Trial Outcomes & Findings for Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals (NCT NCT00743951)
NCT ID: NCT00743951
Last Updated: 2025-01-17
Results Overview
Feasibility was the number of participants who completed data collection at 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
Data collection occurred at month 12
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
|
Overall Study
COMPLETED
|
69
|
71
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was missing data for 3 patients in the usual education (control) arm of the study and missing data for 2 patients in the patient decision aid arm who dropped out of the study
Baseline characteristics by cohort
| Measure |
1 Patient Decision Aid
n=71 Participants
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.
|
2 Usual Care
n=71 Participants
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.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 10.85 • n=69 Participants • There was missing data for 3 patients in the usual education (control) arm of the study and missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
67.3 years
STANDARD_DEVIATION 12.16 • n=68 Participants • There was missing data for 3 patients in the usual education (control) arm of the study and missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
67.2 years
STANDARD_DEVIATION 11.51 • n=137 Participants • There was missing data for 3 patients in the usual education (control) arm of the study and missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
|
Sex/Gender, Customized
Gender · Men
|
19 Participants
n=69 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
25 Participants
n=71 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
44 Participants
n=140 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
|
Sex/Gender, Customized
Gender · Women
|
50 Participants
n=69 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
46 Participants
n=71 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
96 Participants
n=140 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study
|
|
Region of Enrollment
Canada
|
71 participants
n=71 Participants
|
71 participants
n=71 Participants
|
142 participants
n=142 Participants
|
|
Education Achieved
Less than secondary school
|
10 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
12 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
22 Participants
n=142 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
|
Education Achieved
Secondary school/trades school
|
25 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
30 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
55 Participants
n=142 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
|
Education Achieved
post-secondary education (e.g., university)
|
32 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
24 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
56 Participants
n=142 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
|
Education Achieved
missing
|
4 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
5 Participants
n=71 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
9 Participants
n=142 Participants • missing data - patients did not respond to the question on the survey or dropped out of the study
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
60 units on a scale
STANDARD_DEVIATION 0.17 • n=69 Participants • There was missing data for 2 patients in the patient decision aid intervention arm and 3 patients in the usual education arm.
|
64 units on a scale
STANDARD_DEVIATION 0.18 • n=68 Participants • There was missing data for 2 patients in the patient decision aid intervention arm and 3 patients in the usual education arm.
|
62 units on a scale
STANDARD_DEVIATION 0.176 • n=137 Participants • There was missing data for 2 patients in the patient decision aid intervention arm and 3 patients in the usual education arm.
|
|
Hip-Knee Priority Tool (HKPT)
|
43.9 units on a scale
STANDARD_DEVIATION 12.4 • n=69 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study and for 3 patients in the usual education
|
45.1 units on a scale
STANDARD_DEVIATION 17.5 • n=68 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study and for 3 patients in the usual education
|
44.5 units on a scale
STANDARD_DEVIATION 15.0 • n=137 Participants • There was missing data for 2 patients in the patient decision aid arm who dropped out of the study and for 3 patients in the usual education
|
PRIMARY outcome
Timeframe: Data collection occurred at month 12Population: Two in the intervention group withdrew from the study and 3 in the control group were lost to follow-up
Feasibility was the number of participants who completed data collection at 12 months
Outcome measures
| Measure |
Patient Decision Aid Intervention
n=69 Participants
Participants were given the patient decision aid plus usual education materials
|
Usual Education (Control)
n=68 Participants
Participants were only given usual education materials
|
|---|---|---|
|
Feasibility of Data Collection at Month 12
Non-surgery management
|
5 Participants
|
9 Participants
|
|
Feasibility of Data Collection at Month 12
Waiting list for surgery
|
8 Participants
|
10 Participants
|
|
Feasibility of Data Collection at Month 12
Died
|
1 Participants
|
1 Participants
|
|
Feasibility of Data Collection at Month 12
Surgery
|
55 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Patient Decision Aid Intervention
n=69 Participants
Participants were given the patient decision aid plus usual education materials
|
Usual Education (Control)
n=71 Participants
Participants were only given usual education materials
|
|---|---|---|
|
Wait Times
|
33.4 weeks
Interval 26.0 to 41.4
|
33.0 weeks
Interval 26.1 to 39.9
|
SECONDARY outcome
Timeframe: Data collection occurred at week 2Population: participants who completed the knowledge test after receiving the intervention/control intervention
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.
Outcome measures
| Measure |
Patient Decision Aid Intervention
n=66 Participants
Participants were given the patient decision aid plus usual education materials
|
Usual Education (Control)
n=66 Participants
Participants were only given usual education materials
|
|---|---|---|
|
Participant's Knowledge
|
71.2 percentage of correct answers
Standard Deviation 23.7
|
46.6 percentage of correct answers
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Patient Decision Aid Intervention
n=55 Participants
Participants were given the patient decision aid plus usual education materials
|
Usual Education (Control)
n=56 Participants
Participants were only given usual education materials
|
|---|---|---|
|
Number of Participants With Sufficient Decision Quality
|
31 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Data collection occurred at week 2SURE 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.
Outcome measures
| Measure |
Patient Decision Aid Intervention
n=65 Participants
Participants were given the patient decision aid plus usual education materials
|
Usual Education (Control)
n=66 Participants
Participants were only given usual education materials
|
|---|---|---|
|
Number of Participants With no Decisional Conflict
|
45 Participants
|
38 Participants
|
Adverse Events
Patient Decision Aid Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Education (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dawn Stacey
University of Ottawa, Ottawa Hospital Research Institute
Phone: 613-737-8899
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place