Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps, Patients Requiring Infusion With an Ambulatory Infusion Pump
Conditions
Keywords
Drug Library, Ambulatory Infusion Pump, Medication Safety Software, CADD®-Solis VIP, Pump Programming, Home Infusion Workflow
Brief summary
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.
Detailed description
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.
Interventions
DEVICECADD®-Solis VIP Pump
DEVICECADD™ Solis Medication Safety Software Administrator
Sponsors
Smiths Medical, ASD, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 Inclusion Criteria: * Part 1: Licensed clinicians that would be responsible for protocol library creation at the center * Part 2: Individuals that are responsible for ambulatory infusion pump programming per the organization's standard operating procedure * Part 3: Licensed clinicians that are responsible for performing the pump set-up and implementation activities within the home setting * Part 4: Center personnel that are involved in the CADD®-Solis VIP System implementation process
Exclusion criteria
* Individuals that are unwilling or unable to answer questions as required by the protocol Phase 2 Inclusion Criteria: * Patients 18 years of age or older * Patients prescribed a home infusion requiring use of the CADD®-Solis VIP pump * Patients with infusions prescribed for a minimum duration of five (5) days * Patient or patient's personal caregiver on behalf of the patient is willing and able to comply with the data collection requirements * Patient is willing and able to provide informed consent for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Patient/Caregiver Satisfaction with the Pump | 5-7 Days Post-Enrollment | Assess the overall patient/personal caregiver satisfaction with the CADD®-Solis VIP pump |
| Pump Programming Errors | Day 1 - Immediately post-enrollment | Summarize and describe any possible programming errors |
| Patient Training and Pump Set-up | 2-4 months post-enrollment | Characterize the home health nurse perception of patient training and pump set-up within the home |
| Characterize Training Time for the New Pump System | 2-4 months post-enrollment | Describe the training time associated with implementing a new ambulatory infusion pump in each step of a home healthcare organization's workflow |
| Workflow Changes | 2-4 months post-enrollment | Characterize the workflow changes that need to be implemented at home healthcare organizations when adopting the CADD®-Solis VIP System |
| Protocol Library Creation | 2-6 weeks post-enrollment | Characterize the effort required to create a new drug protocol library |
| Describe Library Protocols and Safety Limits Utilized | 2-6 weeks post-enrollment | Summarize the drug protocols that were created in the library and describe the soft and hard safety limits that were utilized |
| Pump Programming Ease of Use | Day 1 - Immediately post-enrollment | Characterize the ease of use associated with programming the CADD®-Solis VIP pump |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alarm Troubleshooting | 5-7 Days Post-Enrollment | Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms |
| Pump Difficulties | 5-7 Days Post-Enrollment | Characterize any difficulties experienced with use of the pump |
| Pump Ease of Use | 5-7 Days Post-Enrollment | Characterize the ease of use of the pump |
| Number of Alarms Reported | 5-7 Days Post-Enrollment | Summarize the number of alarms reported |
Countries
United States
Outcome results
None listed