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2 PROTOCOL
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Impact of an Artificial Intelligence-Enabled Decision Aid on Decision Quality, Shared Decision Making, 31
Patient Experience and Functional Outcomes in the Management of Knee Osteoarthritis: A Randomized 32 Clinical Trial 33 Objectives 34 35
Assessing impact of a technology-enabled decision aid on: 36
37
- Knee decision quality K-DQI survey
38
- Shared decision-making CollaboRATE survey
39
- Patient experience (satisfaction with decision-making process NRS Satisfaction 40
- Change in functional outcomes KOOS JR
41
- Processes Consult duration / TKR Rate
42
- Concordance Alignment of treatment choice
43 44
Subject Selection 45
46
Inclusion Criteria (to be checked during/after huddle/after x-ray/at consent): 47
i) All new patients with a presumptive diagnosis of knee OA aged between 45 and 89 years* 48
ii) Patients fluent in English or Spanish 49
iii) BMI between 20 and 46* 50
iv) Primary diagnosis of advanced knee OA (K-L grade of 3 or 4 i.e. moderate to severe) 51
v) KOOS JR scores between 0-85* 52
vi) Participant able to give informed consent for participation in the study 53
vii) Medical fitness for TKR 54
55
* Age, BMI, KOOS JR cut-offs based on range limits set by decision aid algorithm 56
57
Exclusion Criteria: 58
i) Patients seeking care for knee problem not primarily related to knee OA e.g. trauma condition, or 59
psoriatic/rheumatoid arthritis 60
ii) Patient with advanced knee OA but primarily requiring care for a different joint problem 61
iii) Patients with a prior experience of lower extremity total joint replacement or OA work-up 62
iv) Prior experience with the pilot form of this decision aid tool 63
v) Patients undergoing consideration for revision joint replacement 64 65 1. Subject Recruitment 66 67 Sources 68
Subjects will be identified and recruited through the Lower Extremity Musculoskeletal Institute (MSKI) 69
Integrated Practice Unit (IPU) Clinic schedule at the University of Texas at Austin / Dell Medical School. The 70
subjects will be identified as new patients presenting with knee pain with a presumptive diagnosis of OA and a 71
scheduled appointment with Dr. Kevin Bozic or Dr. Karl Koenig, the two lead orthopaedic surgeons for 72
respective clinics. Patients will be randomized to the AI-enabled decision aid (Intervention group, Group A), or 73
usual care with patient education only (Control group, Group B). 74
75
Recruitment methods 76
3 Patients will be identified as suitable candidates for the study during the pre-clinic meeting (huddle). Once the 77
patient has entered the clinic room, they will be met by a researcher and invited to participate in the study 78
then provide informed consent. If they agree to partake, the researcher will perform randomization using an 79
online platform (see T0.2 Randomization) inside or outside the clinic room depending on internet access. 80
Patients will be informed if they are in the intervention group (full decision aid i.e. education, preference and 81
personalized outcomes modules, denoted Gp A) or control group (educational module only and usual care, 82
denoted Gp B). Researchers will be provided with standard script for explanations (see below in relevant 83
sections). 84
85
2. Enrollment / Consent Process and Documentation 86
87
Enrollment 88
All potential patients assessed for eligibility will be entered into an Excel worksheet. 89
Documentation will include: 90
o Enrollment Status: 91
Consented (patients consented to be part of the study and randomized into either 92
intervention or control group) 93
Declined: 94
Reason for decline: 95
o Not enough time 96 o Privacy concerns 97 o Not interested 98 o No reason given 99
o Other (record reason) 100
Screening failure: 101
Reason for screening failure 102
o Not OA 103
o Patient had a prior experience of TJA / TJA discussion 104
o Patient was being considered for revision joint replacement 105
o Patient seeking care for trauma condition or other joint concern 106
o Non-English or Non-Spanish speakers 107
o BMI below 20 or above 46 108
o Age under 45 or over 89 109
o Unable to give informed consent / issue with cognitive status 110
o Other 111
Withdrawn by PI 112
o Etiology of joint pain is not OA 113
o Patient had a prior experience of TJA 114
o Patient had a prior experience of the decision aid 115
o Patient was being considered for revision joint replacement 116
o Patient seeking care for trauma condition 117
o Non-English or Non-Spanish speakers 118
o Patients with BMI below 20 or above 46 119
o Age under 45 or over 89 120
o Participant unable to give informed consent / issue with cognitive status 121
or ability 122
o Other 123
4 Withdrawn by patient (patient was enrolled, randomized, and decided not to participate 124
in the study) 125
126
The centralized REDCap will be utilized to keep track of patients deemed not eligible during the 127
morning huddle on each clinic day, and specific rationale for exclusion (i.e. exclusion criteria) will be 128
delineated. 129
Etiology of joint pain is not OA 130
Patient had a prior experience of TJA 131
Patient had a prior experience of the decision aid 132
Patient was being considered for revision joint replacement 133
Patient seeking care for trauma condition or other joint concern 134
Non-English or Non-Spanish speakers 135
Patients with BMI below 20 or above 46 136
Age under 45 or over 89 137
Participant unable to give informed consent / issue with cognitive status 138 Other - specify 139 140 Consent Process 141
A research associate (RA) will explain the purpose of the study, what is involved in the study, the risks and 142
benefits of the study, and determine if the patient is interested in participating – standard prose will be 143
provided to all research assistants (see below in relevant sections). Consenting patients will be randomized 144
into either the intervention (Gp A) or control group (Gp B). At any time, potential subjects can request 145
additional time to think about the study or decline participation. All questions the patient may have will aim to 146
be answered to the best of their ability by the research assistant, project leads or PI. At the time of this initial 147
consultation, the patient will be asked to sign a paper consent form and offered a blank form for their records. 148 149 3. Procedures 150 151 Intervention Arm 152 153 T0. Screening/Study Recruitment 154 See above. 155 156 T0.1 Patient Enrollment 157 158
Assess all new patients for eligibility according to the schedule. Patients who are not eligible and therefore will 159
not be approached for enrollment will be noted as such along with the reason for not approaching the patient 160
on a spreadsheet specifying one of the rationales stated above in #2. 161
162
“Hi, my name is ______. I’m working with Dr. Bozic / Dr. Koenig, your physician today, on a study 163
involving software that aims to support treatment decisions related to knee arthritis. This tool provides 164
educational materials on your condition—the reason for your knee pain—and uses your age, sex, BMI and 165
questions about health you already answered on the iPads to make personalized calculations of risks, benefits, 166
and aspects related to your knee problem. 167
The purpose of this study is to learn more about the impact of the software on aspects of decision 168
making and assess your satisfaction with the decision making process. This will be done using questionnaires at 169
5 the end of the visit. If you agree to participate, we will let you know whether you were randomly selected to a 170
group receiving educational materials, a risk:benefit report, and some interactive components or a group 171
receiving educational materials only. 172
This is a fair way of studying an intervention, in this case the software, and learn about its impact. 173
Regardless of what group you are in, after consultation you will be asked to complete a set of questionnaires 174
that should take less than 10 minutes. Questions will be about the quality of decision made, how well your 175
preferences were considered in making the decision, knowledge on knee replacement surgery, and your 176
satisfaction with the decision-making process.” 177
The tool does not replace the usual care you receive at our clinic so you will still see all the health care 178
professionals you would usually meet and be able to discuss all the things you want to discuss with each 179
member of our team. 180
Your participation is completely voluntary and does not impact whether you will receive care. No 181
penalty will be applied should you decide not to participate. Do you have any questions? Do you agree to take 182
part in the study regardless of the group you may be assigned? Would you like more time to think about it?” 183
184
If yes… 185
“Thank you so much for your agreement to participate. I will now momentarily randomize you into 186
either Group A or Group B. Regardless of which group you are assigned, your continued participation is 187
very important for our study outcomes. 188
189
If no… 190
“That’s okay. Could you kindly tell me your reason why? This is useful for feedback and enables us to 191
improve our studies in future...” 192 193 194 T0.2 Randomization 195 196
Randomize the patient in the following manner: 197
o Go to Add/Edit Records on the left hand side of REDCap, then “Add new record” 198
o Answer whether or not the patient consents to be included. 199
o If the patient consents, select the clinic/surgeon, then hit the “Randomize” button. 200
o Inform the patient as to the group into which they have been randomized (see script below). 201
o Change form status to Complete, then go to top right to “Survey Options” and then hit Submit before 202
handing to patient. 203
Values/labels for "randomization_group" (Randomization Group): 204
1 Group A - Full tool 205
2 Group B - Educational materials only 206
207
Values/labels for "clinic" (Site & Clinic-Associated Surgeon): 208
1 UT Health Austin - Bozic 209
2 UT Health Austin - Koenig 210
211 212
- For those assigned Group A: 213
214
“You have been selected to receive the educational materials, a calculated risk:benefit report and 215
some interactive components. 216
6 217
“Let me briefly talk you through the process. Please kindly read the education material on this iPad at
218
your own pace, answer the questions at the end, and use the sliders to tell us about your preferences 219
and experiences. You will then receive a report customized to you which can guide discussion with 220
your provider. Please feel free to ask any questions during this consultation. Thanks in advance for 221
completing some survey questions on how it all went at the end of the visit, please be sure to wait for 222
me to return before leaving.” 223
224
- For those assigned Group B: 225
226
“You have been selected to receive the educational materials.” 227
228
“Let me briefly talk you through the process. Please kindly read the education material on this iPad at
229
your own pace. You will then have a chance to discuss you problem and treatment options with your 230
provider. Please feel free to ask any questions during this consultation. Thanks in advance for 231
completing some survey questions on how it all went at the end of the visit, please be sure to wait for 232
me to return before leaving.” 233
234
For Group A - Both provider and patient will have printed copies of the risk:benefit report, answers to a set of 235
5 test questions patients are provided following the education information, and the interactive components 236
(e.g. preference scales, sense of knowledge, preferences, and values..) that will be referred to during the 237
consultation. Following this discussion, patients will be asked to complete the K-DQI, CollaboRATE survey, 238
NRS-C before leaving clinic. They will complete the KOOS JR at 6 weeks and 6 months following the visit as per 239
standard of care. 240
241
For Group B – Patients will read the educational material and prior to their consultation with their provider. 242
Following this discussion, patients will be asked to complete the K-DQI, CollaboRATE survey, NRS-C before 243
leaving clinic. They will complete the KOOS JR at 6 weeks and 6 months following the visit as per standard of 244
care. 245
246
T0.3 Reasons for ineligibility
247
The patient is ineligible for the study if any of the following comes to light at any point during the clinic visit: 248 - Patient declined 249 - Screening failure 250 - Patient withdrawal 251 - PI withdrawal of patient 252 o Reasons: 253
o Patient or provider determination that pt. does not have OA 254
o Patient had a prior experience of TJA / TJA discussion 255
o Patient was being considered for revision joint replacement 256
o Patient seeking care for trauma condition 257
o Non-English or Non-Spanish speakers 258
o Patients with BMI below 20 or above 46 259
o Age under 45 or over 89 260
o Participant unable to give informed consent / issue with cognitive status 261
o Other 262
7 These reasons will be documented with patient informed: “As part of the study it is useful for us to note the 264
reason behind why patients decline to participate. May I ask for your reason?” 265 266 267 T0.4 Patient FAQs 268 269
Ask if there are any further questions. Some FAQ from patients are: 270
271
Will I have to make any additional trips for the purposes of this study? 272
o No, everything that is not conducted on the day of your appointment will be conducted either 273
over the phone or via email. 274
Will this involve any experimental procedures or drugs? 275
o No, the only experimental part of this study consists of whether you receive just educational 276
materials or educational materials plus a risk:benefit report. 277
How long will this take? 278
o The total commitment time for the study will be approximately 1 hour over a period of 6 279
months. 280
How will this affect my appointment? 281
o Your appointment will be conducted in the usual manner. This study will not affect the doctor’s 282
or medical team’s actions. 283
Will my information be released to insurance companies? 284
o No, your information will remain private. 285
286
T1.1: Pre-Consultation 287
RA will populate the patient profile on the OM1 portal, thereby generating a token for the patient to access 288
the in-browser educational materials on the iPad. 289
- Responses will be recorded by the OM1 system. 290
- To fill all fields, RA must question patient about 1) hospitalizations and emergency department visits 291
over the past 12 months, and 2) confirmation of any conditions listed on the health history form 292
located visible in AthenaHealth. 293
- The RA will also obtain height and weight from the Vitals section of AthenaHealth. 294
295
T1.2 PRO population
296
While patient is reading over the iPad materials and answering questions embedded in these educational 297
materials, the RA completes the patient’s OM1 profile utilizing individual patient-reported outcome measure 298
question responses to the KOOS, JR and PROMIS-10 Global as viewable in AthenaHealth. 299
300
T1.3 Risk:Benefit Report Generation 301
RA ensures completion of all details required to generate the customized report, including a second module 302
(for bilateral knee pain) where applicable. RA will print two copies of this report, placing one inside the exam 303
door basket (with verbalization to the clinician) and handing the other to the patient with encouragement to 304
use this as a guide throughout the appointment. RA reminds the patient that he/she will return following 305 clinician consultation. 306 307 T1.4 Timing Prep 308
Research assistant will remind clinician seeing any enrolled patient to write with dry erase marker on the 309
status whiteboard to indicate time entering and time leaving the exam room. 310
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REDCap timestamps will be used to clock the duration of the visit, since both pre-surveys and post-surveys will 312 be administered. 313 314 T2: Post-Consultation 315 316 T.2.1. Patient Post-Consultation 317
After the patient’s consultation, he/she will be asked to complete a post-consultation survey, stage of decision 318
making, and visit satisfaction survey. These surveys will be administered by the RA. 319
320
Retrieve the iPad from the patient once they are finished and check for completeness. 321
322
T.2.2. Research Assistant Process Post-Consultation
323
RA will fill in the “Initial Visit Details” form on REDCap, utilizing patient details from the AthenaHealth EMR for 324
patient-reported outcome scores and comorbidities specified. This form includes a question on duration of 325
time provider spent with patient – this will be calculated via subtraction of the entry time from the exit time 326
by the research assistant based on the entry/exit times written on the status board by the provider. In cases 327
where timings were missed, the researcher will confirm duration estimates (in minutes) with the provider. 328
329
The RA will also communicate with the provider(s) who saw the patient regarding the patient’s final decision 330
on surgery or no surgical intervention. 331
332
Timeline of data collection: Majority of the measures are acquired at the baseline consultation visit, while a 333
few are extracted from electronic health record (e.g. actual treatment after consultation). Physical/ functional 334
limitations on KOOS JR, however, are acquired at both the baseline consultation visit and at follow-up 335
appointment 4-6 months out from initial consultation. 336
337
T3: 6 Months Post
338
Patients will be called by study personnel to complete a KOOS JR survey via telephone or emailed link in the 339
case that a new (6-month follow-up) KOOS JR score has not already been obtained by the UTHA call team; as 340
per standard of care, there is a 6-month call, so calls by the investigator team will be made only in the case 341
that these scores are not successfully recorded by usual UTHA outreach. 342
343
Patients Opting out of Participation 344
345
Patients who do not wish to participate in the study will continue with their normal course of medical care. 346
They will be marked as “Declined.” 347
348
Patients Withdrawn from the Study by the physician 349
350
The patient may be withdrawn from the study following the consultation if the physician deems that the 351
patient meets one or more of the exclusion criteria. The status for these patients will be changed to 352 “Withdrawn.” 353 354 4. Statistical Analysis 355 356
Primary outcome measures: 357
9 - Decision quality using percent scaling from the Decision Quality Index (DQI),
358 359
Secondary outcome measures: 360
- Sense of collaboration in decision making total scale score obtained from CollaboRATE 361
- Physical/functional limitations scale from the KOOS JR 362
- Duration of initial consultation 363
- Satisfaction with consultation from the NRS 364
- Actual treatment outcome as either TKA or non-surgical options 365
- Concordance between initial treatment preference and actual treatment outcome. 366
367
Statistical Analysis Plan
368 369
Measures from the DQI, KOOS JR, and consultation duration will be treated as continuous. Assumptions of 370
unequal variance across the two groups will be checked for these continuous measures and if violated, 371
Satterthwaite adjustments will be reported for independent sample t-tests. 372
373
Satisfaction, collaboration total scores were treated will be treated as ordinal. Mann-Whitney U tests were 374
conducted to test differences between these groups. 375
376
Treatment outcome and concordance will be treated as binary measures. 377
378
To accommodate all available information in the context of missing data points, linear mixed effect models 379
with random intercepts at the subject level can be fitted to test the interaction of group assignment with time. 380
381
We will use Fisher’s exact test to evaluate whether the two study arms differed in total knee replacement 382
surgery rates and concordance between initial treatment preference and eventual treatment outcome. 383
384
To control for inflations of type-I errors rate, we will set alpha = .05 for the group of primary outcome 385
measures and did the same for the group of secondary outcome measures. The Hochberg-Y procedure was 386
applied to correct individual test alpha’s in both groups of outcomes to maintain a familywise Type I error rate 387
of .05 for each (Hochberg, 1988). 388
10 389 390 Patient Flow Researcher Flow Surgeon Flow Researcher logs clinic record including EMR details Patient gets registered by clinic concierge Patient completes PROMs in check-in area Patient roomed Researcher notes potential patient Checks inclusion / exclusion criteria Consents patient Completes post-visit surveys Patient attends MSKI Researcher attends morning huddle Surgeon attends morning huddle Administers post-visit surveys Administers full tool or education materials only Patient Consultation Affirms suitable patients by confirmation of diagnosis
391 392 393 394 395 396
