Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 Patient decision aid

Patient decision aid about treatment options for osteoarthritis

Group Type EXPERIMENTAL

1 Patient decision aid

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

2 Usual care

Usual patient educational materials

Group Type ACTIVE_COMPARATOR

2 Usual care

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes