An observational study in Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps and Patients Requiring Infusion With an Ambulatory Infusion Pump, sponsored by Smiths Medical, ASD, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by Smiths Medical, ASD, Inc. · Observational
The purpose of this study is to describe the home healthcare organization ambulatory infusion pump programming workflow and the process that was followed to introduce the new CADD®-Solis VIP System to each home healthcare organization or facility. In addition, this study will characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use and satisfaction with the CADD®-Solis VIP System.
This is a prospective, multi-center, non-randomized, post-market study conducted within the United States. There will be two independent components (Phases) to this study. Phase 1 will involve data collection to describe the home infusion pump programming workflow and the process that was used to introduce the new CADD®-Solis VIP System to each home healthcare organization. This phase is further broken down into data collection consisting of four parts: drug protocol library creation and development within the CADD™ Solis Medication Safety Software Administrator, pump programming, home care implementation, and overall workflow and new smart pump implementation. Phase 2 will involve data collection from patients that receive a prescription requiring use of the CADD®-Solis VIP pump.
Smiths Medical, ASD, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study
Phase 1
Inclusion Criteria:
Exclusion Criteria:
Phase 2
Inclusion Criteria:
Exclusion Criteria:
Individuals responsible for creating the drug library
Device: CADD™ Solis Medication Safety Software Administrator
Individuals responsible for programming ambulatory infusion pumps
Device: CADD®-Solis VIP Pump
Individuals responsible for implementing ambulatory infusion pumps in patients' homes
Device: CADD®-Solis VIP Pump
Individual at the facility responsible for describing the workflow of processing and implementing an ambulatory infusion pump prior to and after introducing the CADD®-Solis VIP System.
Device: CADD®-Solis VIP Pump · Device: CADD™ Solis Medication Safety Software Administrator
Patients that receive a prescription requiring use of the CADD®-Solis VIP pump
Device: CADD®-Solis VIP Pump
Protocol Library Creation
Characterize the effort required to create a new drug protocol library
Time frame: 2-6 weeks post-enrollment
Describe Library Protocols and Safety Limits Utilized
Summarize the drug protocols that were created in the library and describe the soft and hard safety limits that were utilized
Time frame: 2-6 weeks post-enrollment
Pump Programming Ease of Use
Characterize the ease of use associated with programming the CADD®-Solis VIP pump
Time frame: Day 1 - Immediately post-enrollment
Pump Programming Errors
Summarize and describe any possible programming errors
Time frame: Day 1 - Immediately post-enrollment
Patient Training and Pump Set-up
Characterize the home health nurse perception of patient training and pump set-up within the home
Time frame: 2-4 months post-enrollment
Characterize Training Time for the New Pump System
Describe the training time associated with implementing a new ambulatory infusion pump in each step of a home healthcare organization's workflow
Time frame: 2-4 months post-enrollment
Workflow Changes
Characterize the workflow changes that need to be implemented at home healthcare organizations when adopting the CADD®-Solis VIP System
Time frame: 2-4 months post-enrollment
Overall Patient/Caregiver Satisfaction with the Pump
Assess the overall patient/personal caregiver satisfaction with the CADD®-Solis VIP pump
Time frame: 5-7 Days Post-Enrollment
Number of Alarms Reported
Summarize the number of alarms reported
Time frame: 5-7 Days Post-Enrollment
Alarm Troubleshooting
Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms
Time frame: 5-7 Days Post-Enrollment
Pump Difficulties
Characterize any difficulties experienced with use of the pump
Time frame: 5-7 Days Post-Enrollment
Pump Ease of Use
Characterize the ease of use of the pump
Time frame: 5-7 Days Post-Enrollment
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Smiths Medical, ASD, Inc.