A Workflow and Satisfaction Study Evaluating the Implementation of a New Smart Ambulatory Infusion System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Workflow and Satisfaction Study Evaluating the Implementation of a New Smart Ambulatory Infusion System: Work Smart Study

Conditions
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Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps, Patients Requiring Infusion With an Ambulatory Infusion Pump

Intervention / Treatment
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* Device: CADD®-Solis VIP Pump
* Device: CADD™ Solis Medication Safety Software Administrator


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Patient is currently enrolled or plans to enroll in a concurrent study that may confound the results of this study Based upon a clinician's opinion, the patient has health conditions or a psychological/cognitive status that would preclude proper participation in the study and does not have a personal caregiver available to perform study activities on behalf of the patient Previous use or experience with the CADD®-Solis VIP pump

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Library Creation<br>Individuals responsible for creating the drug library | Device: CADD™ Solis Medication Safety Software Administrator<br> <br> |
| Pump Programming<br>Individuals responsible for programming ambulatory infusion pumps | Device: CADD®-Solis VIP Pump<br> <br> |
| Home Implementation<br>Individuals responsible for implementing ambulatory infusion pumps in patients' homes | Device: CADD®-Solis VIP Pump<br> <br> |
| Workflow<br>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<br> <br> Device: CADD™ Solis Medication Safety Software Administrator<br> <br> |
| Ambulatory Infusion Pump Patients<br>Patients that receive a prescription requiring use of the CADD®-Solis VIP pump | Device: CADD®-Solis VIP Pump<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Library, Ambulatory Infusion Pump, Medication Safety Software, CADD®-Solis VIP, Pump Programming, Home Infusion Workflow