A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
- Conditions
- Home Healthcare Organizations Utilizing Ambulatory Infusion PumpsPatients Requiring Infusion With an Ambulatory Infusion Pump
- Interventions
- Device: CADD™ Solis Medication Safety Software AdministratorDevice: CADD®-Solis VIP Pump
- Registration Number
- NCT01997099
- Lead Sponsor
- Smiths Medical, ASD, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Library Creation CADD™ Solis Medication Safety Software Administrator Individuals responsible for creating the drug library Pump Programming CADD®-Solis VIP Pump Individuals responsible for programming ambulatory infusion pumps Home Implementation CADD®-Solis VIP Pump Individuals responsible for implementing ambulatory infusion pumps in patients' homes Ambulatory Infusion Pump Patients CADD®-Solis VIP Pump Patients that receive a prescription requiring use of the CADD®-Solis VIP pump Workflow 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. Workflow CADD™ Solis Medication Safety Software Administrator 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.
- Primary Outcome Measures
Name Time Method Pump Programming Ease of Use Day 1 - Immediately post-enrollment Characterize the ease of use associated with programming the CADD®-Solis VIP pump
Pump Programming Errors Day 1 - Immediately post-enrollment Summarize and describe any possible programming errors
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
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
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
- Secondary Outcome Measures
Name Time Method Pump Ease of Use 5-7 Days Post-Enrollment Characterize the ease of use of the pump
Alarm Troubleshooting 5-7 Days Post-Enrollment Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms
Number of Alarms Reported 5-7 Days Post-Enrollment Summarize the number of alarms reported
Pump Difficulties 5-7 Days Post-Enrollment Characterize any difficulties experienced with use of the pump
Trial Locations
- Locations (2)
Thomas Jefferson University Hospital - Jefferson Home Infusion
🇺🇸Philadelphia, Pennsylvania, United States
Big Sky IV Care
🇺🇸Kalispell, Montana, United States