Early Mobilization in Cardiovascular Units

Cardiovascular Diseases Clinical Trial

Official title:

Implementation of an Early Mobilization Program in Cardiovascular Units

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393829
• Other study ID #: 2024-4090
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2024
• Source: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Contact: Diana M Zidarov
• Phone: 5143402085
• Email: diana.zidarov[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insufficient mobility contributes to functional decline in hospitalized cardiac patients. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay [1]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. The overall goal of this study is to adapt and implement an early mobilization program in the Cardiovascular units of the Jewish General Hospital (JGH).

Description:

Background: Insufficient mobility contributes to functional decline in cardiovascular units. Early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay [1]. One example is the Level of Function (LOF) Mobility Scale implemented in the Cardiovascular units at the Jewish General Hospital, an academic tertiary care centre in Montreal, Quebec [2]. Despite evidence supporting the benefits of early mobilization programs, hospitalized individuals in cardiovascular units spend most of the day in bed [1-6]. Therefore, there is a need to adapt and implement early mobilization programs in Quebec hospitals. This project is research nested in a quality improvement initiative for the Jewish General Hospital Cardiovascular units.

Objectives: 1) Adapt an early mobilization program in a hospital setting; 2) Develop strategies to overcome individual and organizational barriers to implementing an early mobilization program; 3) Assess the reach, acceptability, and fidelity of implementing an early mobilization program; and 4) Assess the program's impact on patients and the organization.

Methods: A 3-phase study using an iterative participative approach. Phase 1: a qualitative design to adapt an early mobilization program. Phase 2: mixed methods repeated measures design to assess barriers and facilitators to implementing the program and develop implementation strategies.

Phase 3: An interrupted time series design to assess the implementation and the impact of the program.

Expected contribution: Early mobilization programs in the Cardiovascular units can improve the quality of care provided to these patients and promote further clinician-researcher partnerships, contributing to improved uptake of best practices in this clinical context.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: July 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All healthcare professionals working in the cardiovascular unit at the Jewish General Hospital.

• All patients admitted to the cardiovascular unit at the Jewish General Hospital.

Exclusion Criteria:

• Patients who don't speak English or French.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Applying the Early Mobilization Program
A mobilization intervention based on the level of function (LOF) ( i.e. patients should be assessed for mobilization status within 24 hours of admission; mobilization should occur at least three times a day, and mobility should be progressive and scaled, tailored to the patient's abilities); The frequency of patient mobilization (primary outcome) will be assessed 20 weeks before implementation, during the 20 weeks of implementation and 20 weeks after the end of implementation (60 weeks in total).

Locations

Country	Name	City	State
Canada	Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal/Centre de rech interdisciplinaire en réadaptation du Montréal métropolitain	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Anekwe DE, Biswas S, Bussieres A, Spahija J. Early rehabilitation reduces the likelihood of developing intensive care unit-acquired weakness: a systematic review and meta-analysis. Physiotherapy. 2020 Jun;107:1-10. doi: 10.1016/j.physio.2019.12.004. Epub 2019 Dec 19. — View Citation

Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015. — View Citation

Dima D, Valiquette J, Berube-Dufour J, Goldfarb M. Level of function mobility scale for nurse-driven early mobilisation in people with acute cardiovascular disease. J Clin Nurs. 2020 Mar;29(5-6):778-784. doi: 10.1111/jocn.15124. Epub 2019 Dec 18. — View Citation

Dubb R, Nydahl P, Hermes C, Schwabbauer N, Toonstra A, Parker AM, Kaltwasser A, Needham DM. Barriers and Strategies for Early Mobilization of Patients in Intensive Care Units. Ann Am Thorac Soc. 2016 May;13(5):724-30. doi: 10.1513/AnnalsATS.201509-586CME. — View Citation

Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47. — View Citation

Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0. — View Citation

TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4. — View Citation

Zanni JM, Korupolu R, Fan E, Pradhan P, Janjua K, Palmer JB, Brower RG, Needham DM. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010 Jun;25(2):254-62. doi: 10.1016/j.jcrc.2009.10.010. Epub 2009 Nov 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of implementation strategies developed to overcome the identified individual and organizational barriers and leverage the facilitators to implement an early mobilization program in this hospital setting.	Investigators will develop strategies to overcome identified barriers and leverage the facilitators to implement the early mobilization program using data obtained from a mixed methods repeated measures design, including: A) Shadowing: an observational grid will be developed, including frequency of mobilization, length of mobilization activity, Health care professionals (HCPs) performing mobilization intervention, type of mobilization intervention, patient and caregiver acceptance and reaction, environmental barriers, available equipment, communication strategies among HCPs, reporting of mobilization interventions in the medical charts, clinicians' comment and observers' impressions and thoughts.; B) HCPs will be invited to respond to a survey and participate in a focus group to assess perceived barriers and facilitators to early mobilization.; C) Patients and caregivers will participate in a focus group to better understand barriers and facilitators to early mobilization.	3 months
Primary	Number of patients mobilized divided by the total number of admitted patients during the evaluation period.	Reach of the early mobilization program among patients will be measured with the following indicator: the number of patients mobilized (defined as the patient not being in bed during direct observation) divided by the total number of admitted patients during the evaluation period.	3 months
Primary	Number of Patients refused being mobilized compared to number of admited patients during the evaluation period.	Acceptability of the early mobilization program among patients will be measured with the refusal rate of being mobilized using the site's administrative data and a file audit that will include a form developed for this purpose.	3 months
Primary	Number of days between admission and the development of a mobilization plan, between admission and first mobilization and number of patients with at least 3 mobilizations per day per week.	Fidelity of intervention among HCPs will be measured with the following indicators: Number of days between admission and the development of a mobilization plan; Number of days between admission and first mobilization; Number of patients with at least 3 mobilizations per day per week.	3 months
Primary	Change in mobility levels during the unit's stay.	Change in in mobility levels according to the LOF mobility scaleoccurring during the unit's stay.	3 months
Primary	Change in number of Pressure ulcers occurance in the unit during the evaluation period.	Change in Pressure ulcers rate in the unit during the evaluation period.	3 months
Primary	Number of fall incidents occurring in the unit' during the evaluation period.	Change in rate of falls occurring in the unit' during the evaluation period.	3 months
Primary	Change in Length of stay	Change in organizational outcomes measured by change in number of days the patient stay in the hospital.	3 months
Primary	Number of patients discharged to home versus number discharged to an institutional care.	Number of patients discharged to home versus number discharged to an institutional care used to evaluate the Effect of early monbilization on the discharge destination (home or institutional care).	3 months