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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Library Creation | Individuals responsible for creating the drug library |
| |
| Pump Programming | Individuals responsible for programming ambulatory infusion pumps |
| |
| Home Implementation | Individuals responsible for implementing ambulatory infusion pumps in patients' homes |
| |
| Workflow | 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. |
| |
| Ambulatory Infusion Pump Patients | Patients that receive a prescription requiring use of the CADD®-Solis VIP pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADD®-Solis VIP Pump | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Library Creation | Characterize the effort required to create a new drug protocol library | 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 | 2-6 weeks post-enrollment |
| Pump Programming Ease of Use | Characterize the ease of use associated with programming the CADD®-Solis VIP pump | Day 1 - Immediately post-enrollment |
| Pump Programming Errors | Summarize and describe any possible programming errors | 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 | 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 | 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 | 2-4 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alarms Reported | Summarize the number of alarms reported | 5-7 Days Post-Enrollment |
| Alarm Troubleshooting | Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms |
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Phase 1
Inclusion Criteria:
Exclusion Criteria:
Phase 2
Inclusion Criteria:
Exclusion Criteria:
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Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Thomas D Brown, MBA, PharmD | Thomas Jefferson University Hospital - Jefferson Home Infusion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Big Sky IV Care | Kalispell | Montana | 59901 | United States | ||
| Thomas Jefferson University Hospital - Jefferson Home Infusion |
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| CADD™ Solis Medication Safety Software Administrator |
| Device |
|
| Overall Patient/Caregiver Satisfaction with the Pump | Assess the overall patient/personal caregiver satisfaction with the CADD®-Solis VIP pump | 5-7 Days Post-Enrollment |
| 5-7 Days Post-Enrollment |
| Pump Difficulties | Characterize any difficulties experienced with use of the pump | 5-7 Days Post-Enrollment |
| Pump Ease of Use | Characterize the ease of use of the pump | 5-7 Days Post-Enrollment |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |