OsteoarthritisNCT00743951
Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
A study testing 1 Patient decision aid in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- 1 Patient decision aid
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Who cannot join
- Patients with inflammatory arthritis
- Previous TJA
- Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- 1 Patient decision aid, 2 Usual care
- Keywords
- patient decision aids, patient preferences, osteoarthritis, joint replacement, waiting times
- Medical subject headings
- Osteoarthritis, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Patient decision aidBehavioural
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).
2 Usual careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Patient decision aid | Experimental | Patient decision aid about treatment options for osteoarthritis Receives: Behavioral: 1 Patient decision aid; Behavioral: 2 Usual care |
| 2 Usual care | Active comparator | Usual patient educational materials Receives: Behavioral: 2 Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Data Collection at Month 12
Feasibility was the number of participants who completed data collection at 12 months
Measured: Data collection occurred at month 12
Secondary outcomes (4)
Wait Times
length of time from screening consultation to a definitive decision - underwent surgery or off the wait list for non-surgical management
Measured: Data collection occurred at surgeon consult and month 12.
Participant's Knowledge
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.
Measured: Data collection occurred at week 2
Number of Participants With Sufficient Decision Quality
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
Measured: Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).
Number of Participants With no Decisional Conflict
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.
Measured: Data collection occurred at week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Dawn Stacey, PHD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743951
- Sponsor's protocol ID
- OHREB 2006724-01H
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2007
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 18397937Stacey 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.
PubMed 24564877
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT00743951
- Acronym / sponsor ID
- OHREB 2006724-01H
- Conditions
- Osteoarthritis
- Keywords
- patient decision aids, patient preferences, osteoarthritis, joint replacement, waiting times
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa, University of Toronto
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Patient decision aid | Experimental | Behavioral: 1 Patient decision aid, Behavioral: 2 Usual carePatient decision aid about treatment options for osteoarthritis |
| 2 Usual care | Active comparator | Behavioral: 2 Usual careUsual patient educational materials |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Key exclusion criteria (3 listed)
- Patients with inflammatory arthritis
- Previous TJA
- Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
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 |
|---|---|---|
| 1 Patient decision aidPatients 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). | Behavioural | 1 Patient decision aid |
| 2 Usual carePatient 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. | Behavioural | 1 Patient decision aid, 2 Usual care |
Primary outcome
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
4 secondary outcomes
Wait Times
Time frame: Data collection occurred at surgeon consult and month 12.
Participant's Knowledge
Time frame: 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).
Number of Participants With no Decisional Conflict
Time frame: Data collection occurred at week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18397937Stacey 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.
- Results publication: PubMed 24564877Stacey 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.
- Clinical and Decision Summary toolLink provided by the sponsor.
- 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.
Dawn Stacey, PHD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Patient decision aid in people with Osteoarthritis, run by Ottawa Hospital Research Institute 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 1 inclusion and 3 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 17 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Data Collection at Month 12 (time frame: Data collection occurred at month 12). 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 NCT00743951, which also lists 2 linked publications.
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 17 Jan 2025.