ATTACH 3_Evidence Based Telehealth Network Program Report 4

OMB # 0906-XXXX-NEW. Expiration Date: (XX/XX/20XX)

RTRC Study Protocol
Protocol to Collect Data on a Uniform Set of Data Elements
by EB THNP Grantees and SAT TNGP Grantees
Using the Behavioral-Telehealth Evidence Collection (B-TEC) Tool

Overview
The high prevalence of behavioral health conditions, shortage of available treatment
services, and initial evidence supporting telehealth approaches point to the need for
additional, well-designed studies to help build the evidence base to support the further
adoption of and reimbursement for telebehavioral health services (both mental health
and substance use) to increase access in rural settings. The Rural Telehealth
Research Center (RTRC) has been charged by the Federal Office of Rural Health
Policy (FORHP) to identify approaches that can be used across the Evidence-Based
Telebehavioral Health Network Program (EB THNP) grantees and the Substance Abuse
Treatment Telehealth Network Grant Program (SAT TNGP) grantees to enhance the
evidence base for telebehavioral health use in rural communities.
Purpose
The purpose of this document is to describe the research design and procedures for a
study to routinely collect data on a uniform set of data elements to be submitted by the
grantees to RTRC for analysis and dissemination. The ultimate objective of this project
is to enhance the evidence base for telehealth in rural settings using a standardized set
of data elements related to clinical outcomes, access/utilization, and cost/efficiency
measures.
Sample for Data Collection
Three organizations were awarded three-year grants beginning in September 2017 in
response to a FORHP notice of funding opportunity (NOFO) for the Substance Abuse
Treatment Telehealth Network Grant Program (SAT TNGP) and 14 organizations were
awarded three-year grants beginning in September 2018 in response to a FORHP
NOFO for the Evidence Based Telebehavioral Health Network Program (EB THNP).
Study Design
Data are to be collected on all patients where telehealth services are used as part of the
grant (Telehealth group) and on a 1 to 1 comparison sample of patients who receive
comparable services face-to-face (Non-telehealth comparison group). Ideally, grantees
will be able to identify clinics or treatment sites that provide face-to-face services that
are comparable to those delivered through telehealth, and to patients who are similar to
those receiving telehealth services. Collecting data on Non-telehealth comparison
groups is an important component of the research design and will enable us to answer
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important research questions using a more rigorous research approach. We recognize
that collecting these data elements on Non-telehealth comparison sites will present
challenges for grantees. Ideally across grantees, we will end up with roughly equal
numbers of patients in the Non-telehealth comparison group and the Telehealth group
and the patient characteristics (e.g. age, sex, race, ethnicity, insurance coverage,
principle diagnosis) will be similar for the two groups.
Data Elements to be Included in Data Collection
In a FORHP-funded project, RTRC identified a set of evidence-based behavioral health
data elements appropriate for use in telehealth studies. A list of the 28 data elements is
shown in Tables 1-3. These data elements are grouped into five domains: (1)
Identification; (2) Demographics; (3) Access; (4) Clinical Outcomes; and (5) Cost
Savings/Cost Effectiveness.
Table 1. Data Elements to be Collected Once at Baseline for Each Patient
Domain

Data Element

Access

1. Treatment group

ID
ID

2. Treatment Site ID
3. Patient ID

Demographics
Demographics
Demographics
Demographics
Cost Savings/
Effectiveness
Cost Savings/
Effectiveness

4.
5.
6.
7.
8.

Cost Savings/
Effectiveness

Cost Savings/
Effectiveness

Cost Savings/
Effectiveness

Age
Sex
Race
Ethnicity
Patient’s insurance status

9. Patient travel miles to the
initial planned place of
behavioral health
services
10. Patient travel time to the
initial planned place of
behavioral health
services
11. Patient travel miles to
next likely source of
behavioral health
services
12. Patient travel time to
next likely source of
behavioral health
services

Description of Data Element

Indicates whether the patient is in the telehealth
group or the non-telehealth comparison group
An ID assigned to each treatment site
An ID assigned to each patient that is converted to a
non-linkable ID when data are submitted to RTRC
The patient's age (years) at intake
The patient's sex
The patient’s racial group
The patient’s ethnic group
The type of insurance that the patient has at intake
Miles from the patient’s location to where the patient
plans to receive behavioral health services

Travel time from the patient’s location to where the
patient plans to receive behavioral health services

Miles from the patient’s location to the next likely
source of behavioral health services if the planned
place of services was not available
Travel time from the patient’s location to the next
likely source of behavioral health services if the
planned place of services was not available

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Cost Savings/
Effectiveness

13. Patient likelihood of using
next source of behavioral
health services

The patient’s likelihood of using next source of care
for type of service delivered

Table 2. Data Elements to be Collected at Baseline and Monthly for Each Patient
(for the first three months)
Domain
Clinical
Outcomes
Clinical
Outcomes
Clinical
Outcomes
Clinical
Outcomes
Clinical
Outcomes
Clinical
Outcomes
Clinical
Outcomes

Data Element
14. Survey instrument
administration timing
15. PROMIS Global Health –
Mental Health score
(component)
16. PROMIS Global Health –
Physical Health score
(component)
17. PROMIS Global Health score
(total)
18. PHQ-9 depression
symptoms score
19. GAD-7 generalized anxiety
symptoms score
20. DUDIT-C substance use
severity score

Description of Data Element
The number of weeks from initiation of treatment to when
the survey instrument(s) were re-administered
Use the PROMIS to track patient functioning scores
(mental health component)
Use the PROMIS to track patient functioning scores
(physical health component)
Use the PROMIS to track patient functioning scores (total
global health score)
Use the PHQ-9 to assess depression symptoms
Use the GAD-7 to assess anxiety symptoms
Use the DUDIT-C to assess substance use severity

Table 3. Data Elements to be Collected for Each Encounter for Each Patient (for
the first three months)
Domain

Data Element

Access

21. Treatment type

Access

22. Timing of encounter

Access

23. Therapy scheduling
success
24. Provider type

Access
Clinical
Outcomes
Access & Cost
Savings/
Effectiveness
Clinical
Outcomes
Cost Savings/
Effectiveness

25. Patient’s behavioral
health diagnosis
26. Treatment service type

27. Disposition
recommendation
28. Treatment billing

Description of Data Element

Whether encounter was planned for telehealth or
non-telehealth services
Number of days since first treatment encounter
Whether or not scheduled session was completed
Type of provider/clinician seen for behavioral health
services during this encounter
The ICD-10 code(s) associated with the diagnosis
chiefly responsible for the behavioral health services
CPT code for each encounter

Indicates the provider’s recommended disposition for
the patient at the end of the encounter
Indicates whether or not the behavioral health
services encounter was billed to insurance

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Data elements were identified that met multiple priorities: 1) manageable data set that
addresses access, clinical outcomes, or cost/efficiency; 2) derived from the published
literature on tele-behavioral health and prioritized for usefulness in building the
evidence-base; 3) alignment with commonly used clinical outcome assessment
instruments to permit benchmarking against published norms; 4) demographics needed
for describing the study sample; and 5) HIPAA compliant (no personal health
information) to decrease barriers to data collection.
Data Collection Procedure
Data use agreements will be established between RTRC and each of the EB THNP and
SAT TNGP grantees. Likewise, the University of Iowa IRB has approved the protocol
for collection of data on these measures in conjunction with the grantees. Moreover,
FORHP has submitted the data elements and data dictionary to OMB for clearance.
In addition to extensive work to review the related published literature to identify and
define the data elements, work is underway on developing a Behavioral-Telehealth
Evidence Collection (B-TEC) Tool for data collection and a user manual. Using the BTEC Tool and B-TEC User Manual, grantees will be responsible for capturing data
relevant to this set of data elements, either through working with coders at their
participating clinics or centrally reviewing and coding patient records. Grantees are
expected to use the B-TEC Tool to input the data, and to export and submit, on a
periodic basis, a de-identified patient-level data file to RTRC for analysis. Secure data
transmission processes will be employed.
Data Transmission Schedule
RTRC will establish a schedule of data transmission with grantees. The B-TEC Tool will
be designed so that data for each patient will be entered only once, at the conclusion of
their 3-month follow-up period. Thus, at the conclusion of the three-month follow-up
period for a given patient, all of their data will be entered into the B-TEC Tool and
submitted to RTRC at the next scheduled data transmission period. This process will
simplify data entry for grantees. As shown in Table 1, a set of data elements including
demographic data are to be collected when the patient goes through intake or baseline
at the beginning of entering into treatment. As shown in Table 2, a set of data elements
involving the clinical outcome assessment instruments are to be administered to
patients at intake/baseline and then ideally repeated at 1 month, 2 months, and 3
months after the initiation of treatment. This is an ideal schedule and we realize that it
may not be attainable for all grantees. The clinical outcome assessment instruments
are some of the most important data elements and we ask grantees to make sure that
there are at least two repeated administrations within the first 3 months of treatment
(e.g., we understand that some grantees are planning for repeated administrations
every 6 weeks). As shown in Table 3, a set of data elements involving treatment
processes are to be gathered for each encounter during the first 3 months of treatment.
We understand that there will be patients who are lost to follow-up during the first 3
months of treatment, in which case the planned number of encounters will not be
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realized. The research design follows “intent to treat” principles and thus it is important
that data are transmitted for every patient who enters treatment, even if they are lost to
follow-up.
Data Management Procedure
Data monitoring and management activities will include: 1) overseeing the progress of
the data collection process; 2) quality control measures to identify trends and areas for
improvement; 3) identifying root cause of problem; and 4) taking steps to correct
processes and reduce or eliminate problems. The aim of the data monitoring and
management function is to verify data validity (e.g. responses are within valid value
ranges), accuracy (e.g. responses are clinically meaningful), completeness (e.g. low
percent of missing data), consistency (e.g. data extraction practices are consistent
within and across organizations), and timeliness (e.g. data are transferred to RTRC in a
timely fashion). Thus, after each data submission period, RTRC will process the
submitted data from each grantee and will create “issue reports” for grantees to review
and address.
Analysis and Dissemination
The purpose of this data collection effort is not to evaluate any individual grantee’s
efforts, but rather to pool data across grantees to provide sufficient data for statistical
analysis aimed at addressing important research questions. The goal will be to
contribute to the evidence base by publishing multiple peer-reviewed journal articles.
Individual grantee data will be kept confidential and will not be identified in manuscripts.

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. The
OMB control number for this project is 0906-XXXX-NEW. Public reporting burden for this collection of
information is estimated to average 14 hours per response, including the time for reviewing instructions,
searching existing data sources, and completing and reviewing the collection of information. Send
comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room
14N136B, Rockville, Maryland, 20857.

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