[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Pages 15057-15059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05840]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Telehealth for Acute
and Chronic Care Consultations
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 to inform
our review on Telehealth for Acute and Chronic Care Consultations,
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 Access to published and unpublished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. AHRQ is conducting this systematic review pursuant to the
Public Health Service Act.
DATES: Submission Deadline on or before April 24, 2017.
ADDRESSES:
Email submissions: src.org">SEADS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 51723 or Email: src.org">SEADS@epc-src.org.
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 for Acute
and Chronic Care Consultations.
The EPC Program is dedicated to identifying as many studies as
possible
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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 for Acute and Chronic Care Consultations,
including those that describe adverse events. The entire research
protocol, including the key questions, is also available online at:
https://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2434.
This is to notify the public that the EPC Program would find the
following information on Telehealth for Acute and Chronic Care
Consultations 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, please provide 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 will be very beneficial to the EPC Program. The
contents of all submissions will be made available to the public upon
request. 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 Web
site 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/index.cfm/join-the-email-list1/.
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.
The Key Questions
KQ 1: Are telehealth consultations effective in improving clinical
and economic outcomes?
Telehealth consultations can be for any acute or chronic clinical
condition across any specialty ranging from infectious disease to
psychiatry.
Clinical and economic outcomes may include, but are not limited to,
mortality and morbidity, utilization of health services, cost of
services, and access to services.
KQ 2: Are telehealth consultations effective in improving
intermediate outcomes?
Intermediate outcomes include both outcomes that precede the
ultimate outcomes of interest and secondary outcomes.
Intermediate outcomes may include, but are not limited to, patient
and provider satisfaction, behavior, and decisions (e.g., patient
completion of treatment, provider antibiotic stewardship); volume of
services; and health care processes (e.g., time to diagnosis or
treatment).
KQ 3: Have telehealth consultations resulted in harms, adverse
events, or negative unintended consequences?
What are the characteristics of telehealth consultations that have
been the subject of comparative studies?
The characteristics include:
(a) Clinical conditions addressed. These can include broad
categories such as diagnosis and treatment of infectious disease or
specific conditions (e.g., upper respiratory infection, hepatitis C,
skin infections) or decisions (e.g., stewardship of antibiotics or
antimicrobials, selection of treatments).
(b) Characteristics of the providers and patients involved.
(c) Relationships among the providers and patients involved
including whether these are new or ongoing relationships.
(d) Telehealth modalities and/or methods for sharing patient data
used.
(e) Whether specifics in (d) meet Medicare's coverage and HIPAA
requirements.
(f) Settings including.
Type of health care organization including the
organizational structure (e.g., integrated delivery system, critical
access) and the type of care (e.g., long-term care, inpatient,
ambulatory care).
Country.
Geographic and economic characteristics such as urban or
rural areas, or areas with high vs. low socioeconomic resources.
(g) Other circumstances (e.g., appropriate transportation,
climate).
(h) Payment models or requirements or limits for payment including.
The payer/insurance for the patient (e.g., Medicare,
Medicaid, commercial).
Any parameters for payment (e.g., relative value units
[RVUs]) or limits on visits.
Any eligibility requirements for payment based on patient,
provider, setting or context characteristics.
KQ 5: Do clinical, economic, intermediate, or negative outcomes
(i.e., the outcomes in Key Questions 1, 2, and 3) vary across
telehealth consultation characteristics (Key Question 4)?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Populations
Patients of any age, with medical care needs for
prevention, treatment, or management of chronic or acute conditions.
Providers (clinicians or health care organizations).
Payers for health care services (public, private,
insurers, patients).
Interventions
Telehealth consultations are defined as the use of
telehealth designed to facilitate collaboration among providers, often
involving a specialist, or between clinical team members, across time
and/or distance, on the assessment, diagnosis, and/or clinical
management of a specific patient or group of patients.
Telehealth consultations can be for any acute or chronic
conditions. The search will be both general as well as focused on
conditions identified as areas of growth and policy interest such as
infection, disease, dermatology, and critical care.
Telehealth consultations can use any technology (e.g.,
real-time video, store and forward).
Comparator
Other locations, patients, or time periods that use in-person
consultations
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or provide usual care (which could include no access to specific
services).
Outcomes for Each Key Question
Key Question 1: Clinical and Economic Outcomes
Clinical outcomes such as mortality, morbidity, function,
recovery, infection, and access to services.
Economic outcomes such as return on investment, cost,
volume of visits, and resource use.
Key Question 2: Intermediate Outcomes
Patient satisfaction, behavior, and decisions such as
completion of treatment, or satisfaction with less travel to access
health care.
Provider satisfaction, behavior, and decisions such as
choice of treatment or antibiotic stewardship.
Time to diagnosis and time to treatment.
Diagnostic concordance or other measures of agreement
between in-person and telehealth consultations.
Key Question 3: Adverse Effects or Unintended Consequences
Loss of privacy or breach of data security.
Misdiagnosis or delayed diagnosis.
Inappropriate treatment.
Increase in resource costs, negative return on investment.
Key Question 4: Not Applicable (This is a Descriptive Question)
Key Question 5: Clinical and Economic Outcomes (see Key Question 1),
Intermediate Outcomes (see Key Question 2), and Adverse Effects or
Unintended Consequences (see Key Question 3).
Timing
Telehealth consultations can be used at any point in the
diagnosis, treatment, or management of a patient.
Outcome measurement needs to occur after the telehealth
consultation.
Setting
The consultation can involve providers and patients in any
location. These could include inpatient, outpatient, or long-term care,
and could be in civilian, Veterans Administration, or military
facilities.
Study Designs
Comparative studies, including trials and observational
studies.
Descriptive studies may be used to inform the decision
model as needed but will not be included in the systematic review.
Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-05840 Filed 3-23-17; 8:45 am]
BILLING CODE 4160-90-P