Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Keywords
decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
Brief summary
This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.
Detailed description
This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.
Interventions
BEHAVIORALInteractive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
BEHAVIORALVideo decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
BEHAVIORALProvider Report
A short report that includes the patients' goals and treatment preferences
Sponsors
Newton-Wellesley Hospital
The New England Baptist Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of either hip or knee osteoarthritis * Scheduled visit with participating orthopedic surgeon
Exclusion criteria
* prior partial or total knee or hip joint replacement within last 5 years * hip fracture or asceptic necrosis (AVN) in last 12 months * Rheumatoid arthritis * Psoriatic arthritis * Unable to read English or Spanish * Unable to consent for self due to cognitive or medical issue * Hip or knee decision aid provided by Partners Healthcare clinician within 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Knowledge | before orthopedic visit | Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge. |
| Percentage of Patients Who Received Preferred Treatment | 1 week after visit with orthopedic surgeon | Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Rates | 6 months after the initial visit | Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit. |
| Percentage of Participants Who Used the Decision Aid | before orthopedic visit | 1 item asking patients how much they reviewed the program (none, some, most, all). The percentage who report viewing most or all will be calculated. |
| Change in Quality of Life | before orthopedic visit; 12 months from date of orthopedic visit | Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points. |
Countries
United States
Participant flow
Recruitment details
April 2016-December 2017. Adults diagnosed with hip or knee osteoarthritis who had a visit scheduled with a participating orthopedic surgeon at 3 sites were invited to participate before their visit.
Pre-assignment details
Participants were randomized to a study arm after screening the surgeons' schedules. To be eligible for the study, patients needed to attend the visit with the surgeon. The majority of post randomization exclusions are due to patients not showing up to the visit. Some are due to limited clinical information available at screening.
Participants by arm
| Arm | Count |
|---|---|
| Interactive Decision Aid and Usual Care Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis | 282 |
| Video Decision Aid and Usual Care Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis | 292 |
| Interactive Decision Aid and Provider Report Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences | 275 |
| Video Decision Aid and Provider Report Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences | 275 |
| Total | 1,124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 1 Week Post-visit | Lost to Follow-up | 43 | 40 | 38 | 36 |
| 6 Month Follow-up | Death | 1 | 3 | 0 | 1 |
| 6 Month Follow-up | Lost to Follow-up | 54 | 51 | 48 | 42 |
| Baseline (Post Decision Aid, Pre-visit) | Ineligible post completion | 38 | 23 | 18 | 17 |
Baseline characteristics
| Characteristic | Interactive Decision Aid and Usual Care | Total | Video Decision Aid and Provider Report | Interactive Decision Aid and Provider Report | Video Decision Aid and Usual Care |
|---|---|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.6 | 64.7 years STANDARD_DEVIATION 9.9 | 64.9 years STANDARD_DEVIATION 9.5 | 64.3 years STANDARD_DEVIATION 10.3 | 64.6 years STANDARD_DEVIATION 9.9 |
| Body Mass Index | 31.4 kg/m^2 STANDARD_DEVIATION 6.8 | 30.1 kg/m^2 STANDARD_DEVIATION 6.5 | 29.7 kg/m^2 STANDARD_DEVIATION 6.3 | 28.9 kg/m^2 STANDARD_DEVIATION 6.4 | 30.9 kg/m^2 STANDARD_DEVIATION 6.3 |
| Charlson co-morbidity index (CCI) 0 | 205 Participants | 826 Participants | 203 Participants | 201 Participants | 217 Participants |
| Charlson co-morbidity index (CCI) 1 | 33 Participants | 142 Participants | 35 Participants | 36 Participants | 38 Participants |
| Charlson co-morbidity index (CCI) 2 | 33 Participants | 106 Participants | 28 Participants | 24 Participants | 21 Participants |
| Charlson co-morbidity index (CCI) 3+ | 10 Participants | 44 Participants | 8 Participants | 12 Participants | 14 Participants |
| Charlson co-morbidity index (CCI) Missing | 1 Participants | 6 Participants | 1 Participants | 2 Participants | 2 Participants |
| Decision aid delivery Online | 57 Participants | 232 Participants | 58 Participants | 57 Participants | 60 Participants |
| Decision aid delivery Paper | 225 Participants | 892 Participants | 217 Participants | 218 Participants | 232 Participants |
| Education 4-year college graduate | 45 Participants | 212 Participants | 53 Participants | 59 Participants | 55 Participants |
| Education 8th grade or less | 4 Participants | 10 Participants | 2 Participants | 1 Participants | 3 Participants |
| Education High school graduate or GED | 31 Participants | 117 Participants | 22 Participants | 26 Participants | 38 Participants |
| Education Missing | 46 Participants | 175 Participants | 43 Participants | 42 Participants | 44 Participants |
| Education More than a 4-year college degree | 101 Participants | 393 Participants | 105 Participants | 98 Participants | 89 Participants |
| Education Some college or 2-year degree | 54 Participants | 208 Participants | 47 Participants | 47 Participants | 60 Participants |
| Education Some high school but did not graduate | 1 Participants | 9 Participants | 3 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 24 Participants | 3 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants | 921 Participants | 229 Participants | 227 Participants | 235 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 49 Participants | 179 Participants | 43 Participants | 43 Participants | 44 Participants |
| Health literacy Always | 8 Participants | 25 Participants | 7 Participants | 5 Participants | 5 Participants |
| Health literacy Missing | 4 Participants | 14 Participants | 2 Participants | 4 Participants | 4 Participants |
| Health literacy Never | 191 Participants | 782 Participants | 197 Participants | 197 Participants | 197 Participants |
| Health literacy Often | 6 Participants | 26 Participants | 7 Participants | 3 Participants | 10 Participants |
| Health literacy Rarely | 43 Participants | 181 Participants | 44 Participants | 42 Participants | 52 Participants |
| Health literacy Sometimes | 30 Participants | 96 Participants | 18 Participants | 24 Participants | 24 Participants |
| Insurance Commercial | 109 Participants | 401 Participants | 80 Participants | 93 Participants | 119 Participants |
| Insurance Medicaid/Dual eligible | 41 Participants | 115 Participants | 25 Participants | 19 Participants | 30 Participants |
| Insurance Medicare | 81 Participants | 321 Participants | 79 Participants | 68 Participants | 93 Participants |
| Insurance Missing | 51 Participants | 287 Participants | 91 Participants | 95 Participants | 50 Participants |
| Joint Hip | 85 Participants | 367 Participants | 108 Participants | 95 Participants | 79 Participants |
| Joint Knee | 197 Participants | 757 Participants | 167 Participants | 180 Participants | 213 Participants |
| Quality of life (EQ-5D) | 0.63 units on a scale STANDARD_DEVIATION 0.19 | 0.64 units on a scale STANDARD_DEVIATION 0.2 | 0.65 units on a scale STANDARD_DEVIATION 0.18 | 0.65 units on a scale STANDARD_DEVIATION 0.2 | 0.62 units on a scale STANDARD_DEVIATION 0.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 17 Participants | 8 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 19 Participants | 4 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 16 Participants | 4 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 52 Participants | 16 Participants | 13 Participants | 12 Participants |
| Race (NIH/OMB) White | 258 Participants | 1017 Participants | 243 Participants | 255 Participants | 261 Participants |
| Sex: Female, Male Female | 152 Participants | 645 Participants | 141 Participants | 173 Participants | 179 Participants |
| Sex: Female, Male Male | 130 Participants | 479 Participants | 134 Participants | 102 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 282 | 0 / 292 | 0 / 275 | 0 / 275 |
| other Total, other adverse events | 0 / 282 | 0 / 292 | 0 / 275 | 0 / 275 |
| serious Total, serious adverse events | 0 / 282 | 0 / 292 | 0 / 275 | 0 / 275 |
Outcome results
Primary
Patients Knowledge
Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.
Time frame: before orthopedic visit
Population: There were a total of 5 hip and knee specific knowledge questions in the DQI. Participants must answer at least 3 out of 5 questions to get a total knowledge score out of 100%. Only 1082/1124 participants provided sufficient information to calculate a knowledge score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive Decision Aid and Usual Care | Patients Knowledge | 79 percentage of correct answers | Standard Deviation 25 |
| Video Decision Aid and Usual Care | Patients Knowledge | 71 percentage of correct answers | Standard Deviation 24 |
| Interactive Decision Aid and Provider Report | Patients Knowledge | 84 percentage of correct answers | Standard Deviation 21 |
| Video Decision Aid and Provider Report | Patients Knowledge | 75 percentage of correct answers | Standard Deviation 23 |
Comparison: The comparison groups were: Interactive decision versus Video decision aid.p-value: <0.00195% CI: [6, 12]Regression, Linear
Primary
Percentage of Patients Who Received Preferred Treatment
Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.
Time frame: 1 week after visit with orthopedic surgeon
Population: Participants must complete the 1 week survey and answer the treatment preference question. Only 956/967 participants provided sufficient information to calculate a treatment match.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Decision Aid and Usual Care | Percentage of Patients Who Received Preferred Treatment | 175 Participants |
| Video Decision Aid and Usual Care | Percentage of Patients Who Received Preferred Treatment | 182 Participants |
| Interactive Decision Aid and Provider Report | Percentage of Patients Who Received Preferred Treatment | 166 Participants |
| Video Decision Aid and Provider Report | Percentage of Patients Who Received Preferred Treatment | 177 Participants |
Comparison: We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.p-value: 0.8695% CI: [0.74, 1.44]Regression, Logistic
Comparison: We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aidp-value: 0.7595% CI: [0.76, 1.47]Regression, Logistic
Secondary
Change in Quality of Life
Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points.
Time frame: before orthopedic visit; 12 months from date of orthopedic visit
Population: Participants must answer all 5 items of the EQ-5D measure from the Baseline and 6 months follow-up survey. Only 868/1124 participants provided sufficient information at both time points to calculate a change in quality of life score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive Decision Aid and Usual Care | Change in Quality of Life | 0.17 units on a scale | Standard Deviation 0.21 |
| Video Decision Aid and Usual Care | Change in Quality of Life | 0.15 units on a scale | Standard Deviation 0.22 |
| Interactive Decision Aid and Provider Report | Change in Quality of Life | 0.15 units on a scale | Standard Deviation 0.23 |
| Video Decision Aid and Provider Report | Change in Quality of Life | 0.16 units on a scale | Standard Deviation 0.2 |
Comparison: We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.p-value: <0.00195% CI: [0.016, 0.065]Regression, Linear
Secondary
Percentage of Participants Who Used the Decision Aid
1 item asking patients how much they reviewed the program (none, some, most, all). The percentage who report viewing most or all will be calculated.
Time frame: before orthopedic visit
Population: Participants must answer the program usage question on the Baseline survey. Only 1091/1124 participants provided sufficient information to calculate decision aid usage.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interactive Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | None | 42 Participants |
| Interactive Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | Some | 38 Participants |
| Interactive Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | Most | 24 Participants |
| Interactive Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | All | 173 Participants |
| Video Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | All | 132 Participants |
| Video Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | Most | 68 Participants |
| Video Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | Some | 45 Participants |
| Video Decision Aid and Usual Care | Percentage of Participants Who Used the Decision Aid | None | 38 Participants |
| Interactive Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | Most | 24 Participants |
| Interactive Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | All | 179 Participants |
| Interactive Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | Some | 32 Participants |
| Interactive Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | None | 27 Participants |
| Video Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | Some | 42 Participants |
| Video Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | None | 34 Participants |
| Video Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | All | 127 Participants |
| Video Decision Aid and Provider Report | Percentage of Participants Who Used the Decision Aid | Most | 66 Participants |
Comparison: Comparison groups were: patients who reported using all of the DA versus everyone else.p-value: <0.00195% CI: [12.8, 24.5]Chi-squared
Secondary
Surgical Rates
Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.
Time frame: 6 months after the initial visit
Population: Excluding patients who did not provide information to calculate the Informed, Patient-Centered (IPC) variable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interactive Decision Aid and Usual Care | Surgical Rates | 140 Participants |
| Video Decision Aid and Usual Care | Surgical Rates | 153 Participants |
| Interactive Decision Aid and Provider Report | Surgical Rates | 134 Participants |
| Video Decision Aid and Provider Report | Surgical Rates | 154 Participants |
Comparison: We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.p-value: <0.00195% CI: [16.5, 40.1]Regression, Logistic