Osteoarthritis
Conditions
Keywords
patient decision aids, patient preferences, osteoarthritis, joint replacement, waiting times
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.
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.
Interventions
BEHAVIORAL1 Patient decision aid
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).
BEHAVIORAL2 Usual care
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.
Sponsors
The Ottawa Hospital
University of Ottawa
University of Toronto
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Data Collection at Month 12 | Data collection occurred at month 12 | Feasibility was the number of participants who completed data collection at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wait Times | 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 |
| Participant's Knowledge | 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. |
| Number of Participants With Sufficient Decision Quality | 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 |
| Number of Participants With no Decisional Conflict | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Patient Decision Aid Patient decision aid about treatment options for osteoarthritis
1. Patient decision aid: 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 care: 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. | 71 |
| 2 Usual Care Usual patient educational materials
2 Usual care: 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. | 71 |
| Total | 142 |
Baseline characteristics
| Characteristic | 1 Patient Decision Aid | 2 Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 10.85 | 67.3 years STANDARD_DEVIATION 12.16 | 67.2 years STANDARD_DEVIATION 11.51 |
| Education Achieved Less than secondary school | 10 Participants | 12 Participants | 22 Participants |
| Education Achieved missing | 4 Participants | 5 Participants | 9 Participants |
| Education Achieved post-secondary education (e.g., university) | 32 Participants | 24 Participants | 56 Participants |
| Education Achieved Secondary school/trades school | 25 Participants | 30 Participants | 55 Participants |
| Hip-Knee Priority Tool (HKPT) | 43.9 units on a scale STANDARD_DEVIATION 12.4 | 45.1 units on a scale STANDARD_DEVIATION 17.5 | 44.5 units on a scale STANDARD_DEVIATION 15 |
| Region of Enrollment Canada | 71 participants | 71 participants | 142 participants |
| Sex/Gender, Customized Gender Men | 19 Participants | 25 Participants | 44 Participants |
| Sex/Gender, Customized Gender Women | 50 Participants | 46 Participants | 96 Participants |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 60 units on a scale STANDARD_DEVIATION 0.17 | 64 units on a scale STANDARD_DEVIATION 0.18 | 62 units on a scale STANDARD_DEVIATION 0.176 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 71 |
| serious Total, serious adverse events | 0 / 69 | 0 / 71 |
Outcome results
Primary
Feasibility of Data Collection at Month 12
Feasibility was the number of participants who completed data collection at 12 months
Time frame: Data collection occurred at month 12
Population: Two in the intervention group withdrew from the study and 3 in the control group were lost to follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Decision Aid Intervention | Feasibility of Data Collection at Month 12 | Surgery | 55 Participants |
| Patient Decision Aid Intervention | Feasibility of Data Collection at Month 12 | Non-surgery management | 5 Participants |
| Patient Decision Aid Intervention | Feasibility of Data Collection at Month 12 | Waiting list for surgery | 8 Participants |
| Patient Decision Aid Intervention | Feasibility of Data Collection at Month 12 | Died | 1 Participants |
| Usual Education (Control) | Feasibility of Data Collection at Month 12 | Died | 1 Participants |
| Usual Education (Control) | Feasibility of Data Collection at Month 12 | Surgery | 48 Participants |
| Usual Education (Control) | Feasibility of Data Collection at Month 12 | Waiting list for surgery | 10 Participants |
| Usual Education (Control) | Feasibility of Data Collection at Month 12 | Non-surgery management | 9 Participants |
Secondary
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.
Time frame: Data collection occurred at week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Decision Aid Intervention | Number of Participants With no Decisional Conflict | 45 Participants |
| Usual Education (Control) | Number of Participants With no Decisional Conflict | 38 Participants |
Secondary
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
Time frame: Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Decision Aid Intervention | Number of Participants With Sufficient Decision Quality | 31 Participants |
| Usual Education (Control) | Number of Participants With Sufficient Decision Quality | 14 Participants |
Secondary
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.
Time frame: Data collection occurred at week 2
Population: participants who completed the knowledge test after receiving the intervention/control intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Decision Aid Intervention | Participant's Knowledge | 71.2 percentage of correct answers | Standard Deviation 23.7 |
| Usual Education (Control) | Participant's Knowledge | 46.6 percentage of correct answers | Standard Deviation 21.4 |
Secondary
Wait Times
length of time from screening consultation to a definitive decision - underwent surgery or off the wait list for non-surgical management
Time frame: Data collection occurred at surgeon consult and month 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Decision Aid Intervention | Wait Times | 33.4 weeks |
| Usual Education (Control) | Wait Times | 33.0 weeks |