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

NCT00743951 | Completed Results

• 1 other identifier: OHREB 2006724-01H
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

patient decision aids; patient preferences; osteoarthritis; joint replacement; waiting times

Outcome Measures

Primary Outcomes (1)

• Feasibility of Data Collection at Month 12

  Feasibility was the number of participants who completed data collection at 12 months

  Data collection occurred at month 12

Secondary Outcomes (4)

• Wait Times

  Data collection occurred at surgeon consult and month 12.

• Participant's Knowledge

  Data collection occurred at week 2

• Number of Participants With Sufficient Decision Quality

  Data collection occurred at week 2 (knowledge and values) and month 12 (patients' chosen option).

• Number of Participants With no Decisional Conflict

  Data collection occurred at week 2

Study Arms (2)

1 Patient decision aid

EXPERIMENTAL

Patient decision aid about treatment options for osteoarthritis

Behavioral: 1 Patient decision aid; Behavioral: 2 Usual care

2 Usual care

ACTIVE COMPARATOR

Usual patient educational materials

Behavioral: 2 Usual care

Interventions

1 Patient decision aid 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).

1 Patient decision aid

2 Usual care 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.

1 Patient decision aid; 2 Usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited

You may not qualify if:

• Patients with inflammatory arthritis
• Previous TJA
• Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator
• University of Ottawa: collaborator
• University of Toronto: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 1J7, Canada

Location

Related Publications (2)

• 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.

  PMID: 18397937 BACKGROUND

• Stacey 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.

  PMID: 24564877 RESULT

Related Links

• Clinical and Decision Summary tool

MeSH Terms

Conditions

Osteoarthritis; Patient Preference

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Patients need to be followed for longer given that 13% were still waiting for surgery after one year. Decisional conflict and preferred option were only measured prior to seeing the surgeon. Limitations related to the preliminary effectiveness outcomes are potential for self-report bias given that most outcome measures were patient reported. For actual choice, self-report bias may have been mitigated because data was also extracted from the patients' health record for verification of the data.

Results Point of Contact

• Title: Dawn Stacey
• Organization: University of Ottawa, Ottawa Hospital Research Institute

dstacey@uottawa.ca

613-737-8899

Study Officials

• Dawn Stacey, PHD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: August 29, 2008
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)