Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
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| ClinicalTrials.gov Identifier: NCT00743951 |
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Recruitment Status :
Completed
First Posted : August 29, 2008
Last Update Posted : March 31, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Behavioral: 1 Patient decision aid Behavioral: 2 Usual care | Phase 3 |
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
- Proportion of unnecessary surgical referrals.
- Decision quality, the extent to which patients' decisions are informed and values-based.
- Perception of Preparation for Decision Making.
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 142 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Health Services Research |
| 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? |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | April 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1 Patient decision aid
Patient decision aid about treatment options for osteoarthritis
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Behavioral: 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). Behavioral: 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. |
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Active Comparator: 2 Usual care
Usual patient educational materials
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Behavioral: 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. |
- Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral [ Time Frame: April 2009 ]
- Decision quality [ Time Frame: June 2008 ]
- Satisfaction with preparation for decision making [ Time Frame: June 2008 ]
- Proportion of unnecessary surgical referrals [ Time Frame: April 2009 ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743951
| Canada, Ontario | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1Y 1J7 | |
| Principal Investigator: | Dawn Stacey, PHD | University of Ottawa |
Publications of Results:
Other Publications:
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00743951 |
| Other Study ID Numbers: |
OHREB 2006724-01H |
| First Posted: | August 29, 2008 Key Record Dates |
| Last Update Posted: | March 31, 2016 |
| Last Verified: | March 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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patient decision aids patient preferences osteoarthritis joint replacement waiting times |
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |