Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00743951
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2007-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
Official Title:
Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option.
The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.
The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.
The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.
The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.
Detailed Description:
Background:
Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate the need to establish benchmarks that consider patient preferences. Among clinically appropriate candidates for this procedure, patients' preferences for surgery is very low; between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider TJA.However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indications for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. Therefore, patient decision aids may have a role in ensuring that wait list reforms address under-use of surgical procedures that informed patients need and want, while preventing the over-use of procedures that informed patients do not value. If they were used in combination with screening for surgical eligibility, they might also prevent inappropriate referrals for surgery (i.e., patients who are not clinically eligible or who would not want surgery even if they were clinically eligible).
Objective:
To pilot test the feasibility of a trial evaluating the incremental effects of patient decision aids on reducing unnecessary surgical referrals for TJA, when used in combination with a general practitioner intake clinic that screens patients for surgical eligibility.
Participants \& Setting:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited. Excluded are those with inflammatory arthritis, previous TJA, or those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Design:
In this pilot study, patients will be screened for surgical eligibility by a trained general practitioner using a standardized examination of the hip/knee and questionnaire assessing joint symptoms and disability. Eligible patients will be stratified by affected joint (hip/knee) and randomly allocated to either: a) usual education; or b) a patient decision aid which presents balanced evidence-based information on the treatment options, including the risks and benefits. Automated reports will be sent to the surgeon for all patients.
Primary Outcomes:
* Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcomes
* Wait times to decision
* Knowledge
* Decision quality, the extent to which patients' decisions are informed and values-based.
* Decisional conflict
Timeline and Deliverables:
By the end of this one year study, we will prepare a report and policy brief on the evidence of feasibility to support a larger scale multi-centre trial and a fully implementable set of interventions, with standardized training, to facilitate replication elsewhere.
Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate the need to establish benchmarks that consider patient preferences. Among clinically appropriate candidates for this procedure, patients' preferences for surgery is very low; between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider TJA.However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indications for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. Therefore, patient decision aids may have a role in ensuring that wait list reforms address under-use of surgical procedures that informed patients need and want, while preventing the over-use of procedures that informed patients do not value. If they were used in combination with screening for surgical eligibility, they might also prevent inappropriate referrals for surgery (i.e., patients who are not clinically eligible or who would not want surgery even if they were clinically eligible).
Objective:
To pilot test the feasibility of a trial evaluating the incremental effects of patient decision aids on reducing unnecessary surgical referrals for TJA, when used in combination with a general practitioner intake clinic that screens patients for surgical eligibility.
Participants \& Setting:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited. Excluded are those with inflammatory arthritis, previous TJA, or those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Design:
In this pilot study, patients will be screened for surgical eligibility by a trained general practitioner using a standardized examination of the hip/knee and questionnaire assessing joint symptoms and disability. Eligible patients will be stratified by affected joint (hip/knee) and randomly allocated to either: a) usual education; or b) a patient decision aid which presents balanced evidence-based information on the treatment options, including the risks and benefits. Automated reports will be sent to the surgeon for all patients.
Primary Outcomes:
* Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcomes
* Wait times to decision
* Knowledge
* Decision quality, the extent to which patients' decisions are informed and values-based.
* Decisional conflict
Timeline and Deliverables:
By the end of this one year study, we will prepare a report and policy brief on the evidence of feasibility to support a larger scale multi-centre trial and a fully implementable set of interventions, with standardized training, to facilitate replication elsewhere.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: