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Implementation and Assessment of the BE-FIT Program (BE-FIT)

Primary Purpose

Postoperative Complications, Mobility, Surgery

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BE-FIT exercise program
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Exercise, Postoperative, Surgery

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 65 or older
  • patients admitted to hospital for surgical procedures such as general surgical, urologic, otolaryngologic, and transplant surgery

Exclusion Criteria:

  • non-index admissions (i.e., transferred from another inpatient service)
  • out-of-province
  • palliative surgery
  • multi-system trauma patients
  • patients with a Clinical Frailty Scale score ≥ 7

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BE-FIT

Usual care

Arm Description

The quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/ (10 weeks); during intervention (16 weeks); post-intervention (20 weeks). A cohort of patients on selected wards will receive the BE-FIT program intervention.

We will adopt a before-and-after analysis methodology for complications, functional performance, and patient satisfaction. A control cohort of patients on the same ward will be compared to who received usual care prior to the intervention; this may include physiotherapy consultations ordered at the discretion of the surgical team or any other independent activity initiated by the patient (e.g., walking).

Outcomes

Primary Outcome Measures

The change in percentage of 'Out of bed' observations
The primary outcome is the change in percentage of 'out of bed' observations among older surgery patients assessed for baseline audits (Pre-intervention), compared to audits in the intervention phase, and compared to audits post-intervention. The research team will perform visual audits 6 times/week (three times/day, two days/week or two times/day, three times/week), and will record patient identification numbers and types of mobility observed using the MOVE's audit tool. Frequencies (percentage) of out-of-bed will be compared to frequencies (percentage) of in-bed events.

Secondary Outcome Measures

Time-to-mobility
Time-to-mobility will be obtained from the patient charts. Shorter time-to-mobility indicates better health
Length of stay
Length of stay will be obtained from the patient charts and DIMR. Reduced length of stay will indicate improved health
Complication incidence
Complication incidence will be obtained as assessed by a post-operative morbidity survey and DIMR. Less complication incidence will indicate a beneficial outcome of the quality improvement initiative.
Hospitalization cost
Hospitalization cost including in-hospital costs, readmissions at 30 days' post-discharge will be obtained by utilizing DIMR, Discharge Abstract Database and in-hospital micro-costing data from each site.
Patient satisfaction
patient satisfaction will be assessed by a patient satisfaction questionnaire (PSQ-18)

Full Information

First Posted
April 10, 2022
Last Updated
September 1, 2023
Sponsor
University of Alberta
Collaborators
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05338528
Brief Title
Implementation and Assessment of the BE-FIT Program
Acronym
BE-FIT
Official Title
Implementation and Assessment of the Elder-friendly BEdside Reconditioning for Functional ImprovemenTs (BE-FIT) Following Surgery Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lengthy hospitalization and immobility can lead to muscle loss resulting in reduced recovery rates and prolonged hospital stay or readmission. Older adults discharged from hospitals are at an increased risk for functional decline, falls and disability. Daily exercise and physical activities have proven to enhance the recovery and discharge process for older patients from the hospital and ultimately save vast amounts of dollars each year. The aim of this study is to initiate early mobilization and decrease the rate of functional decline in post-surgical older adults' patients in the acute care hospital setting in Alberta, Canada. The investigators are implementing a BE-FIT (BEdside reconditioning for Functional ImprovemenTs) a quality improvement, evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. Patients enrolled in the program will receive a bedside exercise plan to be completed independently throughout their stay in the hospital. Control patients will receive usual care without the added exercise plan. Patient mobility during their hospital stay will be assessed pre and post BE-FIT initiation according to a predetermined mobility scoring system. Secondary outcomes will include: time-to-mobility, length of stay, complication incidence and hospitalization costs.
Detailed Description
Frailty and post-operative complications are the predictors of increased cost-of-care among older patients who underwent emergency abdominal surgery in Alberta. In addition, older patients are often more vulnerable to the physical stressors following major surgery including risks of falls and disability. There is increasing evidence that daily exercise and physical activities can enhance the recovery and discharge process for older patients. Employing a two-arm trial design we will test whether the initiation of an early mobilization program can decrease the rate of functional decline in post-surgical older adults' patients. The trial will be conducted in an acute care hospital setting in Alberta, Canada. The investigators will implement a quality improvement program BE-FIT (Bedside reconditioning for functional improvements) based on the Mobilization of Vulnerable Elders (MOVE) implementation strategy. BE-FIT is an evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. The intervention consists of a bedside exercise plan completed throughout the hospitalization. It is done independently without the need for additional rehabilitation or healthcare staff. The investigators will implement educational intervention to support the patients, staff, and families in bringing and sustaining change in practice and behavior from sedentary to physically active mobilization approach in the surgical area of the acute care setting. Control patients will receive usual care without the added exercise plan. BE-FIT will be implemented in surgical units at 3 demonstrator sites (University of Alberta Hospital (UAH), Foothills Medical Centre (FMC) and the Misericordia Community Hospital (MCH)). Units may include General surgery, Otolaryngologic surgery, and Urology. The research will include all patients ≥65 years admitted to the hospital (emergency or elective) units. The study is guided by the Knowledge-to-Action Cycle theory (K2A) and the Quality Implementation Framework (QIF) with interrupted time-series (IT) design. Prior to the implementation of the program, the investigators will used readiness assessments, identification of facilitators and barriers to post-operative mobility and co-designs with patients will be conducted. To measure and analyze the impact of our program, the primary outcome will evaluate the percentage of 'out of bed' occurrences as measured by an interrupted time series of mobility audits; secondary outcomes will include: time-to-mobility, length of stay, complication incidence and hospitalization costs. The quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention (10 weeks); during intervention (16 weeks); post-intervention (20 weeks). A pre-intervention model will be created by using the first time-points over 10 weeks to analyze the primary outcome. To evaluate whether this model describes the baseline adequately, an estimate of the time-series models for the entire 84-time points (pre- and post-intervention) will be performed. To examine the impact of the BE-FIT exercise program on patient outcome, the investigators will use segmented linear regression models and correct the models for autocorrelation as required using the Cochrane-Orcutt method. This will be used to calculate the median daily length-of-stay for each week in the study period, classified into pre-, during and post-intervention. Regression methods will be used to assess mobilization outcome to investigate and compare the trend in median length-of-stay. A before-and-after analysis methodology will be adopted for complications, functional performance, and patient satisfaction. Regression models will be constructed using the parsimonious approach, multivariable linear (or transformed linear) regression, and logistic regression. Potential confounding baseline variables (i.e., age, sex, patient location before admission, admitting diagnosis, etc.) will be entered into the model and kept if deemed statistically (p<0.05) and/or clinically important. Health economic assessment will estimate mean cost for different sub-categories using appropriate regressions models for skewed cost data, adjusted for potential risk differences. The impact on patient's function and quality-of-life will be assessed with Short Performance Physical Battery (SPPB) and EQ-5D questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Mobility, Surgery
Keywords
Exercise, Postoperative, Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A quasi-experimental unblinded interrupted time-series (ITS) design in three phases: pre-intervention; during intervention; post-intervention. A before-and-after analysis methodology for complications, functional performance, and patient satisfaction.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BE-FIT
Arm Type
Experimental
Arm Description
The quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/ (10 weeks); during intervention (16 weeks); post-intervention (20 weeks). A cohort of patients on selected wards will receive the BE-FIT program intervention.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
We will adopt a before-and-after analysis methodology for complications, functional performance, and patient satisfaction. A control cohort of patients on the same ward will be compared to who received usual care prior to the intervention; this may include physiotherapy consultations ordered at the discretion of the surgical team or any other independent activity initiated by the patient (e.g., walking).
Intervention Type
Behavioral
Intervention Name(s)
BE-FIT exercise program
Intervention Description
BE-FIT is an evidence-based exercise program that focuses on early mobilization and recovery by minimizing bed rest, promoting functional tasks, and encouraging self-management. The intervention ist based on the Mobilization of Vulnerable Elders (MOVE) program and consists of a bedside exercise plan, done independently by the patient without the need for additional rehabilitation or healthcare staff.
Primary Outcome Measure Information:
Title
The change in percentage of 'Out of bed' observations
Description
The primary outcome is the change in percentage of 'out of bed' observations among older surgery patients assessed for baseline audits (Pre-intervention), compared to audits in the intervention phase, and compared to audits post-intervention. The research team will perform visual audits 6 times/week (three times/day, two days/week or two times/day, three times/week), and will record patient identification numbers and types of mobility observed using the MOVE's audit tool. Frequencies (percentage) of out-of-bed will be compared to frequencies (percentage) of in-bed events.
Time Frame
A quasi-experimental unblinded interrupted time-series (ITS) design will be conducted in three phases: pre-intervention/(10 weeks); during intervention (16 weeks); post-intervention (20 weeks).
Secondary Outcome Measure Information:
Title
Time-to-mobility
Description
Time-to-mobility will be obtained from the patient charts. Shorter time-to-mobility indicates better health
Time Frame
within 20 weeks post intervention
Title
Length of stay
Description
Length of stay will be obtained from the patient charts and DIMR. Reduced length of stay will indicate improved health
Time Frame
within 20 weeks post intervention
Title
Complication incidence
Description
Complication incidence will be obtained as assessed by a post-operative morbidity survey and DIMR. Less complication incidence will indicate a beneficial outcome of the quality improvement initiative.
Time Frame
within 20 weeks post intervention
Title
Hospitalization cost
Description
Hospitalization cost including in-hospital costs, readmissions at 30 days' post-discharge will be obtained by utilizing DIMR, Discharge Abstract Database and in-hospital micro-costing data from each site.
Time Frame
within 20 weeks post intervention
Title
Patient satisfaction
Description
patient satisfaction will be assessed by a patient satisfaction questionnaire (PSQ-18)
Time Frame
within 20 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 65 or older patients admitted to hospital for surgical procedures such as general surgical, urologic, otolaryngologic, and transplant surgery Exclusion Criteria: non-index admissions (i.e., transferred from another inpatient service) out-of-province palliative surgery multi-system trauma patients patients with a Clinical Frailty Scale score ≥ 7
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel G Khadaroo, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share IPD with other researchers outside the collaborator group
Citations:
PubMed Identifier
32049271
Citation
Khadaroo RG, Warkentin LM, Wagg AS, Padwal RS, Clement F, Wang X, Buie WD, Holroyd-Leduc J. Clinical Effectiveness of the Elder-Friendly Approaches to the Surgical Environment Initiative in Emergency General Surgery. JAMA Surg. 2020 Apr 1;155(4):e196021. doi: 10.1001/jamasurg.2019.6021. Epub 2020 Apr 15.
Results Reference
background
PubMed Identifier
33156849
Citation
Pederson JL, Padwal RS, Warkentin LM, Holroyd-Leduc JM, Wagg A, Khadaroo RG. The impact of delayed mobilization on post-discharge outcomes after emergency abdominal surgery: A prospective cohort study in older patients. PLoS One. 2020 Nov 6;15(11):e0241554. doi: 10.1371/journal.pone.0241554. eCollection 2020.
Results Reference
background
PubMed Identifier
32242905
Citation
Hofmeister M, Khadaroo RG, Holroyd-Leduc J, Padwal R, Wagg A, Warkentin L, Clement F. Cost-effectiveness Analysis of the Elder-Friendly Approaches to the Surgical Environment (EASE) Intervention for Emergency Abdominal Surgical Care of Adults Aged 65 Years and Older. JAMA Netw Open. 2020 Apr 1;3(4):e202034. doi: 10.1001/jamanetworkopen.2020.2034.
Results Reference
background
PubMed Identifier
29942346
Citation
McComb A, Warkentin LM, McNeely ML, Khadaroo RG. Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.
Results Reference
background
Links:
URL
http://sites.google.com/ualberta.ca/drkhadarooresearch/
Description
Dr. Khadaroo's Reserach Website

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Implementation and Assessment of the BE-FIT Program

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