Supplemental Evidence and Data Request on Telehealth During COVID-19, 56950-56953 [2021-22239]
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Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices
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[FR Doc. 2021–22200 Filed 10–12–21; 8:45 am]
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Board of Governors of the Federal Reserve
System, October 7, 2021.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2021–22261 Filed 10–12–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Telehealth During COVID–
19
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Telehealth During COVID–19, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before November 12, 2021.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A.
Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers
Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Telehealth During COVID–
19. AHRQ is conducting this technical
brief pursuant to Section 902 of the
Public Health Service Act, 42 U.S.C.
299a.
The EPC Program is dedicated to
identifying as many studies as possible
SUMMARY:
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Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Telehealth During
COVID–19, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/virtual-health-covid/protocol.
This is to notify the public that the
EPC Program would find the following
information on Telehealth During
COVID–19 helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1. What are the characteristics of
patient, provider, and health systems
using telehealth during the COVID–19
era, specifically:
a. What are the characteristics of
patients (e.g., age, race/ethnicity,
gender, socioeconomic status,
education, geographic location (urban
versus rural))?
b. What are the provider and health
system characteristics (e.g., specialty,
geographic location, private practice,
hospital-based practice)?
c. How do the characteristics of
patients, providers, and health systems
differ between the first four months of
the COVID–19 era versus the remainder
of the COVID–19 era?
KQ 2. What are the benefits and
harms of telehealth during the COVID–
19 era?
a. Does this vary by type of telehealth
intervention (i.e., telephone, video
visits)?
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b. Does this vary by patient
characteristic (i.e., age, gender, race/
ethnicity, type of clinical condition or
health concern, geographic location)?
c. Does this vary by provider and
health system characteristic (e.g.,
specialty, geographic location, private
practice, hospital-based practice)?
KQ 3. What is considered a successful
telehealth intervention during the
COVID–19 era:
a. From the patient or caregiver
perspective?
b. From the provider perspective?
c. From the health system
perspective?
KQ 4. What strategies have been used
to implement telehealth interventions
during the COVID–19 era?
a. What are the barriers and enablers
of a successful telehealth strategy (e.g.,
setting, reimbursement, access to
technology)?
Æ From the patient or caregiver
perspective?
Æ From the provider perspective?
Æ From the health system
perspective?
Contextual Questions (CQ)
CQ 1. What are the costs of
implementation and return on
investment for telehealth during the
COVID–19 era to the provider/
healthcare system?
CQ 2. What are the policy and
reimbursement considerations for
telehealth during the COVID–19 era?
a. How are these policy and
reimbursement considerations for
telehealth changing in the post-COVID–
19 era (from March 2020, when the
World Health Organization declared
COVID–19 a pandemic to present); at
the federal level (policies such as
Medicare), state level (policies such as
Medicaid), and by private insurance
payers?
b. How do changes in reimbursement
policies impact telehealth strategies?
PICOTS (Population, Intervention,
Comparator, Outcome, Timing, Setting)
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TABLE 1—PICOTS: INCLUSION AND EXCLUSION CRITERIA
PICOT
Inclusion
Exclusion
Population ..........
All KQ:
• Patients of any age (or their caregivers for KQ3 KQ4)
• Health systems
• Hospitals
• Providers
KQ 1–3:
• Remotely delivered synchronous medical services (e.g., telephone, video visits) between a patient and a healthcare provider in an ambulatory setting (e.g., outpatient and community-based clinics) or ED providing.
All KQ: Patients receiving inpatient care. Providers
providing inpatient care.
Interventions ......
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All KQ: Remotely delivered, non-synchronous medical
services (e.g., remote monitoring devices, health
apps, wearable devices, patient portals).
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Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices
TABLE 1—PICOTS: INCLUSION AND EXCLUSION CRITERIA—Continued
PICOT
Inclusion
Comparators ......
Outcomes ..........
Timing ................
Setting ...............
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Study Design † ..
Exclusion
Æ acute/urgent care (e.g., symptom management); routine/
chronic care (e.g., preventive services, chronic disease management); mental health services; wellness visits; post-hospital discharge care (e.g., routine follow-up and care for
nonacute issues).
• Patient and specialist communications facilitated by an ED
physician in an ED (particularly important in rural care setting).
KQ4: Implementation strategies for telehealth.
KQ 1–3: In-person care, no care, no comparison
KQ 4: Implementation strategies for telehealth
KQ 1: Not applicable
KQs 2 and 3:
Æ Patient/provider-level outcomes
D Patient satisfaction/perceptions
D Physician/provider satisfaction/engagement/burnout
Æ System outcomes
D Healthcare access (e.g., insurance coverage, WIFI and
smartphone access)
D Healthcare utilization (e.g., hospitalization, readmission,
ED visit)
D Healthcare performance and quality measures (e.g., adhering or meeting Healthcare Effectiveness Data and Information Set (HEDIS) standards or other validated quality measures), e.g.:
• Practice efficiency
• No-show rates
• Staffing hours
• Cycle times
D Communication
Æ Clinical outcomes(any)
D Medication adherence
D Up to date lab values
Æ Adverse effects/patient safety issues
D Inappropriate treatment
D Misdiagnosis/delayed diagnosis/care
D Case resolution/Duplication of services (telehealth followed immediately by in-person visit)
D Privacy/confidentiality breaches
Æ Cost (see Appendix A for detailed cost outcomes)
KQ4:
Æ Barriers and enablers
All KQ: the era of COVID–19 (March 2020-present)
KQ1d: During the first 4 months or beyond the initial phase.*
ALL KQ:
Æ Healthcare provided outside of a medical office via phone or
video.
Æ Healthcare provided in an ED by a specialist via phone or
video.
Æ U.S.-like outpatient population (including ED) (see Appendix
B for a list of included countries)
KQ1: Claims and EHR data
KQ 2 and 4
Æ Qualitative studies: Focus groups, interviews
Æ Quantitative studies: RCT, CT, observational studies, and
surveys
KQ3: Qualitative studies: Focus groups, interviews.
NA.
NA.
Studies completed prior to the era of COVID–19.
Inpatient setting. Non-U.S. based studies with different
patient population or health system characteristics.
* Studies that began before the era of COVID–19 (11 March 2020) and extend into the era of COVID–19 will be excluded unless they meet the
following criteria: Data from the pre and post COVID–19 era are stratified—the stratified data will be extracted; studies initiated as early as 1 January 2020 can be included if they are studies of telehealth in response to COVID–19.
† To be eligible for inclusion as a qualitative study, the Sampling, data collection, and data analyses must be systematically conducted; data
must be analyzed using methods of qualitative data analysis (such as thematic analysis).
CT = controlled trial; ED = emergency department; EHR = electronic health record; HEDIS = Healthcare Effectiveness Data and Information
Set; KQ = key question(s); NA = not applicable, RCT = randomized controlled trial.
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Federal Register / Vol. 86, No. 195 / Wednesday, October 13, 2021 / Notices
Dated: October 7, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–22239 Filed 10–12–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Request for Information: AHRQ’s Role
in Climate Change and Environmental
Justice
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of request for
information.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
information from the public on how the
agency may have the greatest impact in
addressing climate change through its
core competencies of health systems
research, practice improvement, and
data & analytics. Specifically, AHRQ
wants to learn how the agency can best
use its resources to help build the
healthcare system’s resilience to climate
threats, reduce the healthcare industry’s
contribution to climate change while
increasing sustainability, and address
environmental justice issues in
healthcare.
SUMMARY:
Comments on this notice must be
received by December 13, 2021. AHRQ
will not respond individually to
responders but will consider all
comments submitted by the deadline.
ADDRESSES: Please submit all responses
via email to ClimateChange@
AHRQ.HHS.gov as a Word document or
in the body of an email.
FOR FURTHER INFORMATION CONTACT:
Brent Sandmeyer, Social Science
Analyst, Email: Brent.Sandmeyer@
AHRQ.HHS.gov, Telephone: 301–427–
1441.
DATES:
The
Agency for Healthcare Research and
Quality’s mission is to produce
evidence to make healthcare safer,
higher quality, more accessible,
equitable, and affordable, and to work
within the U.S. Department of Health
and Human Services and with other
partners to make sure that the evidence
is understood and used.
In pursuit of that mission, AHRQ
recognizes that climate change is a large
and growing threat to public health and
the ability of the U.S. healthcare system
to provide high quality, equitable care.
Climate change has contributed to heat
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SUPPLEMENTARY INFORMATION:
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waves, wildfires, hurricanes, droughts,
flooding, and associated infrastructure
failures. All of these have detrimental
physical and behavioral health
consequences and place increased
demands on the healthcare system as it
also struggles to respond to the COVID–
19 pandemic. Both climate change and
the COVID–19 pandemic have
highlighted and exacerbated longstanding racial, ethnic, and economic
health disparities.
AHRQ is seeking the public’s input on
how the agency may have the greatest
impact in addressing climate change
through its core competencies of health
systems research, practice improvement,
and data & analytics. Specifically,
AHRQ wants to learn how the agency
can best use its resources to help build
the healthcare system’s resilience to
climate threats, reduce the healthcare
industry’s contribution to climate
change while increasing sustainability,
and address environmental justice
issues in healthcare.
AHRQ is requesting information from
the public regarding the following broad
questions:
1. What should AHRQ’s role be at the
intersection of climate change,
healthcare, and environmental justice to
maximize the agency’s impact?
2. How can AHRQ incorporate climate
change and environmental justice issues
into its core competencies of healthcare
systems research, practice improvement,
and data & analytics?
3. What are the most pressing
healthcare-related areas of climate
change and environmental justice
research and actions that AHRQ could
address? Relatedly, what evidence do
healthcare systems and policymakers
need to make decisions on responding
to climate change?
4. How can AHRQ help healthcare
systems prepare for and respond to the
impacts of climate change on patient
care, especially for vulnerable
populations?
5. What role could AHRQ play in
identifying, gathering, and
disseminating data on climate-related
risks and impacts, and making the
information timely and easily available
for researchers, healthcare systems, and
policy makers?
6. What practice improvement
resources (e.g., tools, strategies) could
AHRQ provide to help healthcare
systems improve patient safety and
system resiliency during climate-related
emergencies?
7. What are the training and education
needs of healthcare professionals related
to climate change and what role could
AHRQ play in addressing those needs?
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8. What key research has been
conducted to assess or mitigate the
impact that healthcare has on climate
change? What are effective strategies to
measure and reduce the carbon footprint
and other environmental impacts of the
healthcare sector?
9. What has been learned about health
systems’ capacity and limitations during
the COVID–19 pandemic that can help
care delivery organizations better
address climate change impacts and
reduce disparities?
10. How might AHRQ take advantage
of the existing national infrastructure to
advance quality and safety (e.g.,
measurement standards, accrediting
bodies, learning networks, incentives) to
accelerate work on climate health and
equity?
11. Which organizations working on
climate change response in healthcare
should AHRQ learn from and
collaborate with? Please describe the
nature of the organization’s work,
evidence, and solutions, as applicable.
AHRQ is interested in all of the
questions listed above, but respondents
are welcome to address as many or as
few as they choose and to address
additional areas of interest not listed.
This RFI is for planning purposes
only and should not be construed as a
policy, solicitation for applications, or
as an obligation on the part of the
Government to provide support for any
ideas identified in response to it. AHRQ
will use the information submitted in
response to this RFI at its discretion and
will not provide comments to any
responder’s submission. However,
responses to the RFI may be reflected in
future solicitation(s) or policies. The
information provided will be analyzed
and may appear in reports. Respondents
will not be identified in any published
reports. Respondents are advised that
the Government is under no obligation
to acknowledge receipt of the
information received or provide
feedback to respondents with respect to
any information submitted. No
proprietary, classified, confidential, or
sensitive information should be
included in your response. The contents
of all submissions will be made
available to the public upon request.
Materials submitted must be publicly
available or can be made public.
Dated: October 6, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–22166 Filed 10–12–21; 8:45 am]
BILLING CODE 4160–90–P
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]]>Agencies
[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56950-56953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22239]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Telehealth During
COVID-19
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Telehealth
During COVID-19, which is currently being conducted by the AHRQ's
Evidence-based Practice Centers (EPC) Program. Access to published and
unpublished pertinent scientific information will improve the quality
of this review.
DATES: Submission Deadline on or before November 12, 2021.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A. Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Telehealth During
COVID-19. AHRQ is conducting this technical brief pursuant to Section
902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible
[[Page 56951]]
that are relevant to the questions for each of its reviews. In order to
do so, we are supplementing the usual manual and electronic database
searches of the literature by requesting information from the public
(e.g., details of studies conducted). We are looking for studies that
report on Telehealth During COVID-19, including those that describe
adverse events. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/virtual-health-covid/protocol.
This is to notify the public that the EPC Program would find the
following information on Telehealth During COVID-19 helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ 1. What are the characteristics of patient, provider, and health
systems using telehealth during the COVID-19 era, specifically:
a. What are the characteristics of patients (e.g., age, race/
ethnicity, gender, socioeconomic status, education, geographic location
(urban versus rural))?
b. What are the provider and health system characteristics (e.g.,
specialty, geographic location, private practice, hospital-based
practice)?
c. How do the characteristics of patients, providers, and health
systems differ between the first four months of the COVID-19 era versus
the remainder of the COVID-19 era?
KQ 2. What are the benefits and harms of telehealth during the
COVID-19 era?
a. Does this vary by type of telehealth intervention (i.e.,
telephone, video visits)?
b. Does this vary by patient characteristic (i.e., age, gender,
race/ethnicity, type of clinical condition or health concern,
geographic location)?
c. Does this vary by provider and health system characteristic
(e.g., specialty, geographic location, private practice, hospital-based
practice)?
KQ 3. What is considered a successful telehealth intervention
during the COVID-19 era:
a. From the patient or caregiver perspective?
b. From the provider perspective?
c. From the health system perspective?
KQ 4. What strategies have been used to implement telehealth
interventions during the COVID-19 era?
a. What are the barriers and enablers of a successful telehealth
strategy (e.g., setting, reimbursement, access to technology)?
[cir] From the patient or caregiver perspective?
[cir] From the provider perspective?
[cir] From the health system perspective?
Contextual Questions (CQ)
CQ 1. What are the costs of implementation and return on investment
for telehealth during the COVID-19 era to the provider/healthcare
system?
CQ 2. What are the policy and reimbursement considerations for
telehealth during the COVID-19 era?
a. How are these policy and reimbursement considerations for
telehealth changing in the post-COVID-19 era (from March 2020, when the
World Health Organization declared COVID-19 a pandemic to present); at
the federal level (policies such as Medicare), state level (policies
such as Medicaid), and by private insurance payers?
b. How do changes in reimbursement policies impact telehealth
strategies?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
Table 1--PICOTS: Inclusion and Exclusion Criteria
------------------------------------------------------------------------
PICOT Inclusion Exclusion
------------------------------------------------------------------------
Population........... All KQ: All KQ: Patients
Patients of any receiving inpatient
age (or their caregivers care. Providers
for KQ3 KQ4). providing inpatient
care.
Health systems
Hospitals
Providers
Interventions........ KQ 1-3: All KQ: Remotely
Remotely delivered, non-
delivered synchronous synchronous medical
medical services (e.g., services (e.g.,
telephone, video visits) remote monitoring
between a patient and a devices, health
healthcare provider in an apps, wearable
ambulatory setting (e.g., devices, patient
outpatient and community- portals).
based clinics) or ED
providing..
[[Page 56952]]
[cir] acute/urgent care
(e.g., symptom
management); routine/
chronic care (e.g.,
preventive services,
chronic disease
management); mental
health services; wellness
visits; post-hospital
discharge care (e.g.,
routine follow-up and
care for nonacute
issues).
Patient and
specialist communications
facilitated by an ED
physician in an ED
(particularly important
in rural care setting).
KQ4: Implementation
strategies for
telehealth.
Comparators.......... KQ 1-3: In-person care, no NA.
care, no comparison
KQ 4: Implementation
strategies for telehealth.
Outcomes............. KQ 1: Not applicable NA.
KQs 2 and 3:..............
[cir] Patient/provider-
level outcomes
[ssquf] Patient
satisfaction/perceptions
[ssquf] Physician/provider
satisfaction/engagement/
burnout
[cir] System outcomes
[ssquf] Healthcare access
(e.g., insurance
coverage, WIFI and
smartphone access)
[ssquf] Healthcare
utilization (e.g.,
hospitalization,
readmission, ED visit)
[ssquf] Healthcare
performance and quality
measures (e.g., adhering
or meeting Healthcare
Effectiveness Data and
Information Set (HEDIS)
standards or other
validated quality
measures), e.g.:
Practice
efficiency
No-show rates
Staffing hours
Cycle times
[ssquf] Communication
[cir] Clinical
outcomes(any)
[ssquf] Medication
adherence
[ssquf] Up to date lab
values
[cir] Adverse effects/
patient safety issues
[ssquf] Inappropriate
treatment
[ssquf] Misdiagnosis/
delayed diagnosis/care
[ssquf] Case resolution/
Duplication of services
(telehealth followed
immediately by in-person
visit)
[ssquf] Privacy/
confidentiality breaches
[cir] Cost (see Appendix A
for detailed cost
outcomes)
KQ4:
[cir] Barriers and
enablers
Timing............... All KQ: the era of COVID- Studies completed
19 (March 2020-present) prior to the era of
KQ1d: During the first 4 COVID-19.
months or beyond the
initial phase.*.
Setting.............. ALL KQ: Inpatient setting.
[cir] Healthcare provided Non-U.S. based
outside of a medical studies with
office via phone or different patient
video.. population or health
system
characteristics.
[cir] Healthcare provided
in an ED by a specialist
via phone or video.
[cir] U.S.-like outpatient
population (including ED)
(see Appendix B for a
list of included
countries)
Study Design [dagger] KQ1: Claims and EHR data
KQ 2 and 4
[cir] Qualitative studies:
Focus groups, interviews
[cir] Quantitative
studies: RCT, CT,
observational studies,
and surveys
KQ3: Qualitative studies:
Focus groups, interviews.
------------------------------------------------------------------------
* Studies that began before the era of COVID-19 (11 March 2020) and
extend into the era of COVID-19 will be excluded unless they meet the
following criteria: Data from the pre and post COVID-19 era are
stratified--the stratified data will be extracted; studies initiated
as early as 1 January 2020 can be included if they are studies of
telehealth in response to COVID-19.
[dagger] To be eligible for inclusion as a qualitative study, the
Sampling, data collection, and data analyses must be systematically
conducted; data must be analyzed using methods of qualitative data
analysis (such as thematic analysis).
CT = controlled trial; ED = emergency department; EHR = electronic
health record; HEDIS = Healthcare Effectiveness Data and Information
Set; KQ = key question(s); NA = not applicable, RCT = randomized
controlled trial.
[[Page 56953]]
Dated: October 7, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-22239 Filed 10-12-21; 8:45 am]
BILLING CODE 4160-90-P
