Booster of the "More Time for Patients" Program

Booster of the "More Time for Patients" Program: a Cluster Randomized Controlled Trial

The goal of this clinical trial is to determine if reactivating a hospital program called "Plus de temps au service des patients" (PTP) can improve the quality of pain management for patients and increase job satisfaction among healthcare professionals. The main questions this study aims to answer are:

• Does reactivating PTP improve the quality of pain management?
• Does reactivating PTP increase healthcare professionals' job satisfaction? In this study, researchers will compare the effects of reactivating the program immediately to reactivating it after a 3-month delay.

Participants in the trial are healthcare professionals who will:

• Select 2 or 3 elements of the program they believe would be most beneficial to reactivate in their hospital units.
• Implement the selected elements for 3 months.
• Complete job satisfaction and burnout questionnaires before and after the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Encounter Quality
• Intervention / Treatment: Behavioral: Immediate reactivation

• Study Type: Interventional
• Enrollment (Estimated): 764
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Agoritsas, MD, PhD; Phone Number: 0041 79 553 45 43; Email: thomas.agoritsas@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals
    • Contact: Thomas Agoritsas, MD,PhD; Phone Number: 0041 79 553 45 43; Email: thomas.agoritsas@hug.ch
    • Contact: Delphine S. Courvoisier, PhD; Phone Number: 0041 79 553 11 41; Email: delphine.courvoisier@hug.ch
    • Principal Investigator: Thomas Agoritsas, MD,PhD
    • Principal Investigator: Delphine S. Courvoisier, PhD
    • Sub-Investigator: Clement P. Buclin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for the units:

• Implementation of PTP finished at least 6 months previously
• Agreement to the study from both medical head of service and head of unit (IRES)

Inclusion criteria for healthcare professionals:

• Healthcare professionals >18 yo.
• Healthcare professionals working in a HUG service of medicine or surgery.
• Healthcare professionals include Physicians, Nurses, Assistant Nurses, Pharmacists, Physiotherapists and other physical therapists.
• Provided general informed consent.

Inclusion criteria for patients

• Patients hospitalised in one of the boosted units.
• Cognitive ability to provide satisfaction assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate reactivation; Our intervention will be booster measure of the existing PTP elements that will be designed for each unit that has been randomized to the immediate intervention group. The booster will consist in a reactivation through audit and feedback of 2-3 elements of the PTP program. The selection of the elements to boost will be done locally in each unit through a coordinated discussion between representants of the PTP organization and representants of the unit's medical and nursing professionals. This will create an adaptable intervention that will feature selected standards among the list of 36 existing standards. The boost will be performed over 3 months	Behavioral: Immediate reactivation; Our intervention will be booster measure of the existing PTP elements that will be designed for each unit that has been randomized to the immediate intervention group. The booster will consist in a reactivation through audit and feedback of 2-3 elements of the PTP program. The selection of the elements to boost will be done locally in each unit through a coordinated discussion between representants of the PTP organization and representants of the unit's medical and nursing professionals. This will create an adaptable intervention that will feature selected standards among the list of 36 existing standards. The boost will be performed over 3 months
No Intervention: Delayed reactivation; The control intervention will also be PTP as applied usually, in the control group before the application of the booster measure (applied delayed by three months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timely delivery of appropriate analgesic	Quality of pain management as recorded through the timely delivery of an appropriate level painkiller after any pain Visual Analog Scale (VAS) ≥4. VAS score range from 0 to 10, 0 being no pain and 10 being the worse pain imaginable.	Timely is operationalized as maximum 6 hours before for reserve pain medication, and up to 1 hour after pain measurement for any medication appropriate to the level of pain.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS documentation	Patients stay will be divided in 12 hours segments and documentation will be considered adequate when 90% of the segments have at least 1 pain Visual Analog Scale score documented. VAS score range from 0 to 10, 0 being no pain and 10 being the worse pain imaginable.	12 hours
Patient satisfaction - Picker	Patient satisfaction is already routinely collected via continuous Picker satisfaction questionnaires. They are sent one week after patient discharge to all patients with a valid email address.	1 week after discharge for every patients.
Patient satisfaction - daily	Daily patient satisfaction is already routinely collected in a 3 level scale going from 1 dissatisfied to 3 fully satisfied. Surveys are realized at the bedside, often by nurse assistant in the early afternoon.	Every day from month 1 to month 3 corresponding to the period of study
Healthcare professionals' satisfaction	Healthcare professionals' satisfaction will be evaluated using the satisfaction with work scale. All item range from extremely dissatisfied to extremely satisfied.	Once before the reactivation and once after (month 1 and month 3)
Healthcare professionals' burnout	Burnout will be assessed using the Copenhagen burnout inventory. The Copenhagen Burnout Inventory is a three dimensions scale evaluating the personal, the professional and the relational components of burnout. Each dimension is scored on a scale ranging from 0 to 100, 0 being no burnout and 100 being the maximum burnout.	Once before the reactivation and once after (month 1 and month 3)
Healthcare professionals' risk of turnover	Risk of turnover will be investigated by the following validated single item "If it were possible and you would keep a similar salary, would you like to change profession to take up another one or to keep the same profession but without patient care?" Three answers are possible: "No, I do not want to", "Perhaps", and "Yes, I do want to"	Once before the reactivation and once after (month 1 and month 3)
Healthcare professional's absenteeism rate	If given consent by the participants, individual monthly absenteeism rate will be extracted from the human resources of the hospital. For all others, absenteeism rate will be extracted aggergated at the unit level.	At month 1, 2 and 3 corresponding to the period of study

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Thomas Agoritsas, MD, PhD, University Hospital, Geneva; Principal Investigator: Delphine S. Courvoisier, PhD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; Inpatients; Pain Management; Job satisfaction; Health Care Quality, Access and Evaluation
• Other Study ID Numbers: PTPBooster

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No