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

Smiths Medical

Status: Completed

Conditions: Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps; Patients Requiring Infusion With an Ambulatory Infusion Pump

Treatments: Device: CADD®-Solis VIP Pump; Device: CADD™ Solis Medication Safety Software Administrator

Study type: Observational

Funder types: Industry

Identifiers

NCT01997099

Work Smart Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

62 participants in 5 patient groups

Library Creation

Description:

Individuals responsible for creating the drug library

Treatment:

Device: CADD™ Solis Medication Safety Software Administrator

Pump Programming

Description:

Individuals responsible for programming ambulatory infusion pumps

Treatment:

Device: CADD®-Solis VIP Pump

Home Implementation

Description:

Individuals responsible for implementing ambulatory infusion pumps in patients' homes

Treatment:

Device: CADD®-Solis VIP Pump

Workflow

Description:

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.

Treatment:

Device: CADD™ Solis Medication Safety Software Administrator

Device: CADD®-Solis VIP Pump

Ambulatory Infusion Pump Patients

Description:

Patients that receive a prescription requiring use of the CADD®-Solis VIP pump

Treatment:

Device: CADD®-Solis VIP Pump