- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893848
Influence of the Culture Care Program on Patient Mobility After Thoracic or Abdominal Surgery: a Mixed-methods Study (CULTURECARE)
Culture Care Program: a Mixed-methods Study Evaluating the Effect of an Innovative In-hospital Experience on Patient Mobility After Thoracic or Abdominal Surgery
A sedentary behavior in the postoperative phase has a negative impact on recovery from various types of surgery (e.g. abdominal, pulmonary, cardiac or esophageal). In fact, sedentary behavior in the days following surgery is associated with an increased risk of postoperative complications, longer hospital stays and, consequently, higher healthcare costs. Stimulating early mobilization and increasing the level of physical activity after surgery therefore remains a relevant current challenge. The Culture Care program will propose a new experience of the hospital towards an attractive and stimulating intrahospital environment, including art and culture. The hypothesis is that the innovative, positive hospital experience offered by the Culture Care program could contribute to increasing patients' mobility in the postoperative phase and thus reduce the sedentary behaviour compared with a control group included before the implementation of the program.
The aim of this study is to explore the effect of the Culture Care program (Control group versus Culture Care group) on the mobility of patients hospitalized after thoracic or abdominal surgery, by determining the level of prediction in relation to the influencing covariates reported in the literature.
The first quantitative part of this research project will compare the mobility of patients hospitalized after surgery, before (control group) and after the implementation of the Culture Care program (Culture Care group). Patients will be asked to wear an accelerometer for the first five post-operative days, and to complete three questionnaires (psychological well-being, physical recovery, perception of their mobility).
Healthcare workers will be asked to complete a survey on their readiness to stimulate patients' mobility before and after the Culture Care program.
The second part will be qualitative including individual semi-structured interviews with patients and healthcare workers during the Culture Care program, to gather their experiences.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan Dugernier, PhD
- Phone Number: +41 0783057932
- Email: jonathan.dugernier@he-arc.ch
Study Locations
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Neuchâtel, Switzerland, 2000
- Recruiting
- Hôpital de Neuchâtel
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Contact:
- Marc-Olivier Sauvain, MD PhD
- Phone Number: +41 079 559 49 81
- Email: Marc-olivier.sauvain@rhne.ch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admission to Surgical Units in the Surgical Department of the Hôpital de Neuchâtel implementing the Culture Care program.
- Elective thoracic or abdominal surgery with an expected hospital stay of at least 2 days (i.e. discharge on postoperative day 3).
- Neurocognitive and physical ability to complete questionnaires and individual participation in the Culture Care program.
- Full capacity of discernment and signed informed consent to participate in the study.
Exclusion Criteria:
- Outpatient surgery.
- Emergency surgery.
- Mobility severely impaired prior to surgery: patients with 1 or 2 lower-limb amputations, patients with wheelchair mobility only, neurodegenerative diseases.
- Bed restiction between POD 1 and POD 5 for medical reasons, i.e. surgery, post-operative complications or other pre-existing cardiorespiratory, neurological or orthopedic reasons.
- Transfer to ICU
- Only during the Culture Care phase, an unplanned transfer to another unit that does not have the Culture Care program (e.g. Medicine units).
- Technical problem with the accelerometer (e.g. disfunctioning battery).
- Allergic reaction to any dressing used to attach the accelerometer.
- End-of-life patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group of patients
Patients hospitalized after thoracic or abdominal surgery in a conventional in-hospital environment (not modified, before the implementation of the Culture Care program).
Patients will receive standard of care, including early mobilization prescribed by the physician according to the ERAS guidelines.
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|
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Experimental: Culture Care group of patients
Patients hospitalized after thoracic or abdominal surgery in an in-hospital environment modernized by the Culture Care program.
As with control patients, patients in the Culture Care group will receive the similar standard of care, including early mobilization prescribed by the physician according to the ERAS guidelines.
|
The Culture Care program modernizes the in-hospital environment by including art and culture proposed in the form of an individualized pathway. It will be offered primarily to hospitalized patients, but also available to families, caregivers and healthcare professionals. It will aim to create a new hospital experience, different from the one we've always known. The Culture Care program will display posters illustrating works of art (paintings, drawings, photographs, etc.) along the hallways. These posters will be interactive, so that a QR code can be scanned to access musical content and audio podcasts (interviews and documentaries) accessible via bone-conduction headphones. The Culture Care program is likely to reduce the sedentary behavior of hospitalized patients, by providing an attractive in-hospital environment that is likely to produce both physical and psychological benefits. |
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No Intervention: Control group of healthcare workers
Healthcare workers working in the surgical units, with a conventional in-hospital environment (before implementation of the Culture Care program)
|
|
|
Experimental: Culture Care group of healthcare workers
Healthcare workers working in the surgical units, with an in-hospital environment modernized by the Culture Care program
|
The Culture Care program modernizes the in-hospital environment by including art and culture proposed in the form of an individualized pathway. It will be offered primarily to hospitalized patients, but also available to families, caregivers and healthcare professionals. It will aim to create a new hospital experience, different from the one we've always known. The Culture Care program will display posters illustrating works of art (paintings, drawings, photographs, etc.) along the hallways. These posters will be interactive, so that a QR code can be scanned to access musical content and audio podcasts (interviews and documentaries) accessible via bone-conduction headphones. The Culture Care program is likely to reduce the sedentary behavior of hospitalized patients, by providing an attractive in-hospital environment that is likely to produce both physical and psychological benefits. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily time spent out of bed
Time Frame: From postoperative day 1 to postoperative day 3.
|
This outcome will be assessed by accelerometry
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From postoperative day 1 to postoperative day 3.
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Daily steps number
Time Frame: From postoperative day 1 to postoperative day 3.
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This outcome will be assessed by accelerometry
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From postoperative day 1 to postoperative day 3.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients mobilized on the day of surgery
Time Frame: The day of surgery (Day 0)
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Out of bed: sitting in the chair, standing, walking, etc.
This outcome will be assessed by accelerometry.
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The day of surgery (Day 0)
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Daily steps number
Time Frame: From postoperative day 1 to postoperative day 5.
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From postoperative day 1 to postoperative day 5.
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Mean daily duration of physical inactivity, light physical activity and moderate-to-vigorous physical activity
Time Frame: From postoperative day 1 to postoperative day 5.
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From postoperative day 1 to postoperative day 5.
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Quality of recovery after surgery
Time Frame: At postoperative day 2 and at discharge (maximum 1 day before)
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This outcome will be assessed using the Quality of Recovery in 15 questions questionnaire (QoR-15) with a 11-point numerical rating scale with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery)
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At postoperative day 2 and at discharge (maximum 1 day before)
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Psychological well-being
Time Frame: At postoperative day 2
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This outcome will be assessed using the Hospital Anxiety and Depression scale to measure anxiety and depression, with a score of 0 to 7 considered normal, 8 to 10 indicate mild symptoms, 11 to 14 indicate moderate symptoms and 15 to 21 indicate severe symptoms.
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At postoperative day 2
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Experience of in-hospital mobility
Time Frame: At postoperative day 2
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This outcome will be assessed using a survey with Likert scale questions with seven point scale to express how much they agree or disagree with different statements about barriers and facilitators to mobility during the hospital stay. In addition, patients will be asked to rate their satisfaction about the in-hospital environment (with 0 being the lowest and 10 being the highest). |
At postoperative day 2
|
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Postoperative complications rate
Time Frame: From the day of surgery to hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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This outcome will be assessed using the Comprehensive Complications Index (CCI®), a score ranging from 0 (no complication) to 100 (death).
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From the day of surgery to hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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Length of hospital stay
Time Frame: At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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|
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Number of patients with adverse events
Time Frame: At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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Adverse events related to early mobilization of patients in the postoperative phase up to discharge, i.e. number of falls or loss of consciousness, accidental removal of drains or catheters
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At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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Number of adverse events per patients
Time Frame: At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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Adverse events related to early mobilization of patients in the postoperative phase up to discharge, i.e. number of falls or loss of consciousness, accidental removal of drains or catheters
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At hospital discharge (from maximum 1 day before discharge to 2 days after discharge)
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Perception of the work environment and readiness to stimulate the mobility of hospitalized patients after surgery
Time Frame: During the 2 month period before the implementation of the Culture Care. This outcome will be assessed 3 month after the implementation of the Culture Care program.
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This outcome will be assessed among the healthcare workers via a survey.
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During the 2 month period before the implementation of the Culture Care. This outcome will be assessed 3 month after the implementation of the Culture Care program.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients experience of the Culture Care intervention
Time Frame: Interviews will start after the end of the quantitative study, for a anticipated duration from 1 to 5 months, maximum 8 months). Interviews will be conducted with patients between postoperative day 2 and postoperative day 5.
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Semi-structured interview (for the intervention group)
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Interviews will start after the end of the quantitative study, for a anticipated duration from 1 to 5 months, maximum 8 months). Interviews will be conducted with patients between postoperative day 2 and postoperative day 5.
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Healthcare workers experience of the Culture Care intervention
Time Frame: Interviews will start after the end of the quantitative study, for an anticipated duration from 1 to 5 months, maximum 8 months)
|
Semi-structured interview (for the intervention group only) conducted with the healthcare workers working in the units modernized with the Culture Care program.
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Interviews will start after the end of the quantitative study, for an anticipated duration from 1 to 5 months, maximum 8 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study 2024-02620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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