[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 Access to published and unpublished 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

[[Page 15058]]

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

[[Page 15059]]

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