A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
Work Smart
1 other identifier
observational
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 5, 2015
November 1, 2015
1.9 years
November 18, 2013
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (4)
Number of Alarms Reported
5-7 Days Post-Enrollment
Alarm Troubleshooting
5-7 Days Post-Enrollment
Pump Difficulties
5-7 Days Post-Enrollment
Pump Ease of Use
5-7 Days Post-Enrollment
Study Arms (5)
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
Interventions
Eligibility Criteria
Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study
You may qualify if:
- 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
You may not qualify if:
- Individuals that are unwilling or unable to answer questions as required by the protocol
- Phase 2
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Big Sky IV Care
Kalispell, Montana, 59901, United States
Thomas Jefferson University Hospital - Jefferson Home Infusion
Philadelphia, Pennsylvania, 19107, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas D Brown, MBA, PharmD
Thomas Jefferson University Hospital - Jefferson Home Infusion
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 27, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 5, 2015
Record last verified: 2015-11