Notice2021-22239
Supplemental Evidence and Data Request on Telehealth During COVID-19
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 13, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 86 Issue 195 (Wednesday, October 13, 2021)</title>
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[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56950-56953]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22239]
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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.
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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unpublished pertinent scientific information will improve the quality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: <a href="/cdn-cgi/l/email-protection#086d786b4869607a792660607b266f677e"><span class="__cf_email__" data-cfemail="3550455675545d47441b5d5d461b525a43">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#3c594c5f7c5d544e4d1254544f125b534a"><span class="__cf_email__" data-cfemail="ff9a8f9cbf9e978d8ed197978cd1989089">[email protected]</span></a>.
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:
<a href="https://effectivehealthcare.ahrq.gov/products/virtual-health-covid/protocol">https://effectivehealthcare.ahrq.gov/products/virtual-health-covid/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
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PICOT Inclusion Exclusion
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Population........... All KQ: All KQ: Patients
<bullet> Patients of any receiving inpatient
age (or their caregivers care. Providers
for KQ3 KQ4). providing inpatient
care.
<bullet> Health systems
<bullet> Hospitals
<bullet> Providers
Interventions........ KQ 1-3: All KQ: Remotely
<bullet> 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).
<bullet> 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.:
<bullet> Practice
efficiency
<bullet> No-show rates
<bullet> Staffing hours
<bullet> 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.
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* 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
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