Effectiveness and Costs of Remote Monitoring for Clinical Trials
Condition: Remote Monitoring
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Remote source document verification; On-site source document verification
Intervention type(s): Other; Other
Intervention description(s): Remote access to electronic medical records of the 5 participating sites; Study monitor will perform on-site source document verification during routine visit to the five participating sites
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be subjects who have already been enrolled in an ARDS or BARC/CLiC
        clinical trial network study.
      
Biospecimen description: 
      No biospecimens collected for this protocol
    
Keywords: Clinical Trial Monitoring; Effectiveness of remote monitoring; Efficiency of remote monitoring; Costs of remote monitoring