Enhancing Rehabilitation Participation in Patients With Spinal Cord Injury or Disorder Using Motivational Interviewing
Phase: NA
Conditions: Spinal Cord Injuries (SCI), Spinal Cord Disease
Sponsor: Shirley Ryan AbilityLab

 
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STUDY TITLE: 
Enhancing Rehabilitation Participation in Patients with SCI/D Using Motivational 
Interviewing 
 
PRINCIPAL INVESTIGATOR: 
Name: Linda Ehrlich-Jones 
Department sponsoring/supporting the study: Center for Rehabilitation 
Outcomes Research 
Telephone Number: 312-238-0743 
Email Address: ljones1@sralab.org  
 
 
 
VERSION DATE: 
12/12/2024 
 
 
RELATED STUDIES:  
STU00204701- Training Therapists in Motivational Interviewing to Enhance 
Rehabilitation Participation for SCI 
 

 
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Check any applicable boxes in the table below – you will be asked for 
further detail on these topics later in the protocol form: 
 
Indicate Vulnerable Populations to be enrolled: 
☐ Children  
☐ Cognitively Impaired Adults   
☐ Pregnant Women (IF the research activities will affect the pregnancy or the fetus) 
☐ Prisoners (or other detained/paroled individuals)  
☐ International Research (check this box if you will collect data from individuals located 
outside the United States) 
☒ Research involving external collaborators (some research activities will be carried out by 
individuals not employed by Northwestern or NU affiliates will carry out some research 
activities) 
☐ Research has U.S. Federal government funding via one or more direct awards or a sub-
award (e.g., NIH, NSF, other federal agencies or departments) 
 
 
1.0 
Purpose and rationale of the study: 
1.1 
Purpose 
We plan to conduct a multi-site randomized controlled trial of motivational 
interviewing (MI) training for physical therapists (PTs) and occupational 
therapists (OTs) who treat people with SCI during inpatient rehabilitation. We 
will test whether patients treated by MI trained PTs and OTs demonstrate 
greater participation in therapy sessions and better functional, social, and 
educational/occupational outcomes relative to patients treated by therapists 
without MI training. This stage of research is appropriate because a Neilsen 
Foundation funded pilot study that we recently completed had promising 
results. Study results showed that SCI patients treated by MI trained PTs and OTs 
participated significantly more actively in therapy sessions compared to controls. 
However, the study had several limitations that need to be addressed to produce 
a more definitive and influential trial. First, the study was conducted at a single 
site and results may not generalize to other sites. Second, we did not examine 
whether MI training and improved participation resulted in patients having 
better clinically meaningful outcomes such as higher likelihood of discharge to 
home or superior functional, social, or educational/occupational outcomes. 
Third, therapists trained in MI achieved only minimal competency in MI skills. 
We hypothesize that if therapists received ongoing coaching to improve their MI 

 
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skills during the trial the positive impact on patient participation and other 
outcomes might be even more robust.  
 
1.2 
Project Aims: 
1. To determine whether inpatients with SCI/D treated by PTs and OTs who 
receive MI training and coaching demonstrate greater therapy 
participation compared to those treated by therapists who do not receive 
MI training and coaching.  
2. To determine whether inpatients with SCI/D treated by PTs and OTs who 
receive MI training and coaching demonstrate greater functional 
improvement at discharge from inpatient rehabilitation and greater 
community integration at 6 months after discharge compared to those 
treated by therapists who do not receive MI training and coaching.  
3. To document an effect of training and coaching on MI skills and explore 
potential moderators and mediators of the effect of the intervention on 
therapy participation.  
 
1.3 
Background and rationale 
Patient participation in physical and occupational therapy during inpatient spinal 
cord injury (SCI) rehabilitation is not always optimal. The cost of suboptimal 
participation is that patients with SCI experience significantly poorer outcomes in 
important functional domains such as whether the person discharges to home, 
their functional mobility at discharge from inpatient rehabilitation and at one-
year, social integration, and whether they return to work or school one year 
after SCI. As such, the problem of suboptimal participation in inpatient therapies 
represents a critical gap in the field of SCI rehabilitation that merits increased 
attention. Therapy participation is a biopsychosocial phenomenon and strength 
of participation has downstream effects on physical, social, and occupational 
functioning. An intervention that improved therapy participation and then led to 
more people being discharged to home environments, returning to work or 
school, and having better functional and social integration outcomes could be 
quite beneficial based on the number of people affected and the importance of 
the results.  
 
Motivational interviewing is an evidence-based counseling style found to be 
effective in fostering positive health behavior change, including adherence to 
treatment in 119 randomized controlled trials and multiple meta-
analyses.(Lundahl, 2010) MI counseling consists of five major skills: open-ended 
questions, affirmations, reflective listening, summarization and providing 
information and advice with permission. There is no theoretical framework for 
MI, but it is most closely associated with Self-Determination Theory (Deci & 
Ryan). Self-determination theory focuses on supporting intrinsic motivation, self-
regulation and mental health in social contexts and posits that intrinsic 
motivation and self-regulation require competence, relatedness and autonomy. 

 
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In our pilot study, “Training Therapists in Motivational Interviewing to Enhance 
Rehabilitation Participation for SCI” (STU00204701), we recruited 62 inpatients 
with SCI/D to participate in the project. Patient participation in therapy was 
scored by therapists, the patients themselves, and a blinded project coordinator 
(researcher). In general, patients with SCI/D improved their therapy participation 
from Week 1 to Week 4. Multi-level modeling analysis revealed that patients 
treated by MI trained therapists scored significantly higher on the Pittsburgh 
Rehabilitation Participation Scale (PRPS) (M=4.26, SD=0.91) compared to 
controls (M=3.79, SD=1.15) after controlling for sex, age, and trauma type. The 
effect size was medium according to Cohen’s d at 0.56. Patients in the MI 
intervention group had a flatter slope of PRPS improvement than patients in the 
control group across time. Patient-rated and therapist-rated PRPS scores had 
similar trends as researcher-rated PRPS despite less significant difference. 
Therapist-rated PRPS showed significant group difference between groups (MI 
intervention group had higher scores), but no difference was noted across Week 
1 to Week 4. We aim to build on these initial outcomes by providing additional 
MI coaching to the trained therapists and recruiting a larger sample.  
 
This is a multi-site project with two sites, Shirley Ryan AbilityLab and Baylor Scott 
White, each of which will follow the same protocol under review of their local 
IRBs. This protocol only covers research activities at SRAlab requiring 
Northwestern IRB approval. Any data shared between researchers at SRAlab and 
Baylor for analysis and/or quality assurance will be deidentified. 
 
 
2.0 
Enrollment Criteria: 
 
2.1 
Occupational and Physical Therapist participants will be recruited from 
the inpatient spinal cord injury units at Shirley Ryan Ability Lab. They will 
be recruited at staff meetings and through email communication by the 
research team through coordination with allied health managers. During 
the staff meeting, the verbal therapist recruitment script will be read. An 
informational flyer will also be available. Recruitment emails will be sent 
out to the therapist listserv and followed up with each therapist 
individually. 
Therapist inclusion criteria: 
• Inpatient therapist specializing in spinal cord injury patients for at 
least 3 months;  
• Practicing on one of the two designated SCI inpatient units at SRAlab 
(Floor 21 or 22);  
• Willing to audio record conversations during regularly-scheduled 
rehabilitation therapy sessions with patients;  

 
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• Willing and able to participate in 16 hours of MI training; and  
• Willing to receive feedback on MI skills. 
Therapist exclusion criteria: 
• Inability to speak and understand English 
• Inpatient therapist specializing in spinal cord injury patients for less 
than 3 months; and 
• Unwilling or unable to follow the study protocol 
 
2.2 
Patients with SCI will be recruited using participating therapists’ 
caseloads and randomly selecting participants to be approached about 
participating in the study. When approached, patients will be read the patient 
recruitment script. 
Patient Inclusion Criteria: 
• Adults (18+) 
• Presence of a traumatic or non-traumatic spinal cord injury 
• Inpatient in the spinal cord injury unit of SRAlab 
• Has a physical or occupational therapist who is a participant in the 
study 
Patient Exclusion Criteria: 
• Inability to speak and understand English 
• Cognitive deficits 
• Unwilling to allow for therapy sessions to be recorded 
 
3.0 
Sample Size: 
3.1 
Local sample size 
We expect to enroll 90 participants at SRAlab: 6 occupational or physical 
therapists plus 84 of their patients with SCI (of which n = 18 patients will only be 
enrolled as audio-only test participants).  
 
The recruitment breakdown and timeline is as follows: 
• Recruitment phase 1: 6 occupational or physical therapists 
• Recruitment phase 2: 12 patients with SCI, 2 patients per therapist, 
will be recruited as audio-only test participants to assess baseline 
motivational interviewing skills prior to therapist randomization and 
training.   
• Recruitment phase 3: Half (n = 3) of the therapists at each site will be 
trained in MI, so we will recruit 6 additional patients (2 per MI-trained 
therapist) as audio-only test participants to assess MI competency 
during the initial MI training phase.  
• Recruitment phase 4: We will recruit 60-66 patients with SCI—10-11 
patients per enrolled therapist—for the experimental phase, which 
includes audio recording of therapy sessions plus two additional 
questionnaires.  
 

 
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3.2 
Total sample size 
Across sites, we expect to enroll 180 participants: 12 OT/PT’s (6 per site) and 168 
patients with SCI (84 per site).  
 
3.3 
Sample size justification 
We anticipate a sufficient number of patients; full time therapists are budgeted 
to work with six patients daily while half time therapists are budgeted to work 
with three patients daily. 
 
The effect size obtained from the pilot study was 0.56 (Cohen’s d). Based on the 
G*Power 3.1.9.6 program we would need to study 104 patients (52 per group) to 
adequately power the study assuming an alpha level of .05, power = .80, two-
tailed test, and 1:1 allocation. We anticipate 20% attrition rate leading to a total 
of 126 patient participants. 
 
 
4.0 
Recruitment and Screening Methods: 
 
4.1 
Recruitment and screening of therapists 
The research team at SRAlab will recruit 6 rehabilitation therapists—ideally 3 
physical therapists and 3 occupational therapists—working on the designated 
inpatient SCI units (floor 21 and 22). Therapists will be approached on the 
therapy floor during breaks in their workday using the therapist recruitment 
script and therapist recruitment flyer. The research team will notify and work 
with the allied health managers on each floor as needed to coordinate 
recruitment efforts with therapist schedules.  
The research assistant will screen interested therapists based on the inclusion 
criteria: (1) inpatient spinal cord injury rehabilitation therapist working on floors 
21 or 22 for at least 3 months, (2) willing and able to participate in 16 hours of 
MI training, and (3) willing to record audio of therapy sessions with enrolled 
patients. 
Therapists who meet eligibility criteria will proceed with informed consent if still 
interested after screening questions. The research assistant will obtain written 
informed consent either on paper or REDCap e-signature. The therapist will be 
given a copy of the consent form, and they will be encouraged to read through 
the consent form and ask questions prior to enrolling. 
 
4.2 
Authorization form for audio-only test patients 
As described in the sample size breakdown, 18 patients with SCI will be audio 
recorded to (1) assess baseline motivational interviewing skills (n = 12, 2 patients 
per therapist) and (2) assess post-training motivational interviewing skills (n = 6, 
2 patients per MI-trained therapist). This activity does not qualify as human 

 
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subjects research because the patient identities will not be documented by the 
research team or associated with the recordings, and no survey data will be 
obtained. The audio will only be used to assess MI skills of the therapist 
participants. The recordings will be destroyed once the pre-experimental phase 
of the study is completed. Please see “SRAlabAudioConsentForm” in lieu of full 
informed consent document.  
 
4.3 
Recruitment and screening of inpatients with SCI 
A convenience sample of patients with SCI will be recruited based on new 
admissions to inpatient rehabilitation and the participation of their rehabilitation 
therapist in the study. The research team will approach patients assigned to one 
of the enrolled therapists at the time of their admission to an SRAlab inpatient 
SCI unit (on floor 21 or 22).  
A research assistant will screen patients newly admitted to the 21 or 22 floor for 
presence of a traumatic or non-traumatic SCI via admission records in Cerner. 
Patients must be 18 years or older at time of admission and must speak English 
without a translator. Potential participants must also agree to having audio 
recordings of their therapy sessions.   
The research team will communicate with the enrolled therapist to schedule a 
time before, during, or after rehabilitation sessions to recruit and screen 
patients. We will approach eligible patients using the recruitment script and flyer 
after assessing initial eligibility through medical records.  
Interested patients will review the informed consent document with a member 
of the research team.  
During the consent process, patients must agree to audio recordings of their 
therapy sessions—they will be informed that the audio recordings focus on the 
therapist and not the patient, but both sides of the conversation are needed to 
provide context to the therapist’s verbiage. We will instruct therapists to avoid 
using patients’ full names when recording therapy sessions. Audio recordings will 
be uploaded to Shirley Ryan AbilityLab OneDrive with limited permissions to 
maintain privacy of therapists and patients.  
 
5.0 
Research Locations: 
This protocol describes research activities that will take place at Shirley Ryan AbilityLab 
under review of the Northwestern IRB. Therapy sessions will be held and recorded in 
the usual SCI rehabilitation units on the 21 or 22 floor. Research documents will be 
saved on the secure SRAlab network using SRAlab-approved devices. The research team 
will use REDCap to collect survey data and otherwise store participant information in 
password-protected files on the SRAlab server.  
 
An identical protocol will be conducted at Baylor Scott White in Texas which will be 
reviewed under their local IRB. Any information that the SRAlab research team must 
share with the Baylor research team will be stripped of direct patient identifiers, such as 
full name and address. 

 
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6.0 
Multi-Site or Collaborative Research:  
6.1 
Primary research sites 
This study is funded by the Craig H Neilsen Foundation (non-federal) and involves two 
primary research sites, SRAlab (Chicago, IL) and Baylor Scott White (Dallas, TX).  
 
The Principal Investigator at SRAlab is Dr. Linda Ehrlich-Jones, PhD, RN, Associate 
Director of the Center for Rehabilitation Outcomes Research. The Co-Investiagor at 
Baylor Research Institute is Simon Driver, PhD, Research Center Director.  
 
Each site will administer an identical protocol under the review of their local IRB. 
 
6.2 
Motivational Interviewing Consultant 
Dr. Charles Bombardier is a clinical psychologist and Professor in the Department of 
Rehabilitation Medicine at the University of Washington. Dr. Bombardier is a co-
Investigator on this study, serving as an expert on motivational interviewing (MI).  
 
He is a member of the international Motivational Interviewing Network of Trainers 
(MINT). He collaborated with Dr. Ehrlich-Jones on the pilot study that set the stage for 
this trial. As a Co-Investigator, he will assist with training and coaching of the PTs and 
OTs to use motivational interviewing techniques in their work with inpatients with SCI. 
He will also assist with interpretation of study results, co-authoring publications and 
presentations, and contributing to other dissemination efforts.  
 
The University of Washington is not a research site, and Dr. Bombardier will not be 
involved in the recruitment or data collection activities taking place at SRAlab and 
Baylor. He will assist the Principal Investiagor in motivational interviewer training, initial 
assessment of therapist MI competency, and analysis, interpretation, and dissemination 
of findings. These activities will take place through secure, remote technology platforms 
hosted by the primary research sites, SRAlab and Baylor. 
 
 
7.0 
International Research (where data collection will occur outside the 
United States and U.S. territories, including online activities) 
N/A 
 
 
8.0 
Procedures Involved: 
 

 
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8.1 
Baseline data collection and randomization of therapists: 
• Once the research team enrolls 6 physical therapists or 
occupational therapists, demographic information will be 
collected by the research assistant via REDCap survey (see 
‘DemographicSurvey’ under ‘supporting documents’). The 
therapist participant may fill out the demographic survey via 
REDCap themselves if they prefer – the research assistant will 
review the answers and follow up with participants in-person to 
clarify as needed..  
• All therapists will audio record two therapy sessions with SCI/D 
patients wearing a digital recorder on their name badge lanyard 
or on their clothing. This will provide a baseline level of MI skills. 
Audio-only test patients will sign an authorization to have their 
therapy session recorded (see 
“EditedSRAlabAudioConsentForm”). We will not obtain full 
informed consent from the audio-only patients because their 
identities will not be recorded and they will not participate in the 
patient questionnaires described below. The test audio recordings 
obtained in steps 8.1 and 8.2 will be destroyed after therapists’ 
motivational interviewing skills are assessed. 
• After all baseline recordings are complete, the data manager will 
perform a central computer-generated randomization and then 
transmit treatment allocation to Dr. Ehrlich-Jones, the MI trainer, 
via secure email. Dr. Ehrlich-Jones will then contact enrolled PTs 
and OTs at each site to set up training as indicated. 
Randomization will be stratified based on therapist type (PT vs. 
Please check the boxes for all applicable data collection procedures you plan to use: 
☐One-on-one interviews 
☐Focus Groups 
☒Questionnaires/surveys 
☒Secondary Data Analysis (medical record data, educational records, government or 
private sector datasets, etc.) 
☐Ethnographic observation 
☐Physiological measurements (e.g., EEG, EKG, MRI) 
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.) 
☒Mobile applications/data collection devices (e.g., Fitbits, actigraphs, etc.) 
☐Behavioral decision making tasks (e.g., puzzles, interactive games, etc.) 
☐Physical activities such as walking and other forms of exercise 
☐Other procedures (briefly list types of procedures here if not covered by the check-
boxes above): ______________________________________________ 
 

 
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OT). The allocation sequence will be concealed from any study 
staff involved in enrollment of  participants or data collection via a 
restricted access database program. 
• Half of the therapists will be assigned to the experimental 
Motivational Interviewing group, and the other half will be 
assigned to the control group. 
8.2 
Train therapists in Motivational Interviewing 
• MI training will follow the standard, evidence-based training 
model recommended within the MI expert community of 16 
hours of training.(Miller, Yahne et al, 2004 Journal of consulting 
and clinical psychology, 72: 1050-1062.) Dr. Ehrlich-Jones is an 
experienced trainer and a member of the international MI 
Network of Trainers (MINT). Dr. Bombardier (co-I, University of 
Washington) is also an experienced trainer and member of the 
MINT will assist her with the training. The training will take place 
virtually via Zoom in eight 2-hour time blocks either weekly or bi-
weekly dependent on the therapists’ work schedule. Training 
times will take place outside of patient treatment times.  
• After all training is complete, each therapist in the MI training and 
coaching group will provide Dr. Ehrlich-Jones with two audio 
recordings so that she can assess the therapists for MI 
competency using the MITI 4.2.1. Based on prior research training 
of rehabilitation professionals as well as published research, basic 
competency in MI can be attained with this amount of training 
and coaching. (Miller, Yahne, et al., 2004).  
• We will ask the therapists who are trained in MI not to share any 
of the training with the untrained therapists over the course of 
the study. We will provide free MI training to the untrained 
therapists once the treatment phase of the study is complete. 
• Therapist participants in the MI group will receive $200 as 
compensation for participation in training. Those in the control 
group will be offered the MI training and $200 compensation at 
the end of the study. All payment will be administered via 
ClinCard.  
8.3 
Recruit participants – Inpatients with SCI  
• Once the MI trained PTs and OTs achieve basic MI competency, 
the experimental phase of the study will begin. The research 
assistants at both sites will approach a convenience sample of 
eligible inpatients that the PTs and OTs in the study are treating, 
for participation in the study. The research assistants will recruit 
and consent 10-11 inpatients for each of the therapists who were 
trained in MI as well as for each of the therapists who were not 
trained in MI for a total of 126 inpatients. 

 
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• The research assistants will ask the therapists when they feel 
comfortable to add another patient participant to their research 
caseload so as not to overburden the therapist with the research 
tasks. The patients will be kept blinded to whether their therapist 
has been trained in MI or not. 
8.4 
Data collection 
• Patient participants will be asked demographic questions 
following informed consent, and the research assistant will enter 
answers via REDCap (see ‘DemographicSurvey’ under ‘supporting 
documents). The research assistant will abstract available 
variables about patient demographics and SCI injury 
characteristics, such as diagnosis and injury level, from the 
medical record. The patient participant may fill out the 
demographic survey via REDCap themselves if they prefer – the 
research assistant will review the answers, confirm with medical 
records if available, and follow up with participants in-person to 
clarify as needed.  
• A research assistant will complete the Pittsburgh Rehabilitation 
Participation Scale (PRPS) for each patient participant during one 
randomly selected therapy session each week throughout the 4 
weeks the participant is enrolled in the study. These PRPS scores 
will be recorded through REDCap, averaged, and analyzed. 
• A research assistant will extract demographic data for each 
patient from the electronic medical record as well as minutes of 
therapy for each day from the electronic medical record for each 
patient participant. Demographic data extracted from the medical 
records will include: age, sex, injury level and severity, traumatic 
vs non-traumatic, injury etiology, years of education, and marital 
status, at the start of participation.  
• All therapists will audio record therapy sessions with their 
patients as many times a week as possible (at least 3 sessions). 
They will download the recordings to a secure site so that a 
weekly session can be randomly chosen to send for Motivational 
Interviewing Treatment Integrity (MITI) coding. The MITI 
provides a global rating on five concepts of motivational 
interviewing: evocation, collaboration, autonomy/support, 
direction, and empathy. The ratings are on a 5-point Likert scale 
from 1 (low) to 5 (high). An average rating of 3.5 in the five 
concepts is considered beginning proficiency. In addition, 
frequency counts of MI behaviors that are open-ended questions, 
simple and complex reflections and MI adherent behaviors are 
tallied. Summary scores of reflection to question ratio, percent 
open questions, percent complex reflections and percent MI 
adherent behavior are computed. 

 
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• A research assistant will administer the Spinal Cord Injury 
Functional Indedependence (SCI-FI) via interview within 
approximately one week of patient discharge from inpatient 
rehabilitation. A research assistant will administer the 
Participation Assessment with Recombined Tools-Objective 
(PART-O) to patient participants at 6 months post-discharge from 
inpatient rehabilitation. Scores will be recorded on a fillable PDF 
and then entered into REDCap. 
8.5 
Study Duration and Compensation 
• Enrolled therapists are expected to be in the study for the 
duration of the data collection window, approximately 1 year. 
•  Therapists will be compensated $200 via Clincard for participating 
in MI training and $5 for uploading each audio recording of their 
therapy session with enrolled patients. We expect therapist 
participants to upload 2 recordings per week per patient 
participant.  
• Patient participants will receive $25 for completion of the SCI-FI 
measure and $25 for completion of the PART-O measure.  
• All research payment will be administered via ClinCard 
 
9.0 
Research with Vulnerable Populations  
We will not recruit children, prisoners, or adults with cognitive impairments. 
 
This research does not involve any physical procedures outside of regular inpatient 
rehabilitation care, so activities are not expected to affect pregnancy. It is unlikely that 
pregnant women will be enrolled due to the low incidence of pregnant inpatients with 
SCI, but we will not exclude participants who are pregnant if they meet all other 
eligibility criteria.  
 
The research assistant conducting initial screening via medical chart review will exclude 
participants with cognitive deficits noted in the admissions records. If the presence of 
cognitive deficits is unclear based on chart review, the research team will contact the 
patient’s clinical team to ask if the person is able to provide informed consent without 
presence of a witness of proxy. The clinical team can also advise against approach if they 
determine that research participation is not in the patient’s best interest. 
 
10.0 Incomplete Disclosure or Deception: 
10.1 
Randomization and blinding  
Half of the therapists will be trained in motivational interviewing, and the other 
half will proceed with normal care. As such, therapist participants cannot be 
blinded to their group assignment. Therapists who are not assigned to the MI 
group will have the opportunity to complete the training after completion of the 
study intervention. 

 
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Group assignments will be randomized by the study investigator, but the rest of 
the research team participating in data collection will be blinded to MI 
assignments. The research assistants collecting data and observing therapy 
sessions will not be trained in MI to further prevent bias. 
 
Patient participants will be blinded to their group assignment—the therapists 
will be instructed not to disclose whether they are using MI techniques during 
therapy sessions or not. Patient participants will be told the nature of the 
intervention during the informed consent process. 
 
 
 
11.0 Consent Process:  
11.1 
Written, informed consent will be obtained for all participants in the 
study, including therapist participants (n = 6 local) and SCI participants (n = 66 
local).  
11.2 
The informed consent process will take place at Shirely Ryan AbilityLab by 
IRB-approved team members. 
11.3 
The research member obtaining consent will explain the study to 
potential participants in-person and provide a hard copy of the consent 
document for review. Participants will be encouraged to read the full consent 
document and ask any questions prior to signing. Two copies of the consent 
form will be created for each enrolled participant—the original copy will be 
stored in locked filing cabinets on the study team unit, and the second copy will 
be provided to the participant for their personal records. Consent may also be 
obtained online via REDCap if the participant prefers this process to a hard copy. 
11.4 
Any potential patient participant may refuse to participate and this will 
not impact the care that they receive at SRAlab. Similarly, therapists’ 
participation in this research study is entirely voluntary and unrelated to their 
responsibilities as an employee of SRAlab. They will be neither rewarded nor 
penalized for their activities related to the research study.  Also, these activities 
should not impact their responsibility to perform their duties as an SRAlab-
employed therapist. Participants can also withdraw at any time by verbally 
stating that they do not wish to participate anymore.   
 
 
12.0 Waiver of Participant Signature on Consent Form: 
N/A 
 
 
13.0 Waivers and Alterations of Consent Information: 
N/A 
 

 
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14.0 Financial Compensation: 
Patient participants for the randomized controlled trial will receive $25 for completion 
of the SCI-FI measure and $25 for completion of the PART-O measure. Therapists will be 
compensated $200 for participating in MI training and $5 for uploading each audio 
recording of their therapy session with enrolled patients. We expect therapist 
participants to upload 2 recordings per week per patient participant. 
 All research payment will be administered via ClinCard. 
 
15.0 Audio/Video Recording/Photography 
 
Therapy sessions will be audio recorded 2 times per week on mobile audio recording 
devices. The research team led by Dr. Ehrlich-Jones will provide the therapist 
participants with the devices after they are enrolled in the study. The recordings will be 
the length of the therapist’s typical session, approximately one hour but up to two 
hours. The therapists will download the audio recordings to a secure file (Shirley Ryan 
AbilityLabMicrosoft Teams secure network). Then Dr. Ehrlich-Jones and Dr. Bombardier 
will listen to a sample of the audio recordings and rate the therapists’ competency in MI 
using the Motivational Interviewing Treatment Integrity skill coding system during the 
baseline and MI competency phase. 
 
Audio recordings will be stored separately from participant identifiers and will be 
labeled with Subject ID #’s rather than names. Audio recordings will be uploaded to 
Shirley Ryan AbilityLab OneDrive with limited permissions to maintain privacy of 
therapists and patients. 
 
Participants will be informed of audio recordings during the informed consent process 
and throughout their study participation period. Audio recordings will be deleted after 
completion of the data analysis period. 
 
During the randomized control trial phase, one random recording per week per patient 
participant will be shared with the Motivational Interviewing Treatment Integrity coding 
lab who will rate the motivational interviewing skills of the therapists by listening to 20 
minutes of the recording and rating the session using the MITI 4.2.1 rating scale. These 
scores will be used to provide feedback to the therapists on their MI skills and to guide 
coaching sessions of the therapists for their MI skills. Coaching sessions of the therapists 
will take place individually approximately monthly or more often as needed based on 
the MITI scores. 
 
 
16.0 Potential Benefits of this Research:  
16.1 
Therapist participants will be trained in motivational interviewing, an 
evidence-based skill that requires at least 16 hours of training by a designated 
instructor. Therapists who are not randomly assigned to the MI group during the 

 
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study period will have the opportunity to be trained in MI after completion of 
the study period. CEU credits will be offered upon completion of the MI 
workshop. 
16.2 
SCI patient participants may experience increased participation in 
physical/occupational therapy, improved treatment satisfaction, and improved 
therapy outcomes including self-care and mobility. 
 
17.0 Potential Risks to Participants: 
There is no physical risk associated with participation in this study, either as a therapist 
or patient participant.  
 
It is possible that therapists may lose their recorders with audio still on the device that 
may have identifying information. Therapists will have a place to lock recorders when 
not in use and will be asked not to use patient’s full name in recordings to prevent 
against a breach in confidentiality. 
 
18.0 Provisions to Protect Participant Privacy and Data Confidentiality: 
18.1 
Participant Privacy 
All recruitment, informed consent, assessments, and intervention sessions will 
take place in as private a setting as possible, away from public waiting areas. 
Therapists will be instructed not to use the patient participant’s full name on 
audio recordings of therapy sessions. Participants will be assigned unique 
identifiers (i.e. subject ID #) that will be used for data collection and storage. 
Participant identities will be crosslinked on a password-protected Excel file on 
the secure SRAlab network. During both the initial assessment and all follow-up 
assessments, participants will have the option to skip any questions they do not 
wish to answer. 
 
18.2 
Confidentiality of data 
All paper forms are kept in locked file cabinets. Digital data files, tracking logs, 
etc. are kept in encrypted, password-protected files on a server at the Shirley 
Ryan AbilityLab with access restricted to investigators and their staff through 
password-protected computers. Access to the Shirley Ryan AbilityLab’s server 
using off-site computers requires a verification process, which involves a Duo 
Mobile logon utility and remote network approval. Survey data will be collected 
and stored on SRAlab’s REDCap, which requires authenticated access that will be 
limited to members of the study team. 
 
Audio recordings will be uploaded and kept on Shirley Ryan AbilityLab OneDrive, 
a secure online server. Audio will not be associated with direct participant 
identifiers and will be identified using Subject ID #’s. A random subset of audio 

 
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recordings will be assessed for MI quality throughout the study, and the audio 
files will be destroyed after completion of the study period. 
 
The data will have restricted access, unless required by law, to only the study 
investigators, members of the investigators’ staff, representatives of the 
sponsor, the Northwestern University Institutional Review Board, and 
representatives from relevant medical oversight committees, and these persons 
are required to maintain confidentiality regarding subjects’ identities. 
 
 
19.0 Data Monitoring Plan to Ensure the Safety of Participants: 
This is a minimal risk clinical trial. There are no invasive interventions or sensitive 
questions involved in data collection that may result in physical or emotional harm to 
any participants.  
 
20.0 Long-term Data and Specimen Storage and Sharing:  
N/A 
 
21.0 Qualifications of Research Team to Conduct the Research: 
The Principal Investigator, Linda Ehrlich-Jones, PhD, RN, is a Clinical Research Scientist at 
Shirley Ryan AbilityLab’s Center for Rehabilitation Outcomes Research and a Research 
Associate Professor in the Department of Physical Medicine and Rehabilitation at NU’s 
Feinberg School of Medicine. She received her BSN from Rush University, her MSN from 
Loyola University of Chicago, and her PhD in Nursing Sciences at the University of Illinois 
at Chicago. Her research interests include development and implementation of 
behavioral interventions to improve the QOL of patients with chronic illnesses. 
 
Dr. Ehrlich-Jones, with research staff in the Center for Rehabilitation Outcomes 
Research, previously led a pilot randomized controlled trial of MI training for PTs and 
OTs to improve patient participation during SCI rehabilitation. The study was a single 
site randomized controlled study in which seven therapists were randomized to a MI 
training condition and seven were randomized to a no training control condition. After 
PTs and OTs were trained, the study enrolled and followed 62 patients undergoing 
inpatient rehabilitation for SCI/D. The main outcome of the study was independently 
rated patient participation in therapy sessions using the PRPS. The results of the study 
were promising. Analyses revealed a significant group effect (patients treated by MI 
trained therapists scored significantly higher on the PRPS (M = 4.26, SD = 0.91) 
compared to controls (M = 3.79, SD = 1.15) after controlling for sex, age, and trauma 
type. The Cohen’s d was 0.56, which is a medium effect. Analyses also showed a group x 
time effect based on adjusted and unadjusted models (adjusted odds ratio = 0.35, p< 
.01). MI training had a larger effect relative to controls during the first 1-2 weeks while 

 
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PRPS scores converged by week 4. There was a significant time effect with PRPS scores 
improving over time, particularly in the control group (adjusted odds ratio = 2.36, p < 
.01). 
 
Motivational interviewing is an evidence-based approach to behavior change counseling 
demonstrated to be effective in multiple meta-analyses. Dr. Ehrlich-Jones is an expert in 
motivational interviewing and has used it successfully in previous physical activity and 
behavior change trials. Dr. Ehrlich-Jones is an experienced trainer and a member of the 
international MI Network of Trainers (MINT). Dr Bombardier, also an experienced 
trainer and member of the MINT, will assist her with the training. Fidelity to the 
treatment protocol will be assured through education, specific training in protocol 
related procedures and practicing and troubleshooting the procedures in role-plays with 
staff in the intervention group. During the trial, Dr. Ehrlich-Jones will assure fidelity 
through completion of session content and via review of audiotaped sessions for MI 
skill. 
 
After all training is complete, each therapist in the MI training and coaching group will 
provide Dr. Ehrlich-Jones with two audio recordings so that she and Dr. Bombardier can 
assess the therapists for MI competency using the MITI 4.2.1. Based on prior research 
training of rehabilitation professionals as well as published research, basic competency 
in MI can be attained with this amount of training and coaching. 
 
All research team members will complete CITI training, and receive training on the 
informed consent process, and data collection, as appropriate to their role in the study.