ClinicalTrials.gg
CompletedNCT06107699Updated Oct 15, 2024

The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures

An interventional study of Patient Navigation in Fracture, Frailty and Aging, sponsored by Horizon Health Network. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Horizon Health Network · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Background: Fall-related injuries like fractures are on the rise among older adults in New Brunswick. These injuries can lead to hospitalization and adverse health effects. Moreover, transitions from acute care can be complicated and overwhelming, especially for patients and their families. Researching patient navigators as a means of enhancing inpatient care, while also ensuring successful transitions in care for patients, may have positive impacts and help older adults successfully age in place.

Objective: This study seeks to investigate the effects of having support from patient navigators in helping older adults admitted to the Orthopedic Unit with a fracture. Specifically, the objectives are to investigate whether there are differences between patients with patient navigators and those patients receiving standard of care, regarding: the length of stay in acute care; healthcare utilization post-discharge; patient and family experience and satisfaction with care; and, healthcare provider experiences working with patient navigators.

Methods: This study uses a mixed-method concurrent embedded design, in which the quantitative randomized control trial has an embedded qualitative component.

Potential Benefits/Risks: This study is considered low risk. Potential benefits of this study include a better understanding of the impact of support from a patient navigator on inpatient care and patient transitions. This information will be used to inform the development of practical recommendations for policymakers and clinicians on how to enhance inpatient acute care and successful transitions for older adults.

02

Conditions studied

  • Fracture
  • Frailty
  • Aging

Keywords

  • Patient Navigation
03

In context

Fractures, Bone

723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 458 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Horizon Health Network is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Patients 65 years of age and older admitted to the Orthopedic Unit at SJRH (OU) for a fracture -

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Patient Navigator

    Other: Patient Navigation

  • No intervention
    Standard of Care

Interventions

  • OtherPatient Navigation

    Assigned a Patient Navigator to provide information on transitional care and community resources.

06

What researchers measure

Primary outcomes

  1. Canadian Patient Experiences Survey Inpatient Care (CPES-IC)

    Patient satisfaction with care

    Time frame: through study completion, 3 months

  2. Healthcare utilization- study specific questionnaire

    Time frame: through study completion, 3 months

  3. Length of stay in acute care

    Time frame: through study completion, 3 months

  4. Global Patient Satisfaction Question- study specific

    Time frame: at study completion, 3 months

Secondary outcomes

  1. Patient experiences- qualitative semi-structured interviews

    Time frame: at study completion, 3 months

07

Study locations

1 site
  • Saint John Regional Hospital
    Saint John, New Brunswick E2L 4L2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Feb 2024, 17 months.

Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's 17 months is below that.

Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2023
First posted
Oct 30, 2023
StartActual
Sep 1, 2022
Primary completionActual
Feb 29, 2024
CompletionActual
Feb 29, 2024
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06107699
Lead sponsor
Horizon Health Network
Responsible party
Sponsor
First posted
Oct 30, 2023
Start date
Sep 1, 2022
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Last update
Oct 15, 2024

Study contacts

Natasha Hanson, PhD
study chair · Horizon Health Network

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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