A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System (Work Smart)

November 4, 2015 updated by: Smiths Medical, ASD, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Kalispell, Montana, United States, 59901
        • Big Sky IV Care
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital - Jefferson Home Infusion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Home healthcare organizations that utilize ambulatory infusion pumps for their patients will be approached for participation in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Library Creation
Individuals responsible for creating the drug library
Device: CADD™ Solis Medication Safety Software Administrator
Pump Programming
Individuals responsible for programming ambulatory infusion pumps
Device: CADD®-Solis VIP Pump
Home Implementation
Individuals responsible for implementing ambulatory infusion pumps in patients' homes
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.
Device: CADD™ Solis Medication Safety Software Administrator
Device: CADD®-Solis VIP Pump
Ambulatory Infusion Pump Patients
Patients that receive a prescription requiring use of the CADD®-Solis VIP pump
Device: CADD®-Solis VIP Pump

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Protocol Library Creation
Time Frame: 2-6 weeks post-enrollment
Characterize the effort required to create a new drug protocol library
2-6 weeks post-enrollment
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
2-6 weeks post-enrollment
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
Day 1 - Immediately post-enrollment
Pump Programming Errors
Time Frame: Day 1 - Immediately post-enrollment
Summarize and describe any possible programming errors
Day 1 - Immediately post-enrollment
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
2-4 months post-enrollment
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
2-4 months post-enrollment
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
2-4 months post-enrollment
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
5-7 Days Post-Enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Alarms Reported
Time Frame: 5-7 Days Post-Enrollment
Summarize the number of alarms reported
5-7 Days Post-Enrollment
Alarm Troubleshooting
Time Frame: 5-7 Days Post-Enrollment
Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms
5-7 Days Post-Enrollment
Pump Difficulties
Time Frame: 5-7 Days Post-Enrollment
Characterize any difficulties experienced with use of the pump
5-7 Days Post-Enrollment
Pump Ease of Use
Time Frame: 5-7 Days Post-Enrollment
Characterize the ease of use of the pump
5-7 Days Post-Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smiths Medical, ASD, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas D Brown, MBA, PharmD, Thomas Jefferson University Hospital - Jefferson Home Infusion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Work Smart Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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