenous (AV) fistula at the time of the initial clinic visit.
Contacts and Locations
Contacts
| Contact: Albeir Y Mousa, MD | 3043884875 | amousa@hsc.wvu.edu | |
| Contact: Mike Broce, BA | 3043889923 | Mike.broce@camc.org |
Sponsors and Collaborators
CAMC Health System
Sarah & Pauline Maier Foundation, Inc.
WVCTSI
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||||||
| First Posted Date ICMJE | May 13, 2019 | ||||||||
| Last Update Posted Date | January 27, 2020 | ||||||||
| Estimated Study Start Date ICMJE | July 2020 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Categorization of physician treatment plans. (Physicians will classify treatment plans as low, moderate or high need for vascular intervention) [ Time Frame: 1 week ] Comparison of virtual visit treatment plans to physical treatment plans. After assessments, physicians will classify patients' treatment plans into low (treat medically), moderate (vascular intervention in the future, but not immediately) or high (needs immediately, within 2 weeks). The distribution of low, moderate and high among the two types of visits (Virtual and Physical) will be compared.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Patient satisfaction [ Time Frame: 1 week ] Comparison of patient satisfaction after virtual and physical visits. Satisfaction will be measured by two survey questions based on a 1 to 5 Likert scale.
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Virtual and Physical Health Assessments and Treatment Plans | ||||||||
| Official Title ICMJE | Comparison of Virtual to Physical Health Assessments and Treatment Plans for Patients Presenting for Initial Vascular Clinic Visits | ||||||||
| Brief Summary | The aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. After both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. It is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. That is, virtual visit classifications will be as good as those made after physical visits. | ||||||||
| Detailed Description | Patient dissatisfaction can increase because of the complexities associated with navigating modern health care systems. It is easy to speculate that some of this dissatisfaction is associated with travel, wait times and other issues that arise during routine clinic visits. The authors of recent studies have demonstrated that it is possible and feasible to conduct many routine visits remotely. It is our belief that virtual health assessments and treatment plans (VHAT) conducted remotely can be as effective, perhaps be more efficient and increase patient satisfaction when compared to regular physical health assessments and treatment plans (PHAT). Physicians want to provide optimal health care; however, in geographically isolated areas such as some locations in West Virginia that can be a challenge. It seems reasonable to believe that monitoring patients with telehealth technology, collecting on-going real time data and conducting VHAT can provide high quality health care for patients. It can also help to classify health risk, increase patient and medical staff satisfaction, decrease staff time for visits, while at the same time increase the efficiency of the follow-up process. The investigators plan to compare the physician assessments and future treatment plans made using VHAT to those made after PHAT. It is believed that VHAT assessments will be in agreement with those made with PHAT. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single arm crossover design where all participants receive both types of visits (Virtual and Physical visits). Masking: None (Open Label)Masking Description: Open label Primary Purpose: Health Services Research
|
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| Condition ICMJE | Vascular Diseases | ||||||||
| Intervention ICMJE | Procedure: Virtual visit
Type of visit
Other Name: Physical visit
|
||||||||
| Study Arms ICMJE | Experimental: Type of visit
Single arm, non-randomized crossover design. All patients will receive both types of visits virtual and physical, and after assessments are made, participants will be classified by physicians into low, moderate or high risk for intervention.
Intervention: Procedure: Virtual visit
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2021 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: -Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE). Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03947905 | ||||||||
| Other Study ID Numbers ICMJE | 19-558 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Albeir Mousa, CAMC Health System | ||||||||
| Study Sponsor ICMJE | CAMC Health System | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | CAMC Health System | ||||||||
| Verification Date | January 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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