Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Agency for Healthcare Research and Quality

# 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                         *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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: 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                     *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:                

                     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.*

*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.                

*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.                

                     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                           ( print 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?

○ Who are the current patients, providers, and payers engaged in provider-to-provider telehealth in rural areas?

○ 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

### • Population(s)

○ Rural individual patients, patient families/care partners, and patient populations.

○ Healthcare providers (individuals and organizations) who provide health care services to rural patients or populations.
    - Providers include any profession or occupation providing formal, paid services.
    - Family or informal care partners are not considered providers.

○ Payers who pay for healthcare services for rural patients or populations.

### • Interventions

○ 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.

### • Comparators

                    ○                     *KQ1:*                     Other telehealth facilitated care (not provider-to-provider), usual (in-person) provider-to-provider supports, no interaction or no care.                

                    ○                     *KQ2:*                     Different strategies for dissemination, implementation, or spread; no strategies; time periods prior to implementation.                

### • Outcomes

                    ○                     *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.                

                    ○                     *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.                

### • Settings

○ Outpatient (primary care and specialty care), inpatient, prehospital and emergency care, post-acute and long-term care.

○ Civilian, Veterans Administration, or military.

○ Health care and non-healthcare settings where health services are delivered including in the home.

                    ○ 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