Randomized Controlled Trial to Evaluate the Relative Efficacy of Motivational Interviewing and Guided Opioid Tapering Support vs. Enhanced Usual Care to Promote Opioid Cessation After Orthopedic Surgery
Phase: NA
Conditions: Opioid Cessation
Sponsor: Stanford University

Study Title:  
 
Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid 
Cessation 
 
NCT03659734 
 
Document Date: 10/15/2020 

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Study Overview 
Name of study: Mood and Postoperative Pain (MAP-Pain) Trial  
Enrollment Goals:  
Observational Arm N = 558*  
Intervention Arm N = 220* 
*Assumes 15% attrition in the observational arm, and 10% censoring in the intervention arm 
Start Date:  
IRB approved April 18, 2018 
NIH Certificate of Confidentiality: Automatically granted for NIH-funded research. 
Patient Endpoint Definition:  
Observational Arm: The endpoint is the first of 2 consecutive reports of zero overall opioid use. 
Secondary endpoint is opioid misuse defined as a score of 9 or higher on the Current Opioid Misuse 
Measure. In addition to the endpoints defined above, time to pain cessation (1st of 2 consecutive reports 
of zero average pain) and indicating they consider themselves recovered from surgery are additional 
endpoints.   
Intervention Arm: The endpoint is the first of 2 consecutive reports of return to baseline opioid dose or 
lower. Secondary endpoints are opioid misuse defined as a score of 9 or higher on the Current Opioid 
Misuse Measure, and time to complete opioid cessation (1st of 2 consecutive reports of opioid 
cessation).  
 

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Table of Contents 
Study Overview 
1 
Name of study: Mood and Postoperative Pain Study (MAP-Pain) 
1 
Enrollment Goals: 
1 
Start Date: 
1 
Patient Endpoint Definition: 
1 
Table of Contents 
2 
Education and Training 
4 
Research Staff 
4 
Principal Investigator 
4 
Clinic Staff 
4 
Recruitment 
4 
Clinical staff referral 
5 
CT.gov posting 
5 
Screening 
5 
Inclusion criteria 
5 
Exclusion Criteria 
6 
Patient Enrollment 
6 
Eligible and interested patients: 
6 
Phone consent - 
6 
In-person consent – 
6 
Patient not interested or ineligible: 
6 
Patient Welcome Packet 
7 
Preoperative Medication Instructions 
7 
Database Registration 
7 
Pre-Surgical Assessment 
8 
Baseline Questionnaire Packet: 
8 
Pre-surgical Reminder Call 
9 
Day of Surgery Assessment 
9 
Randomization 
9 
Usual Care 
9 
Intervention 
9 
Schedule 
10 
Intervention Protocol 
10 
Follow-up* 
11 
Post-operative Days 1 to 3 
11 
Daily Pain and Opioid Questionnaire 
11 
Discharge Date and Time 
11 
Medical Chart Review 
11 
Post-operative Days 3 until Endpoint 
11 
Daily Phone Calls: 
11 
Weekly Reports: 
11 
Monthly Reports: 
12 
Censoring 
12 
Patient Withdrawn or Study Completion 
12 
Data Management 
12 

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Patient Identification Codes 
13 
Data Storage 
13 
Screening & Eligibility Forms 
14 
Case Report Forms 
14 
Consent Forms 
14 
Case Report Form Scoring 
14 
Daily Pain and Opioid Use Form 
14 
Patient Adherence 
14 
Patient Retention 
14 
Trial Safety 
15 
Potential Risks & Response to Risks 
15 
Risk of Telephone Contact 
15 
Risks of Intervention 
15 
Trial Stopping Rules 
16 
Adverse Event Reporting 
16 
Trial Monitoring 
17 
Data Safety and Monitoring Plan 
18 
Frequency of DSM 
18 
Content of DSM Report: 
18 
Case Report Form Completion 
18 
Consent Form Completion 
19 
Electronic Data Verification 
19 
Analysis 
19 
Data Analysis Plan 
19 
Quality Assurance 
20 
Power Analysis and sample size 
20 
Primary Feasibility Outcome 
20 
Secondary Feasibility Outcomes 
20 
Primary Efficacy Outcome 
21 
Secondary Efficacy Outcomes 
21 
Methods for handling missing data and non-adherence to protocol: 
21 
Interim Analyses 
21 
Appendix 
23 
Modifications History 
24 
 

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Education and Training  
Research Staff 
All research team members will perform the responsibilities as outlined by the delegation of authority 
log. Human Subjects Training, CITI training, and HIPAA training will occur as required by Stanford Policy. 
Additionally, all team members will receive a copy of this document, the Lab Policy Manual, and will be 
trained directly by the Principal Investigator (PI) or Lead Clinical Research Coordinator (LCRC) on the 
purpose of the study and their responsibilities. Research staff will be trained on Informed Consent, 
Phone Screening, and Case Report Form Completion by the research manager, who will monitor 
appropriate conduct and form completion on an ongoing basis, in collaboration with the PI and study 
monitor.  Recruitment and patient contact will first be conducted under the direct supervision of the PI 
or LCRC, until they deem the research team member capable of carrying on responsibilities 
independently.  Research team meetings will occur frequently with the PI to ensure ongoing 
understanding by study staff and to address any concerns.   
Training for the Intervention Arm 
 Training of the NP (Tracey Mallick) will be supervised by S. Berg-Smith, and include a 3-day introductory 
intensive workshop introducing the theory, principles, and skills of MI and related motivation-
enhancing, behavior change approaches; and a 3-day advanced training workshop. Learning activities 
will include demonstrations, video examples, “real-plays”, case studies, and small group exercises. Pilot 
MI+GOW sessions completed by T. Mallick will be evaluated using global ratings from the MI Treatment 
Integrity coding system 4.0. Prior to counseling study participants, ratings ≥3 on all global scores 
(cultivating change talk, softening sustain talk, partnership, and empathy) of 2 consecutive pilot 
participants will be required. Ongoing supervision of MI skills will include monthly reviews of recorded 
interventions (after MI treatment integrity coding) and meetings with S. Berg-Smith to optimize 
treatment fidelity and minimize drift. 
The Principal Investigator (PI), Dr. Jennifer Hah, will train the NP (Maristella Butler) on the components 
of the enhanced usual care calls including topics of: 1) standardized instructions on taking opioid 
medications after surgery, 2) safe opioid use, 3) avoiding medication mistakes, 4) local mental health 
resources (including a suicide prevention hotline), 5) alternative methods for pain management after 
orthopedic surgery, 6) understanding complementary and alternative medicine, and 7) prescription drug 
abuse. 
Principal Investigator 
The Principal Investigator, Dr. Jennifer Hah, will speak directly with all participating surgeons and 
preoperative clinic staff to inform them of the purpose of the research and the process for recruitment 
and patient referrals.  Referring physicians will be informed of the study design such that they are aware 
of what intervention their patients may be receiving. A Q&A form will also be provided to the patient’s 
physician(s) for informational purposes.   

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Recruitment 
Recruitment may take place via one of following methods: 
Clinical staff referral 
Surgeons, anesthesiologists, or clinical care staff may ask a patient if they are interested in speaking with 
a member of the research team.  With the patient’s permission, the staff will fill out an “okay to 
contact” form that indicates permission by the patient for a member of the research team to contact 
them about research studies that they may be interested in. This form will be submitted to and stored 
by a Surgical Coordinator, and be collected by a study team member weekly. A member of the research 
team will document OK to contact forms, and input participants into the REDCap MAP-Pain Enrollment 
project for screening and enrollment. 
Direct Contact 
Clinical staff may also inform research staff of those who can be approached directly. Direct approach 
with prior permission from providing staff may take place in the Anesthesia Preoperative Evaluation 
Clinic, or the orthopedic clinic, or via the clinic schedulers. The research coordinator should ask the 
patient if he/she is interested in participating in a postoperative pain research study and fill out the 
“okay to contact” form accordingly. The patient should be consented at a later time.  
CT.gov posting 
The STOP clinical trial is posted on the Stanford Clinical Trial site, which is uploaded to clinicaltrials.gov. 
Site status is listed as “enrolling by invitation”. Interested patients may contact the study team at the 
contact information provided, but will only be considered for inclusion if they are receiving an eligible 
surgery at Stanford Hospital and Clinics.   
Perioperative CHOIR 
Patients completing Perioperative CHOIR as part of their routine care prior to, or during their visit to the 
Anesthesia Preoperative Evaluation Clinic may elect to enroll in the study directly, and complete 
additional questions after information regarding the study is provided. Patients will be contacted at a 
later date by the research team to obtain written informed consent for continued participation in the 
study.  
Email Invitation Survey 
Patients scheduled with the Anesthesia Preoperative Evaluation Clinic are automatically screened, and 
patients meeting basic inclusion criteria are identified. Identified patients will be contacted via invitation 
email, and invited to complete a brief online screen to determine eligibility and interest. All eligible 
potential participants will be contacted by the research coordinator by phone. The coordinator will call 
the patient three times or until the patient picks up. If possible and necessary, the coordinator should 
leave a voicemail and specify the first name of the patient, give a quick summary of the study, and leave 
a return name and number. Patients will first be given a description of the study as per the approved 
phone screen to assess interest and answer any questions (see Screening Questions document). 

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Phone Invitation Survey 
Patients scheduled with the Anesthesia Preoperative Evaluation Clinic are automatically screened, and 
THR/TKR patients meeting basic inclusion criteria are identified. If participants are unable to be 
contacted via email, the research team will call to determine eligibility and interest. The coordinator will 
call the patient three times or until the patient picks up. If possible and necessary, the coordinator 
should leave a voicemail and specify the first name of the patient, give a quick summary of the study, 
and leave a return name and number. Patients will first be given a description of the study as per the 
approved phone screen to assess interest and answer any questions (see Screening Questions 
document). 
Screening 
Inclusion criteria 
1. Age 18 and above, inclusive† 
2. Scheduled to undergo elective surgery at Stanford Hospital† 
3. English speaking 
4. Ability and willingness to complete assessments via the internet† 
5. Scheduled to undergo total knee replacement or total hip replacement at Stanford Hospital* 
Exclusion Criteria 
1. Inability to complete assessments, (education, cognitive ability, mental status, medical status)  
2. Pregnant women† 
3. Elevated suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression 
Inventory*  
4. Current pain management provider* 
5. Enrollment in another perioperative trial* 
 
*Applies to Intervention Arm only 
†Assessed via Email Invitation Survey 
 
 
To attain a more comprehensive understanding of the patient’s medication, the research coordinator 
may need to access the electronic health record (EPIC). EPIC can be used to confirm a patient’s 
medications during the phone screen.  
 
Observation Arm 
For the observation arm, patients undergoing any eligible elective surgery at Stanford will be considered 
for inclusion (See MAP-Pain Observation Eligible Procedures). 

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Patients will be recruited via methods described above. After completion of the phone or email 
eligibility screening, the research coordinator will contact all participants to obtain full electronic 
consent for continued study participation. 
Intervention Arm 
For the intervention arm, the following operations will be considered for inclusion. These are chosen for 
the appropriateness of the intervention in the context of the surgery, and the willingness of the surgeon 
to refer eligible patients.  
 
Total Knee Replacement  
 
Total Hip Replacement  
Patients will be recruited via methods described above.  Initial screening will take place via a brief online 
eligibility survey, or with an approved phone screen either on the phone or via an in-person interview 
during the patient’s pre-operative appointment. Patients will first be given a description of the study as 
per the approved phone screen to assess interest and answer any questions (see Screening Questions 
document). Eligibility will be determined by the research coordinator and/or PI, who will input 
responses to screening questions into REDCap or complete an eligibility checklist at the time of 
screening (see Eligibility Checklist document). Eligibility to continue into the intervention randomization 
will be confirmed at 2-weeks post-surgery. Patients who do not meet the criteria at this time-point will 
continue in the observational arm.    
Patient Eligibility and Enrollment 
Eligible and interested patients: 
Priority consent is the Intervention; observational consent is offered secondarily when a patient is 
ineligible or not interested in the Intervention.  
Written Informed consent may be obtained electronically, through completing of the “Electronic 
Consent” instrument through REDCap. 
Live phone consent - For eligible and interested patients who have a working device that has 
access to the internet at the time of the consent, a url-link to the electronic consent form should 
be sent to the participant through REDCap. The research coordinator will select the appropriate 
consent type (Observation or Intervention) via radio button, check the “Send Consent Form” 
box, and save the REDCap instrument to email the participant the link. If the participant has not 
received the email link after five minutes, the Coordinator will manually compose a survey 
invitation email, and send it to the participant. Participants should be alerted that the research 
coordinator will read through the consent form with them, taking a maximum of 20 minutes to 
complete the process. The participant should only sign the form once all his/her questions have 

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been answered. Completion of the Electronic Consent Form will be verified by the research 
coordinator, who will view the form upon submission. 
Later-date phone consent – For eligible and interested participants who do not have live access 
to a device with available internet or for those who do not have time to go over the consent 
form with the research coordinator at the time of the call, a url-link to the electronic consent 
form may be sent to the participant through REDCap. The research coordinator will select the 
appropriate consent type (Observation or Intervention) via radio button, check the “Send 
Consent Form” box, and save the REDCap instrument to email the participant the link. 
Participants should be told to contact the research coordinator with any questions they have 
regarding the form before they sign it. During the call, the research coordinator may highlight 
the participant responsibilities, as listed on the consent form, and emphasize study procedures 
and confidentiality. Completion of the Electronic Consent Form will be verified by the research 
coordinator, who will view the form upon submission. 
Once completed, signed consent forms will be stored in the File Repository of the MAP-Pain Enrollment 
REDCap Project. 
Patients not interested or ineligible: 
Patients who are ineligible or not interested in proceeding with the intervention will be offered 
enrollment in an observational only arm in which no intervention is given, but participants complete the 
same baseline preoperative questions, and are followed longitudinally with the same questionnaires.  
Informed consent for the observational only arm will proceed in the same manner as the full trial using 
the appropriate, approved consent form (see Observational Trial Consent with COC document). Consent 
is obtained via one of the same three methods mentioned for intervention trial consent. 
Patients who are not interested in the clinical trial component or the observational component or 
unable to participate in either arm due to eligibility concerns will be asked to provide basic de-identified 
demographic information to allow comparison with participating patients using the Anonymous Data 
Form (see Consent for Anonymous Data document). This may be obtained through discussion with the 
patient him/herself or by accessing the patient’s medical record.  Patients should be asked the reason 
they chose not to participate. 
Patient Rewards 
Patients enrolling in either the trial or observational arms of the study are rewarded at three time-
points: 
● $20 Amazon EGift Card for completing the baseline questions 
● $20 Amazon EGift Card for completing the 6-month follow-up assessment 
● $20 Amazon EGift Card for completing the 12-month follow-up assessment 
 

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Rewards will be distributed automatically from a group of available gift cards stored in the “MAP-Pain 
Rewards” REDCap Project upon completion of relevant assessments. Alternatively, rewards will be 
distributed individually by the study staff upon completion of relevant assessments. 
EGift Cards will be obtained through the Administrative Assistant (Kristen Honesto) as needed. The study 
team will complete and sign a Human Subjects Incentive Compensation Form (HSIC) for all participants 
receiving rewards upon exhaustion of available gift card codes.  
Participant Copy of Consent Form & Patient Welcome Packet 
Upon completing consent, all participants will be sent a standard welcome email with study team 
contact information, a copy of their signed consent form, and the Bay Area Resources brochure. 
Participant Initiation 
Immediately after receiving (and if applicable, locking the consent form), the date of consent must be 
filled in COORD: Consent Call. The Baseline Questionnaire must be sent via REDCap by checking the 
correct box. Participants are encouraged to complete the Baseline Packet immediately. The research 
coordinator will schedule the Pre-Surgery for the first workday preceding their date of surgery, and 
confirm the pre-surgery call appointment with the participant. The coordinator will save the form to 
send the Baseline Packet URL-Link to the Participant, and schedule the pre-surgery call in the REDCap 
Calendar. 
Pre-Surgical Assessment 
Baseline Questionnaire Packet 
After enrollment, participants will complete a pre-surgical questionnaire packet (AKA the Baseline 
Packet) via REDCap. Participants are given access to the Baseline Packet immediately after Electronic 
Consent is obtained and reviewed, and are encouraged to complete it immediately after receiving 
access. 
Pre-surgical assessments in addition to Preoperative CHOIR are documented below: 
1. Contact, surgical, and demographic information (labeled “Baseline Packet” in REDCap) 
2. PHQ-9 – Patient Health Questionnaire-9 
3. Baseline BPI-II – Modified Brief Pain Inventory-II including PAINMAP. 
4. BPOQ - Baseline Pain and Opioid Questionnaire (Current opioid use and addiction 
susceptibility) 
5. HADS – Hospital Anxiety and Depression Scale 
6. TAPS - Tobacco, Alcohol, Prescription medications, and other Substance Tool 
7. COMM – Current Opioid Misuse Measure  
8. DSO - DSM-5 Opioids 
a. Administered if COMM Total Score >9 
9. BDI – Beck Depression Inventory-II 

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10. ACE- Adverse Childhood Event Questionnaire 
a. Administered to Observation Participants only. 
11. PROMIS Measures 
a. PROMIS Bank v1.0- Depression 
b. PROMIS Bank v1.0- Anxiety 
c. PROMIS Bank v1.0- Sleep Disturbance 
d. PROMIS Bank v2.0- Physical Function 
 
Pre-Surgical Call Scheduling 
Once consent is obtained, the research coordinator will schedule the Pre-Surgery Call with the 
participant. This call is to be scheduled the first workday prior to the participant’s date of surgery. 
Unless a specific timeslot is requested by the participant, Pre-Surgery calls should be scheduled at 23:15 
in the REDCap Calendar, and completed in the afternoon.  
Pre-Surgical Call 
The research coordinator should call the participant on the first workday prior to the date of surgery. 
During this call, the coordinator should confirm completion of the Baseline Packet and reception of the 
gift card code reward. The coordinator will confirm that the participant has a time slot scheduled on 
their date of surgery, and schedule the post-surgery follow-up call fourteen days after the participant’s 
date of surgery. The coordinator will remind the participant that online follow-up assessments will 
commence once week after surgery. 
If this call cannot be completed, the research coordinator should leave a voicemail message reminding 
the participant of participation in the study, and describing upcoming follow-up dates (week 1 
assessment, post-surgery follow-up call). This message should include contact information for the 
coordinator, and instructions to contact the research team if the surgery has been cancelled or 
postponed.  
Transfer to Longitudinal Study 
On Monday and Friday of each week, participants who have completed all pre-surgical assessments and 
are past their date of surgery will be transferred to the MAP-Pain Longitudinal Observation REDCap 
project for follow-up. Participants to this transfer are identified by the “Move to Longitudinal” REDCap 
Report (Report ID# 58489). Each Monday and Friday, the report will be edited to include only 
participants completing their surgery on or before the day of transfer, and after the date of the last 
transfer.  
Participants meeting transfer criteria will be assigned a new longitudinal record ID through the “Info 
Transfer to Operations” Instrument in the Enrollment REDCap project. The Record ID is to be formatted 
as First Initial Last Initial-Record ID in enrollment Project (displayed as AA-0000). The Surgery type is to 
be selected. Observational Participants (non-THA/TKA procedures) are to be recorded in the “Other 
Surgery Type” text field, “mark the form as “complete”, and save the form to complete the transfer.  

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For intervention Participants (THA/TKA procedures), mark the form as “unverified”, and save the form to 
complete the transfer. The form is not to be marked as “complete” for intervention participants until 
post-surgical follow-up is completed, and the participant has been randomized or assigned to the 
observational study.  
Post-Surgical Assessment 
Post-Surgical Call Scheduling 
During the pre-surgery call, the coordinator will schedule the post-surgical call fourteen days after the 
participant’s date of surgery. Unless a specific timeslot is requested by the participant, Post-Surgery calls 
should be scheduled in the REDCap Calendar at 23:45 for observation participants, and 23:59 for 
intervention Participants.  
Post-Surgical Call 
Fourteen days after the participant’s date of surgery, the study coordinator will call the participant to 
confirm their date of surgery, the date and time they were discharged from the hospital, and verify if the 
participant has been prescribed and is still using opioid medications for surgical pain. The coordinator 
will call the patient five times, or until the patient picks up. If possible and necessary, the coordinator 
should leave a voicemail and specify the name of the patient, the purpose of the call, and leave a return 
name and number. If appropriate, the coordinator will randomize the study participant immediately 
after their call. 
 
 
Randomization 
During the Post-Surgical Call (Fourteen days after surgery) the research coordinator should verify 
whether or not the intervention participant in question has been prescribed and is still using opioid 
medications for surgical pain. Those who meet this criteria will be randomized to either the Motivational 
Interviewing and Guided Opioid Weaning intervention, or Enhanced Usual Care. Those who do not meet 
this criteria will be placed in the Observational arm of the study. 
Participants are randomized in the Transfer to Longitudinal Instrument in the MAP-Pain Enrollment 
REDCap. Upon clicking the “Randomize” button, the coordinator will be prompted to select the surgery 
type (THR/TKR) and confirm the randomization. The participant will be randomized to “1” or “0”, 
denoting MI+GOW and EUC respectively. Once randomized, the part the participant cannot be moved to 
a different study group, so care must be taken to ensure participant is randomized correctly. 

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After random group assignment, the Transfer to Longitudinal instrument must be saved to transfer the 
participant’s group assignment to the MAP-Pain: Longitudinal Observation REDCap project. The 
coordinator will send an email to the appropriate NP, to inform them of a newly randomized participant, 
and set up an appointment for MI+GOW or EUC sessions to begin. 
Blinding and Randomization Methodology 
Randomization table was pre-generated using SAS.  Randomization occurs using blocked, stratified 
randomization by operation. Randomization table was pre-generated onto spreadsheets, with rows 
hidden (in Excel). Each randomized patient will receive the next available row (unhidden by the 
coordinator at 14 days post-surgery for randomization as needed). 
The PI will be blind to the patient’s randomization status until completion of analyses. Due to the 
limitations of REDCap’s randomization module, the research coordinator cannot be blinded to the 
randomization status of the participant. 
Enhanced Usual Care (EUC) 
Participants will receive phone calls matching the duration and frequency of MI+GOW calls. Maristella 
Butler, NP will contact participants via phone to review one topic per call in this sequence: 1) 
standardized instructions on taking opioid medications after surgery, 2) avoiding medication mistakes, 3) 
alternative methods for pain management after orthopedic surgery, 4) understanding complementary 
and alternative medicine, 5) safe opioid use, 6) local mental health resources (including a suicide 
prevention hotline), 7) prescription drug abuse. She will briefly review patient education brochures in a 
didactic style without a tailored discussion. She will remind participants to complete REDCap 
assessments. 
Intervention 
The experimental intervention arm is Motivational Interviewing and Guided Opioid Weaning (MI+GOW). 
A pain medicine nurse practitioner (Theresa Mallick-Searle, NP) will administer MI+GOW. See table 
below for MI Components. The GOW protocol will be a 25% total daily opioid dose reduction every 7 
days with opioid discontinuation 7 days after reaching 1 opioid pill per day. During phone sessions, 
patients will be monitored for worsening pain and opioid withdrawal through administration of the NRS 
and SOWS with the protocol specified in the “Guided Opioid Weaning” table below. Participants will be 
reminded that they can always use less opioids than recommended. Non-adherence is opioid use 
greater than previously recommended via the last phone call.  During the randomization call, the first MI 
appointment should be scheduled by referring to Tracy Mallick’s schedule. 
Table MI Components 
Principles 
Strategies 
Information Recorded by 
Interventionist  
Information and Advice 
Offered in an MI-consistent 
manner (Elicit patient’s 
knowledge, Provide advice, 
Elicit feedback) 

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Engaging 
and focusing 
the agenda  
● Thank for participation 
● Share the agenda and discuss autonomy 
● Answer patient questions 
● Preferred contact phone 
number and times for calls 
● Explain the role of the 
interventionist and discuss 
length of phone calls 
Enhance 
motivation to 
wean opioids 
Elicit self-motivational statements that 
support the following: 
● The patient’s recognition of opioid side 
effects and the risks of opioid misuse, 
addiction, and overdose 
● The patient’s concern about how he or she 
is currently managing their pain 
medications 
● The patient’s own reasons to stop opioid 
use 
● The patient’s intention to wean or stop 
taking their opioids. 
● The patient’s optimism that opioid 
cessation is possible. 
● Identify personal strengths and goals 
● Current pain management 
including non-opioid 
medications and adjuvant 
treatments (e.g. icing, 
acupuncture) 
● Opioid-related adverse 
effects 
● Patient’s reasons for opioid 
weaning/cessation 
● Informing patients of 
current opioid and non-
opioid prescriptions 
prescribed by the surgeon 
● Education regarding 
multimodal postoperative 
pain management  
● Information regarding 
opioid-related adverse 
effects patient is 
experiencing (e.g. 
management of opioid-
induced constipation)  
Strengthen 
commitment 
to opioid 
weaning 
● Help the patient develop a plan for 
weaning 
● Communicating free choice 
● Review consequences of continued opioid 
use vs. cessation 
● Explore barriers to opioid weaning and 
identify support  
● Elicit a final commitment 
● Current NRS score 
● Current SOWS score 
● GOW recommendations for 
the following week  
● Patient’s plans for tapering 
opioids and optimizing pain 
management 
● Contingency planning for 
barriers 
● Advice concordant with 
GOW protocol based on 
NRS and SOWS scores 
● Information regarding 
optimal timing of pain 
medication doses for 
maximal effect 
● Information regarding 
current opioid tapering 
guidelines 
Relapse 
prevention 
(non-
adherence to 
the GOW 
protocol) 
● Reviewing progress: Any progress should 
be praised and reinforced as much as 
possible 
● Renewing motivation: Review behavioral 
indicators of motivation, and patient’s 
responses to questions for reasons for 
weaning or continuing to taper opioids  
● Renewing commitment:  
o Discuss what can be learned from non-
adherence 
o Revise the opioid weaning 
recommendations and obtain a 
commitment to follow-through with the 
revised plan 
● Episodes of non-adherence 
to GOW protocol, and 
reasons for non-adherence 
● Perceived barriers to opioid 
weaning (e.g. physical 
therapy causing increased 
pain) 
● Education regarding safe 
opioid storage and 
disposal. 
● Education regarding 
opioid misuse.  
● Advice to increase self-
efficacy (e.g. encouraging 
patient communication 
with the surgical team and 
efforts to increase 
physical activity) 
 
Key MI Tools for GOW Sessions 
● 
Open-ended questions to evoke patient’s goals for pain management and opioid cessation 
● 
Affirmations to focus on strengths, abilities, or efforts to reduce opioid use 
● 
Reflective (empathic) listening, strategically emphasizing “change talk” such as patient-generated 
reasons to wean opioids 
● 
Summarizing “change talk” focusing on desire, ability, and reasons for opioid weaning   
● 
Developing discrepancies between goals for opioid cessation and current behavior 
● 
Avoiding argumentation for opioid tapering 
● 
Handling resistance, through reframing or reflecting patient’s views to elicit patient’s arguments for 
opioid cessation 
● 
Supporting self-efficacy, noting effort to taper opioids to foster patient’s own belief in their ability to 
reach opioid cessation 
 
 
 
Guided Opioid Weaning Protocol 
Mean SOWS 
Score 
NRS 
Score 
Total Daily Opioid 
Dose 
>  2 
>  7 
25% Increase 
≤  2 
≤  7 
25% Decrease 

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>  2 
≤  7 
Maintain Current Dose 
≤  2 
>  7 
25% Increase 
 
Schedule 
Both groups will receive weekly phone calls from weeks 2 to 7, and at week 11 for 7 total calls. All calls 
will be limited to 20 minutes, and the duration of each call will be recorded. 
Rescheduling of the intervention can occur up to 31 days after the previous session; if patient is unable 
to receive the intervention within this timeframe, the patient will be moved to observation-only follow-
up.   
The first session will be scheduled by the research coordinator; subsequent appointments will be made 
directly between the NP’s and the patient. The first session must be scheduled between 14 and 21 days 
after the participant’s date of surgery. After the initial call, NP’s will be responsible for tracking and 
competing intervention calls. 
Intervention Protocol 
Participants randomized to MI+GOW will receive the intervention from a single provider (T. Mallick). Of 
note, participants will have all opioids and additional pain medications prescribed by their surgeon 
during the study. T. Mallick will only be providing advice regarding participants’ opioid medications. 
Content of the MI call is detailed in the Intervention section above. Treatment engagement is defined as 
participation in >50% of phone sessions. Treatment initiation is defined as participation in at least 1 
phone session. 
Longitudinal Follow-up 
Scheduling Follow-Up Assessments 
Electronic surveys will be sent out automatically based on confirmed dates of surgery. Distribution of 
online assessments will occur via the REDCap survey invitations calendar defined in the Longitudinal 
Observation Project, beginning seven days after the date of surgery. A patient’s official date of surgery 
will be entered into the “Pre-Surgery Call” instrument in REDCap during the Pre-Surgery call, and 
confirmed during the Post-Surgery call. The study team member may verify the date of surgery and time 
of discharge in EPIC and record it on the “Post-Surgery Call” instrument. 
Medical Chart Review 
Research team member will review the patient’s medical record for information required on the case 
report form.   
Compliance Monitoring 
Participant compliance with follow-up assessments will be assessed weekly through an automated 
reporting dashboard. Patients failing to complete two consecutive follow-up assessments be contacted 

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by the research coordinator, to encourage continued participation. The coordinator may offer to limit 
the participant’s follow-up to monthly surveys, to maintain follow-up data collection for the participant. 
Survey Frequency Reduction 
To reduce instances of participants lost to follow-up or withdrawing, the coordinator can reduce the 
frequency of participant surveys from weekly to monthly. To complete this, the coordinator will check 
the “Monthly Surveys Only” checkbox in the “Coordinator Controls” instrument of the Longitudinal 
Observation REDCap project, and save the instrument. 
Lost to Follow-up Participants 
A participant is considered “Lost to Follow-up” if they have not completed a follow-up assessment for 
two months, and cannot be reached by the research coordinator. The Research coordinator will attempt 
to call the participant three times before declaring them lost to follow-up, leaving a voicemail message 
able. If a participant has alternative numbers listed (like a spouse or relative), those numbers should be 
attempted many times before inactivating the participant. 
If the coordinator has determine the participant is lost to follow-up, the coordinator will mark the 
participant status as “Inactive” in the Coordinator Controls Instrument of Longitudinal Observation 
REDCap. The coordinator will also input the date of last contact with the participant, and select “Lost to 
follow-up” as the reason for withdrawal. Participant notes may be used to elaborate on the 
circumstances of the participant’s withdrawal. 
Patient Withdrawn or Study Completion 
If a patient is withdrawn from the study, the study coordinator will mark the participant status as 
“Inactive” in the Coordinator Controls Instrument of Longitudinal Observation REDCap and document 
the date of the last contact and reason for withdrawal. The study coordinator will also input the date of 
last contact with the participant, and select “Lost to follow-up” as the reason for withdrawal. Participant 
notes may be used to elaborate on the circumstances of the participant’s withdrawal. 
Weekly and Monthly Surveys 
Weekly Assessments 
The following assessments will be completed weekly via online assessment up to 6 months, and then 
monthly up to 12 months for all participants. 
1. Weekly Pain and Opioid Questionnaire (WPOQ, combined into one instrument with BPI) 
2. Modified Brief Pain Inventory-II (BPI, combined with WPOQ into one instrument) 
Monthly Assessments up to 6 months 
The following assessments will be completed monthly via online assessment up to 12 months for all 
participants. 
1. Patient Health Questionnaire-9 (PHQ-9) 

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2. Common Opioid Misuse Measure (COMM) 
3. PROMIS Measures 
a. PROMIS Bank v1.0- Depression 
b. PROMIS Bank v1.0- Anxiety 
c. PROMIS Bank v1.0- Sleep Disturbance 
d. PROMIS Bank v2.0- Physical Function 
Monthly Assessments from 6 to 12 months 
From 6 to 12 months, online assessments alternate to reduce participant burden. These assessments 
can be grouped in to the following categories 
Regular Monthly Assessments 
Administered via online survey monthly. Assessments Include: 
1. Common Opioid Misuse Measure (COMM) 
2. PROMIS Measures 
a. PROMIS Bank v1.0- Sleep Disturbance 
b. PROMIS Bank v2.0- Physical Function 
Alternating Monthly Assessments 
These assessments alternate each month, the help reduce participant burden. Assessments Include: 
1. Patient Health Questionnaire-9 (PHQ-9): Assessed on Weeks 24, 32, 40, and 48 
2. PROMIS Measures: Assessed on Weeks 28, 36, 44, and 52. 
a. PROMIS Bank v1.0- Depression 
b. PROMIS Bank v1.0- Anxiety 
Irregular Assessments 
The following assessments are to be completed via online assessment at time points in addition to 
Weekly/Monthly Assessments, or have schedules that are best described more specifically. 
1. Self-Efficacy for Appropriate Medication Use Scale (SEAMS): Administered to intervention 
participants on Week 1 only 
2. Motivation Interviewing Rulers (MI-Rulers): Administered to intervention participants on Weeks 
2, 4, 7, and 12 only 
Censoring 
Participants may be withdrawn for the following reasons:  
● Additional surgery 
● Postoperative complication 
● Death 

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● Patients expressing concerns regarding pain management will be offered study withdrawal and 
referral to a pain medicine specialist 
 
Withdrawn participants will be removed from all future data collection.   
Patient Withdrawn or Study Completion 
If a patient is withdrawn from the study, or lost to follow-up, the study coordinator will document the 
events by filling out the “Study Stop Point” instrument electronically in REDCap. 
Upon a patient being withdrawn or lost to follow-up, the study coordinator must also go into the 
REDCap instrument “Participant Entry” and switch the patient’s status to “Inactive.” At that point a 
warning message will automatically appear listing all of the future events for that participant, which the 
coordinator will then remove by clicking “Clean up Calendar Entries” under the project bookmark 
heading on the left side of the screen. Coordinator will also clean up calendar entries in the Calling 
Project for participants who have withdrawn or reached study completion. 
Data Management 
Data will be maintained on appropriate case report forms and participant questionnaires.  Case Report 
Form data will be entered into a REDCap database.  
Patient Identification Codes 
Both Intervention and Observation arm participants will receive two unique codes identifying their 
records, saved as the “record_id” in both projects. In the Enrollment project, this code is a 4-digit 
number, assigned sequentially and automatically when the participant’s information is imported into 
the project (Example: 0000). In the Longitudinal observation project, the research coordinator assigns an 
alphanumeric code to serve as the participant’s record_id, consisting of their First and Last Initial, and 
the enrollment record_id (Example: AA-0000) 
Tracking Events 
Consent, Pre-Surgery, and Post-Surgery calls will be tracked in the REDCap Study Calendar, and are 
generated by completion of the brief eligibility screen, and manual scheduling by the research 
coordinator.  
Online assessments will be distributed and tracked by the Longitudinal Event Calendar in the 
Longitudinal Observation REDCap Projects 
Intervention calls are initially scheduled between the research coordinator, participant, and appropriate 
study team member. All subsequent calls will be independently scheduled and tracked by the NP and 
participant. 

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Hard-copy Data Storage 
 
All data received or collected in paper form must filed in lockable cabinets, and documented in the 
appropriate event of the REDCap Enrollment Project. Physical Okay to contact forms, Eligibility 
checklists, screening checklists, and consent forms must be filed in a binder and stored in lockable 
cabinets.  
Okay to Contact Forms 
Nurse practitioners or physician assistants in the Ortho-Joint located at 450 Broadway St. Redwood City, 
CA will ask their patients during their preoperative visits if they would like to be contacted about a pain 
study. These forms, known as “okay to contact” forms, should be picked up at the ortho-joint clinic 
weekly. When the status of a participant is determined, the okay to contact forms should be placed in 
the appropriately labeled binder (one binder per study calendar year) and locked. The coordinator will 
review the patient’s EPIC health record to collect the necessary information to create a REDCap record 
for the participant. 
Screening & Eligibility Forms  
Screening information will be maintained electronically in the REDCap enrollment project, in the “Initial 
Eligibility Survey” instrument or “COORD: Consent Call’ instrument. Screening information will be 
complied regularly into a report detailing the patient name, the date the screening occurred, the 
method of screening, the study team member performing the screen (if applicable), the screening result 
(eligible, ineligible, declined to participate and reason), whether the patient was enrolled, and any 
comments. 
Consent Forms 
Electronic Consent forms will be stored in PDF format in the File Repository of the REDCap MAP-Pain 
Enrollment Project. Hard copy consent forms should be scanned and uploaded to the REDCap File 
Repository as backup storage. Physical Copies of consent forms will be stored in a study binder in a 
secure cabinet. 
For every consent form that is signed, regardless of method of signing, a copy of the signed form must 
be sent to the participant. For those signing online, a secure email (sent by writing “Secure:” in the 
subject line) with the signed consent attached must be sent. For those signing in paper form, a hard 
copy of the signed form must be sent via mail. 

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For Intervention participants, a copy of the consent form will also be sent to Medical Records for storage 
in the patient’s chart; this will have the patient’s MRN on each page. The electronic consent document 
from REDCap will be printed out and will include an electronic version of the study bar code, or a sticker 
with the study bar code.  It is then sent to HIMS, room HC032, MC5200, with coordinator’s contact 
information included. If asked, MAP-Pain has been IRB approved to use the eConsent method; 
participant names typed into the eConsent form are in lieu of signatures. 
Patient Adherence 
Non-adherence is considered greater than recommended opioid use that is still within the range of the 
patient’s prescription. 
Patient Retention 
Patient retention is at its highest rate when participants feel like they are aware of what is occurring in 
the study, when they have their needs met, and when they are greeted with optimistic and attentive 
staff. 
 
To keep participants engaged: 
● Research staff must ensure that participants know exactly what the study goals are and how the 
study staff are working to meet these goals. 
● Participants should be completely aware of what is required for effective, active participation. 
The level of time commitment must be made clear at the beginning in order to avoid future 
dissatisfaction.  
● Participants should know that we greatly appreciate their efforts, especially since they are 
volunteering their time. It must be made clear how important their contribution is to this 
science. 
● Participants must be told that they can withdraw from the study at any time even though we 
would be sad to let them go. They must be made aware of the effort it takes on all fronts in 
designing this study and collecting data, so they should try their best to remain in the study. 
● Research staff must ensure that all other staff know what to communicate to participants, 
especially in times of dissatisfaction. 
 
To retain participants who are dissatisfied with the study: 
● If the issue comes from participants feeling overwhelmed by assessments, research staff must 
make an effort to reduce assessments. (See Survey Frequency Reduction above)  

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Trial Safety 
Potential Risks & Response to Risks 
Risk of Telephone Contact 
The primary risk of telephone and online contact involves breach of confidentiality. All research 
personnel are trained in confidentiality procedures and adequate protections will be in place to 
minimize this risk. All research personnel must be HIPAA trained. Personnel enrolling participants must 
complete CITI training. 
Risks of Intervention 
In addition to risks of confidentiality, there are few other risks involved in enrollment into the 
intervention. Those who are randomized into MI+GOW may be exposed to greater risk. These risks, 
however, are only relevant if a participant follows the recommendations. Because T. Mallick is not a part 
of a participant’s regular care team, the participant has the freedom to choose which recommendations 
to follow, with no obligation to follow any at all. T. Mallick’s role is to recommend courses of action that 
meet the participant’s needs, to the extent that it does not do additional medical harm. 
Despite these rules, the following are risks that may be associated with participating in MI. 
The physical and psychological risks to subjects are the effects opioid withdrawal including tachycardia, 
diaphoresis, restlessness, rhinorrhea, bone or joint aches, gastrointestinal upset, tremor, irritability, 
anxiety, and piloerection. Also, patients may experience increased pain if opioids are tapered 
prematurely. The seriousness of these side effects is moderate, as withdrawal symptoms and pain will 
be monitored during the intervention. Protocols are in place to hold the tapering schedule with the 
development of moderate opioid withdrawal and to increase the opioid dose with the development of 
severe pain. This type of opioid withdrawal is not fatal (as opposed to iatrogenic opioid withdrawal 
precipitated by opioid antagonists that could lead to mortality). Patients will be encouraged to contact 
the nurse practitioner (T. Mallick) at any time regarding the development of any adverse effects. 
Patients will be able to reach the PI (Dr. Hah) or an alternate qualified member of the research team 24 
hours a day. Also, participants reporting dramatically increased pain potentially related to other medical 
causes-e.g. infection, dislocation, thromboembolic disease, new neurologic deficits, will be referred to 
their nearest emergency department, and their PCP or surgeon will be contacted at the discretion of T. 
Mallick or Dr. Hah.  
The alternative treatment is enhanced usual care, and a subset of these participants is at risk for delayed 
opioid cessation and potential opioid misuse and abuse. Although participants will be instructed to call 
911, or to seek immediate medical attention for medical emergencies, we will encourage participants to 
call regarding any questions or unusual symptoms they are experiencing. Also, participants will be 
instructed to contact their primary care provider or surgeon for medical questions unrelated to the 
study. 

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Trial Stopping Rules 
Given that the research does not involve a high-risk intervention or a population based on previous 
studies, absolute stopping rules will not be identified in the statistical plan. Any individual participant 
may choose to end participation for any reason, and this will be noted. The PI may choose to end an 
individual participant’s participation if the participant is non-compliant with study procedures such that 
the study integrity is harmed or the participant is put at risk by continued participation. 
Reporting Study Events to the IRB 
Adverse Event Reporting 
An adverse event is defined as any undesirable symptom or event experienced by the participant while 
he/she is in the study. An adverse event can be expected, unexpected, related, or unrelated to the 
study. If the event does not require great intervention and is addressed by the participant’s normal care 
team, it can be recorded as a study adverse event and does not have to be reported to the IRB.  
Serious Adverse Event Reporting 
Serious adverse events (SAEs) are defined as: 
● Life-threatening  
● Fatal/Death  
● Hospitalization/prolongation of hospitalization  
● Congenital anomaly  
● Persistent or significant disability/incapacity  
● Required intervention to prevent permanent impairment/damage 
 
SAEs must be tracked using the NIDA SAE form. The PI/Coordinator will report all SAEs in the annual 
report to NIDA, including any IRB recommendations on SAEs related to the study. All adverse events will 
be recorded and reported in aggregate on an annual basis to NIDA, as well as the IRB, and quarterly to 
the DSMB.  
Any unexpected events will be reviewed by the Research Manager, in consultation with the PI, for 
determination as to whether it meets the definition of an Unanticipated Problem. If determined to be an 
Unanticipated Problem, or any of the following below, the issue must be reported to the IRB within 10 
working days.   
a. New Information that indicates a change to the risks or potential benefits of the 
research in terms of severity or frequency or impacts the subject’s willingness to 
participate 
b. Noncompliance: An action or activity in human subject research at variance with the 
approved IRB protocol, other requirements and determinations of the IRB, the HRPP 
Policy Manual and other applicable policies of Stanford University, SHC, LPCH, VAPAHCS 

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(e.g., VHA Handbook 1200.5), Palo Alto Veterans Institute for Research (PAVIR) or 
relevant state or federal laws. When the event is: 
• 
Possibly serious: Noncompliance that affects the rights or welfare of human 
subject research participants. 
• 
Possibly continuing: A pattern of noncompliance that continues to occur after 
a report of noncompliance and a corrective action plan has been reviewed 
and approved by the IRB, after an investigator has been warned to correct 
errors or noncompliance, or a circumstance in which an investigator fails to 
cooperate with investigating or correcting non-compliance. 
c. Complaint unresolved by the research team 
d. Incarceration when in the opinion of the PD it is in the best interest of the participant to 
remain on the study. 
e. Other events or information: Examples include a deviation intended to eliminate an 
immediate hazard to a participant, suicide or suicide attempt of a participant, other 
Audit or Monitoring Visit reports and Corrective Action Preventative Action (CAPA) 
plans. Report only after consulting with the IRB Panel Manager. 
 
Unexpected deaths or life-threatening experiences related to the research (at Stanford, or when 
STANFORD is the coordinating institution in a multi-site study) must be reported to the IRB within 5 
working days from PD learning of event. 
Unanticipated Problems Involving Risks to Participants or Others (UPs): Events (internal or external, 
deaths, life-threatening experiences, injuries, or other) occurring during the research study, which in the 
opinion of the Monitoring Entity or the PD meet all of the following criteria: 
a) Unexpected 
in terms of nature, severity, or frequency, given (a) the research procedures described in the protocol-
related documents, and (b) the characteristics of the subject population being studied; 
AND 
b) Related to participation in the research or there is a reasonable possibility or likelihood that the 
incident, experience, or outcome may have been caused by the procedures involved in the research; 
AND 
c) Harmful: the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized 
All records of trial safety must be documented and stored in the “Trial Safety” folder of the STOP server. 

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Trial Monitoring 
Adverse Events, Serious Adverse Events, Unanticipated Problems, and Protocol Deviations will be 
monitored on a continual basis and reported per information in the Study Events section. 
Patient Adherence will be monitored as described in the relevant section, and in Compliance Monitoring 
section above. 
The PI will hold regular staff meetings at least twice monthly to assess study team member 
understanding of responsibilities as per the Education section. 
The first 10 participants will have case report forms and consent forms reviewed for accuracy and 
completion immediately after enrollment and entry into the follow-up period.  After the first ten 
participants, case report forms and consent forms will be evaluated for completeness every 50 
participants, or every 3 months.  The results of these evaluations will be discussed at the quarterly 
DSMB meeting. 
Participant Monitoring 
The research team must check all active participants in REDCap at least once a week to identify any 
missing assessments, and to call participants with reminders to complete the assessments.  
Data Safety and Monitoring Plan 
Ultimately, the PI will be responsible for monitoring the safety and efficacy of this trial, executing the 
Data and Safety Monitoring (DSM) plan, and complying with the reporting requirements. In addition, Dr. 
Hah will conduct periodic internal reviews to monitor the trial with a rotating panel of 2 additional 
physicians, and 2 Stanford Systems Neuroscience and Pain Lab members. The Stanford Systems 
Neuroscience and Pain Lab members will have with no conflicts of interest with, or financial stakes in 
the research outcomes that would make them ineligible to participate in the internal review. 
Frequency of DSM 
The internal committee will analyze the DSM monitoring report every 3 months in the course of the 
trial. At minimum, Dr. Hah will meet with one member of the rotating internal panel every 3 months to 
evaluate the safety and efficacy of the trial, the execution of the DSM plan, and compliance with 
reporting. 
Content of DSM Report: 
A DSM report will be included in the annual progress report to NIDA and will include: 

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● Brief description of the trial 
● Retention and disposition of study participants (including review of the study’s progress toward 
recruitment goals, treatment adherence, participant attrition/retention rates) 
● Q.A. Issues (including analysis of appropriate completion of forms) 
● Regulatory Issues (including IRB regulatory actions and changes or amendments to the research 
protocol approved by the IRB) 
● AEs 
● SAEs 
Case Report Form Completion 
Missing data that is available through patient records such as EPIC will be recorded with a notation of 
such.  Data discrepancies will be compared to any source data such as EPIC and corrections made by 
crossing out the original value, providing the correct value, dating, initialing, and providing a reason for 
the correction. If there is no hard copy, a comment should be made on REDCap.  Missing data or data 
discrepancies that cannot be resolved by verifying source data will be left as missing.   
Consent Form Completion 
Consent forms will be evaluated for completeness of all signatures, required initials, and dates.  Any 
missing signatures will be obtained by mailing the patient a copy of the consent form and requesting the 
signature with the current date.  Any missing PI or staff signatures will be obtained and dated with the 
current date.  Patients with missing signatures who are unable, or unwilling, to provide missing 
signature will be withdrawn from the study and data will not be used.   
Electronic Data Verification 
Electronic data is entered via the Stanford REDCap system or Perioperative CHOIR.  Participants enter 
responses directly into the electronic system, unless they specifically request responding via phone calls.  
Hard-copy Case Report Forms are entered into REDCap manually by study staff, after they have 
completed instructional training and a mock-entry packet that is reviewed by the Research Manager, 
coordinator, or study monitor.   
An additional 10% of data will be randomly verified by study staff prior to data analysis.  Verification will 
occur via visual inspection. Discrepancies will be noted, original source data checked, and the correct 
value entered.  All verified data will be noted with the reviewer’s initials and date.  Corrections will be 
noted with the date, initials, and reason for correction.  Consistent errors will prompt a more 
comprehensive review of the data at the PI’s discretion.   
 

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Primary Efficacy Outcome-Observation Arm 
Time to opioid cessation, defined as the first of 2 consecutive reports of opioid cessation on the 
modified BPI. 
 Secondary Efficacy Outcomes-Observation Arm 
1. Opioid misuse (This will be defined as a score of 9 or higher on the Current Opioid Misuse 
Measure). 
2. Time to pain cessation (This will be defined as the first of five consecutive days of 0 average pain). 
3. Time to recovery (First report of patient indicated “Yes” to having recovered from surgery).  
Primary Efficacy Outcome-Intervention Arm 
Time to opioid cessation, defined as 1st of 2 consecutive reports of return to baseline opioid dose or 
lower. 
Secondary Efficacy Outcomes-Intervention Arm 
1. Opioid misuse (This will be defined as a score of 9 or higher on the Current Opioid Misuse 
Measure). 
2. Time to complete opioid cessation, defined as the first of 2 consecutive reports of opioid 
cessation on the modified BPI. 
3. Time to pain cessation (This will be defined as the first of five consecutive days of 0 average pain). 
4. Time to recovery (First report of patient indicated “Yes” to having recovered from surgery).  
5. Treatment engagement is defined as participation in >50% of phone sessions.  
6. Treatment initiation is defined as participation in at least 1 phone session. 
 
Methods for handling missing data and non-adherence to protocol: 
Subjects dropping out will be censored at the last known data point. Competing events such as a second 
surgery will be reasons for censoring at the time of the competing event. Missing data will not be 
imputed. 
Modifications History 
Last Updated 10/15/2020 by Luke Pirrotta, CRC.