A Feasibility Study to Test if Adding Patient Decision Aids to Screening for Eligibility for Surgery Decreases Unnecessary Referrals for Total Joint Replacement

This study has been completed.
Sponsor:
Collaborators:
The Ottawa Hospital
University of Ottawa
University of Toronto
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00743951
First received: July 25, 2007
Last updated: June 2, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Joint Replacement
Behavioral: Patient decision aid and referral onward.
Behavioral: Patient education and referral onward
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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?

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decision quality [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
  • Satisfaction with preparation for decision making [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
  • Proportion of unnecessary surgical referrals [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient Decision Aid plus referral onward.
Behavioral: Patient decision aid and referral onward.

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).

Active Comparator: 2
Patient education
Behavioral: Patient education and referral onward

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.


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

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743951

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 1J7
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital
University of Ottawa
University of Toronto
Investigators
Principal Investigator: Dawn Stacey, PHD University of Ottawa
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Dawn Stacey, University of Ottawa
ClinicalTrials.gov Identifier: NCT00743951     History of Changes
Other Study ID Numbers: OHREB 2006724-01H
Study First Received: July 25, 2007
Last Updated: June 2, 2009
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
patient decision aids
patient preferences
osteoarthritis
joint replacement
waiting times

ClinicalTrials.gov processed this record on September 18, 2014