[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Pages 12190-12191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Improving Rural Health 
Through Telehealth-Guided Provider-to-Provider Communication

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 Improving Rural 
Health Through Telehealth-Guided Provider-to-Provider Communication, 
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 Access to published and unpublished 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 April 1, 2021.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#d6b3a6b596b7bea4a7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="3653465576575e4447185e5e4518515940">[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#f1948192b190998380df999982df969e87"><span class="__cf_email__" data-cfemail="1174617251707963603f7979623f767e67">[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 Improving Rural Health 
Through Telehealth-Guided Provider-to-Provider Communication. AHRQ is 
conducting this systematic review 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 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 Improving Rural Health Through Telehealth-Guided 
Provider-to-Provider Communication, including those that describe 
adverse events. Telehealth for this review of provider-to-provider 
communication is defined as any telecommunications facilitated 
interaction among, or support for, healthcare professionals designed to 
improve access, quality of care, or health outcomes for rural patients 
and populations. This includes a wide range of clinical applications 
such as remote ICU management; consultations for inpatient and 
outpatient care; and remote rounds or group education and case review 
(e.g., Project ECHO, etc.). The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/rural-telehealth/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Improving Rural Health Through Telehealth-
Guided Provider-to-Provider Communication 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

[[Page 12191]]

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 (KQs)

KQ 1. What is the effectiveness of provider-to-provider telehealth for 
rural patients?

    a. What is the impact of provider-to-provider telehealth on rural 
patient and population outcomes?
    b. What is the impact of provider-to-provider telehealth on 
healthcare providers?
    c. What is the impact of provider-to-provider telehealth on private 
and public (ex. CMS, TriCare, VA, etc.) payers?
    d. What adverse events or unintended consequences are associated 
with provider-to-provider telehealth for rural patients?
    e. What are the methodological weaknesses of the identified 
effectiveness studies of provider-to-provider telehealth for rural 
patients and what improvements in study design (e.g., focus on relevant 
comparisons and outcomes) might increase the impact of future research?

KQ 2. What is the effectiveness of implementation strategies for 
provider-to-provider telehealth in rural areas?

    a. What is the uptake of different types of provider-to-provider 
telehealth in rural areas?
    [cir] Who are the current patients, providers, and payers engaged 
in provider-to-provider telehealth in rural areas?
    [cir] What factors affect whether provider-to-provider telehealth 
in rural areas can be sustained?
    b. Which barriers and facilitators impact adoption and 
implementation of provider-to-provider telehealth in rural areas?
    c. Which strategies are effective in sustaining provider-to-
provider telehealth in rural areas?
    d. What are the methodological weaknesses of the identified studies 
of implementation and sustainability of provider-to-provider telehealth 
in rural areas and what improvements in study design (e.g., focus on 
relevant comparisons and outcomes) might increase the impact of future 
research?

Populations, Interventions, Comparators, Outcomes, Settings

<bullet> Population(s)

    [cir] Rural individual patients, patient families/care partners, 
and patient populations.
    [cir] Healthcare providers (individuals and organizations) who 
provide health care services to rural patients or populations.
    <bullet> Providers include any profession or occupation providing 
formal, paid services.
    <bullet> Family or informal care partners are not considered 
providers.
    [cir] Payers who pay for healthcare services for rural patients or 
populations.

<bullet> Interventions

    [cir] Provider-to-provider telehealth defined as: Any 
telecommunications facilitated interaction among, or support for, 
healthcare professionals designed to improve access, quality of care, 
or health outcomes for rural patients and populations.

<bullet> Comparators

    [cir] KQ1: Other telehealth facilitated care (not provider-to-
provider), usual (in-person) provider-to-provider supports, no 
interaction or no care.
    [cir] KQ2: Different strategies for dissemination, implementation, 
or spread; no strategies; time periods prior to implementation.

<bullet> Outcomes

    [cir] KQ1: Clinical outcomes for the identified conditions 
(patient-reported outcomes, mortality, morbidity, such as function, 
illness recovery, infection); Economic outcomes such as return on 
investment, cost, volume of visits, and resource use, including length 
of stay and readmissions; Intermediate Outcomes; Patient satisfaction, 
behavior (such as care-seeking and compliance), and decisions such as 
completion of treatment, or satisfaction with less travel to access 
healthcare; Provider satisfaction, behavior, and decisions such as 
choice of treatment or antibiotic stewardship; Access measures and 
indicators including but not limited to time to diagnosis or time to 
treatment.
    [cir] KQ2: Indicators and measures of uptake (e.g., rates of use, 
timing to implementation) and characteristics of users; categories and 
descriptors of barriers and facilitators; categories and descriptors of 
strategies.

<bullet> Settings

    [cir] Outpatient (primary care and specialty care), inpatient, 
prehospital and emergency care, post-acute and long-term care.
    [cir] Civilian, Veterans Administration, or military.
    [cir] Health care and non-healthcare settings where health services 
are delivered including in the home.
    [cir] U.S. relevant settings [Note that studies from countries with 
significantly different healthcare systems and fewer resources (e.g., 
low-income countries) are excluded.]

    Dated: February 24, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-04187 Filed 3-1-21; 8:45 am]
BILLING CODE 4160-90-P


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