Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
Phase: NA
Conditions: Rheumatic Diseases
Sponsor: University of Michigan

PROMIS Integration Phase II (HUM00149448) 
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Patient-Reported Outcomes Measurement Information System (PROMIS) Integration into 
Rheumatology Clinical Practice 
NCT05026853 
16 July 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROMIS Integration Phase II (HUM00149448) 
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Patient-Reported Outcomes Measurement Information System (PROMIS) Integration into 
Rheumatology Clinical Practice 
Pilot Trial 
1.0. Background 
Chronic medical conditions, such as rheumatic diseases (RD), have a detrimental effect on self-reported 
physical, mental, and social health, i.e., health-related quality of life (HRQOL) [1, 2]. RDs are diverse with 
variable impact on HRQOL, can fluctuate over time, and may mirror disease flares [3-5]. A patient-
reported outcome (PRO) is any report of the status of a patient’s health condition that comes directly 
from the patient, without interpretation of the patient’s response by a clinician or anyone else [6]. PROs 
can supplement clinical decision making by aiding assessment and management of these conditions. 
There is increased enthusiasm within the rheumatology research community to integrate PRO measures 
with clinical assessments [7-9]. 
The National Institutes of Health Patient-Reported Outcomes Measurement Information System 
(PROMIS®) Roadmap initiative (available at http://www.nihpromisorg) is a cooperative research 
program designed to develop, evaluate, and standardize item banks to measure PROs across patients 
with varying medical conditions and in a cross section of the US population [10]. PROMIS ® aims to use 
item response theory (IRT) to develop reliable and valid item banks that can be administered as short 
forms and computerized adaptive tests (CAT) [11, 12]. As it improves measurement precision, it lessens 
burden on the patient. PROMIS short forms are available for incorporation in the electronic medical 
records [13]. 
The overarching aim of our project is to lay the groundwork for a well powered randomized controlled 
trial to assess the impact of incorporating PROs – specifically PROMIS questionnaires – at the point of 
care in clinical rheumatology practice. This IRB application is for a pilot study to assess the feasibility of a 
future randomized controlled trial (RCT) of strategies to promote review and discussion of PROs during 
rheumatology consultations. The current pilot trial will yield important preliminary results to help us 
design a future RCT, including assessment of the following: 
• 
Recruitment and retention 
• 
Data collection procedures 
• 
Required resources and management capacity 
• 
Intervention acceptability and feasibility 
• 
Expected intervention effect and variability  
• 
Provide data to assess sample size for definitive trial  
We will also qualitatively assess health care provider (HCP) and patient perspectives on the barriers and 
facilitators of integrating PRO use into rheumatology care 
 

PROMIS Integration Phase II (HUM00149448) 
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2.0. Preliminary Work 
There are a number of requirements of integrating PRO assessment into a clinical practice to make it 
feasible and easily acceptable amongst providers – (a) PRO data should be collected completely and 
accurately with little effort, (b) the scoring of the data should be automated and happen in real time 
during the clinic visit, (c) the PRO data should be longitudinally stored in patient’s electronic medical 
record and should be easily retrievable to allow monitoring, and (d) the scores should be represented in 
a format that is easy to understand for both the provider and patient [14-16]. 
We conducted a multi-phase study at MM titled Patient Reported Outcomes Measurement Information 
System (PROMIS) in Rheumatology - HUM00076269. In this study, we iteratively collected data to 1) 
identify the PROMIS health domains most relevant to the care of patients with RDs; 2) identify clinically 
meaningful cut-points for PROMIS domains with input from patients and HCPs using real patient data 
collected at MM, and 3) incorporate PROMIS domains in the MM EMR. 
Completed Preliminary Work Phase 1: Consensus from rheumatology care providers 
We conducted focus group discussions with practicing rheumatologists at MM to identify PROMIS 
domains that are clinically relevant and actionable at the point of care. They identified four domains—
physical function, pain interference, sleep disturbance, and depression—as important in patients with 
rheumatic diseases and actionable in clinical practice [7]. There was also consensus among HCPs to 
incorporate PROMIS domains in the EMR along with guidance where appropriate action needs 
consideration. 
Completed Preliminary Work Phase 2: Identify clinically meaningful cut-points for chosen domains 
Initially, data on T-scores across different domains - physical function, pain interference, sleep 
disturbance, and depression – were collected in a convenience sample of patients with RDs at MM. 
Subjects were enrolled, and data was collected using the Assessment Center® (a free, online data 
collection tool that enables researchers to create study-specific websites for capturing PROMIS). The 
scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US 
general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the 
concept being measured (except physical function where a lower T-score indicates increased 
impairment). The team adapted the bookmark standard-setting procedure for creating clinical vignettes 
at different cut-points. This method is routinely used in educational and psychological testing and was 
recently used to develop vignettes in multiple sclerosis, juvenile inflammatory arthritis, and in oncology 
settings [17-19]. 
Nine patients and 10 HCPs participated in a 2-day expert panel meeting at MM. Eight of the nine 
patients were women. There was large variability in patients classified as having severe impairment in 
physical function (24% by patients and 2% by HCPs). 
 
 

PROMIS Integration Phase II (HUM00149448) 
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Table 1: Clinically Meaningful Scores for Different Severity of Physical Function 
 
Table 1 shows cut points reached separately by patients and HCPs for the physical function domain. In 
the patient classification, across physical function domains, the categories tended to have a T-score 
distribution that was within 0.5-1 SD of HCPs, except for moderate and severe problems where the 
difference was 1 SD. Based on these, a majority of the patients [75-96%] would be classified as having 
none to mild to moderate problems with physical function. 
Completed Preliminary Work Phase 3: Incorporate PROMIS short forms in MM EMR 
The PROMIS item banks for physical function, pain intensity, and sleep disturbance have now been 
integrated into MiChart (EPIC EMR at MM). The PROMIS data is collected in selected MM rheumatology 
clinic locations and by selected HCPs as part of standard of care. The PROMIS questionnaires are 
completed by patients either via online portal or on tablet at check-in before the clinic appointment 
with the HCP). Currently, two rheumatology clinic locations are equipped with portable tablets for 
collecting PROMIS questionnaire data. Rheumatology HCPs currently participate in this set-up where in, 
all their patients are given these tablets to complete the questionnaire while in the waiting room. The 
scores from these PROMIS questionnaires are available for display in two formats (Figures 1-2) on 
MiChart (electronic medical record used at MM). The box labeled ‘PROMIS score interpretation’ denotes 
the interpretation of the physical function score and also provides an actionable cut point (chosen as 30 
[Table 1]—the average between patients’ and HCPs’ cut-scores for severe physical limitations in Table 1) 
and recommendations. While the tabular format (Figure 1) is importable into the encounter note, the 
graphical format is not importable. HCPs can generate the graphical format with numerical scores 
(Figure 2) for discussions with the patients during the encounter. Figure 2 shows incorporation of the 
PROMIS item bank (physical function and pain intensity are shown as examples) in the MM EMR. Also, 
HCPs can track changes in PROMIS scores over time (red arrow). The pre-visit PROMIS questionnaires 
are administered as standard of care to patients across all MM Rheumatology clinics. 
 
 
Clinically Meaningful Scores for Different Severity of Physical Function 
Clinical vignettes 
Category 
Cut scores* 
Severity level when applied to UM cohort 
(N=233) 
Patient 
classification 
HCP classification 
Patient classification 
HCP classification 
% 
% 
No problem 
>65 
>60 
0.4 
1 
Mild problem 
45-65 
45-60 
27 
26 
Moderate problem 
35-45 
25-45 
48 
70 
Severe problem 
<35 
<25 
24 
2 
*Mean for US population is 50 with higher score is better physical function 

PROMIS Integration Phase II (HUM00149448) 
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Figure 1: Tabular display of PROMIS physical function, pain intensity, and sleep disturbance imported 
into the EMR note 
 
 
 

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Figure 2: Screenshot of PROMIS physical function, pain intensity, and sleep disturbance on MiChart 
 
2.1. Phase I (HUM00145286) 
Part A: The feasibility of administering the PROMIS questionnaire to patients using a tablet in multi-HCP 
rheumatology clinics at Michigan Medicine was assessed between July 1, 2016 and March 31, 2018 [20]. 
Of all patients seen in clinic, 87.2% completed the PROMIS® questionnaires, of which 82.4% used tablets 
at check-in, 14.1% completed at home (portal), and 3.4% were assisted on a clinic desktop computer to 
complete the questionnaire. Around 13% of patients did not complete questionnaires due to various 
reasons – lack of portal access, limited tablet availability at check-in, time constraints for MAs in a busy 
clinic, and rarely, patient refusal to complete. 
Part B: Seven rheumatology HCPs were invited to participate in a study from January 2019-January 2020 
to assess the feasibility and impact of training on use of the PROMIS scores. Participating HCPs were 
educated in a session on how to import the PROMIS scores into the encounter note. Of 5041 clinical 
encounters reviewed, patients had not completed PROMIS® questionnaires in 1072 (21%) of the 
encounters. Of the remaining 3969 encounters, PROMIS® scores were imported to the note in 2745 
encounters (69.2%). In these encounters, providers had documented their interpretation of the 
PROMIS® scores in 2261 (82.3%) notes. In feedback sessions over the course of the year, HCPs shared 
challenges they encountered with using PROs in practice. The most frequent reason for not importing 
the scores to the note was a new workflow pattern for the providers to remember during their office 
encounters. Another less common reason for not importing PRO scores into the note was the presence 
of a trainee participating in the visit and doing the initial documentation. Overall, the providers felt it 
was easy to import the scores using the dot phrase and to complete the subsequent documentation.  
 
 

PROMIS Integration Phase II (HUM00149448) 
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3.0. The Proposed Study: PROMIS Integration into Clinical Rheumatology Practice (Pilot trial) 
3.1. Specific Aims 
The goals identified for this study are centered on appraising HCP documentation and referrals as well 
as patient-provider communication. 
Aim 1: To assess the HCP documentation of PROs in the electronic medical record (EMR) as a 
result of PROMIS report card availability at the point-of-care. 
Aim 2: To determine the presence or absence of appropriate HCP referrals in the electronic 
medical record (EMR) as a result of PROMIS report card availability at point-of-care. 
Aim 3: To evaluate the patient-provider communication due to PROMIS score availability at 
point-of-care. 
 
3.2. Hypotheses 
Providing PROMIS scores to patients and HCPs at point-of-care will give both patients and HCPs an 
objective tool to track symptoms’ progression over time. Patients will be empowered to discuss 
symptoms and issues of concern with their HCPs, and can be actively involved in decisions about 
medications and other treatments. We hypothesize that, compared to not, providing PROMIS scores to 
patients and HCPs at the point-of-care will be associated with: 
1. Improved documentation of PRO scores in the EMR (primary outcome) 
2. Incorporation of the interpreted data in medical decision-making about treatments or 
referrals (secondary outcome) 
3. Improved patient-provider communication (secondary outcome) 
4. Improved PROMIS symptoms (secondary outcome) 
5. Improvements in health outcomes as measured by PROs (exploratory) 
6. Improved patient satisfaction with treatment (exploratory outcome) 
7. Improved patient satisfaction with care (exploratory outcome) 
A comprehensive integration of PROs into clinical care involves not only patients, but also HCPs, and 
may be even more effective than providing PRO scores to patients alone. In addition, we will use 
qualitative research approaches to explore the effects of PRO implementation as well as patient and 
HCP expectations and doubts regarding PRO implementation. 
 
 

PROMIS Integration Phase II (HUM00149448) 
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Table 2. Primary, Secondary, and Exploratory Endpoints 
Assessment 
Description 
Timeframe 
PRIMARY ENDPOINTS 
Percent of appointments at which 
PROMIS scores are documented in 
the EMR note by the participating 
HCP 
Documentation in EMR notes will be 
categorized as either ‘yes’ or ‘no’ and 
identified through EMR data pulls. 
Each appointment 
with the HCP during 
the trial period 
SECONDARY ENDPOINTS 
Percent of appointments at which 
referrals/recommendations related 
to PROMIS scores are documented 
in the EMR note by the participating 
HCP 
Documentation in EMR notes will be 
either ‘yes’ or ‘no’ and identified through 
EMR data pulls. 
Each appointment 
with the HCP during 
the trial period 
Quality of patient-provider 
communication 
Patient-reported assessment of different 
aspects of patient-provider 
communication using the Interpersonal 
Processes of Care (IPC) Survey (29 items), 
which measures 7 subscales: hurried 
communication, elicited 
concerns/responded, explained 
results/medications, patient-centered 
decision making, compassion, 
discrimination, and disrespectful office 
staff (score for each subscale ranges from 
1-5; a higher score indicates better IPC) 
[24].  
Up to 2 weeks after 
baseline 
appointment 
Change in score of the most 
bothersome PROMIS domain from 
baseline to 3 months 
Change in the T-score of the most 
bothersome PROMIS domain at baseline 
for sleep disturbance and physical 
function domains, and change in actual 
score on a scale 0-10 for pain intensity 
domain. 
3 months post-
baseline 
appointment 
EXPLORATORY ENDPOINTS 
Percent of participants reporting 
discussion of PROs with their 
rheumatology provider during 
appointments 
Patient report of whether or not PROs 
were discussed during appointment 
(assessed via survey). 
Up to 2 weeks after 
baseline 
appointment 

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Patient satisfaction with treatment 
Patient reported satisfaction with 
treatment, assessed with the Treatment 
Satisfaction Questionnaire for Medication 
1.4 (TSQM) [25]. (Measures 4 domains, 
including Effectiveness, Side Effects, 
Convenience, and one global scale item, 
Global Satisfaction; each domain score 
ranges from 0-100, with higher score 
indicating greater satisfaction). 
Up to 2 weeks after 
baseline 
appointment 
Patient satisfaction with care 
Patient reported satisfaction with 
rheumatology care, assessed with the 
Leeds Satisfaction with Care 
Questionnaire (score ranges from 1-5, 
with higher value indicating greater 
satisfaction) [26]. 
Up to 2 weeks after 
baseline 
appointment 
Percent of participants achieving a 
clinically meaningful improvement at 
3 months in the most bothersome 
PROMIS domain at baseline 
Percent of participants achieving a 
clinically significant improvement in the 
most bothersome PROMIS domain T-
score in sleep disturbance and physical 
function domains and actual score on 0-
10 scale for pain intensity domain from 
baseline to 3 month’s post-baseline.  
3 months post-
baseline 
appointment 
Change in PROMIS pain intensity 
between Arms 1 and 2 among 
participants for whom pain is the 
most bothersome domain at 
baseline 
Among those for whom pain is the most 
bothersome domain at baseline, we will 
compare the change in PROMIS pain 
intensity scores in Arm 2 vs. Arm 1. 
3 months post-
baseline 
appointment 
Change in PROMIS physical function 
between Arms 1 and 2 among 
participants for whom physical 
function is the most bothersome 
domain at baseline 
Among those for whom physical function 
is the most bothersome domain at 
baseline, we will compare the change in 
PROMIS physical function scores in Arm 2 
vs. Arm 1. 
3 months post-
baseline 
appointment 
Change in PROMIS sleep disturbance 
between Arms 1 and 2 among 
participants for whom physical 
function is the most bothersome 
domain at baseline 
Among those for whom sleep disturbance 
is the most bothersome domain at 
baseline, we will compare the change in 
PROMIS sleep disturbance scores in Arm 2 
vs. Arm 1. 
3 months post-
baseline 
appointment 
3.3. Study Period 

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The study intervention will be active for a period of at least 12 months or until the adequate sample size 
is recruited. 
3.4. Study Population 
The study will include participation of patients with rheumatic diseases. 
1. Patients: New and established patients seeking care at Michigan Medicine rheumatology clinics. 
a. Eligibility criteria: 
i. 
Age ≥ 18 years 
ii. 
Patients should be able to read and write English 
iii. 
Patients should have access to the MyUofMHealth patient portal 
iv. 
Patients should have access to the internet to be able to complete the PROMIS 
PRO measures and study surveys online 
b. Trial inclusion criteria:  
i. 
Patients should have completed PROMIS pain, physical function, and sleep 
disturbance measures at least one day before their baseline appointment 
ii. 
At least one of the PROMIS PRO scores should be in the concerning zone (pain 
intensity ≥ 5 (0-10), physical function ≤ 40 (on a T-score), or sleep disturbance ≥ 
60 (on a T-score)). 
2. Providers: Rheumatology HCPs, including clinicians and advanced practice providers at Michigan 
Medicine 
a. Eligibility criteria: 
i. 
Currently treating rheumatology patients 
3.5. Recruitment 
We will inform HCPs in the Division of Rheumatology about the study and what it will entail for patients 
who decide to participate. To ensure that non-participating HCPs will not be surprised by patients’ 
questions about interventions in the study, we will also inform the rheumatology HCPs about where 
they can view PROMIS scores in the EMR and about the information that will be shared with patient 
participants. 
We will approach eligible patients with upcoming appointments scheduled with an initial recruitment 
email, with follow-up contact via email, phone call, or text. Patients will be able to opt out of further 
communications regarding this study at any time. We will also approach rheumatology HCPs at 
University of Michigan clinics interested in participating.  
Interested patients and HCPs will be contacted and informed about the details of the study. All 
interested patients and HCPs will be given an informed consent. Patients will be given the choice to opt 
in to participating in the qualitative portions of the study if interested. 
3.6. Study Activities 
This study will have two components: a controlled trial to assess the impact of integrating PROs into 
clinical practice, and qualitative interviewing (optional for patients and HCP’s) to identify barriers to and 
facilitators of effective integration. This protocol is for the controlled trial. 

PROMIS Integration Phase II (HUM00149448) 
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Figure 3 (Study Flowchart) and Figure 4 (Study Schedule of Events) show how the different parts of the 
study will fit together. 
Figure 3. Study Flowchart 
 
 

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Figure 4. Study Schedule of Events 
Screening* 
Baseline/ 
enrollment** 
3 months after 
baseline 
appointment 
End of study 
For patients: 
Informed consent 
X 
Patient background survey 
X 
PROMIS questionnaires *** (pain intensity, 
physical function, and sleep disturbance) 
X 
 
X 
 
Email with PRO scores to patients in Arm 1**** 
 
X 
 
 
Post-appointment survey 
X 
3 month follow-up survey 
X 
Patient interview (Optional) 
X 
For HCPs: 
Informed consent 
X 
Email Arm 1 enrolled patient PRO score 
summaries to HCP1 
 
X 
 
 
Post-study interview 
X 
*Patients will be in the screening phase from time of consent to first reported concerning PROMIS score. 
**Patients are enrolled only after reporting a concerning PROMIS score. 
***Patients are asked to complete PROMIS questionnaires prior to visits as part of standard of care; 
only PROMIS scores from patients who opt in for screening will be reviewed for eligibility. 
****Only Arm 1 receives scores 
 
Patients will have up to 2 weeks to complete surveys/questionnaires. 

PROMIS Integration Phase II (HUM00149448) 
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3.6.1. Pre-trial Period 
Once consented to the study, patients will be asked to complete PRO questionnaires online (which 
includes PROMIS pain intensity, physical function, and sleep disturbance) that are integrated in the 
MiChart before their next rheumatology appointment (within 3 weeks prior to their scheduled 
appointment), as part of the current standard of care for UM rheumatology patients. To promote 
completion of the PRO questionnaires, we will send email and/or text reminders to all consented 
patients.  
Patients will be enrolled in the trial the first time that they report a concerning level of symptoms (pain 
intensity ≥ 5, physical function ≤ 40, or sleep disturbance ≥ 60). Enrolled patients will be randomized to 
Arm 1 or Arm 2 in 1:1 fashion. Patients who do not have concerning scores will not be enrolled and 
excluded from the trial. 
3.6.2. Controlled Trial  
3.6.2.1. Trial Study Design 
There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care (Figure 3).  
• 
Arm 1: PRO Integration into Clinical Practice Intervention Group 
• 
Arm 2: Usual Care Control Group 
3.6.2.2. Interventions 
PRO Integration into Clinical Practice Treatment Group 
For Arm 1, PRO scores will be shared with patients and HCPs via an emailed report card in order to 
facilitate discussion of the PRO scores during consultation. HCPs will document their discussion and 
recommendations/referrals using the dot phrase in MiChart (Epic EMR). 
Usual Care Control Group 
For Arm 2, patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, 
however, will be available in the EMR as usual. This arm will receive usual care.  
3.6.2.3 Stratification, Randomization, and Blinding/masking 
Patients eligible for randomization to Arm 1 or Arm 2 will be first stratified based on their concerning 
PRO domain. 
• 
If the patient has only one concerning PRO domain: 
o 
Patients will be placed into one of 3 groups: “Concerning pain”, “Concerning sleep” or 
“Concerning physical function” 
• 
If the patient has more than one concerning PRO domain: 

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o 
Patient will be asked to complete a single-item survey to rank the PRO domains in order 
of importance. 
o 
Depending on what domain patients indicate is the most concerning to them, patients 
will be placed into one of 3 groups: “Concerning pain”, “Concerning sleep”, or 
“Concerning physical function”. 
A permuted block randomization scheme stratified by most concerning PRO domain (pain, sleep, 
physical function) will be created before enrollment begins. Once a participant has completed the 
screening and evaluation for inclusion/exclusion criteria, the participant will enter the randomization 
process. Participants will be randomized to Arm 1 and Arm 2 with equal probability (1:1) in RedCap. At 
time of randomization, the investigator or study coordinator will use the randomization sheet to obtain 
the assigned randomization number and intervention assignment. In this study, participants and 
physicians will know the assigned treatment group. 
3.6.2.4. Outcome Assessment 
Health outcomes (PROMIS pain intensity, physical function and sleep disturbance) will be assessed 
before appointments and at three (3) months post appointment with an online patient-reported survey. 
Patient-provider communication, the patient’s experience with the PRO scores, and satisfaction with 
disease management will be assessed with a patient-reported survey after the appointment. 
Process of care measures (documentation and interpretation of PRO scores, clinical decisions) will be 
assessed for each appointment using data from the EMR (notes, medication changes, and referrals). We 
will utilize the Data Direct tool to assist with exporting quantitative data from the EMR, and the EMERSE 
tool to assist with reviewing textual data from the EMR (https://research.medicine.umich.edu/our-
units/data-office-clinical-translational-research/data-access/self-serve-data-tools). 
Study Measures/outcome Variables 
Table 3 below summarizes the measures and outcomes to be used to compare health outcomes and 
processes of care for the different study arms.  
Patient-provider communication will be measured using the Interpersonal Process of Care Survey (IPCS) 
with a 12-item communication subscale and an 8-item patient-centered decision making subscale [24]. It 
has been used to predict patient satisfaction [30]. 
Satisfaction with treatment will be measured using the Treatment Satisfaction Questionnaire for 
Medication (TSQM version 1.4) [25].  
Satisfaction with care will be measured using the Leeds Satisfaction with Care Questionnaire, which was 
developed for patients to assess quality of rheumatology care [26].  

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Table 3. Study Measures/outcome Variables 
Measure/variable name 
Description 
Type 
PROMIS Numeric Rating Scale v1.0 – 
Pain Intensity 1a 
Patient reported rating of average pain 
intensity over the last 7 days 
(instrument, 1 item) 
Continuous. Ranges from 0 (no 
pain) to 10 (worst pain you can 
think of) 
PROMIS Physical Function Computer 
Adaptive Test (CAT) 
Patient reported ability to do activities 
of daily living (computer adaptive test 
instrument) 
Continuous. T-score ranges from 
approximately 20 (extreme 
impairment)-80 (no impairment) 
PROMIS Sleep Disturbance CAT 
Patient reported sleep quality 
(computer adaptive test instrument) 
Continuous. T-score ranges from 
approximately 20 (no problems 
with sleep)-80 (severe problems 
with sleep) 
Interpersonal Processes of Care 
Survey  
Patient reported quality of patient-
provider communication (instrument, 
29 items) [24] 
Continuous scores for 7 domains: 
hurried communication, elicited 
concerns/responded, explained 
results/medications, patient-
centered decision making, 
compassion, discrimination, and 
disrespectful office staff. Scores 
range from 1-5 for each domain. 
Discussion of PRO scores with patient 
during the appointment 
Patient report of whether the physician 
discussed the PRO scores during the 
appointment (post-appointment survey 
question). 
Binary 
Satisfaction with rheumatology care 
Leeds Satisfaction with Care 
Questionnaire (post-appointment 
survey) [26] 
Continuous.  Score ranges from 1-
5, with higher value indicating 
greater satisfaction.  
Satisfaction with treatment 
Treatment Satisfaction Questionnaire 
for Medication 1.4 (post-appointment 
survey) [25] 
Continuous. Measures 4 domains, 
including Effectiveness, Side 
Effects, Convenience, and one 
global scale item, Global 
Satisfaction; each domain score 
ranges from 0-100, with higher 
score indicating greater 
satisfaction. 
Documentation of PRO scores in the 
EMR note 
Whether the HCP imported the PRO 
scores into the EMR note (outcome) 
Binary 

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Interpretation of PRO scores 
Whether the HCP interpreted the PRO 
scores (outcome) 
Binary 
Clinical decision 
What decision was taken at the 
appointment to address the patient’s 
issues (outcome).  
Categorical. Possible decisions 
include: medication change, 
referral to another provider, and 
no action taken. 
3.6.2.5. Qualitative Assessment of the PRO Integration Process 
We will use a combination of qualitative interviews with patients and HCPs participating in the study, 
and open-ended survey questions to identify the barriers and facilitators to integrating PROs into the 
clinical workflow, as well as the reasons these barriers and facilitators are arising, and how they may be 
addressed in the future. Using varied sources of information collected from different stakeholders 
(patients and HCPs) and at different times will allow us to develop a more objective and richer picture of 
how the PROs fit into the clinical workflow and how to facilitate increased uptake and more effective 
usage in the future.  
The RE-AIM model will [31] be used to guide investigation of specific aspects of implementation, 
including recruitment and retention of patient and HCP participants, the impact of interventions on 
study outcomes, adaptations made to the interventions during the study, factors influencing use of 
PROs during the study, intention to continue using PROs after the study, and long-term sustainability of 
the interventions and behaviors. 
3.6.2.5.1. Qualitative Interviews with Patients and HCPs 
We will conduct semi-structured interviews with up to 10 patients from Arm 1 to understand patients’ 
perspectives on how the PRO information was discussed and used during their appointments, and how 
PROs fit into their overall care. Interviews will take place after completion of the three (3) month 
PROMIS questionnaire. During interviews, patients will be asked to discuss their rheumatic disease 
status, their needs and expectations for the appointment, how the PRO information was discussed or 
used during the appointment, what decisions were made to address their needs, and their satisfaction 
with the appointment.  
We will also conduct semi-structured interviews with up to 5 HCPs who have patients in Arm 1. During 
the interview, HCPs will be asked to discuss their experience using PROs in clinical practice, what went 
well/not well, why, and what changes could help facilitate integration of PROs into practice. HCP 
interviews will take place toward the end of the study. 
Interviews for both patients and HCPs will be conducted via telephone or Zoom Health, and will be 
recorded and transcribed. Transcripts will be deidentified before analysis to protect interviewees’ 
privacy. 
 
 

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3.6.2.5.2. Open-ended Survey Questions 
Open-ended survey questions will be included in the post-appointment survey for patients and the 3-
month follow-up surveys for patients. 
These questions will allow patients and to communicate anything they think is relevant about their 
experience which cannot be otherwise conveyed through the remaining survey questions.  
3.7. Study Analyses 
Our data sources for this study will be electronic medical records (EMR), survey responses collected 
through REDCap, and qualitative data collected through semi-structured interviews. We will utilize the 
Data Direct tool to assist with exporting quantitative data from the EMR, and the EMERSE tool to assist 
with reviewing textual data from the EMR (https://research.medicine.umich.edu/our-units/data-office-
clinical-translational-research/data-access/self-serve-data-tools).  
3.7.1. Statistical Analysis 
Sample Size Calculation:  
Up to 300 patients will be randomized. Based on our preliminary review, we believe that 70% of the 
consented patients will meet the inclusion criteria with concerning zone. We expect to screen up to 
1,000 patients to meet the randomization goals. 
The current study is a convenience sample size since we don’t have a priori data to calculate sample size. 
We believe that approximately 300 patients randomized in 1:1 fashion will give robust point estimates 
to design a Phase 3 trial. 
Planned Analyses: 
Characteristics of patients will be summarized descriptively, by treatment group and overall, using 
numerical and graphical methods. We will compare Intervention groups on baseline characteristics, 
including demographics and PRO measurements, using descriptive statistics. Fisher’s exact test and 
ANOVA/Kruskal-Wallis will be used to comparing the three treatment arms.  
For categorical outcomes, count and proportion and 95% confidence interval will be reported. For 
continuous outcomes, mean, standard deviation, median, and inter-quartile range will be reported. P 
value < 0.05 will be considered statistically significant. 
T-scores for the physical function, sleep disturbance and actual score on 0-10 scale for pain intensityat 
baseline and 3 month follow-up will be calculated based on the guidelines provided by 
http://www.healthmeasures.net/media/kunena/attachments/257/PROMIS29_Scoring_08082018.pdf. 
The planned statistical analyses will enable us to assess the feasibility of the study and assess the 
potential effects of the interventions. The information gained from this project will help us design the 

PROMIS Integration Phase II (HUM00149448) 
18 
 
next trial to formally test the effect of PRO integration on communication, decision making, and health 
outcomes. 
3.7.2. Analysis of Qualitative Data 
The qualitative data gathered will include transcriptions of interviews and free text comments from 
post-appointment surveys. Analysts will code the deidentified data using CAQDAS software such as 
NVIVO. The analysts will perform inter-rater reliability checks periodically to ensure coding is reconciled. 
Coded concepts will be organized into themes describing barriers and facilitators to PRO integration into 
clinical practice, and ways to facilitate more effective PRO integration and uptake in the future.  

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19 
 
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