Attitudes Towards Receiving Mental Health Care Using Telehealth During the COVID-19 Pandemic
Conditions: Psychiatric Disorder, Mental Health Disorder, Stress, Adjustment Disorders
Sponsor: Northwestern University

 
 
 
 
v3.0 12/08/2020 
 
STUDY TITLE: Attitudes towards receiving mental health care using telehealth during 
the COVID-19 pandemic 
 
PRINCIPAL INVESTIGATOR: 
Name: Jeffrey T. Rado, MD, MPH 
Department: Psychiatry and Behavioral Sciences 
 
VERSION DATE: 
 
v3.0 12/08/2020 
 
Indicate Vulnerable 
Population(s) to be Enrolled 
☐ Children (you must complete Appendix A in addition 
to this protocol document if you plan to enroll children) 
☐ Cognitively Impaired Adults   
☐ Pregnant Women (IF the research activities will affect    
the pregnancy or the fetus) 
☐ Prisoners (or other detained/paroled individuals)  
 
International Research 
(check this box if you will 
collect data from individuals 
located outside the United 
States) 
 
 
☐ 
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates) 
 
 
 
☐ 
 
Research has U.S. Federal 
government funding via 
direct award or a sub-award 
(e.g., NIH, NSF, other 
federal agencies or 
departments) 
 
☐ 
 
 
 
1.0 
Purpose and rationale of the study: 
 
During the COVID-19 pandemic, starting around mid-March 2020, most healthcare 
providers began offering telehealth appointments to minimize the risk of spreading 
COVID-19 infection. While mental health care is considered essential care, most 
healthcare organizations including academic hospitals began offering telehealth 
primarily, with limited presence of staff onsite for any long acting injectable medication 
administrations or if care cannot be administered through telehealth. This care has been 
offered through various forms including phone calls and video calls through various 
platforms not limited to Zoom, doxy.me, Doximity, and WhatsApp.  
 
During this time private insurance companies and public aid Medicare and Medicaid all 
have offered reimbursement for care at a similar rate as in-person visits. This had not 

 
 
 
 
v3.0 12/08/2020 
 
been the case previously, and telehealth for mental health care had been primarily 
limited to rural areas. However, it is uncertain how long insurance companies will 
continue to pay for these telehealth services at a similar rate. The COVID-19 pandemic 
situation remains uncertain with potential for a second wave with reduction in limits of 
social distancing.  
 
Psychiatric and mental health care is different from other forms of medical care in that it 
is a more emotionally intimate and personal setting. However, with changes in 
technology, it may be possible to provide continued mental health care through 
telehealth appointments to prevent the risk of spread of COVID-19 infection and 
maintain social distancing.  
 
Based on our literature review, we have found a few articles showing promising 
outcomes for using telehealth appointments specifically for mental health care during the 
COVID-19 pandemic.  An article published in April 2020 by 1 Kannarkat, J.T indicates 
outpatient attendance has increased dramatically through use of telehealth during the 
COVID-19 pandemic.  
 
An article by 2 Uscher-Pines, Lori published in Psychiatric Services stresses the 
importance of telehealth visits and mentions while there are limitations, many 
psychiatrists had a positive perception of telehealth. The limitations of telehealth were 
directly mostly at phone calls rather than video calls, but more patients had access to a 
phone compared to video. Lindsay et al. (2020)3 conducted a study investigating the 
benefits of video appointments for rural patients during the pandemic and found that 
patients felt that conversational rhythm and rapport with their provider was maintained 
well through video.   
 
An article published by Perrin et al. (2020)4  in the Journal of Clinical Psychology 
suggests that telehealth is well‐suited to become a permanent part of mental health care 
practice if there are appropriate policies in place. While this article focuses on 
psychology rather than psychiatry, many of the implications and benefits of telehealth 
can carry over to psychiatry.  
 
 We did not find any controlled, randomized experimental studies comparing mental 
health care delivered via telehealth appointments to in-person appointments during the 
pandemic, nor did we find any quantitative survey studies asking patients about their 
experiences and perceptions of telehealth appointments during the pandemic. While 
Perrin et al. (2020) and Lindsay et al. (2020) touch on some patient feedback in their 
findings, Perrin et al. report anecdotal feedback from patients and Lindsay et al. 
conducted qualitative interviews to solicit feedback from patients. 
 
Our search on clinicaltrials.gov did not yield any current studies focused on attitudes of 
mental health care patients towards receiving care through telehealth. We found only 
one study in the US, which is a survey focused towards getting perceptions of telehealth 
use among clinical psychologists but does not include patients’ perceptions. 
(ClinicalTrials.gov Identifier: NCT04360850) 
 
Our hypothesis is that most patients may like receiving mental health care through 
telehealth and would potentially be interested in continuing a combination of telehealth 
and in-person appointments in the future. Understanding patient perceptions and 
collecting their feedback now is critically important as the spread of COVID-19 infection 

 
 
 
 
v3.0 12/08/2020 
 
is unknown, and telehealth appointments may continue throughout the course of the 
pandemic. If we can learn more now about patients’ perceived benefits and challenges 
using telehealth services, we can prioritize improvements to better their experience and 
potentially, patient adoption of and comfort with remote appointments. This study’s 
results would also inform policy makers and insurance companies about the potential 
utility of delivering mental health care through telehealth, even beyond the duration of 
the COVID-19 pandemic.  
 
We will collect data from patients who had in-person mental health care appointments at 
Northwestern prior to telehealth implementation due to the COVID-19 pandemic, and 
who had at least one mental health care appointment at Northwestern between mid-
March 2020 and September30th 2020. Our analysis will focus on patients’ perceptions of 
availability of care, usage, ease of use, comfort of use, quality of interaction, interface 
interaction, overall quality, and satisfaction with mental health care appointments via 
telehealth. We will also ask them if they would prefer to continue receiving telehealth 
care after the COVID-19 situation resolves and how it compares to receiving in-person 
care, as well as reasons why they might choose a telehealth appointment if offered in 
the future. They will be also asked to answer some self-report questions about their 
mental health and demographic.  
 
 
2.0 
Enrollment Criteria (who can be in your study and who would not be 
eligible to participate in your study): 
 
Inclusion Criteria 
1. Adults age 18 and over who received mental health care at Northwestern 
prior to telehealth implementation from March 15th 2019 to March 14th 2020 
and had at least one mental health care appointment at Northwestern 
between March 15th 2020 and September 30th 2020. 
 
Exclusion Criteria 
1. Adults unable to access study questionnaires via computer or mobile device 
 
 
3.0 
Sample Size: 
 
We will recruit participants through Northwestern’s outpatient behavioral health clinics. 
We plan to have about 600 participants with completed surveys.  
 
4.0 
Recruitment and Screening Methods: 
 
Participants will be pre-screened through Northwestern Medicine Enterprise 
Datawarehouse (NM EDW) report. The EDW report would only contain participant’s 
name, email, and if they received care through telehealth or not between March 15, 
2020 and September 30th 2020. No mental health information would be extracted in the 
EDW report. There will be no reviewing of participants’ medical charts during both 
prescreening and post screening phases for the purposes of this study. Participants in 
the EDW report would be sent an email link to a REDCap online survey to complete the 
study questionnaire. The REDCap survey will be created using the Northwestern 
REDCap platform and Northwestern email. Participants will be emailed up to five (5) 

 
 
 
 
v3.0 12/08/2020 
 
times to remind them to complete the survey, in addition to the original invitation email. 
The reminders will be sent no more than six (6) days apart, with the exception of the final 
email reminder sent on the day the survey closes.  
 
5.0 
Research Locations: 
 
Participants will receive a link to a REDCap online survey on their email to complete the 
study questionnaires. The REDCap surveys will be created using the Northwestern 
REDCap platform and Northwestern email and will be accessible on any internet 
enabled electronic device. The research regulatory, and other files will be maintained on 
NU research storage servers, secure Microsoft team’s sharepoint channel and NU 
REDCap software.   
 
 
6.0 
Multi-site Research (research that involves external collaborating 
institutions and individuals): 
 
This is a single site research study. 
 
 
7.0 
Procedures Involved: 
 
We plan to use Questionnaire/survey to be sent to participants. Participants will receive 
a link to a REDCap online survey to complete the study questionnaires. The REDCap 
survey will be created using the Northwestern REDCap platform and the sender will 
show up as a Northwestern email address. Participants will be emailed up to five (5) 
times to remind them to complete the survey, in addition to the original invitation email. 
The reminders will be sent no more than six (6) days apart, with the exception of the final 
email reminder sent on the day the survey closes.  
Our analysis will focus on patients’ perceptions of availability of care, usage, ease of 
use, comfort of use, quality of interaction, interface interaction, overall quality, and 
satisfaction with mental health care appointments via telehealth. We will also ask them if 
they would prefer to continue receiving telehealth care after the COVID-19 situation 
resolves and how it compares to receiving in-person care, as well as reasons why they 
might choose a telehealth appointment if offered in the future. They will be also asked to 
answer some self-report questions about their mental health and demographics. 
These surveys will ask participants perception on availability of care, usage, ease of use, 
comfort of use, quality of interaction, interface interaction, overall quality, and 
satisfaction.   We will also ask them if they would prefer to continue receiving telehealth 
care after the COVID-19 situation resolves and how it compares to receiving in-person 
care, as well as reasons why they might choose a telehealth appointment if offered in 
the future. They will be also asked to answer some self-report questions about their 
mental health and demographic. Many of these questions will be answered on a five-
point Likert scale.  Participants’ medical charts will not be reviewed for purposes of this 
study. This will be only a one-time survey. We anticipate it will take participants an 
average of 5-10 minutes to complete this survey.  
 
Once enrollment begins, we plan to complete all data collection in a period of six 
months. Participants will have access to complete the survey before the survey is 
shutdown. 

 
 
 
 
v3.0 12/08/2020 
 
 
8.0 
Consent Process:  
This study collects anonymous self-reported responses and participant’s medical chart 
will not be reviewed for purposes of this study and would hence qualify for a waiver of 
HIPAA authorization. We will utilize an online consent and potential participants will read 
the consent form on their own online using REDCap and answer “I Agree” if they choose 
to consent or “I Disagree” if they do not consent. They will also be informed that they can 
skip any answers they do not want to answer, and they can close the window at any time 
to exit the survey. They will also be given the option to download a blank PDF copy of 
the consent form. Once participants agree to consent, they will be routed to the study 
questionnaires/surveys. Respondents who do not consent will receive a termination 
message stating that they are choosing to end the survey. 
  
9.0 
Waiver of Participant Signature on Consent Form: 
 
This study collects anonymous self-reported responses and participant’s medical chart 
will not be reviewed for purposes of this study and would hence qualify for a waiver of 
HIPAA authorization. We will utilize an online consent without HIPAA section and 
participants will not sign the form instead click “I Agree” if they choose to consent or “I 
Disagree” if they do not want to consent. 
 
10.0 Waivers and Alterations of Consent Information: 
 
This study collects anonymous self-reported responses and participant’s medical chart 
will not be reviewed for purposes of this study and would hence qualify for a waiver of 
HIPAA authorization. We will utilize an online consent without HIPAA section and 
participants will not sign the form instead click “I Agree” if they choose to consent or “I 
Disagree” if they do not want to consent. 
 
11.0 Financial Compensation 
Participants who complete the entire survey honestly will be provided a $5 Starbucks gift 
card for their time.  
 
12.0 Potential Benefits of this Research:  
 
There is no direct benefit to participants participating in this study. However, if the 
results of this study lead to policy changes towards reimbursement of mental 
health care through telehealth, participants who prefer receiving mental health 
care through telehealth may benefit in having this additional choice. 
 
13.0 Potential Risks to Participants: 
A potential risk of participating in this study includes accidental disclosure of 
information.  However, we are not collecting any health information from medical 
charts neither during prescreening nor during the study.   
 
 
14.0 Provisions to Protect Participant Privacy and Data Confidentiality: 
 

 
 
 
 
v3.0 12/08/2020 
 
 
Participant Privacy: 
All responses will be collected anonymously and will not be linked to their medical 
record. No identifying information is being collected except their name and contact 
information during prescreening. Also, participant’s individual responses will not be 
viewed by their mental health care provider including the director of the study Dr. Jeffrey 
T. Rado MD, MPH. Only research team will have access to the data, and it will be stored 
on secure password-protected Northwestern servers. De-identified data may be shared 
with the larger community or with collaborators.  
 
The participant’s identifiers will be removed prior to data analysis. Contact information 
and responses will be retained in REDCap until it is determined we have the required 
study sample for analysis. After we have the required data, all contact information and 
identifiers would be removed from all platforms and NM EDW portal access report for 
this study would be removed. 
 
Confidentiality of data 
All responses will be collected anonymously. Only research team will have access to this 
data, and it will be stored on secure password-protected Northwestern servers.   
After all data is analyzed the patient name and email identifiers will be removed.  
 
15.0 Data Monitoring Plan to Ensure the Safety of Participants: 
 
The assessments collected do not affect participant mental health or physical health. 
There will be no specific data monitoring plan for this study. Data storage will be stored 
per NU policy  
 
16.0 Long-term Data and Specimen Storage and Sharing:   
 
Data will be stored per NU policy. 
 
 
 

 
 
 
 
v3.0 12/08/2020 
 
17.0 Qualifications of Research Team to Conduct the Research:  
Staff and qualifications  
  
Person  
Research Role  
Research Experience  
Jeffrey Rado, MD   
Principal investigator  
15+ years in clinical trials 
acting as  
principal and sub 
investigator.  
Marko Mihailovic, MA,  
LCPC, CCRC  
Project 
Manager/Backup coordinator  
10+ years of research  
experience as a rater and  
budget contact.  
Experience in  
management,  
coordination, and rating in  
clinical trials. 6+ years in  
psychology and 7+ years  
in biological research.  
Ankit Jain, MS  
Study Coordinator  
3+year experience in  
clinical trials, 6 years’ 
experience in IT  
Rebecca Prettyman, MA  Research Assistant  
7 years psychology  
research experience and  
1+years’ experience in  
clinical trials  
  
Prior to the study start date, research personnel will undergo the protocol training as well 
as training on assessments, evaluations, study specific procedures, and data-reporting 
tools utilized in this trial.  
 
 
 

 
 
 
 
v3.0 12/08/2020 
 
References 
 
1. Kannarkat, J.T., Smith, N.N. & McLeod-Bryant, S.A. Mobilization of 
Telepsychiatry in Response to COVID-19—Moving Toward 21st Century Access 
to Care. Adm Policy Ment Health 47, 489–491 (2020). 
https://doi.org/10.1007/s10488-020-01044-z 
2. Lori Uscher-Pines, Jessica Sousa, Pushpa Raja, Ateev Mehrotra, Michael L. 
Barnett, Haiden A. Huskamp Suddenly Becoming a "Virtual Doctor" Experiences 
of Psychiatrists Transitioning to Telemedicine During the COVID-19 Pandemic, 
Psychiatric Services (2020). doi: 10.1176/appi.ps.202000250 , RAND.org (May 
19, 2020) 
3. Lindsay et al. (2020). The Importance of Video Visits in the Time of COVID-19. 
The Journal of Rural Health. Accepted, unedited article available from 
https://doi.org/10.1111/jrh.12480  
4. Perrin, PB, Rybarczyk, BD, Pierce, BS, Jones, HA, Shaffer, C, Islam, L. Rapid 
telepsychology deployment during the COVID‐19 pandemic: A special issue 
commentary and lessons from primary care psychology training. J Clin Psychol. 
2020; 76: 1173– 1185. https://doi.org/10.1002/jclp.22969