Remote MonitoringNCT01151995
Effectiveness and Costs of Remote Monitoring for Clinical Trials
An observational study of Remote Monitoring, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Remote Monitoring
- What is being tested?
- Remote source document verification and On-site source document verification
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be subjects who have already been enrolled in an ARDS or BARC/CLiC clinical trial network study.
Who may be able to join
- Enrollment in the NIH-sponsored ARDS and BARC/CLiC clinical trial networks
Who cannot join
- Not enrolled in the NIH-sponsored ARDS and BARC/CLiC clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
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
Read the 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.
- Conditions
- Remote Monitoring
- Being tested
- Remote source document verification, On-site source document verification
- Keywords
- Clinical Trial Monitoring, Effectiveness of remote monitoring, Efficiency of remote monitoring, Costs of remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote source document verificationOther
Remote access to electronic medical records of the 5 participating sites
On-site source document verificationOther
Study monitor will perform on-site source document verification during routine visit to the five participating sites
| Study group | Role | What they receive |
|---|---|---|
| Remote plus on-site | Subjects will have remote source document verification performed 2-4 weeks prior to study monitors scheduled visit and any variables that were not able to be verified remotely will be verified on-site. Receives: Other: Remote source document verification | |
| On-site monitoring | Traditional source document verification will be performed when study monitor is on site Receives: Other: On-site source document verification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Can remote source document verification replace on-site source document verification?
Measured: 9/2011
Efficiency and Cost
Differences in time and costs
Measured: 9/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote MonitoringStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151995
- Sponsor's protocol ID
- 09-0735
- Status last verified
- Dec 2012
- First submitted
- 24 Jun 2010
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Costs of Remote Monitoring for Clinical Trials
- ClinicalTrials.gov ID
- NCT01151995
- Acronym / sponsor ID
- 09-0735
- Conditions
- Remote Monitoring
- Keywords
- Clinical Trial Monitoring, Effectiveness of remote monitoring, Efficiency of remote monitoring, Costs of remote monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Michigan
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote plus on-site | – | Other: Remote source document verificationSubjects will have remote source document verification performed 2-4 weeks prior to study monitors scheduled visit and any variables that were not able to be verified remotely will be verified on-site. |
| On-site monitoring | – | Other: On-site source document verificationTraditional source document verification will be performed when study monitor is on site |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be subjects who have already been enrolled in an ARDS or BARC/CLiC clinical trial network study.
Key inclusion criteria (1 listed)
- Enrollment in the NIH-sponsored ARDS and BARC/CLiC clinical trial networks
Key exclusion criteria (1 listed)
- Not enrolled in the NIH-sponsored ARDS and BARC/CLiC clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote source document verificationRemote access to electronic medical records of the 5 participating sites | Other | Remote plus on-site |
| On-site source document verificationStudy monitor will perform on-site source document verification during routine visit to the five participating sites | Other | On-site monitoring |
Primary outcome
Effectiveness
Time frame: 9/2011
Can remote source document verification replace on-site source document verification?
Efficiency and Cost
Time frame: 9/2011
Differences in time and costs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
Related trials for Remote Monitoring
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Active, not recruiting
Parent Tube Weaning Interviews
Feeding Difficulties, Remote Patient Monitoring
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remote Monitoring, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 9/2011). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.