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

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: Completed
• Conditions: Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps; Patients Requiring Infusion With an Ambulatory Infusion Pump
• Intervention / Treatment: Device: CADD™ Solis Medication Safety Software Administrator; Device: CADD®-Solis VIP Pump

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: Observational
• Enrollment (Actual): 62

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Alarms Reported	Summarize the number of alarms reported	5-7 Days Post-Enrollment
Alarm Troubleshooting	Quantify the ability of the patient or caregiver to successfully troubleshoot the alarms	5-7 Days Post-Enrollment
Pump Difficulties	Characterize any difficulties experienced with use of the pump	5-7 Days Post-Enrollment
Pump Ease of Use	Characterize the ease of use of the pump	5-7 Days Post-Enrollment

Collaborators and Investigators

• Sponsor: Smiths Medical, ASD, Inc.
• Investigators: Principal Investigator: Thomas D Brown, MBA, PharmD, Thomas Jefferson University Hospital - Jefferson Home Infusion

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Drug Library; Ambulatory Infusion Pump; Medication Safety Software; CADD®-Solis VIP; Pump Programming; Home Infusion Workflow
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: Work Smart Study