Completed
NCT Number: NCT01997099
A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Big Sky IV Care, Kalispell, Montana, United States
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
CADD™ Solis Medication Safety Software Administrator
DevicePrimary outcomes
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Protocol Library Creation
Time frame: 2-6 weeks post-enrollment
Characterize the effort required to create a new drug protocol library
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Describe Library Protocols and Safety Limits Utilized
Time frame: 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
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Pump Programming Ease of Use
Time frame: Day 1 - Immediately post-enrollment
Characterize the ease of use associated with programming the CADD®-Solis VIP pump
-
Pump Programming Errors
Time frame: Day 1 - Immediately post-enrollment
Summarize and describe any possible programming errors
-
Patient Training and Pump Set-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5-7 Days Post-Enrollment
Assess the overall patient/personal caregiver satisfaction with the CADD®-Solis VIP pump
Secondary outcomes
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Number of Alarms Reported
Time frame: 5-7 Days Post-Enrollment
Summarize the number of alarms reported
-
Alarm Troubleshooting
Time frame: 5-7 Days Post-Enrollment
Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms
-
Pump Difficulties
Time frame: 5-7 Days Post-Enrollment
Characterize any difficulties experienced with use of the pump
-
Pump Ease of Use
Time frame: 5-7 Days Post-Enrollment
Characterize the ease of use of the pump
Sponsors and collaborators
Lead sponsor
Smiths Medical, ASD, Inc.
Industry
Registry information
Official study title
A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System: Work Smart Study
Acronym: Work Smart
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Nov 27, 2013
- Registry last updated
- Nov 5, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.