Home Healthcare Organizations Utilizing Ambulatory Infusion PumpsWork SmartNCT01997099
A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
An observational study of Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps and Patients Requiring Infusion With an Ambulatory Infusion Pump, run by Smiths Medical, ASD, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps, Patients Requiring Infusion With an Ambulatory Infusion Pump
- What is being tested?
- CADD®-Solis VIP Pump and CADD™ Solis Medication Safety Software Administrator
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study
Who may be able to join
- 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
- Patients 18 years of age or older
- Patients prescribed a home infusion requiring use of the CADD®-Solis VIP pump
Show all 9Show fewer
- 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
Who cannot join
- Individuals that are unwilling or unable to answer questions as required by the protocol
- Phase 2
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Big Sky IV Care
Kalispell, Montana, 59901
Thomas Jefferson University Hospital - Jefferson Home Infusion
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System: Work Smart Study
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.
Read the 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.
- Conditions
- Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps, Patients Requiring Infusion With an Ambulatory Infusion Pump
- Being tested
- CADD®-Solis VIP Pump, CADD™ Solis Medication Safety Software Administrator
- Keywords
- Drug Library, Ambulatory Infusion Pump, Medication Safety Software, CADD®-Solis VIP, Pump Programming, Home Infusion Workflow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADD®-Solis VIP PumpDevice
CADD™ Solis Medication Safety Software AdministratorDevice
| Study group | Role | What they receive |
|---|---|---|
| Library Creation | Individuals responsible for creating the drug library Receives: Device: CADD™ Solis Medication Safety Software Administrator | |
| Pump Programming | Individuals responsible for programming ambulatory infusion pumps Receives: Device: CADD®-Solis VIP Pump | |
| Home Implementation | Individuals responsible for implementing ambulatory infusion pumps in patients' homes Receives: Device: CADD®-Solis VIP Pump | |
| 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. Receives: Device: CADD®-Solis VIP Pump; Device: CADD™ Solis Medication Safety Software Administrator | |
| Ambulatory Infusion Pump Patients | Patients that receive a prescription requiring use of the CADD®-Solis VIP pump Receives: Device: CADD®-Solis VIP Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Library Creation
Characterize the effort required to create a new drug protocol library
Measured: 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
Measured: 2-6 weeks post-enrollment
Pump Programming Ease of Use
Characterize the ease of use associated with programming the CADD®-Solis VIP pump
Measured: Day 1 - Immediately post-enrollment
Pump Programming Errors
Summarize and describe any possible programming errors
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5-7 Days Post-Enrollment
Secondary outcomes (4)
Number of Alarms Reported
Summarize the number of alarms reported
Measured: 5-7 Days Post-Enrollment
Alarm Troubleshooting
Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms
Measured: 5-7 Days Post-Enrollment
Pump Difficulties
Characterize any difficulties experienced with use of the pump
Measured: 5-7 Days Post-Enrollment
Pump Ease of Use
Characterize the ease of use of the pump
Measured: 5-7 Days Post-Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Healthcare Organizations Utilizing Ambulatory Infusion PumpsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smiths Medical, ASD, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas D Brown, MBA, PharmD, Principal investigator, Thomas Jefferson University Hospital - Jefferson Home Infusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997099
- Sponsor's protocol ID
- Work Smart Study
- Acronym
- Work Smart
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System: Work Smart Study
- ClinicalTrials.gov ID
- NCT01997099
- Acronym / sponsor ID
- Work Smart / Work Smart Study
- Conditions
- Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps, Patients Requiring Infusion With an Ambulatory Infusion Pump
- Keywords
- Drug Library, Ambulatory Infusion Pump, Medication Safety Software, CADD®-Solis VIP, Pump Programming, Home Infusion Workflow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Smiths Medical, ASD, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Library Creation | – | Device: CADD™ Solis Medication Safety Software AdministratorIndividuals responsible for creating the drug library |
| Pump Programming | – | Device: CADD®-Solis VIP PumpIndividuals responsible for programming ambulatory infusion pumps |
| Home Implementation | – | Device: CADD®-Solis VIP PumpIndividuals responsible for implementing ambulatory infusion pumps in patients' homes |
| Workflow | – | Device: CADD®-Solis VIP Pump, Device: CADD™ Solis Medication Safety Software AdministratorIndividual 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 | – | Device: CADD®-Solis VIP PumpPatients that receive a prescription requiring use of the CADD®-Solis VIP pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study
Key inclusion criteria (9 listed)
- 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
- Patients 18 years of age or older
Key exclusion criteria (5 listed)
- Individuals that are unwilling or unable to answer questions as required by the protocol
- Phase 2
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CADD®-Solis VIP Pump | Device | Ambulatory Infusion Pump Patients, Home Implementation, Pump Programming, Workflow |
| CADD™ Solis Medication Safety Software Administrator | Device | Library Creation, Workflow |
Primary outcome
Protocol Library Creation
Time frame: 2-6 weeks post-enrollment
Characterize the effort required to create a new drug protocol library
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
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
4 secondary outcomes
Number of Alarms Reported
Time frame: 5-7 Days Post-Enrollment
Alarm Troubleshooting
Time frame: 5-7 Days Post-Enrollment
Pump Difficulties
Time frame: 5-7 Days Post-Enrollment
Pump Ease of Use
Time frame: 5-7 Days Post-Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Brown, MBA, PharmD principal investigator
Thomas Jefferson University Hospital - Jefferson Home Infusion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps and Patients Requiring Infusion With an Ambulatory Infusion Pump, run by Smiths Medical, ASD, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Library Creation (time frame: 2-6 weeks post-enrollment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.