Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 1J7
- The Ottawa Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Exclusion Criteria:
- Patients with inflammatory arthritis
- Previous TJA
- Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 Patient decision aid
Patient decision aid about treatment options for osteoarthritis
|
Patients will receive: i)patient education booklet ii) a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005. iii) a personal decision form is an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process. iv) Referral to the surgeon with a standardized report of their clinical findings plus decisional data (knowledge, values, preference). Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans. ii) Referral to the surgeon with a standardized report of their clinical findings. |
|
Active Comparator: 2 Usual care
Usual patient educational materials
|
Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans. ii) Referral to the surgeon with a standardized report of their clinical findings. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Data Collection at Month 12
Time Frame: Data collection occurred at month 12
|
Feasibility was the number of participants who completed data collection at 12 months
|
Data collection occurred at month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wait Times
Time Frame: Data collection occurred at surgeon consult and month 12.
|
length of time from screening consultation to a definitive decision - underwent surgery or off the wait list for non-surgical management
|
Data collection occurred at surgeon consult and month 12.
|
|
Participant's Knowledge
Time Frame: Data collection occurred at week 2
|
The participants' knowledge was measured using 4-multiple choice questions (e.g., osteoarthritis progress over time, need for revision joint replacement, proportion of patients with reduced pain, length of time for recovery) taken from the Hip-Knee Osteoarthritis Decision Quality Instrument.
The total score range was 0 to 4 based on correct responses to the questions.
Higher score was higher knowledge.
|
Data collection occurred at week 2
|
|
Number of Participants With Sufficient Decision Quality
Time Frame: Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).
|
Decision quality was deemed sufficient if a patient scored 66% or higher on the knowledge test (measured at 2 weeks) and if their predicted probability of surgery based on values corresponded with their actual choice (measured at 12 months).
Values measured were from the Hip-Knee Osteoarthritis Decision Quality Instrument (measured at 2 weeks).
Patients' values were measured by asking patients to rate the personal importance of the benefits and harms of outcomes for 6 items (e.g., relief of pain) on a 10 point rating scale with 1 indicating low importance and 10 indicating high importance.
The match between the patients' choice and their values for benefits/risks was calculated as a dichotomous measure.
The predicted probability of surgery was calculated for each patient using a logistic regression equation derived from three items assessing the patient's values.
The equation was [1 + exp (-S)]-1 where S = -0.338
|
Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).
|
|
Number of Participants With no Decisional Conflict
Time Frame: Data collection occurred at week 2
|
SURE test version of the Decisional Conflict Scale was used to measure no decisional conflict.
This scale is called the SURE test and has 4 items.
Total score range is 0 to 4 and a score of 4 indicates no decisional conflict.
Any score less than 4 indicates decisional conflict.
|
Data collection occurred at week 2
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dawn Stacey, PHD, University of Ottawa
Publications and helpful links
General Publications
- Stacey D, Hawker G, Dervin G, Tomek I, Cochran N, Tugwell P, O'Connor AM. Management of Chronic Pain: Improving shared decision making in osteoarthritis. BMJ. 2008 Apr 26;336(7650):954-5. doi: 10.1136/bmj.39520.701748.94. Epub 2008 Apr 8.
- Stacey D, Hawker G, Dervin G, Tugwell P, Boland L, Pomey MP, O'Connor AM, Taljaard M. Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial. BMC Musculoskelet Disord. 2014 Feb 24;15:54. doi: 10.1186/1471-2474-15-54.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHREB 2006724-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.