FractureNCT06107699
The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures
A study testing Patient Navigation in people with Fracture and Frailty, run by Horizon Health Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures: an Interventional Mixed Methods Study
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.
Read more
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.
- Being tested
- Patient Navigation
- Keywords
- Patient Navigation
- Medical subject headings
- Fractures, Bone, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationOther
Assigned a Patient Navigator to provide information on transitional care and community resources.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator | Experimental | Not described Receives: Other: Patient Navigation |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Patient Experiences Survey Inpatient Care (CPES-IC)
Patient satisfaction with care
Measured: through study completion, 3 months
Healthcare utilization- study specific questionnaire
Measured: through study completion, 3 months
Length of stay in acute care
Measured: through study completion, 3 months
Global Patient Satisfaction Question- study specific
Measured: at study completion, 3 months
Secondary outcomes (1)
Patient experiences- qualitative semi-structured interviews
Measured: at study completion, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Sep 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha Hanson, PhD, Study chair, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107699
- Sponsor's protocol ID
- 101586
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanson N, Freeze T, Skerry L, O'Keefe K, Nguyen C, Somal R, Faig K, Jarrett P. Investigating patient navigator impact on older adults' transitions from acute care: A randomized controlled trial with embedded qualitative component. PLoS One. 2026 Feb 4;21(2):e0341251. doi: 10.1371/journal.pone.0341251. eCollection 2026.
PubMed 41637440
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures: an Interventional Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06107699
- Acronym / sponsor ID
- 101586
- Keywords
- Patient Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator | Experimental | Other: Patient Navigation |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationAssigned a Patient Navigator to provide information on transitional care and community resources. | Other | Patient Navigator |
Primary outcome
Canadian Patient Experiences Survey Inpatient Care (CPES-IC)
Time frame: through study completion, 3 months
Patient satisfaction with care
Healthcare utilization- study specific questionnaire
Time frame: through study completion, 3 months
Length of stay in acute care
Time frame: through study completion, 3 months
Global Patient Satisfaction Question- study specific
Time frame: at study completion, 3 months
1 secondary outcome
Patient experiences- qualitative semi-structured interviews
Time frame: at study completion, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41637440Hanson N, Freeze T, Skerry L, O'Keefe K, Nguyen C, Somal R, Faig K, Jarrett P. Investigating patient navigator impact on older adults' transitions from acute care: A randomized controlled trial with embedded qualitative component. PLoS One. 2026 Feb 4;21(2):e0341251. doi: 10.1371/journal.pone.0341251. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Hanson, PhD study chair
Horizon Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Fracture and Frailty, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Patient Experiences Survey Inpatient Care (CPES-IC) (time frame: through study completion, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.