A proposed protocol for the comparison of virtual to physical health assessments and treatment plans for patients presenting for initial vascular clinic visits

Abstract

The current manuscript contains a protocol proposal for a prospective research trial comparing virtual vascular clinic visits to actual physical clinic visits. 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. We plan to compare the physician assessments and future treatment plans made using VHAT to those made after PHAT. It is believed that VHAT will be in agreement with those made with PHAT.

Aims/objectives:

The primary objective of the current project is to compare assessment and future treatment plans for low-risk patients made via VHAT and PHAT visits. A secondary objective is to measure patient and physician satisfaction.

Methods:

Study hypotheses:

1. There will be good agreement (kappa coefficient ≥ 0.80) between VHAT and PHAT assessments and treatment plans. More specifically, VHATand PHAT assessments will be used to classify patients into low, moderate and high risk for intervention and there will be good agreement between the two methods.

2. Patient satisfaction will be greater for VHAT as compared to PHAT visits.

Introduction

There is ongoing evolution for how we deliver health care. This ongoing evolution aims to increase utilization of care, and increase satisfaction by lowering annoyances for many patients and physicians at all levels. For instance, vascular surgery evolved from mostly open surgery to minimally invasive interventions. Telehealth has been developed to improve healthcare and its value. Virtual health assessments and treatment (VHAT) have the potential to improve healthcare, healthcare access and reduce outpatient clinic time.

In a Dutch multicenter trial, asthmatic children were randomized to usual care (four-monthly outpatient visits) and online care using a virtual asthma clinic (VAC) (eight-monthly outpatient visits with monthly web-based monitoring). The VAC group had a significantly higher difference in the number of symptom-free days and more improvement in asthma control. The authors concluded that routine outpatient visits can partly be replaced by monitoring asthmatic children via eHealth.¹ The idea was also examined for cardiac patients and found that it may decrease routine clinic time and increase safety of pharmacotherapy.²

Another advantage to telehealth is the “reach out” approach. The feasibility, appropriateness and access to a telehealth clinic to meet the needs of people living in rural and remote regions were reported in one south Australian pilot study.³ In that study, the outcomes of telehealth clinic were compared with the outreach clinic for patients with spinal disorders requiring non-urgent surgical consultation. The telehealth model of care demonstrated the efficient management of patients with no adverse outcomes reported. The total cost of AUD$11,187 demonstrated a 23% reduction in favor of telehealth with the greatest savings in travel costs.

Telehealth or VHAT is also a tool that can be used to determine if information provided by patients remotely can be used to support work processes. One study⁴ utilized video telehealth during care coordination workflow to provide visual information unavailable during telephone interactions. Despite additional tasks and interactions needed to obtain the visual information, the authors concluded that workflow efficiency, as measured by time, was not significantly changed, although there was an increase in visual information afforded by video telehealth that supported the assessment and diagnostic processes.

VHAT is a sensitive tool that can provide remote evaluation. In an Australian study,⁵ there was a high level of agreement between telehealth and in-person assessments with respect to clinical management decisions and diagnosis of patients with chronic musculoskeletal conditions managed in an advanced-practice physiotherapy screening clinic. The authors concluded that Telehealth can be considered as a viable and effective medium to assess those patients who are unable to attend these services in person.

Telehealth was examined in large veterans study⁶ and found to save 8981 miles in travel distance, and saved $2317.51 due to averted travel reimbursement. There was a 90% satisfaction rate with that telehealth pain management clinic, and 90% of patients agreed that they would recommend telehealth to other veterans. In addition, telehealth technology demonstrated efficiency to improve simplicity and standardization of videoconferencing.⁷

VHAT has been shown to increase patient satisfaction. A review⁸ examined the construct validity and internal consistency reliability of the Telehealth Satisfaction Scale (TeSS), a 10-item scale adapted for use in a rural and remote memory clinic (RRMC). The TeSS items demonstrated high internal consistency reliability (Cronbach’s alpha = 0.90). Satisfaction scores on the TeSS items ranged from 3.43 to 3.72 on a 4-point Likert scale, indicating high satisfaction. In a non-inferiority trial⁹ of 49 children who stuttered were randomized to either clinic or telehealth group. There was an increase in parent satisfaction and a paralleled decrease in stuttering severity across the three time points universally; however, the relationship between parent satisfaction and stuttering severity was not found at every time point. One study¹⁰ demonstrated the utilization of telehealth in heart failure patients and the ability to solve many challenges with that cohort in conjunction with payment reform and pragmatic research study design.

In another study,¹¹ telehealth was positively viewed by caregivers, and multidisciplinary team members. Also, the same study reported an improvement in technology and provided satisfactory remote care without person-to-person contact. In one study,¹² 115 open herniorrhaphy and 26 laparoscopic cholecystectomy patients had attempted telehealth follow-up. Seventy-eight percent (110) of all patients were successfully contacted; of those, 70.8% (63) of hernia patients and 90.5% (19) of cholecystectomy patients accepted telehealth as the sole means of follow-up. Complications in the telehealth patients were zero for cholecystectomy and 4.8% (3) for herniorrhaphy. Nearly all patients expressed great satisfaction with the telephone follow-up method. The authors concluded that telehealth can be safely used in selected ambulatory patients as a substitute for the standard postoperative clinic visit with a high degree of patient satisfaction.

In another study,¹³ patients with a diagnosis of mood and/or anxiety disorder completed weekly intervention sessions (10 face-to-face; 8 video conferencing). Adherence to protocol was coded in both intervention formats and generated pre-post changes in scores on the Beck Depression Inventory Second Edition (BDI-II) for each participant. Pre-post intervention scores for the BDI-II were comparable across the two delivery formats, with 60% of participants in each group showing a positive change in BDI-II severity classification (e.g. from moderate to low symptoms). Likewise, in another study,¹⁴ telehealth enabled rapid bundling breast care service including telemammography, telepathology, and teleoncology services into a single day process. The authors concluded that virtual slide telepathology found a small number of significant diagnostic discrepancies. The virtual slide telepathology program service increased the job satisfaction of subspecialty pathologists without special training in breast pathology, and improved the timeliness of appointments.⁹

However, telehealth does have some limitations. Telehealth technology is still hampered by regulatory, reimbursement, and other policy issues.¹⁰ Another review of the literature showed the efficiency of telehealth, and suggested that Medicare funding be increased to allow sufficient administrative support.⁷

Significance

1. Information and results obtained from this study could be used to help triage patients and perhaps help with the scheduling of patients who are waiting for the initial visit at the vascular clinic.

2. Information and results obtained from this study could be used to help promote greater patient satisfaction.

3. If successful this approach may impact direct costs and improve savings of time and money.

Health care institutions need to evaluate all methods used for patient encounters, and make efforts to provide the best care in the most pleasant and efficient manner as possible. Over 50% of the hospitals in acute care settings are using some form of telemedicine.¹⁵ Telehealth has expanded into many areas of patient care including surgical care, preoperative and postoperative care.^16–18 In the postoperative care setting, patients receiving care by telehealth have excellent clinical outcomes, increased satisfaction, increased accessibility, reduced wait times and cost savings to patients and health care institutions.¹⁶ Based on our recent telehealth clinical trial¹⁹ conducted at our tertiary care center, we found an increase in patient satisfaction and quality of life and an acceptance of telehealth technology.²⁰ Both groups reported an increase in SF8 physical summary scores, but was more pronounced in the patients that received Telehealth electronic monitoring (THEM) (p = 0.076). THEM patients reported a significantly greater improvement in quality of life on three of the SF8 quality subscales (physical function, role-physical and role-emotional; THEM Δ 7.5 vs. control Δ 1.1; THEM Δ 8.7 vs. control Δ 1.1; and THEM Δ 6.3 vs. control Δ −0.5; all p < 0.05). THEM patients reported trends for higher satisfaction in terms of general satisfaction, technical quality and accessibility for PSQ18 survey questions (4.2 vs. 3.7, p = 0.072; 4.5 vs. 4.1, p = 0.081; and 4.2 vs. 3.8, p = 0.063), respectively.

Methods

1. The study design is a non-randomized single cohort crossover design. All patients will receive both types of visits VHAT and PHAT.

2. Patients scheduled for an initial vascular assessment at the Vascular Center of Excellence (VCOE) will receive an information packet in the mail that contains information about the study, an offer to screen statement with a call-in phone number for questions and two unsigned consent and HIPAA forms.

3. Consented patients will receive (i.e. by shipment) the necessary telehealth equipment for the study. After 10–14 days, a virtual health assessment and treatment plan will be conducted (VHAT) followed by the actual visit at the vascular clinic (PHAT). The PHAT visit will be scheduled within two to three days following the VHAT visit.

4. Based on the VHAT assessment, a physician will classify patients into one of three groups (low, moderate or high risk for intervention). Low = can be treated medically, moderate = intervention is needed in the future, but not immediately, high risk = immediate intervention is necessary or within two weeks.

5. The VHAT result will be compared to the results that occur after the PHAT visit and recorded in the same manner (i.e. low, moderate or high risk).

Outcomes

The primary outcome is the measure of agreement between VHAT and PHAT assessments and treatment plans. Secondary outcomes will include patient satisfaction and physician satisfaction.

The current study is designed to be a prospective single cohort cross-over design. More specifically, all consented patients will receive both the virtual clinic visit (VHAT) and the actual clinic visit (PHAT). Thus, each participant serves as the own control and participates in both arms.

The primary endpoint will be measured as simply the VHAT classification of patients into low, moderate or high risk of intervention and compared with the actual intervention that occurs following the actual physical clinic visit (PHAT).

Study hypotheses

1. It is predicted that there will be good agreement (kappa coefficient ≥0.80) between VHAT and PHAT assessments and treatment plans. More specifically, VHAT and PHAT assessments will be used to classify patients into low, moderate and high risk for intervention and there will be good agreement between the two methods.

2. It is predicted that patient satisfaction will be greater for VHAT as compared to PHAT visits.

Sample

The population for this study will be patients who are referred to and scheduled for an initial vascular visit at the VCOE.

Sample size.

This will be a pilot study of 100 continuous participants who agree to be in the study.

Inclusion/exclusion criteria.

Patients with initial scheduled visits at the Vascular Center of Excellence (VCOE) between the ages of 18–89 years of age will be considered as possible participants for the study. Low-risk patients that can be safely scheduled at least two weeks from the initial VCOE contact are prime candidates for the VHAT study. The two weeks or more is needed to ship the VHAT equipment and for the participants to become familiar with the equipment. Currently, the VCOE triages patients in the attempt to ensure patients with more serious conditions are scheduled as soon as possible. In some serious cases, patients could possibly be scheduled the same day or within a couple of days. For our study, we will exclude cases that are deemed “urgent” by the VCOE and urgent is defined as an office visit within two weeks of initial VCOE contact. In addition, we will exclude patients who are scheduled to have the placement of an arteriovenous (AV) fistula.

Randomization.

No randomization, all patients will participate in both arms and receive both types of visits (VHAT versus PHAT). The current requires no follow-up and will conclude at the end of PHAT visit.

Project proposal

Our current proposal is to conduct a pilot study of 100 patients who are referred and scheduled for an initial clinic visit at the VCOE. We believe that a patient visit using VHAT will result in an encounter that is equivalent to that of a PHAT. More specifically, we believe that there will be good agreement between the VHAT assessment and the physical health assessment and treatment plan (PHAT). VHAT and PHAT visits will be scheduled in a manner where the physician that performs the VHAT visit will not perform the PHAT visit for the same participant.

As described in our previous study,¹⁹ all patients will receive a tablet computer and home monitoring medical devices with sensors to transmit the information to a central website that will be monitored by care managers. Monitoring devices will include blood pressure cuffs, thermometers and oxygen saturation monitors. The TeleMed 2020 electronic home health monitoring system will be used to provide surveillance of patients. The care manager will login to the TeleMed2020 web portal to monitor data that are transmitted or participant entered. The care manager will be able to notice any out-of-range values (e.g. high systolic blood pressure) or conditions (e.g. patient reports a change in medical condition) and if necessary consult with the VHAT physician. The tablets will have the ability to send a high resolution photographs if needed. All equipment will be provided to participants at no charge and will be returned during the PHAT visit. Clinical care mangers will remotely monitor the health of patients by viewing all electronic readings. Study care managers will call or send electronic messages to the patients based on alerts generated by the tele-monitoring system for out-of-range values. In order to reduce physician bias, the physician scheduled to do the virtual visit will be a physician from the VCOE and will not be the same physician who is scheduled to do the physical visit. It is estimated that it will take the participant about 30–45 min to complete the virtual visit. The care manager will begin the virtual visit by assisting the participant to complete the majority of the virtual visit, while the physician will perform the last part of the exam, which is estimated to take less than 15 min. The main focus of this approach is to have a direct, specific, objective and measurable assessments either by the care manager or during the scheduled virtual health assessment and treatment plan (VHAT) provided by a physician.

TeleMed 2020

Company overview.

TeleMed 2020, Inc. owns and operates a cloud-based SaaS solution for remote patient monitoring. The company allows clinician scheduling and ongoing patient capture and sharing of critical information yielding earlier and more active care plan management. The company is based in Indianapolis, Indiana.

https://www.telemed2020.vom

The VHAT phase care manager will:

1. Monitor patient vital signs: blood pressure, pulse, oxygen saturation and temperature.

2. Contact on call virtual physician or patient if necessary.

3. Assess compliance with entering information.

4. Schedule virtual health assessment (see Figure 1 and Table 1).

Figure 1.

Patient flow chart.

Table 1.

Schedule of events.

Information:	Virtual visit	Physical visit
Sign informed consent	Before starting	Before starting
Equipment and instructions	After consent	After consent
Health care assessment	After virtual visit	After physical visit
Health care plan	After virtual visit	After physical visit

Data collection

Data collection will include:

1. Signed consent forms.

2. Enrollment and demographics form.

3. Tablet quiz questions (see Tables 2 and 3)

4. Virtual visit data collection (see Table 4).

Table 2.

Daily/weekly tablet questions.

Daily questions
1 On a scale of 1 to 5 how is your pain today?___
2 The condition of my limb or body part appears.
A lot worse	A little worse	About the same	A little better	A lot better
1	2	3	4	5
3 Swelling or redness around limb or body part is?
A lot worse	A little worse	About the same	A little better	A lot better
1	2	3	4	5
4 In general, on a scale of 1 to 5, how would you rate your mental or emotional health?
5 In general, on a scale of 1 to 5, how would you rate your physical health?
Weekly questions
1 During the past week, how often did your Care Manager(s) treat you with courtesy and respect?
Never	Not very often	Sometimes	Often	Always
1	2	3	4	5
2 During the past week, how often did you Care Manager(s) explain things in a way you could understand?
Never	Not very often	Sometimes	Often	Always
1	2	3	4	5
3 During the past week, how often did information you sent from Enform™, your tablet, result in a call from your case manager(s).
Never	Not very often	Sometimes	Often	Always
1	2	3	4	5
4 During the past week, what number would you use to rate the ease-of-use of Enform™?
Difficult to use	Somewhat easy to use	Moderately easy to use	Easy to use	Very easy to use
1	2	3	4	5
5 During the past week, would you say that information you provided to your Care Manage(s) via Enform™ enriched the conversation or quality of care provided?
Never	Not very often	Sometimes	Often	Always
1	2	3	4	5

Table 3.

Post visit satisfaction questions.

Post virtual visit participant questions
1 In your estimation, how long in minutes did the virtual visit take? Consider all of the time, including travel, preparation and waiting. ___ minutes
2 How satisfied were you with your virtual visit today?
Not at all	Very little	Somewhat	Satisfied	Very satisfied
1	2	3	4	5
3 How would you rate your participation (the health information that you provided) as to influencing the treatment that you received?
Not at all	Very little	Somewhat	Much	Very much
1	2	3	4	5
4 How would you rate the quality of your virtual visit?
Very poor	Poor	Fair	Good	Excellent
1	2	3	4	5
5 How likely are you to recommend a virtual visit to others?
Not likely	Possibly likely	Somewhat likely	Likely	Very likely
1	2	3	4	5
Post physical visit participant questions
1 In your estimation, how long in minutes did the physical visit take? Consider all of the time, including visit preparation and assessment ___ minutes
2 In your estimation, how many miles did you travel for your visit? ___ miles
3 How satisfied were you with your physical visit today?
Not at all	Very little	Somewhat	Satisfied	Very satisfied
1	2	3	4	5
4 How would you rate the quality of your virtual visit?
Very poor	Poor	Fair	Good	Excellent
1	2	3	4	5
5 How likely are you to recommend a physical visit to others?
Not likely	Possibly likely	Somewhat likely	Likely	Very likely
1	2	3	4	5
6 If you participated in both the virtual and in-person visit, would you have been satisfied with the virtual visit enough to have omitted the in-person visit?
	Yes	No
	1	2

Table 4.

Virtual visit data collection.

Assessment (Specify)
Plan (Specify); In addition, Physician will rate the patient’s need for intervention as low, moderate or high.
At the time of virtual visit was patient’s condition found to be greater than low risk (resulting in patient’s in-person visit being moved up or sent to the ED? Y/N
Outcome of the virtual visit: order for compression stockings, prescription medication order (specify), or no intervention necessary
Physician satisfaction questions
The quality of the transmitted images was sufficient to aid in patient assessment.
Strongly agree	Moderately agree	Agree	Moderately disagree	Strongly disagree
I was able to determine a diagnosis and treatment plan based on information obtained during the virtual visit?
Strongly agree	Moderately agree	Agree	Moderately disagree	Strongly disagree
I found the timing of the virtual visit fit well into my schedule.
Strongly agree	Moderately agree	Agree	Moderately disagree	Strongly disagree

Statistical analysis

All analyses will be based on intention-to-treat (ITT) analyses. Descriptive statistics will be expressed in terms of frequencies, percentages, or means standard deviation (SD). Categorical variables will be tested by Chi-square or Fisher exact tests and continuous variables will be tested by Student t-test or paired t-test for pre/post measures where deemed appropriate, and pre/post patient satisfaction questions will be compared using the Friedman test, a non-parametric alternative to the one-way analysis of variance (ANOVA) with repeated measures. Cohen’s kappa coefficient (κ), which is a statistic which measures inter-rater agreement for qualitative (categorical) items will be used to measure the agreement between the two methods (VHAT versus PHAT). All probability values will be two sided and ‘p’ values <0.05 will be considered significant. Statistical analyses will be performed using SPSS version 19.0 for Windows. This study will be registered at ClinicalTrials.gov.

Human subjects

Recruitment method(s).

The study group participants will sign consent forms before enrolling in the study. Study staff will be trained and knowledgeable on the research protocol. This study will not offer any direct benefit for the study participants, but will receive a $20 gift cards for the return of all study equipment at the time of the PHAT visit. Staff will not begin consenting patients until they have completed this training and are in compliance with any pertinent trainings offered by Research and Grants.