Clinical trial NCT01997099: A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
Official title: A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System: Work Smart Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Smiths Medical, ASD, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol Library Creation
timeFrame: 2-6 weeks post-enrollment
measure: Describe Library Protocols and Safety Limits Utilized
timeFrame: 2-6 weeks post-enrollment
measure: Pump Programming Ease of Use
timeFrame: Day 1 - Immediately post-enrollment
measure: Pump Programming Errors
timeFrame: Day 1 - Immediately post-enrollment
measure: Patient Training and Pump Set-up
timeFrame: 2-4 months post-enrollment
measure: Characterize Training Time for the New Pump System
timeFrame: 2-4 months post-enrollment
measure: Workflow Changes
timeFrame: 2-4 months post-enrollment
measure: Overall Patient/Caregiver Satisfaction with the Pump
timeFrame: 5-7 Days Post-Enrollment
Secondary outcomes:
measure: Number of Alarms Reported
timeFrame: 5-7 Days Post-Enrollment
measure: Alarm Troubleshooting
timeFrame: 5-7 Days Post-Enrollment
measure: Pump Difficulties
timeFrame: 5-7 Days Post-Enrollment
measure: Pump Ease of Use
timeFrame: 5-7 Days Post-Enrollment
Other outcomes:
Locations:
city: Kalispell
country: United States
facility: Big Sky IV Care
state: Montana
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital - Jefferson Home Infusion
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University Hospital - Jefferson Home Infusion
name: Thomas D Brown, MBA, PharmD
role: PRINCIPAL_INVESTIGATOR
References: