Effectiveness and Costs of Remote Monitoring for Clinical Trials
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2010 |
| Contact: | Meredith Mealer, MS |
| Email: | Meredith.Mealer@ucdenver.edu |
| Phone: | 303-724-6080 |
This pilot project will evaluate Internet-based remote access to electronic clinical systems
to support study monitoring tasks. The project engages two NIH-sponsored clinical trial
networks (adult: ARDS network; pediatrics: ChiLDREN network) at five trial locations and two
coordinating centers located across four states, which engages three collaborating
NCRR-funded CTSA institutions. Each study location uses different electronic clinical
systems and remote access methods, replicating the diversity of clinical applications and
access methods found across large research networks. The results of this pilot project will
inform a broader project that will engage all trial sites with electronic clinical systems
in both national networks.
This proposal extends Specific Aim 1.2 of the Research Informatics Integrated Core (RIIC) in
the parent grant (UL1 RR025780) for the Colorado Clinical and Translational Sciences
Institute (CCTSI): "The RIIC will develop and implement tools and services that will….(2)
support the efficient execution of the CCTSI translational research projects." (CCTSI grant
page 1053). Specific Aim 1.2 proposes to develop new informatics methods that increase the
translational research capacity by improving the efficiency of executing clinical studies.
Reducing barriers to study monitoring via remote access will enable new innovative
approaches to protecting study subjects, ensuring study data quality and documenting
regulatory compliance. An example of a completely new model for study monitoring could be
continuous study monitoring from any coordinating center to any study location in the
Internet-connected world.
We hypothesize that remote monitoring will demonstrate substantial improvements in study
monitoring efficiency, effectiveness, and possibly overall costs when compared to present
monitoring plans that require a prolonged on-site visit by a study monitor from the
coordinating center. We do not claim that remote study monitoring will replace all
monitoring tasks . But, for monitoring tasks that require access to electronic clinical
data, we seek to demonstrate that remote access can enable more frequent SDV and regulatory
documentation compliance, which in turn could facilitate new models of continuous study
monitoring. The results of these studies would support improvements in study monitoring that
would both significantly reduce the cost of conducting large multi-center clinical while
improving the safety of those patients who are enrolled into these trials
II. Research Project Plan Specific Aim 1: To determine the effectiveness of remote access to
electronic clinical systems for clinical trial study monitoring. Accuracy and completeness
of source document verification (SDV) and compliance with regulatory documentation
requirements will be the effectiveness outcome measures.
Specific Aim 2: To determine the efficiency of remote access to electronic clinical systems
for clinical trial study monitoring. The time to complete SDV and regulatory review with and
without remote access prior to an on-site visit will be the efficiency outcome measures.
Specific Aim 3: To determine the data monitoring site costs of study data verification and
regulatory documentation compliance with and without remote access prior to an on-site
visit.
Research Methods and Design The specific aims focus on evaluating the effectiveness (Aim 1),
efficiency (Aim 2), and cost (Aim 3) of remote study monitoring compared to on-site SDV. The
study design for the three Specific Aims is identical. The analysis variables and analytic
plan vary by Specific Aim. There are five phases to this project: (1) IT development, (2)
local pre-pilot, (3) remote monitoring, (4) on-site monitoring, and (5) study analysis.
Study Phase 1: Initial IT development and testing Five study sites will provide remote
access to existing clinical systems using commercial or self-developed access methods. Phase
1 will ensure that these access methods can be configured to provide appropriate security
and auditing capabilities. The University of Colorado Hospital (UCH) has identified the need
to integrate the McKesson CareManager clinical documentation system into their MedXplore
remote access system. The budget provides programming resources to support this integration
development during Year 1. Should a technical limitation arise at any location, Phase 1 will
be used to alter or extend existing access methods to meet institutional requirements.
Contingency plans include using remote desktop sharing, as proposed by Vanderbilt, to export
local application screens to remote desktops securely. This contingency ensures that the
remote monitor experiences the identical application screens as are seen during on-site
visits.
Study Phase 2: Pre-pilot testing of remote monitoring using local study coordinators Study
coordinators, local to the five study sites and who have clinical research access privileges
already established at their respective hospitals, will perform remote study monitoring
review of one or more study subjects to fully test the technical issues of remote access to
required applications and the execution features of the data collection instruments. The
local coordinators will connect to the hospital systems from a secure computer that is off
site from the hospital. The study coordinator will then conduct an on-site chart review. The
study coordinator will collect the study measures outlined in Table 2. Procedures for when
to stop searching for a data element, how to account for work breaks, and other
interruptions, and when to call for additional help from local site managers will be
developed. Data collection instruments will be tested and altered as needed. The pre-pilot
tests will simulate the activities for Phase 3 & 4 so that all operational issues are
resolved. Once completed, study procedures and data collection instruments will be finalized
for use in Phases 3 & 4.
Study Phase 3: Remote monitoring by data coordinating centers Randomization of study
subjects into two equal arms will be stratified at each individual hospital. Subjects
assigned to Arm A will have remote monitoring performed 2-4 weeks prior to the scheduled
on-site visit. Subjects assigned to Arm B will have no remote monitoring performed. Both
arms will have traditional on-site study monitoring performed. Remote access provisioning
performed by IT at the five study locations will allow remote monitors to access electronic
records. Depending on institutional responsibilities, HIM or IT resources will provision
these remote accounts to access those subjects randomized to Arm A (remote + local
monitoring). Remote monitoring will consist of validating all data elements submitted on
CRFs submitted to the coordinating center that require source document verification, using
the same data verification protocols currently used during on-site visits. Remote monitors
will have telephone access to the same HIM and local coordinator resources that are
available when on-site. Rules when to stop searching for a data element will be established
during Phase 2. Data collection instruments for capturing study variables will be
developed and pilot tested during Phase 2. Remote monitors will be trained on the access
procedures for each site and the study data collection procedures developed in Phase 2 using
simultaneous remote desktop sharing and a study subject who is not scheduled for monitoring.
Study Phase 4: On-site monitoring by data coordinating centers On-site monitoring will occur
2-4 weeks following remote monitoring. Subjects from both Study Arms will have source
document verification. Only those elements not verified remotely (Step (A)) will be verified
for subjects from Arm A in Step (B). The same monitor will perform both remote and local
monitoring for subjects from Arm A. The study variables developed in Phase 2 and used
during remote monitoring in Phase 3 will be used during on-site monitoring in Phase 4.
Study Phase 5: Data analysis Specific Aim 1 focuses on accuracy and completeness of remote
monitoring versus on-site monitoring. The study variables are the number of variables
verified and the number of verified variables that were found to be discrepant. Specific Aim
2 focuses on efficiency, measured in this study as time to complete source document
verification and regulatory review. The number of minutes to complete both source document
verification and regulatory review will be captured and compared. Specific Aim 3 focuses on
costs, measured using a time-in-motion method by the study coordinator or monitor. Using a
time log, the time required to complete a CRF to be aggregated for the SDV total. This will
include time estimates for finding charts, making copies, and recording data. If a study
investigator participates in monitoring activities, then they will record their time
estimates separately. Standardized estimates of salaries and benefits for persons in those
positions will be used to standardize across local and regional wage and price
differentials.
Inclusion Criteria:
- Enrollment in the NIH-sponsored ARDS and BARC/CLiC clinical trial networks
Exclusion Criteria:
- Not enrolled in the NIH-sponsored ARDS and BARC/CLiC clinical trials
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