Early Mobilization in Cardiovascular Units

NCT06393829 | Not Yet Recruiting DMC

• 1 other identifier: 2024-4090
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Keywords

Early mobilization program; cardiovascular; Level of mobility

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change in Length of stay

  Change in organizational outcomes measured by change in number of days the patient stay in the hospital.

  3 months

• 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

Study Arms (3)

pre-implementation

NO INTERVENTION

The proportion of patients mobilized pre-intervention period

Implementation

EXPERIMENTAL

The proportion of patients mobilized during the intervention implementation period

Behavioral: Applying the Early Mobilization Program

Post-implementation

NO INTERVENTION

The proportion of patients mobilized post-intervention period

Interventions

Applying the Early Mobilization Program 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).

Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who don't speak English or French.

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead
• Jewish General Hospital: collaborator

Study Sites (1)

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

Montreal, Quebec, H3S 1M9, Canada

Location

Related 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.

  PMID: 32135387 BACKGROUND

• 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.

  PMID: 31793086 BACKGROUND

• 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.

  PMID: 26132803 BACKGROUND

• 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.

  PMID: 25715872 BACKGROUND

• 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.

  PMID: 19942399 BACKGROUND

• 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.

  PMID: 27144796 BACKGROUND

• 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.

  PMID: 16557505 BACKGROUND

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

  PMID: 25895742 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sara Ahmed

  McGill univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana M Zidarov

CONTACT

5143402085; diana.zidarov@umontreal.ca

Rania M Soliman

CONTACT

4384062544; rania.soliman@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: May 1, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data, informed consent forms, and questionnaires completed by patients and health care professionals will be stored at the Constance Lethbridge Rehabilitation Center on the institution's secure server by the researcher in charge of the study for ten years after the end of the project after which they will be permanently destroyed.
• Access Criteria: A research assistant and a statistician will analyze and code the de-identified research data under the supervision of Sara Ahmed and Diana Zidarov, the two principal investigators. These people will have access to the data for analytical purposes.

Locations

CA (1)