Early Mobilization in Cardiovascular Units

April 26, 2024 updated by: Sara Ahmed, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Implementation of an Early Mobilization Program in Cardiovascular Units

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3S 1M9
        • Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal/Centre de rech interdisciplinaire en réadaptation du Montréal métropolitain
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: pre-implementation
The proportion of patients mobilized pre-intervention period
Experimental: Implementation
The proportion of patients mobilized during the intervention implementation period
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).
No Intervention: Post-implementation
The proportion of patients mobilized post-intervention period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months

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.
Time Frame: 3 months
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.
Time Frame: 3 months
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.
Time Frame: 3 months

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.
Time Frame: 3 months
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.
Time Frame: 3 months
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.
Time Frame: 3 months
Change in rate of falls occurring in the unit' during the evaluation period.
3 months
Change in Length of stay
Time Frame: 3 months
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.
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Collaborators

Jewish General Hospital

Investigators

  • Principal Investigator: Sara Ahmed, McGill Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-4090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research assistant will de-identify the participants by generating a random code using a statistical method. The research team will extract and transfer the data using a password-protected Excel spreadsheet where modification is traceable. The private information (participant personal information, i.e., name, birth date) will be coded (unique code for each participant).

The data capturing, coding, and analysis will be conducted on a password-protected computer at Constance Lethbridge Rehabilitation center connected to a secured server.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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