Early Mobilization in Cardiovascular Units

NCT ID: NCT06393829

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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pre-implementation

The proportion of patients mobilized pre-intervention period

Group Type NO_INTERVENTION

No interventions assigned to this group

Implementation

The proportion of patients mobilized during the intervention implementation period

Group Type EXPERIMENTAL

Applying the Early Mobilization Program

Intervention Type BEHAVIORAL

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).

Post-implementation

The proportion of patients mobilized post-intervention period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role collaborator

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role lead

Responsible Party

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Sara Ahmed

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara Ahmed

Role: PRINCIPAL_INVESTIGATOR

McGill univeristy

Locations

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Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal/Centre de rech interdisciplinaire en réadaptation du Montréal métropolitain

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Diana M Zidarov

Role: CONTACT

5143402085 ext. 4711

Rania M Soliman

Role: CONTACT

4384062544

Facility Contacts

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Role: primary

514 340-2085 ext. 144778

References

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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.

Reference Type BACKGROUND
PMID: 32135387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31793086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26132803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25715872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19942399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27144796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16557505 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 25895742 (View on PubMed)

Other Identifiers

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2024-4090

Identifier Type: -

Identifier Source: org_study_id

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