Clinical trial NCT06393829: Early Mobilization in Cardiovascular Units
Official title: Implementation of an Early Mobilization Program in Cardiovascular Units
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Early mobilization program
cardiovascular
Level of mobility
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2024-05-01
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The proposed project will follow the steps of the Knowledge-to-Action framework (KTA) \[7\]. The KTA is a process model that provides practical guidance in planning and implementing research evidence into practice \[8\]. It is comprised of a Knowledge Creation Funnel and an Action Cycle. Our project will follow the steps of the Action Cycle from adapting to the local context through evaluating outcomes with a concern for sustaining knowledge use.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
measure: Number of patients mobilized divided by the total number of admitted patients during the evaluation period.
timeFrame: 3 months
measure: Number of Patients refused being mobilized compared to number of admited patients during the evaluation period.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Change in mobility levels during the unit's stay.
timeFrame: 3 months
measure: Change in number of Pressure ulcers occurance in the unit during the evaluation period.
timeFrame: 3 months
measure: Number of fall incidents occurring in the unit' during the evaluation period.
timeFrame: 3 months
measure: Change in Length of stay
timeFrame: 3 months
measure: Number of patients discharged to home versus number discharged to an institutional care.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal/Centre de rech interdisciplinaire en réadaptation du Montréal métropolitain
state: Quebec
Study officials:
affiliation: McGill univeristy
name: Sara Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.