De-implementing Inhaled Steroids to Improve Care and Safety in COPD (DISCUSS COPD) (QUE 15-471)
Phase: NA
Conditions: Treatment of Chronic Obstructive Pulmonary Disease
Sponsor: VA Office of Research and Development

DISCuS COPD PROTOCOL 
 
12/1/2021 
 
 
 
 
 
De-implementing Inhaled Steroids to improve Care and Safety in 
Chronic Obstructive Pulmonary Disease (DISCuS COPD): A randomized 
control trial 
 
Protocol 
12/1/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents  
1.   
Abbreviations 
 
……………………………………………………………………4 
2.   
Funding/Regulatory 
...………………………………………………………………….6 
3.   
Study Investigators  
……….…………………………………………………………...6 
4.   
Background/Rationale  
......………………………………………………………………..7 
5.   
Specific Aims 
 
..…………………………………………………………………..7 
6.   
Setting  
 
 
..…………………………………………………………………..8 
7.   
Design  
 
 
..…………………………………………………………………..8 
8.   
Eligibility, Recruitment and Consent  
..…………………………………………………..9 
8.1  
Eligibility 
 
...………………………………………………………………….9 
8.2  
Recruitment and Consent  
………………………………...………………...10 
8.3 
Randomization 
……………………………………..……………………………12 
9.   
Index Clinic Date 
 
…………………………………………………………………..14 
10.    
Intervention Arm 
 
…………………………………………………………………..14 
10.1 
Non-intensive unlearning  
…………………………………………………..14 
10.2 
Recommendations for discontinuation of inappropriate ICS …………………..14 
10.3  Titration to wean off ICS 
 
…………………………………………………..15 
11.   
Usual Care Arm 
 
…………………………………………………………………..16 
12.   
Blinding 
 
 
…………………………………………………………………..16 
13.   
Outcomes 
 
 
…………………………………………………………………..16 
13.1 
Primary Outcome Measure 
…………………………………………………..16 
13.2 
Secondary Outcome Measures 
…………………………………………………..16 
14.   
Additional Assessments 
…………………………………………………………………..19 
14.1  Baseline Assessments 
 
…………………………………………………..19 
14.2 
Qualitative Interviews 
 
…………………………………………………..20 
14.3 
Quantitative Surveys 
 
…………………………………………………..20 
15.   
Analytic Approach  
…………………………………………………………………..21 
15.1.  Baseline Analysis and Descriptive Statistics 
…………………………………..21 
15.2  Sensitivity Analyses 
 
…………………………………………………..22 
15.3 
Missing Data Analyses 
 
…………………………………………………..22 
15.4 
Secondary Analyses 
 
…………………………………………………..22 
15.5 
Sample Size and Power 
 
…………………………………………………..23 
15.6 
Mixed-methods Analysis  
……………………………………………….….24 

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16.   
Protection of Human Subjects 
 
…………………………………………………24 
16.1  Quality Improvement Designation  
 
…………………………………24 
16.2 
Data and Safety Monitoring 
…………………………………………………24 
16.3 
Recommendation Fidelity  
…………………………………………………24 
16.4 
Data Management and Confidentiality  
…………………………………25 
17.   
References 
 
 
…………………………………………………………………25 
18.   
Summary of Changes from Original Protocol 
 
…………………………………27 
19.   
Appendices  
 
…………………………………………………………………30 
Appendix 1: Medications …………………………………………………………………30 
Appendix 2: Chart Abstraction Form 
…………………………………………………32 
Appendix 3: E-consult note template 
…………………………………………………34 
Appendix 4: Baseline Provider Interview Guide 
…………………………………36 
Appendix 5: “Exposed” Provider Interview Guide 
…………………………………37 
Appendix 6: “Maintenance” Provider Interview Guide 
…………………………39 
Appendix 7: “Exposed” Patient Interview Guide 
…………………………………41 
Appendix 8: Baseline: PCP Survey 
…………………………………………………42 
Appendix 9: Follow-up: PCP Survey 
…………………………………………………46 
Appendix 10: 2nd Follow-up PCP Survey  
 
…………………………………49 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Abbreviations 
AFO 
Airflow Obstruction 
CBOC 
Community-Based Outpatient Clinics 
CDW 
Corporate Data Warehouse 
COPD 
Chronic Obstructive Pulmonary Disease 
DISCuS COPD  
De-implementing Inhaled Steroids to improve Care and 
Safety in Chronic Obstructive Pulmonary Disease 
E-consult 
Electronic Consult 
ED 
Emergency Department 
EHR 
Electronic Health Record 
FEV1 
Forced Expiratory Volume in 1 Second 
FVC 
Forced Vital Capacity 
GINA 
Global Initiative for Asthma 
GEE 
Generalized Estimating Equations 
GLMM 
Generalized Linear Mixed Model 
GOLD 
Global Initiative for Chronic Obstructive Lung Disease 
ICD-9 
International Classification of Diseases, Ninth Revision 
ICD-10 
International Classification of Diseases, Tenth Revision 
ICS 
Inhaled Corticosteroids 
LABA 
Long-acting Beta Agonist 
PACT 
Patient-aligned Care Team 
PBM 
Pharmacy Benefits Management 
PCP 
Primary Care Provider 
QI 
Quality Improvement 
QUERI 
Quality Enhancement Research Initiative 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation, 
Maintenance Framework 
SVC  
 
 
 
 
Slow Vital Capacity 

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VA 
 
 
 
 
 
Department of Veterans Affairs 
VC 
 
 
 
 
 
Vital Capacity 
VHA  
 
 
 
 
Veterans Health Administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. Funding/Regulatory 
▪ Funding: Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) 
QUE 15-471 
▪ Designated by the VHA Office of Specialty Care as a non-research operations activity (7/30/2015) 
▪ Trial registration: ClinicalTrials.gov Identifier: NCT02896257 
 
3. Study Investigators 
VA Puget Sound Health Care System: 
Principal Investigator 
David H. Au, MD, MS 
Director, Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services 
Research & Development, VA Puget Sound HCS  
Professor, University of Washington School of Medicine 
 
Co-Investigators: 
Laura C. Feemster, MD, MS 
Core Investigator, Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services 
Research & Development, VA Puget Sound HCS  
Associate Professor, University of Washington School of Medicine 
 
Christian D. Helfrich, PhD, MPH 
Core Investigator, Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services 
Research & Development, VA Puget Sound HCS 
Research Associate Professor, University of Washington School of Public Health 
 
George Sayre, PsyD MA 
Core Investigator, Center of Innovation for Veteran-Centered and Value-Driven Care, Health Services 
Research & Development, VA Puget Sound HCS 
Clinical Assistant Professor, University of Washington School of Public Health 
 
Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA): 
Co-Investigators: 
Renda S. Wiener, MD, MPH  
Co-Associate Director, Center of Healthcare Organization and Implementation Research, Bedford VA 
Associate Professor, Boston University School of Medicine 
 
Seppo T. Rinne, MD, PhD 
Investigator, Center of Healthcare Organization and Implementation Research, Bedford VA 
Assistant Professor, Boston University School of Medicine 

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4. Background/Rationale 
Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnosis 
among Veterans. 1,2 Approximately half of those who carry a diagnosis of COPD are prescribed 
inhaled corticosteroids (ICS) despite having no role among those patients without fixed airflow 
obstruction (AFO) and a limited role among those who do.3  Guidelines explicitly state that ICS 
should be limited to patients with frequent exacerbations despite long-acting bronchodilators.4  Even 
this benefit comes at a cost, as ICS use has been shown in multiple randomized control trials to 
increase rates of pneumonia.5-7 After prolonged exposure, ICS is also associated with higher fracture 
risk,8 cataracts9,10 and poor diabetes control.11 Among patients without disease or with low risk of 
exacerbation, ICS have no demonstrated efficacy, but retain the risk of harm.  For this reason, 
evidence-based guidelines specifically recommend against their use.4 We propose to improve the 
delivery and safety of care by de-implementing the ineffective use of ICS among Veterans with a 
diagnosis of COPD who otherwise lack a clinical indication for the medication.  Framed in the 
context of the de-implementation QUERI, we will compare a substitution approach using a 
proactive patient-tailored electronic consult (E-consult) to usual care. Primary care providers 
assigned to either treatment arm will also receive a single-session academic detailing intervention, 
which represents a non-intensive unlearning approach.  
In collaboration with patient aligned care teams (PACT), we propose to challenge the current referral-
dependent provision of specialty care by having pulmonologists assume responsibility for 
supporting a population of patients with COPD. Understanding how to deploy specialists to improve 
access, timeliness, and quality of care, using a PACT-Veteran-centric approach, is a high priority for 
VA and the Office of Specialty Care Services, just as decreasing ineffective medication use is a high 
priority for the Pharmacy Benefits Management (PBM) Services.  Using a parallel cluster randomized 
trial design grounded in the Chronic Care Model and evaluated using the RE-AIM framework,12-15 we 
propose to test an intervention that retools concepts of specialty care access and existing clinical 
infrastructure to align with VA operational goals to improve safety and value for Veterans with 
COPD. 
 
5. Specific Aims  
 
Primary Aim: 
Among patients with a clinical diagnosis of COPD who have had spirometry and are receiving 
inappropriate inhaled corticosteroids:  
1. Evaluate a multi-faceted intervention that seeks to decrease inappropriate use of ICS. The 
intervention uses a proactive E-consult approach to leverage the VA’s integrated healthcare and 
informatics system to facilitate specialist support of primary care teams to de-implement ICS 
among patients with no clinical indication for the medication. Our primary outcome is the 
percentage of patients that remain off inhaled corticosteroids at six months (index date + 180 
days).  

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Secondary Aims:  
1. Assess whether the intervention is associated with: 
▪ Unchanged rates of COPD exacerbation at 6 months [defined as (index date + 1 day) to (index 
date + 180 days)] 
▪ Decreased rate of pneumonia at 6 months [defined as (index date + 1 day) to (index date + 180 
days)] 
▪ Decreased mortality at 6 months. [defined as (index date + 1 day) to (index date + 180 days)] 
▪ Acceptance of substituted recommendations (Intervention group only). 
▪ Number of patients for whom recommendations were made. 
▪ Number of patients recommended to stop inhaled corticosteroids.  
▪ Proportion of recommendations accepted by primary care providers within 6 months 
(index date + 180 days). 
▪ Percentage of patients where recommendations to stop inhaled corticosteroids are accepted but 
restarted by 6 months [defined as (index date + 1 day) to (index date + 180 days)] 
2. Assess the effect of the intervention on primary care provider (PCP) burnout, professional efficacy, 
and perceptions of evidence for the use of ICS.  
3. Assess acceptability of the intervention to PCPs and Veterans.  
4. Assess implementation costs of the intervention. 
 
6. Setting 
 
The study will be conducted within primary care clinics located at the VA Puget Sound Health Care 
System (Seattle, WA) and the Edith Nourse Memorial VA Medical Center (Bedford, MA). Sites of 
primary care include clinics located at both academic medical centers and their associated 
community-based outpatient clinics (CBOCs). 
 
7. Design 
We will utilize a parallel cluster randomized trial design, with initial randomization occurring at the 
level of the primary care patient-aligned care team (PACT) team. Following study start, the unit of 
randomization will be the PCP, as described in Section 8.3. Data will be collected at the individual 
patient level. 
 

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8. Eligibility, Recruitment, and Consent 
8.1. Eligibility 
Primary Care PACT team: 
Eligible primary care PACT teams will include all PACT teams located within Internal Medicine 
Clinics, Geriatric Clinics, Home-based Primary Care, Women’s Health Clinics, and Spinal Cord Injury 
Clinics located at VA Puget Sound Health Care System and the Edith Nourse Memorial VA Medical 
Center. 
Primary Care Providers: 
All independently licensed providers associated with a Primary Care PACT team at each site will be 
eligible to participate in the study, including attending physicians, nurse practitioners and physician 
assistants. Physician trainees (including residents and fellows) will be eligible to participate in the 
study, but will not be randomized, as they practice under one or more supervising physician 
(attending) already eligible for randomization.  
Patients: 
We will utilize information from the Corporate Data Warehouse (CDW) to identify patients with a 
clinical diagnosis of COPD followed in primary care clinics at VA Puget Sound Healthcare System or 
Edith Nourse Memorial VA Medical Center who are prescribed ICS without a guideline-supported 
indication.  
Eligible patients will meet all of the following inclusion criteria at the time of the CDW data query: 
1. Veteran receiving primary care at the VA Puget Sound Healthcare System or Edith Nourse 
Memorial  VA Medical Center. 
2. Prescribed an inhaled corticosteroid within the past 180 days (Appendix 1) 
3. Performed spirometry within the past 5 years. 
4. At least one outpatient or inpatient ICD-9 or ICD-10 diagnostic code for COPD within the past 
2 years  
i. 
ICD-9 codes: 491.XX, 492.XX, 496.XX, excluding 493.X 
ii. 
ICD-10 codes: J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, J43.9, J44.0, J44.1, J44.9 
 
We will exclude patients meeting ANY of the following criteria at the time of the CDW data query: 
1. Severe fixed airflow obstruction as defined by a post-bronchodilator FEV1/VC <0.70 and FEV1 
<30% predicted.4 If no post-bronchodilator spirometry values are available, then pre-
bronchodilator values will be substituted. 
2. Severe or frequent exacerbations in the past year, defined as:4  
a. 1 or more inpatient COPD exacerbation defined using ICD-9 or ICD-10 diagnostic 
codes.  
i. Primary discharge code of COPD (ICD-9 codes: 491.XX, 492.XX, 496.XX, or 493.2; 
ICD-10 codes: J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, J43.9, J44.0, J44.1, 
J44.9) 
 
OR 
 

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ii. Primary discharge code of acute respiratory failure  (ICD-9: 518.81, 518.82, 
518.84; ICD-10: J80., J96.00, J96.01, J96.02, J96.20, J96.21, J96.22, J96.90, J96.91, 
J96.92)  
AND  
Secondary discharge diagnosis code of COPD (ICD-9: 491.XX, 492.XX, 496.XX, or 
493.2; ICD-10: J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, J43.9, J44.0, J44.1, 
J44.9) 
b. 2 or more outpatient COPD exacerbations, defined as: 
i. A clinic visit, ED visit or Urgent Care visit with an ICD-9 or ICD-10 code of 
COPD and an outpatient prescription for an oral corticosteroid (Appendix 1) 
within 2 days (before or after encounter) 
 
                      Or 
 
ii. A clinic visit, ED visit or Urgent Care visit with an ICD-9 or ICD-10 code of 
COPD and no prescription for oral corticosteroids but an outpatient prescription 
for an oral respiratory antibiotic (Appendix 1) within 2 days (before or after 
encounter) and no ICD-9 or ICD-10 code indicating the presence of:  
1. urinary tract infection (ICD-9: 590.X, 595.X, 597.X; ICD-10:  A56.01, N10., 
N11.X, N12., N13.6, N15.1, N15.9, N16., N28.84, N28.85, N28.86, N30.0, 
N30.1, N30.2, N30.3, N30.4, N30.8, N30.9, N34.X) 
2. skin and soft tissue infection: (ICD-9: 680.X, 681.X, 682.X, 683.X, 684, 
685.X, 686.X; ICD-10:  B78.1, E83.2, K12.2, L01.0X, L01.1, L02.XXX, 
L03.XXX, L04.X, L05.0X, L05.9X, L08.0, L08.8X, L08.9, L88., L92.8, L98.0, 
L98.3) 
3. Acute sinusitis (ICD-9: 461.X, 473.X; ICD-10: J01.XX, J32.X) 
4. Pneumonia (ICD-9: 481.X, 482.X, 483.X, 484.X, 485.X, 486; ICD-10: ICD-10: 
A22.1, A37.01, A37.11, A37.81, A37.91, A48.1, B25.0, B44.0, B77.81, J13., 
J14., J15.XXX, J16.0, J16.8, J17., J18.0, J18.1, J18.8, J18.9) 
 
3. Presence of likely asthma, defined as: 
a. ICD-9 or ICD-10 diagnostic code for asthma (ICD-9: 493.X; ICD-10: J45.20, J45.21, J45.22, 
J45.30, J45.31, J45.32, J45.40, J45.41, J45.42, J45.50, J45.51, J45.52, J45.901, J45.902, J45.909, 
J45.990, J45.991, J45.998) 
                       Or 
b. Post-bronchodilator increase in FEV1 >12% and 375 ml from pre-bronchodilator values 
(based on GINA guidelines that indicate a high probability of comorbid asthma)16 
 
4. Deceased as of the query date 
 
8.2. Recruitment and Consent 
Primary Care Providers:  

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Intervention: This project was designated as a quality improvement (QI) initiative by the VA Office of 
Specialty Care Services. We will attempt to reach all PCPs at the VA Puget Sound Health Care System 
and Edith Nourse Memorial VA Medical Center. PCPs will not be provided an opportunity to opt-out 
of this QI initiative, though they can choose to participate or not in the survey and qualitative 
portions of the study.  
▪ Prior to study start, we will query CDW to create a list of all primary care PACT teams and 
eligible providers, this list will be updated on a regular basis to identify PCPs that have left as 
well as newly eligible PCPs.  
▪ All eligible PCPs will be included in the intervention study. 
Quantitative Surveys: We will invite all eligible PCPs to participate in baseline and follow-up surveys 
that will provide information regarding their perception of inhaled corticosteroid use, efficacy and 
adverse effects. 
▪ Approximately 1 week prior to survey recruitment start, the primary care directors at each site 
will send an introductory email to all eligible PCPs that includes an explanation of the project 
and purpose of the anticipated survey. 
▪ PCPS will be recruited via email invitation 1-2 months prior to their planned entry into the 
trial (baseline survey), again at 12 months, and at study end (follow-up surveys). The email 
invitation will include a unique link to the online survey. 
▪ Following the initial emailed invitation, we will mail out up to 4 additional reminder emails at 
1-week intervals. The final reminder email will be accompanied by a personalized message by 
one or more of the study investigators.  
▪ PCPs who do not respond after the final reminder email will be assumed to not want to 
participate in that survey.  
▪ PCPs who do not respond to the baseline survey will still be eligible to complete the follow-up 
surveys unless they specifically request no further contact. 
Qualitative Interviews: In a similar manner, we will invite eligible PCPs to participate in telephone 
interviews in 3 separate waves. We will attempt to recruit and interview equal numbers of providers 
at both sites. However, we anticipate that more VA Puget Sound providers will participate due to the 
significantly higher number of providers at this site. 
▪ Wave 1: We will invite PCPs to participate in baseline interviews prior to intervention start.   
▪ Wave 2:  
o Intervention PCPS: PCPs who have been “exposed” to the intervention, defined as 
having received 3 or more pulmonary E-consult interventions, will be invited to 
participate in “post-exposure” interviews. PCPs do not have to have “accepted” 
intervention recommendations in order to be eligible for these interviews. We will 
email interview invitations to PCPs withing 1-2 weeks after meeting the exposure 
criteria. 
o Control PCPs: PCPs randomized to the control group will be contacted to complete 
interviews using an interview guide derived from the baseline interview guide. PCPs 
assigned to this group who already participated in the baseline interviews will not be 
contacted again. 

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▪ Wave 3: All PCPs who have completed post-exposure interviews will be invited via email to 
participate in a “maintenance” telephone interview, timed 18-26 months following a 
provider’s site entry date. This timeline may change based on findings from Wave 2 and/or to 
meeting project needs. 
Patients:  
Randomized Intervention Trial: The DISCuS intervention is a variant of usual-care with no direct 
patient interaction. All recommendations made by the intervention team for patients assigned to 
intervention providers are acted upon directly by the patient’s primary care clinician. As a result, 
there will be no attempt to consent patients to participate in the quality improvement initiative.  
▪ Once weekly, we will query CDW to create an updated list of all eligible patients and twice 
weekly identify patients with appointments in the next 1-3 weeks with a participating PACT 
provider.  
▪ Among the eligible patients, if there are greater than 6 patients in the intervention arm, then 
each patient will be assigned a randomly generated number (via SQL) and only the 6 lowest-
numbered intervention patients will be included in the study at that time. These patients will 
be assigned an index clinic date and have their charts reviewed at that week’s collaborative 
review meeting(s). The remaining patients will re-enter the pool of eligible patients. 
 
Qualitative Interviews: Patients of intervention-exposed PCPs will be purposively sampled and 
recruited to participate in qualitative interviews timed approximately 3 months post-intervention.  
▪ To be eligible, patients: 1) will need to be identified by the DISCuS collaborative review team 
for the deprescribing intervention; 2) have had an order to de-implement ICS signed by their 
PCP; and 3) have attended their targeted clinic appointment.   
▪ Patients will be excluded from interview recruitment after chart review if there is 
documentation in the medical record of active suicidal or aggressive behavior, cognitive 
issues, homelessness, current inpatient hospitalization, or co-occurring interventions (i.e. 
current enrollment in COPD research).  
▪ Patient interview recruitment will be evenly spaced throughout the year to control for seasonal 
factors that may affect COPD symptoms. 
▪ Patients will be mailed invitations. Patients not returning an opt-out card will be contacted by 
phone to determine interest in completing the interview. 
 
8.3. Randomization 
The unit of randomization will be at the level of the primary care PACT team. Randomization will 
occur at the team level to help avoid issues with contamination across study arms. At study start, we 
will stratify PACT teams (composed of 1 or more PCPs) into eight separate strata (Figure). These 
strata will be defined by site (Seattle vs. Bedford), provider type (physician vs. advanced practice 
provider), and into “small” or “large” teams based on the median number of eligible patients 
identified.  If the number of eligible patients for a PACT team is equal to the median, then the team 
will be randomly assigned to either the “small” or “large” stratum to help ensure balance across the 
eight strata. Within strata, PACT teams will then be randomly assigned in blocks of 4 to either the 

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intervention arm or the usual care arm of the study. These blocks will be determined using randomly 
generated sequences (i.e. ICIC, IICC, CIIC, etc., where I=intervention and C=usual care arm). 
 
If a provider belongs to multiple PACT teams, their randomization will be based on their team with 
the most eligible patients. If there are equal number of eligible patients across their PACT teams, then 
the PACT team with the greatest panel size will be used for randomization. The providers’ other 
teams will assume the same study arm. After study launch, the level of randomization will move to 
the level of the individual provider, and their randomization assignment will differ depending on 
situation.  
i. 
If a previously randomized PCP moves to a new PACT team, they will retain their original 
randomization assignment.  
ii. 
If a new PCP joins an existing PACT team that has been previously randomized, that PCP 
will be assigned to the same study arm as the existing PACT team providers.  
iii. 
If a PACT is provider-less (e.g. when a PCP leaves VA), then the PACT will be re-
randomized based upon the correct strata when a new PCP is assigned (i.e. defined by 
location, provider type and eligible patient count). The PCP (and his/her associated 
PACT(s)) will be added to the next available pre-randomized slot that will be created by 
the study biostatistician at the time of initial randomization.  
iv. 
If a new PACT team is created for a new PCP, we will determine the correct strata for that 
PCP based upon their location, provider type and eligible patient count. The PCP (and 
his/her associated PACT(s)) will then be added to the next available pre-randomized slot 
that will be created by the study biostatistician at the time of initial randomization. 
 
 
 

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9. Index Clinic Date 
 
Eligible patients with a qualifying appointment as of the time of the weekly collaborative team 
meeting will be assigned an index clinic date. For patients assigned to intervention PCPs, this index 
clinic date corresponds to the date of their scheduled primary care visit following receipt of the 
intervention.  Patients assigned to PCPs in the usual care arm with an upcoming primary care 
appointment in the same week as the collaborative review meeting will also be assigned an index 
clinic date. Patients who are assigned to either arm who subsequently cancel, re-schedule or no-show 
to their clinic appointment will retain this original index date. 
 
10. Intervention Arm 
 
10. 1 Non-intensive unlearning:  
Prior to study start, the Collaborative Review Team will attend a primary care staff meeting and 
provide a 10-15 minute academic detailing session that includes information about: 1) evidence for 
the use of inhaled corticosteroids to reduce exacerbations and symptoms among specific groups of 
patients with COPD; 2) risks associated with their use, and 3) distinguishing appropriate from 
potentially inappropriate use of ICS among patients with COPD. 
 
10.2 Recommendations for discontinuation of inappropriate ICS: 
Each week, for eligible patients identified with an upcoming appointment with an intervention 
primary care provider, we will perform the following: 
 
Chart abstraction: A project coordinator will copy pertinent sections of the EHR into an abstraction 
template (Appendix 2). These abstractions will include smoking status, lists of current medications, 
discharge summaries, notes from primary care, pulmonary, and the emergency department, as well 
as the results of pulmonary function tests, laboratory tests, and imaging studies.  
 
Clinical review: The collaborative review team (consisting of pulmonologists and project coordinators) 
will meet to review the chart abstraction, discuss the patient’s history, determine if the patient is 
inappropriately prescribed an inhaled corticosteroid, and formulate recommendations for any 
changes to the patient’s inhaled therapies (e.g. discontinuation of ICS and substitution of inhaled 
long-acting bronchodilators).  
 
Recommendations to the patient’s inhaled therapies will be categorized as followed: 
1) “Recommendations” will be made when the review team feels that there is sufficient history 
available to endorse a specific inhaled medication regimen for a particular patient. These 
recommendations will be accompanied by unsigned orders for the clinician to sign/modify/or 
discontinue as they see fit (described below). 
 
 
 

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a. A recommendation will be considered “conditional” if it is dependent upon a specific 
criteria being met (e.g. the teams’ understanding that the patient has not had any recent 
exacerbations of their COPD). 
2) “Considerations” will be made in circumstances when the review team feels they are unable to 
strongly endorse a specific inhaled medication regiment for a particular patient. Examples of 
these circumstances may include scenarios where there is insufficient history available in the 
chart to identify if the patient has an indication to remain on an ICS, or if a change is not 
necessarily appropriate now, but may be it the future. 
a. A consideration may be considered “conditional” if it is dependent upon a specific 
criteria being met (e.g. after a period of continued stability with no further 
exacerbations, it may be appropriate to discontinue the patient’s ICS at a later date). 
 
The team may also make additional recommendations relevant to the patient’s pulmonary condition. 
For example, for patients found to have no evidence of COPD, the team may include 
recommendations for additional work-up or pulmonary consultation. 
 
Entering recommendations with or without orders into the EHR: We will provide the PCP with 
recommendations in the form of an E-consult timed to coincide with the patient’s upcoming index 
clinic visit (Appendix 3). The E-consult will be performed/signed by one of the study team 
pulmonologists and include: 
1) A brief introductory paragraph that identifies the clinical team members, the intervention, and 
instructions on how to contact the study team with any questions or concerns.  
2) Specific recommendations for changes to the patient’s inhaled therapies and the rationale and 
evidence behind those recommendations.  
3) Links to evidence-based guidelines that support the recommended changes to the patient’s 
inhaled therapies. 
 
The patient’s PCP will be added as an additional signer on the E-consult note, prompting a view alert 
than ensures that they receive the recommendations. If the patient has a pulmonologist they will be 
included as an additional signer on the E-consult note as well. Clinicians will be encouraged to reach 
out to the study team with questions or concerns. 
 
At the same time that the E-consult is placed in the EHR, we will enter unsigned orders on behalf of 
the PCP that correspond to recommendations contained within the E-consult. These unsigned orders 
will prompt an additional view alert to the PCP. These orders can then be signed, modified or 
discontinued by the PCP as appropriate based on their personal knowledge of the patient’s clinical 
condition. This process ensures that the PCP maintains autonomous care of the patient. As noted 
above, if additional clinical context is needed prior to making a recommendation, we will instead 
offer only “considerations” and will not enter any related orders on behalf of the PCP. 
 
10.3 Titration to wean off Inhaled Corticosteroids 
Patients prescribed budesonide 160/formoterol 4.5 mcg (the most commonly used LABA/ICS in the 
formulary) will be provided with a titration plan to taper off inhaled corticosteroids by initiating a 

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once daily dose of mometasone 220 mcg for one month.17 Note: as of March 2017, additional data has 
emerged that this is potentially not necessary.18 As a result, we will now taper inhaled corticosteroids 
on a case by case basis (e.g. for patients with recent exacerbations and/or high respiratory symptom 
burden) 
 
11. Usual Care Arm 
Providers assigned to the usual care arm will attend the academic detailing session described above. 
We will not perform chart abstraction or formulate recommendations for patients assigned to usual 
care providers. Patients assigned to usual care PCPs will continue to receive inhaled medications and 
management of their COPD from their PCPs and/or pulmonologists. 
 
12. Blinding 
The investigators and participants will be unblinded as to intervention arm. This decision was made 
based on several factors, including: 1) Blinding is impractical as intervention/clinical staff and 
physician investigators must know the patient and provider names in the intervention group in order 
to access the electronic medical record to input orders and notes. Clinician participants can also not 
be blinded because receiving an unexplained intervention would not be acceptable in a clinical 
setting. 2) This is an operations project that is designed to deliver evidence-based care previously 
shown to be effective and the majority of our resources should be used to implement the intervention.  
Data collection to assess outcomes in CDW will occur in a blinded fashion using SQL queries that do 
not incorporate intervention arm. This allows an unbiased assessment of our primary and secondary 
outcomes across the two arms. Chart abstraction will be utilized to collect data on the subset of 
outcomes that will be collected only among the intervention arm. This data collection will necessarily 
occur in an unblinded fashion. 
 
13. Outcomes 
 
13.1 Primary Outcome Measure:  Percentage of patients with discontinued, or expired and not 
renewed, ICS that remain off at 6 months (index date + 180 days). 
▪ We will assess this measure using detailed prescription data extracted from the VA 
Corporate Date Warehouse (CDW). All patients who no longer have an active ICS order at 6 
months (defined as index date + 180 days), will be considered to be “off” ICS.   
o Percentage of patients that remain off ICS at 6 months will be calculated for each 
study arm as: (# of patients off ICS/# of patients) *100. 
▪ Patients who died prior to end of follow-up are considered to be “off” ICS 
 
13.2 Secondary Outcome Measures: 
Among patients in both study arms: 

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▪ Rate of COPD Exacerbation at 6 months [defined as (index date + 1 day) to (index date + 180 
days)]:  
o The rate of exacerbation at 6 months after index date (index date + 180 days) will be 
assessed for each study arm as:  total #of inpatient or outpatient exacerbations 
participant time post index date. 
 
o Inpatient exacerbations will be defined as: 
▪ Primary ICD-9/ICD-10 discharge diagnostic code of COPD (ICD-9: 491.XX, 
492.XX, 496.XX, 493.2; ICD-10: J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, 
J43.9, J44.0, J44.1, J44.9) 
Or 
▪ Primary ICD-9/ICD-10 discharge diagnostic code of acute respiratory failure 
(ICD-9: 518.81, 518.82, 518.84; ICD-10: J80., J96.00, J96.01, J96.02, J96.20, J96.21, 
J96.22, J96.90, J96.91, J96.92) and secondary diagnosis of COPD (ICD-9: 491.XX, 
492.XX, 496.XX, or 493.2; ICD-10: J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, 
J43.9, J44.0, J44.1, J44.9) 
 
o Outpatient exacerbations will be defined as: 
▪ A clinic visit, ED visit or Urgent Care visit with an ICD-9 or ICD-10 code of 
COPD and an outpatient prescription for an oral corticosteroid within 2 days 
(before or after encounter) 
Or 
▪ A clinic visit, ED visit or Urgent Care visit with an ICD-9 or ICD-10 code of 
COPD and no prescription for oral corticosteroids but an outpatient prescription 
for an oral respiratory antibiotic within 2 days (before or after encounter) and no 
ICD-9 or ICD-10 code indicating the presence of:  
• urinary tract infection (ICD-9: 590.X, 595.X, 597.X; ICD-10:  A56.01, N10., 
N11.X, N12., N13.6, N15.1, N15.9, N16., N28.84, N28.85, N28.86, N30.0, 
N30.1, N30.2, N30.3, N30.4, N30.8, N30.9, N34.X) 
• skin and soft tissue infection: (ICD-9: 680.X, 681.X, 682.X, 683.X, 684, 
685.X, 686.X; ICD-10:  B78.1, E83.2, K12.2, L01.0X, L01.1, L02.XXX, 
L03.XXX, L04.X, L05.0X, L05.9X, L08.0, L08.8X, L08.9, L88., L92.8, L98.0, 
L98.3) 
• Acute sinusitis (ICD-9: 461.X, 473.X; ICD-10: J01.XX, J32.X) 
• Pneumonia (ICD-9: 481.X, 482.X, 483.X, 484.X, 485.X, 486; ICD-10: ICD-10: 
A22.1, A37.01, A37.11, A37.81, A37.91, A48.1, B25.0, B44.0, B77.81, J13., 
J14., J15.XXX, J16.0, J16.8, J17., J18.0, J18.1, J18.8, J18.9) 
 
▪ Rate of Pneumonia at 6 months [defined as (index date + 1 day) to (index date + 180 days)]: 
o The rate of pneumonia will be assessed for each study arm as:   
▪ number of new pneumonia cases/participant time post index date.  
o Inpatient pneumonia events will be defined as: 

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▪ ICD-9 or ICD10 code: (ICD-9: 481.X, 482.X, 483.X, 484.X, 485.X, 486; ICD-10: 
A22.1, A37.01, A37.11, A37.81, A37.91, A48.1, B25.0, B44.0, B77.81, J13., J14., 
J15.XXX, J16.0, J16.8, J17., J18.0, J18.1, J18.8, J18.9) 
 
o Outpatient pneumonia events will be defined as: 
▪ ICD-9 or ICD-10 code Dx (ICD-9: 481.X, 482.X, 483.X, 484.X, 485.X, 486; ICD-10: 
A22.1, A37.01, A37.11, A37.81, A37.91, A48.1, B25.0, B44.0, B77.81, J13., J14., 
J15.XXX, J16.0, J16.8, J17., J18.0, J18.1, J18.8, J18.9) 
 
▪ Mortality at 6 months [defined as (index date + 1 day) to (index date + 180 days)]: 
o Mortality will be assessed for each study arm as a percentage:  total # deaths /# of 
patients *100. 
o Mortality will be determined by the presence of a date of death occurring between the 
(index date + 1 day) and (index date + 180 days) 
 
Among patients in the intervention arm only: 
▪ Among intervention patients who meet entry and exclusion criteria (collected at time of 
recommendations/order entry): 
o Number of participants receiving recommendations  
o Number of participants receiving recommendation to stop ICS 
 
▪ Percentage of recommendations accepted by PCPs within 6 months (index date + 180 days)  
a. (Number of accepted recommendations/total recommendations made) * 100 
b. Separated by medication type: ICS recommendation & acceptance rate, LABA 
recommendation & acceptance rate, etc. for all meds within the study scope. 
i. Recommendation is defined as: 
1. Recommended care stated in an EHR note or consult for which an 
order is entered by the project team. 
ii. An accepted recommendation is defined as an order being signed by the 
primary care provider during the index date to (index date + 180 days). 
iii. Order data will be extracted from the VA’s CDW, post-index date, to 
determine status (signed vs unsigned). 
iv. This data will be supplemented by data abstracted from the EHR to allow for 
collection of acceptance rates for recommendations other than those for 
medications (e.g. pulmonary referral or repeat imaging). 
 
▪ Percentage of patients where recommendations to discontinue ICS are accepted but restarted 
by 6 months (180 days) post-index date. 
a. Among all patients where PCP accepted initial recommendation to stop ICS. 
b. Evaluate whether patient was restarted on ICS at 6 months (index date + 180 days). 
c. Pharmacy order and prescribing data will be extracted from the VA’s CDW for the 
period between index date and (index date + 180 days) to determine status. 

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d. ICS is considered restarted at 6 months (180 days) if between index date and (index 
date + 180 days)  
i. Initial ICS order is discontinued and  
ii. A new ICS order is signed or a prescription order or dispense date exists. 
e. This data will be supplemented by data abstracted from the EHR, to help determine 
reasons for restarting medications.   
Additional secondary outcomes: 
Maintenance (to be assessed post-project intervention): 
1. Assess whether PCPs prescribe ICS appropriately for new patients with COPD who do not 
receive our direct intervention. 
a. Use CDW to identify new cohort of patients among intervention PACTs that have 
not received the intervention. 
i. Study-eligible patients not under care of a study PACT/PCP during the 
intervention period. 
ii. Patients with COPD already under care of a study PACT/PCP that become 
eligible following the intervention period. 
b. Assess for temporal changes in the control group (measuring contamination). 
 
Using a combination of surveys and qualitative interviews, the following implementation outcomes 
will also be assessed among PCPs: 1) burnout; 2) professional efficacy; 3) perception of evidence to 
support the use of ICS among patients with COPD; and 3) acceptability of the intervention. Among 
patients, acceptability of the intervention will also be assessed.  
Adoption: The qualitative team will examine factors related to adoption, including patient and 
operational barriers and the fidelity of the implementation. 
Implementation Costs:  The economic core will develop budget impact analyses and assess the 
implementation costs of the intervention. 
 
14. Additional Assessments 
14.1 Baseline Characteristics 
We will utilize CDW to identify the following sociodemographic information for PCPs: 
▪ Provider type (MD vs advanced practice provider) 
▪ Associated PACT team and location 
We will utilize CDW to identify/calculate the following for eligible patients: 
▪ Sociodemographic information (age, race, gender) 
▪ Height, weight and body mass index 
▪ 
Elixhauser Comorbidities: Collected for the year prior to the index date  

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▪ 
Prior inpatient and outpatient COPD exacerbations (defined above) in the year prior to index 
date 
▪ 
Prior inpatient and outpatient pneumonia events (year prior to index date) 
▪ 
Hospitalizations within the year prior to index date: including length of stay, ICU status, and 
use of non-invasive or invasive mechanical ventilation 
▪ 
Health factors: Most recent smoking status known prior to the index date. 
▪ 
Detailed prescription data for inhaled medications in the year prior to the index date 
▪ 
Pulmonary clinic visits in the year prior to index date 
In addition, we will utilize a combination of CDW and EHR chart abstraction to identify spirometry 
performed in the 5 years prior to index date. 
14.2 Qualitative Interviews 
We will utilize a semi-structured guides to interview primary care providers by telephone at 
different 3 timepoints: 1) baseline, prior to planned intervention activities (Appendix 4) 2) after 
“exposure” to the intervention, with “exposure” defined as receipt of 3 pulmonary e-consultations 
(Appendix 5) and 3) in the maintenance phase (Appendix 6), 18-26 months following a provider’s 
site entry date. The interview guides are intended to explore PCP’s experiences with prescribing ICS 
for COPD, familiarity with evidence and guidelines for prescribing ICS, and views on 
discontinuation of ICS.  The interview guides are informed by the de-implementation and 
implementation literature, and include key constructs such as understanding the evidence for and 
against a clinical practice, 19-21 psychological reactance,22,23 and organizational context that support 
clinical change.19-22 
We will similarly utilize semi-structured guides to interview patients assigned to intervention PCPs 
at a single time point, approximately 3 months post-intervention (Appendix 7). 
The interview guides for PCPs and patient participants include open ended-questions and semi-
structured probes to assure uniform data collection of key topics while allowing exploration of 
emerging unanticipated themes. All interviews will be audio-recorded and transcribed verbatim for 
analysis. 
14.3 Quantitative Surveys  
Quantitative surveys will be administered to participating PCPs via REDCap at baseline (Appendix 
8), 12 months following inclusion in the intervention trial (Appendix 9), and at the end of the study 
(Appendix 10). The surveys will be used to elicit clinician perspectives on their experience with ICS 
to treat patients with COPD (e.g. frequency of use, efficacy, and adverse effects), perceptions of 
discontinuing ICS in mild-moderate COPD, as well as their intention for use of ICS in the following 
6 months to treat patients with COPD.  Additional information will also be collected about 
leadership and management behaviors, job-related feelings, turnover intentions, and demographics. 
Select questions from the Maslach Burnout Inventory will be adopted,24 in order to assess trends and 

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direct future quality improvement initiatives. We will have all necessary employee unions review 
and approve the survey instrument and interview guides prior to administration. 
15. Analytic Approach 
Analysis overview:  This is a cluster-randomized trial with patients nested within individual 
provider who are nested within teams.  This type of design invalidates many of the standard 
approaches to assess patient-level randomized trials because of the correlation that exists between 
patients cared for by one clinician within a team.  It is reasonable to expect that patients within a 
physician’s practice are likely not to be independent of one another. This effect, depending on intra-
physician correlations, means that naïve model-based standard errors that assume independence 
between patients will be incorrect. As a result, confidence intervals and p-values based on those 
standard errors would not be valid.  Hierarchical modeling methods, using generalized linear mixed 
model (GLMM), will be necessary to assess the effect of the intervention while taking into account the 
potential correlation between patients seeing the same physician.  The primary hypothesis to be 
tested is that the intervention will lead to a decrease in the inappropriate use of inhaled 
corticosteroids (ICS).   
Statistical analysis will occur in two phases.  First, provider level descriptive profiles will be 
constructed on primary and secondary outcome variables to assess trends and identify potential 
outliers. Second, we will fit GLMM models and conduct hypothesis testing analyses for the specific 
aims as described below. 
15.1. Baseline Analysis and Descriptive Statistics 
Equivalence of participants and providers in the intervention and control arms will be assessed on 
demographic and clinical variables, including outcomes, health status, co-morbidity, and utilization 
variables. Because this is a randomized controlled trial, no systematic bias is anticipated. However, 
we will adjust for the covariates where a statistically significant difference is found and related to the 
primary and secondary outcomes. We will report summary statistics for all baseline covariates and 
outcomes (means, standard deviations, and quartiles for continuous variables; frequencies and 
percentages for binary variables) by randomized treatment group. 
Data Analysis: The primary outcome measure for this study will be whether or not a patient 
remains off ICS at 180 days post targeted PCP visit (index date). The important factors in the study 
design are: Treatment Group, PACT Team, PCP, and Patient.  Initial randomization will occur at the 
level of the PACT, with an anticipated 1:1 relationship between PACT and PCPs. Following study 
start, the unit of randomization will move to the level of the PCP. PCPs with more than one PACT 
will have all PACTs assigned to the same study arm. For these reasons, it is clustering of patients 
within provider that we will be primarily concerned with in this analysis, as grouping by PACTs 
would not provide additional meaningful information.  We will use the patient as the unit of analysis, 
and use generalized linear mixed effect model (GLMM) to account for clustering of patients within 
PCP.  

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GLMM is an extension of traditional regression techniques that accounts for the effect of clustering as 
well as for important confounding factors found to not be balanced between the treatment and 
control groups at baseline.  A GLMM approach will allow us to estimate the effect of the 
randomization group on patient outcome.   
A multivariable model will be constructed based on the outcome of whether the given patient was 
not on ICS at 180 days after the targeted PCP visit, with randomization group and any variables 
found to be imbalanced across arms as adjustment covariates (mixed-effects logistic regression 
model).  The intervention will be considered statistically significant if the indicator variable for the 
intervention group is significantly associated with a change in the odds of a patient being off ICS at 
180 days after the PCP visit.  The GLMM model for this analysis: 
  
ln (
𝜋𝑖𝑗
1 −𝜋𝑖𝑗
) = 𝛽0 + 𝛽1treatmentj + γ𝑗(1) 
  
Where𝜋𝑖𝑗 is the probability of patient i within the jth provider staying off ICS at 180 days after the 
targeted PCP visit, 𝛽1 is an indicator variable equal to 1 if provider j is in the intervention group and 0 
if the provider is in the control group, and γ𝑗 corresponds to the random intercept for the jth 
provider. The random intercepts are assumed to be identically distributed independent draws from a 
mean-zero Normal distribution with unknown variance.  
15.2 Sensitivity Analyses  
In addition to the primary analyses, sensitivity analyses will be conducted using Generalized 
Estimating Equations (GEE) which account for clustering within the data by allowing for the 
specification of a correlation structure if the assumptions of GLMMs are not met.  
15.3 Missing data analyses 
All appropriate efforts will be made to avoid missing data. For example, accruing data will be 
monitored for the presence of missing values, and the study manager and coordinators will 
investigate causes and/or remedies for missing data. For key analysis variables that have 15% or more 
missing values, we will analyze patient and clinical factors that are associated with having a missing 
value. We will then perform our primary analyses using multiple imputation to impute these key 
variables to allow analysis for all subjects and reduce any bias associated with the missing data. 
15.4 Secondary Analyses 
Summary statistics (counts and percentages) will be computed for the following outcome variables 
that will be collected following baseline: 
1. Number and percentage of patients that meet entry criteria 
a. Number and percentage of patients that meet entry criteria overall 

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b. Number and percentage of patients that meet entry criteria and are recommended to 
stop ICS 
2. Number and percentage of patients for whom the substituted recommendations are accepted. 
3. Number and percentage of patients where ICS recommendation accepted but restarted by 180 
post index visit 
Further data analysis will also be performed for secondary outcome measures.  The procedure that is 
outlined above for the analysis of the primary outcome variable will be followed for the binary 
secondary outcome measures listed below.  For each variable listed, model (1) will be modified to 
instead include the listed secondary variable as the outcome variable in the model. 
1. COPD exacerbation within 180 days 
2. Pneumonia within 180 days 
3. Mortality within 180 days 
We will perform additional sensitivity analysis assessing number of COPD exacerbations using 
mixed-effects zero-inflated Poisson regression models and time-to-COPD exacerbation and 
pneumonia using mixed-effects Cox proportional-hazards regression models. 
Further secondary analysis will include summary statistics used to evaluate PCP burnout, 
professional efficacy, perceptions of evidence for the use of ICS, acceptability of the intervention to 
PCPs, implementation costs, and maintenance of the intervention. 
 
15.5 Sample Size and Power 
For a cluster randomized control trial, the hypothesis that will be tested is 𝐻𝑜: 𝑃1 = 𝑃2, where 𝑃1 and 𝑃2 are the 
population success rates in the experimental group and control groups, respectively. According to Friedman 2010,25 the 
total number of subjects required for the study is  
 
𝑛=
2 [𝑍𝛼/2√2𝑃̅(1 −𝑃̅) + 𝑍𝛽√𝑃1(1 −𝑃1) + 𝑃2(1 −𝑃2)]
2
[1 + (𝑚−1)𝜌]
 (𝑃1 −𝑃2)2
,                (1) 
 
where 𝜌 is the intracluster correlation, 𝑚 is the number of individuals in each cluster randomly assigned either the 
experimental group or control group, 𝑍𝛼/2 is the 𝛼/2 th quantile of the standard normal distribution function and 𝑍𝛽 is 
the 𝛽th quantile of the standard normal distribution function.  Solving for 1 −𝛽 we find the equation for power is 
 
1 −𝛽= Φ−1
(
 
 
 √
𝑛(𝑃1 −𝑃2)2
2(1 + (𝑚−1)𝜌) −𝑍𝛼/2√2𝑃̅(1 −𝑃̅)
√𝑃1(1 −𝑃1) + 𝑃2(1 −𝑃2)
 
)
 
 
 
 
 
We further define k to be the number of clusters, where 𝑘= 𝑛/𝑚.   
 
Results: 
 

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Assuming the total number of patients is ~700, two variables can vary, 𝜌 the intracluster correlation and k the number of 
clusters.  We see in the all scenarios ( 𝜌 varying between 0.1, 0.2, 0.3, 0.4) and with 𝑃1 = 1, 𝑃2 = .5, 𝛼= .05 and k = 
120, 60 or 30, that the power exceeds 99.9%. 
 
Assuming 130 (80%) participating providers, ~700 patients, a conservative estimate of 50% of patients remaining off ICS 
in the intervention group, α of 0.05 , and a coefficient of variation of 0.1, we estimate our power to be in excess of 95%. 
 
 
15.6. Mixed-methods Analysis: Quantitative Survey and Qualitative Data Analysis 
We will utilize sequential mixed methods using qualitative interview findings to inform subsequent 
development of quantitative survey questions. Qualitative analysis of baseline interviews will be 
conducted using iterative deductive and inductive content analysis methods.26 Deductive analysis 
will involve application of a priori codes based on key construct definitions from the de-
implementation literature and the interview guide questions.19-22 Inductive content analysis will 
consist of open and unstructured coding to capture data that does not fit into a priori categories. 
Emergent codes will be added throughout the analysis, allowing us to identify emergent and 
previously unidentified or unexpected themes. Broad themes will be identified based on 
representative interview responses and grouped to describe distinct aspects of patient’s experiences. 
The qualitative team will meet weekly to discuss data and reach consensus on interpretation of 
themes and findings. Findings will then inform adaptation of the PCP surveys. 
Following survey data collection, we will use convergent mixed methods to identify qualitative data 
(from both patient and clinician interviews) that enhances our understating of the survey findings or 
indicates potential generalizability of the qualitative findings.27  
 
16. Protection of Human Subjects 
16.1 Quality Improvement Designation 
This project was designated as a quality improvement (QI) initiative by the VA Office of Specialty 
Care Services. As such, we will not obtain informed consent from primary care providers or their 
patients as part of the clinical trial.  
16.2 Data and Safety Monitoring 
Adverse events: As this was a quality improvement intervention, we will not systematically assess 
for all adverse events. We will assess relevant safety outcomes of exacerbations (inpatient, outpatient, 
and combined), pneumonia events (inpatient, outpatient, and combined), and mortality. 
16.3 Recommendation fidelity 
At study start, all participating pulmonologists will attend joint review meetings and discussion and 
reach consensus about wording of recommendations, orders, and standardized language to use for 
the intervention. We will ensure that coordinators have detailed instructions on how to enter notes 

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and/or orders into the EHR for intervention patients. We will require coordinators to consult with a 
study clinician before entering any information in the EHR about which they have any questions.  
16.4 Data management and confidentiality 
This project requires the creation, maintenance, and analysis of a large, multivariate, database that 
includes a variety of measures from multiple sources.  Recognizing that the success of this study 
critically depends on the quality of the data collected, systematic data collection, quality control, and 
data management procedures, we will implement: 1) specification and use of concise protocols; 2) 
rigorous training, certification, and periodic re-training of study personnel, with on-going monitoring 
of adherence to data collection and handling protocol; 3) validation and verification of all data, and 4) 
regular meetings and progress reports to provide specific, well-documented feedback to project 
personnel concerning potential difficulties as well as follow-up to ensure that problems are resolved 
quickly.   
 
We will assign all participants a unique study ID. The master list will be stored separately from the 
data and accessible only by study staff.  For clinical note abstractions, we will not remove identifiers 
because that material is copied verbatim, making it difficult to ensure that any reference to names, 
location, and dates were removed. We believe it is safer to acknowledge that identifiers will be 
present, and to carefully adhere to our strict protocol to store the abstracted notes on a secure server 
accessible only by authorized staff.  Chart abstracted notations will not be entered into the study 
database. 
 
We will store data in strong password protected environment on the secure VA network server.   
 
For provider on-line surveys, we will e-mail a link that populates data on the VA secure server.  Data 
will be secured at the database level, using a role-based and record-level security model.   
 
We will store data on paper in secure, locked file cabinets within secure offices. Any communications 
between study staff and provider participants regarding patient care will occur via encrypted e-mail.   
 
17. References 
1. 
Au DH, McDonell MB, Martin DC, Fihn SD. Regional variations in health status. Med Care. Aug 2001;39(8):879-
88.  
2. 
Fihn SD, McDonell MB, Diehr P, et al. Effects of sustained audit/feedback on self-reported health status of 
primary care patients. Am J Med. Feb 2004;116(4):241-8. doi:S0002934303007150 [pii] 
10.1016/j.amjmed.2003.10.026 
3. 
Collins BF, Ramenofsky D, Au DH, Ma J, Uman JE, Feemster LC. The association of weight with the detection of 
airflow obstruction and inhaled treatment among patients with a clinical diagnosis of COPD. Chest. Dec 
2014;146(6):1513-20. doi:10.1378/chest.13-2759 
4. 
From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic 
Obstructive Lung Disease (GOLD) 2017. Available from: http://www.goldcopd.org/. 
5. 
Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. 
Cochrane Database Syst Rev. 2014;3:CD010115. doi:10.1002/14651858.CD010115.pub2 

DISCuS COPD PROTOCOL 
                                     12/1/2021   
26 
 
6. 
Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic 
obstructive pulmonary disease. N Engl J Med. Feb 2007;356(8):775-89. doi:356/8/775 [pii] 
10.1056/NEJMoa063070 
7. 
Wedzicha JA, Calverley PM, Seemungal TA, et al. The prevention of chronic obstructive pulmonary disease 
exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. Jan 
2008;177(1):19-26. doi:200707-973OC [pii]10.1164/rccm.200707-973OC 
8. 
Loke YK, Cavallazzi R, Singh S. Risk of fractures with inhaled corticosteroids in COPD: systematic review and 
meta-analysis of randomised controlled trials and observational studies. Thorax. Aug 2011;66(8):699-708. 
doi:10.1136/thx.2011.160028 
9. 
Cumming RG, Mitchell P, Leeder SR. Use of inhaled corticosteroids and the risk of cataracts. N Engl J Med. Jul 
1997;337(1):8-14. doi:10.1056/NEJM199707033370102 
10. 
Ernst P, Baltzan M, Deschênes J, Suissa S. Low-dose inhaled and nasal corticosteroid use and the risk of 
cataracts. Eur Respir J. Jun 2006;27(6):1168-74. doi:10.1183/09031936.06.00043005 
11. 
Slatore C, Bryson C, Au D. The association of inhaled corticosteroid use with serum glucose concentration in a 
large cohort. Am J Med. May 2009;122(5):472-8. doi:S0002-9343(08)01187-X [pii] 
10.1016/j.amjmed.2008.09.048 
12. 
Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 
1998 Aug-Sep 1998;1(1):2-4.  
13. 
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating 
evidence into action. Research Support, Non-U.S. Gov't. Health Aff (Millwood). Nov-Dec 2001;20(6):64-78.  
14. 
Wagner EH, Glasgow RE, Davis C, et al. Quality improvement in chronic illness care: a collaborative approach. 
Evaluation Studies Research Support, Non-U.S. Gov't. Jt Comm J Qual Improv. Feb 2001;27(2):63-80.  
15. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-
AIM framework. Am J Public Health. Sep 1999;89(9):1322-7.  
16. 
From the Global Strategy for Asthma Management and Prevention and the Global Strategy for the Diagnsois, 
Management, and Prevention of Chronic Obstructive Pulmonary Disease. Diagnosis of diseases of Chronic Airflow 
Limitation: Asthma, COPD, and Asthma-COPD Overlap Syndrome 2015. Available from http://www.goldcopd.org/. 
17. 
Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of 
COPD. N Engl J Med. Oct 02 2014;371(14):1285-94. doi:10.1056/NEJMoa1407154 
18. 
Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. 
N Engl J Med. 06 09 2016;374(23):2222-34. doi:10.1056/NEJMoa1516385 
19. 
Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful 
implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement 
Sci. Jan 07 2008;3:1. doi:10.1186/1748-5908-3-1 
20. 
Rycroft-Malone J, Seers K, Titchen A, Harvey G, Kitson A, McCormack B. What counts as evidence in evidence-
based practice? J Adv Nurs. Jul 2004;47(1):81-90. doi:10.1111/j.1365-2648.2004.03068.x 
21. 
McCormack B, Kitson A, Harvey G, Rycroft-Malone J, Titchen A, Seers K. Getting evidence into practice: the 
meaning of 'context'. J Adv Nurs. Apr 2002;38(1):94-104. doi:10.1046/j.1365-2648.2002.02150.x 
22. 
Morgan DJ, Brownlee S, Leppin AL, et al. Setting a research agenda for medical overuse. BMJ. Aug 25 
2015;351:h4534. doi:10.1136/bmj.h4534 
23. 
Helfrich CD, Rose AJ, Hartmann CW, et al. How the dual process model of human cognition can inform efforts to 
de-implement ineffective and harmful clinical practices: A preliminary model of unlearning and substitution. J Eval Clin 
Pract. 02 2018;24(1):198-205. doi:10.1111/jep.12855 
24. 
Maslach C, Jackson S, Leiter M. Maslach Burnout Inventory Manual. Third Edition. Menlo Park: Mind Garden. 
2010. 
25. 
Friedman. Fundamentals of Clinical Trials. 4th Edition. Chapter 8. p.139, 157-158. 2010. 
26. 
Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. Apr 2008;62(1):107-15. doi:10.1111/j.1365-
2648.2007.04569.x 
27. 
Creswell J, Plano Clark V. Designing and conducting mixed methods research(2nd ed.). Thousand Oaks, CA: Sage; 
2011. 
 

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18. Summary of Changes from Original Protocol 
 
▪ 
07/19/2016: Patient exclusion criteria: diagnosis of asthma 
o 
Clarified that asthma diagnoses identified in intervention patients at the time of chart 
review (in problem list or from chart abstraction) will not exclude them from the 
intervention; This change was made in order to ensure that patients assigned to 
providers in both arms are treated the same. 
▪ 
09/13/2016: Change in treatment of clinic cancellations/no-shows  
o 
Previously planned to not assign an index date for patients that cancelled/no-showed 
their clinic appointments after the collaborative review meeting, but follow them for   
six additional months to determine if had eligible clinic visit before permanently 
excluding them; Changed to assigning these patients an index date corresponding to the 
planned visit that was cancelled/no-showed. This change is consistent with an 
intention-to-treat approach, as intervention patients would have already had a 
note/unsigned orders placed in the chart. 
▪ 
09/20/2016: Clarification of categorization of recommendations 
o 
Clarified categorization of recommendations for outcome assessment into 
“recommendations” and “considerations”, each with potential to also be “conditional.” 
▪ 
10/18/2016: Frequency of data pulls and team reviews 
o 
Changed from interrogating EHR for upcoming primary care appointments for eligible 
patients from once to twice weekly.  
▪ 
12/05/2016: Patient eligibility criteria 
o 
Patients can be targeted for an index visit if they are found to have a scheduled 
appointment at least 7 days prior to the occurrence of an appointment 
▪ 
12/06/2016: Patient eligibility criteria 
o 
Patients assigned to intervention PCPs previously were noted to be eligible to 
participate in interviews 3 months following their index date. Eligibility criteria clarified 
to ensure that patients interviewed included only those who had had their ICS de-
implemented. 
▪ 
02/01/2017: Patient eligibility criteria: Definition of fixed airflow obstruction 
o 
The definition of fixed airflow obstruction was changed from post-bronchodilator 
FEV1/FVC <0.70 to post-bronchodilator FEV1/VC <0.70, indicating that for the 
denominator, either the post-bronchodilator FVC or SVC could be used, whichever is 
greater. 
▪ 
02/07/2017: Number of eligible patients each week 
o 
Changed from maximum of 3 patients per arm each week to be assigned an index date 
to a maximum of 6 patients per arm; increased meetings of collaborative team from 
once to twice weekly. 
▪ 
03/14/2017: Change in recommendations to taper off ICS 

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o 
Based on re-evaluation of available evidence, Investigators decided to no longer 
routinely recommend tapering off inhaled corticosteroids due to its complexity and lack 
of known efficacy. Case by case basis used to decide if tapering appropriate (e.g. if 
patients had recent exacerbations and/or high respiratory symptom burden, etc.) 
▪ 
05/11/2017: Patient eligibility criteria 
o 
ICD-9 Diagnostic code 493.2x (chronic obstructive asthma) was added to the list of 
exclusionary ICD-9 codes (previously missed); exclusionary code now written as 493.X 
▪ 
05/23/2017: Change in patient eligibility criteria for qualitative interview 
o 
Prior to this date, intervention and control patients were considered to be possibly 
eligible to participate in qualitative interviews. Criteria were changed so that only 
patients assigned to intervention PCPs were to be interviewed. 
▪ 
05/26/2017: Templated E-consult note change 
o 
Templated text changed to include a request that PCP discuss any medication changes 
with their patients at their upcoming appointment. This change was prompted by 
instances of orders/notes being signed by PCP and patients not being made aware of 
change. 
▪ 
11/28/2017: Clarification: PCP Survey Eligibility 
o 
Clarified that all active PCPs are eligible to receive follow-up surveys (not just those 
that received baseline surveys). 
▪ 
01/03/2018: Clarification of randomization process 
o 
Clarified that if a PCP/PACT has a number of eligible patients equal to the median # of 
eligible patients identified for a PACT that they would be randomly assigned to “small” 
or “large” stratum. 
▪ 
5/21/2018: Patient eligibility criteria 
o 
Changed exclusion criteria to FEV1 <30% predicted from <50% predicted based on 
updated GOLD guidelines (severity of airflow limitation alone no longer an indication 
for prescription of inhaled corticosteroids; team decided to still exclude those with very 
severe airflow obstruction). 
o 
Updated background section of protocol to reflect most recent evidence 
▪ 
10/16/2020: Outcome assessment and Analyses 
o 
Decided to supplement CDW data with EHR abstraction to ensure data quality of 
recommendation acceptance and assess non-pharmacologic recommendations 
o 
Changed outcome assessment period for secondary outcomes from (index date + 180 
days) to (index date + 1 day) to (index date + 180 days) 
o 
No longer plan to stratify exacerbation rates by presence or absence of airflow 
obstruction 
o No longer plan to account for clustering of PCPs within PACT team within GLMM 
analysis. This decision was made because at the initial randomization there was 1:1 
relationship between PCPs and PACTS (making them synonymous) and following 
initial randomization the unit of randomization was the PCP. This means that 

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accounting for clustering within PCP sufficiently accounts for clustering within PACT 
team as well; and adding the PACT team to the analysis would not add additional 
meaningful information.  
o 
We initially planned a primary analysis restricted to participants who complete the 
study and have fully observed outcomes and covariates (complete case analysis). 
However, after finding an imbalance in smoking status between groups, smoking status 
was included as an additional covariate in our GLMM analysis. Due to ~ 5% 
missingness of this covariate, we performed our primary analysis using multiple 
imputation with chained equations. 
o 
Additional sensitivity analyses added to account for counts of COPD exacerbations 
(using mixed-effects zero-inflated Poisson regression models) and time-to-COPD 
exacerbation and pneumonia (using mixed-effects Cox proportional-hazards regression 
models). 
▪ 
12/1/2021: Made corrections to protocol to clarify secondary outcomes 
o 
Rate of exacerbation: denominator changed to reflect “participant time” rather than 
“number of participants” 
o 
Rate of pneumonia: removed reference to events/patient and left only correct definition 
of rate (inpatient or outpatient pneumonia events/participant time since index). 
o 
Mortality: incorrectly labeled as rate rather than percentage; corrected. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 1: Medications  
Medication Classification 
Medications included 
Inhaled Corticosteroids 
Beclomethasone Dipropionate 40 mcg/actuation and 80mcg/actuation (oral) 
 
Budesonide 0.5 mg/2ml inhaled suspension (oral) 
 
Budesonide 90 mcg/inhalation  and 200 mcg/inhalation (oral) 
 
Flunisolide 250 mcg/spray (oral) 
 
Fluticasone Propionate 220 mcg/spray (oral) 
 
Mometasone Furoate 220mcg/inhalation (oral) 
 
Triamcinolone 75 mcg/inhalation (oral) 
 
Budesonide 80 mcg/Formoterol 4.5 mcg/spray 
 
Budesonide 160 mcg/Formoterol 4.5 mcg/spray 
 
Fluticasone 100mcg/Salmeterol 50 mcg/spray 
 
Fluticasone 115mcg/Salmeterol 21 mcg/spray 
 
Fluticasone 250mcg/Salmeterol 50 mcg/spray 
 
Fluticasone 500mcg/Salmeterol 50 mcg/spray 
 
Formoterol 5mcg/Mometasone 100 mcg/inhalation 
 
Formoterol 5mcg/Mometasone 200 mcg/inhalation 
Oral Corticosteroids 
Cortisone Acetate 10 mg and 25 mg tablets 
 
Hydrocortisone 5 mg, 10 mg, and 20 mg tablets 
 
Methylprednisolone 2 mg, 4 mg, and 8 mg tablets 
 
Prednisolone Na phosphate 6.75 mg/ml oral solution 
 
Prednisolone 5 mg tablets 
 
Prednisone 5mg/5ml oral solution 
 
Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 50 mg tablets 
 
Triamcinolone 2 mg and 4 mg tablets 
Oral Respiratory 
Antibiotics 
Fluroquinolones 
Gatifloxacin 200mg and 400 mg tablets 
Lomefloxacin 400 mg tablets 
Ofloxacin 200 mg, 300 mg, and 400 mg tablets 
Ciprofloxacin 250 mg, 500 mg, and 750 mg tablets 
Levofloxacin 250 mg, 500 mg, and 750 mg tablets 
Moxifloxacin 400 mg tablets 
Norfloxacin 400 mg tablets 
 
Macrolides 
Azithromycin 250 mg and 600 mg tablets 
Clarithromycin 250 mg and 500 mg tablets 
Erythromycin 125 mg/5ml, 200mg/5ml, 250 mg/5ml and 400mg/5ml 
oral suspension 
Erythromycin 200 mg, 250 mg and 400 mg tablets 
 
Sulfonamides 
             Sulfamethoxazole 200 mg/trimethoprim 40 mg/5ml suspension 
             Sulfamethoxazole 400 mg/trimethoprim 80 mg tab 
Sulfamethoxazole 800 mg/trimethoprim 160 mg tab 
Co-trimoxazole single strength tab 
 
Tetracyclines 

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Demeclocycline 150 mg and 300 mg tablets 
Doxycycline 50 mg and 100 mg tablets 
Minocycline 50 mg and 100 mg capsules 
Tetracycline 250 mg capsules 
Tetracycline 125mg/5ml syrup 
 
Cephalosporins 
Cefadroxil 500 mg capsule 
Cephalexin 250 mg/5 ml suspension 
Cephalexin 250 mg and 500 mg capsules 
Cefaclor 250 mg capsule 
Cefuroxime 250 mg and 500 mg tablets 
Loracarbef 400 mg capsule 
Cefdinir 300 mg capsule 
Cefpodoxime proxetil 100 mg and 200 mg tablets 
 
Beta-Lactams 
Penicillin V K 250 mg tablet 
Penicillin V K 250 mg/5mg solution 
Dicloxacillin 250 mg capsule 
Oxacillin 250 mg capsule 
Amoxicillin 250 mg/5 ml suspension 
Amoxicillin 250 mg and 500 mg capsules 
Amoxicillin 250mg/Clavulanate 125 mg tablets 
Amoxicillin 500mg/Clavulanate 125 mg tablets 
Amoxicillin 875mg/Clavulanate 125 mg tablets 
Amoxicillin 250mg/Clavulanate 62.5 mg/5 ml suspension 
Amoxicillin 600mg/Clavulanate 42.9 mg/5 ml suspension 
Ampicillin 250 mg and 500 mg capsules 
Ampicillin 250mg/5ml suspension 
Bacampicillin 400 mg tablets 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2. Chart Abstraction Form 
Date of abstraction: Click for date. 
Abstractor(s):   
Links: 
Patient Information 
 
Admissions (Discharge Notes) 
PFTs 
 
 
 
Primary Care Visit 
Labs 
 
 
 
Pulmonary Visit 
Medications 
 
 
 
ED Visit 
Imaging 
 
 
 
 
 
Patient:  
Last 4 SSN:  
Station: 
Choose an item. 
 
PCP:   
Team/Location:  
 
Appointment Date/Time:          
 
Age:  
 Sex: 
Click here. 
Race: Choose an 
item. 
Ht (in):   
Wt (lbs):  
BMI:  
Mark if Asthma is on the Problem List in the last 1 year:☐ 
Smoking Status:       
Smoking cessation counseling (last 1 year):       
Date Received:Click to enter a date. 
Provided by:Choose an item. 
Provider name:  
 
 
Outpatient Medications:  Paste in Medication list from CPRS. Includes current, recently expired 
and discontinued. (Recent/current short course of Prednisone? Check for ED eval note). If 
available, include last 2 or 3 ICS med refill dates below the meds. 
Back to top 
 
 
 
 
PFT: Collect worst and additional 2 most recent.  
LLN calculator link: http://www.biostat.jhsph.edu/courses/bio622/misc/calculate.htm 
 
Back to top 
 
Check box if FEV1/FVC is below 0.7 ☐ 
 
 
CXR Chest 2 view: Most recent report 
 
Back to top 
 
 
CT Scan Chest: Most recent report  
Back to top 
 
Upcoming pulm consult or PFTs:  
 
 
 
Hospital Discharges:  Notes from past 1 year. Indicate if 
patient has history of older respiratory-related discharge 
notes 
Back to top 
 
 

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Echo: Most recent report 
 
Back to top 
 
 
 
Labs:  
1. IgE (most recent) 
2. White blood cell count w/differential (most recent) 
“Diff, Automated 5-Part (& Cbc)”, include only values for: Wbc, 
NE%, Ly%, Mo%, Eo%, Ba%, Ne#, Ly#, Mo#, Eo#, Ba# 
3. CO2 (most recent)  
Back to 
top 
 
 
 
 
Primary Care Visits : Notes from past 1 year 
 
Back to 
top 
 
 
Outpatient Pulmonary Visits: most recent note. Could be listed as a Pulmonary outpatient visit or 
Pulmonary consult report 
Back to 
top 
 
 
 
Emergency Department Visit : Note from past 1 
year related to ED visit for COPD 
 
Back to 
top 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 3: E-Consult Note Template 
Pulmonary Non-visit E-Consult Note 
 
 
As part of an ongoing quality improvement initiative (DISCuS COPD) within pulmonary, our team has reviewed your 
patient's medical record to review their use of inhaled corticosteroids.  Our team from pulmonary medicine includes Drs. 
David Au (VAPSHCS), Laura Feemster (VAPSHCS), Renda Wiener (Bedford VA), and Seppo Rinne (Bedford VA).  
 
We have entered any recommendations as orders for you to review, modify as you see fit and sign, if agreeable.  If you 
have questions, please feel free to contact us by encrypted e-mail (VHAPUGSVCICS@va.gov), CPRS, Pulmonary SCAN-
ECHO, or E-Consult. 
 
 
RECOMMENDATIONS:  
1. [enter recommendation to stop inhaled corticosteroid if not indicated (may include taper off of ICS)] 
2. [enter recommendation for substitution of long-acting bronchodilator(s) if indicated] 
3. [enter any additional recommendations] 
 
Please discuss any medication changes that you make with this patient in their upcoming visit with you. 
 
 
 
RATIONALE: 
[provide summary of patient’s history and current inhaled medication regimen] 
 
[provide rationale for recommended changes in inhaled therapies] For example: Recent guidelines advocate that in the 
absence of frequent exacerbations (defined below) patients with COPD should be treated primarily with long-acting 
bronchodilators and to reserve the addition of inhaled corticosteroids for patients with frequent exacerbations.  Inhaled 
corticosteroids have been shown in multiple randomized trials to increase the risk of pneumonia among patients with 
COPD.    
 
 
Frequent exacerbations are defined as 2 or more outpatient exacerbations in the past year AND/OR 1 or more inpatient 
exacerbations in the past 1 year. For patients with COPD that are not controlled with one long-acting bronchodilator, 
combination LABA/LAMA is preferred therapy over LABA/ICS combinations. 
 
Additional information can be found at: 
 
WISDOM Trial  
http://www.nejm.org/doi/full/10.1056/NEJMoa1407154 
 
FLAME Trial: 
http://www.nejm.org/doi/full/10.1056/NEJMoa1516385 
 
*GOLD guidelines 2017, available from:  
http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/ 
 
*VA/DOD Clinical Practice Guideline for the Management of Outpatient Chronic  

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Obstructive Pulmonary Disease, Version 3.0, 2014, available from:  
http://www.healthquality.va.gov/guidelines/cd/copd/ 
Summary: 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDClinicianSummary.pdf 
Pocket Card: 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDPocketCard.pdf 
  
 
End of note 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 4: Baseline Provider Interview Guide 
Grounded prompts:  If responses are limited or require clarification, probes may be used to elicit more detailed responses. 
Probes should use words or phrases presented by the participant using one of the following formats: 
What do you mean by ____________? 
Tell me more about ____________? 
Can you give me an example of ____________? 
Tell me about a time when ____________? 
Can you tell me who ____________? 
Can you clarify the type of inhaler __________? 
Throughout the interview we’ll be referring to inhaled corticosteroids as ICS. Is this okay? 
• 
What is your current position?   
[If needed] What are your main responsibilities? 
[If needed] When did you start this role? 
 
• 
How do you define mild COPD? 
[If needed] How do you define moderate COPD? 
 
• 
Tell me about your experience prescribing ICS for mild COPD. 
 
• 
Tell me about your experience prescribing ICS for moderate COPD. 
 
• 
Have you had patients who have ICS prescriptions from other providers? 
[If Yes] Tell me about discontinuing ICS with these patients.  
[If needed] Have you had patients who request ICS prescriptions based on recommendations from non-VA 
providers?   
[If needed] When another provider has prescribed ICS, how do you decide whether to discontinue a prescription? 
 
• 
Tell me about the evidence related to prescribing ICS for mild COPD. 
[If needed] Tell me about the evidence related to prescribing ICS for moderate COPD. 
 
• 
How clear are the guidelines for prescribing ICS for COPD? 
 
This study is looking at improving patient safety through De-Implementing ICS for Mild COPD by recommending that 
providers discontinue prescribing ICS for mild-to-moderate COPD. 
• 
Are you familiar with this recommendation?  
 
• 
What is your impression of this recommendation? 
 
• 
Tell me about the evidence related to discontinuing the prescribing of ICS for mild-to-moderate COPD. 
• 
Who should be involved in reducing unnecessary prescribing of ICS in patients with mild-to-moderate COPD? 
[If needed] How should they be involved? 
 
• 
Please describe the patient’s role in discontinuing ICS. 
[If needed] What attitudes or preferences do patients express regarding ICS for mild-to-moderate COPD? 
 
• 
How do you think your patients with mild-to-moderate COPD would respond to discontinuing ICS? 
[If needed] Can you give me an example of a time when you discontinued ICS with a patient, and the discussion 
you had with the patient? 
 
• 
Do you have any questions for us, or is there anything else you would like to add? 

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Appendix 5: “Exposed” Provider Interview Guide 
Grounded prompts:  If responses are limited or require clarification, probes may be used to elicit more detailed responses. 
Probes should use words or phrases presented by the participant using one of the following formats: 
 
What do you mean by ____________? 
Tell me more about ____________? 
Can you give me an example of ____________? 
Tell me about a time when ____________? 
Can you tell me who ____________? 
Can you clarify the type of inhaler __________? 
 
We will be referring to the program as DISCUSS. 
 
• 
What is your current position?   
[If needed] What are your main responsibilities? 
What is your role with discontinuing ICS?   
When did you start this role? 
 
• 
Please tell me about your experience prescribing ICS for mild to moderate COPD.  
 
• 
Please tell me about your experience with the DISCUSS program. 
How satisfied have you been with the DISCUSS program? 
Have you received recommendations regarding inhalers from other providers?  
[As needed] How well does DISCUSS fit with your practice?  
 
• 
How aware do you think other prescribers at your site are regarding the recommendations to stop using ICS? 
Who else at your site do you discuss reducing the use of ICS with? 
How receptive do you think other providers at your site have been to reducing the use of ICS? 
 
• 
 [As needed] How easy or difficult has it been to follow through recommendations to stop prescribing ICS for mild to 
moderate COPD? 
Were there any challenges to following through on recommendations to stop using ICS? 
What, if anything, made following through on recommendations to stop using ICS easier?  
 
• 
Was there anything that surprised you about stopping the use of ICS?   
 
• 
Have you had patients who have ICS prescriptions from other providers? 
[If yes] Tell me about discontinuing ICS with these patients.  
Have you had patients who request ICS prescriptions based on recommendations from non-VA providers?   
When another provider has prescribed ICS, how do you decide whether to discontinue a prescription? 
 
• 
Tell me about the effect of discontinuing ICS on patient care. 
Tell me about the patient experience of de-implementing ICSs. 
 
• 
Please describe the evidence related the use of ICS for mild to moderate COPD? 
What are the risks associated with ICSs? 
What alternatives to ICSs are available? 
[If needed] Please describe the evidence related to not using ICS for mild to moderate COPD? 
 
• 
How useful was the training for de-implementing ICS? 
 
• 
What types of unintended consequences have you noticed from discontinuing ICS?  
 

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• 
Please describe the patient’s role in determining ICS use? 
 
• 
What attitudes or preferences do patients express regarding ICS use? 
 
• 
How do you think your patients with mild to moderate COPD would respond to discontinuing ICS? 
Can you give me an example of a time when you discontinued ICS with a patient, and the discussion you had with the 
patient? 
 
• 
How have you felt about receiving these orders from Pulmonology? [Feasibility & Sustainability] 
 
• 
Would you like to see pulmonologists continue to provide this kind of proactive outreach in the form of unsigned 
orders? 
 
• 
At your facility, how involved has leadership been in the DISCUSS program?  
 
• 
Is there anything else you would like us to know about these practices changes?  Is there anyone else you would 
suggest we talk to regarding this project? 
 
• 
Do you have any questions for us?  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 6: “Maintenance” Provider Interview Guide 
[Grounded prompts:  If responses are limited or require clarification, probes may be used to elicit more detailed 
responses. Probes should use words or phrases presented by the participant using one of the following 
formats: 
1. What do you mean by ____________? 
2. Tell me more about ____________? 
3. Can you give me an example of ____________? 
4. Tell me about a time when ____________? 
5. Can you tell me who ____________? 
6. Can you clarify the type of inhaler __________? 
 
We will be referring to the program as DISCUSS. 
 
The DISCUSS COPD intervention involved Pulmonology initiating e-consults to PCPs with ICS treatment 
recommendations for Veterans with mild-to-moderate COPD. 
 
• 
Please tell me about your experience with the DISCUSS program. 
a. How satisfied have you been with the DISCUSS program? 
b. Have you received recommendations regarding inhalers from other providers?  
c. Have you received any additional orders from Pulmonology? 
 
• 
[As needed] How well does DISCUSS fit with your practice? [Acceptability] 
a. How aware do you think other prescribers at your site are regarding the recommendations to 
stop using ICS? 
b. Who else at your site do you discuss reducing the use of ICS with? 
c. How receptive do you think other providers at your site have been to reducing the use of ICS? 
 
• 
 [As needed] How easy or difficult has it been to follow through recommendations to stop prescribing ICS 
for mild to moderate COPD? [Feasibility] 
a. Were there any challenges to following through on recommendations to stop using ICS? 
b. What, if anything, made following through on recommendations to stop using ICS easier?  
 
• 
After receiving a few of these orders, how has this influenced your approach to using ICS with other 
patients [with mild-to-moderate COPD]? 
 
• 
Tell me about the effect of discontinuing ICS on patient care. 
 
 
• 
Have you had patients who have ICS prescriptions from other providers? 
a. [IF Yes]  Tell me about discontinuing ICS with these patients.  
b. Have you had patients who request ICS prescriptions based on recommendations from non-VA 
providers?   
c. When another provider has prescribed ICS, how do you decide whether to discontinue a 
prescription? 
 
• 
How are patients with mild to moderate COPD responding to discontinuing ICS? 
a. Can you give me an example of a time when you discontinued ICS with a patient, and the 
discussion you had with the patient? 
b. What attitudes or preferences do patients express regarding ICS use? 
 
 
• 
Was there anything that surprised you about stopping the use of ICS?   
 

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• 
What types of unexpected changes have you noticed from discontinuing ICS?  
 
• 
How did you feel about getting the notes and suggestions as pre-completed orders from the 
pulmonologists?   [Feasibility & Sustainability] 
 
• 
If this program were to continue in the future, would you like to see pulmonologists continue to provide this 
kind of proactive outreach in the form of unsigned orders? 
a. What do you think could be changed or improved? 
 
• 
How has this program been received?  
 
• 
How has leadership been involved in the DISCUSS program.  
 
 
• 
Is there anything else you would like us to know?  Is there anyone else you would suggest we talk to 
regarding this project? 
 
• 
Do you have any questions for us?  
 
Thank you very much for your time.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 7: “Exposed” Patient Interview Guide 
Grounded prompts:  If responses are limited or require clarification, probes may be used to elicit more detailed responses. 
Probes should use verbatim words or phrases presented by the participant using one of the following formats: 
What do you mean by ____________? 
Can you tell me more about  ____________? 
Can you give me an example of ____________? 
Can you tell me about a time when ____________? 
 
 
• 
Do you see a doctor about your breathing? 
• 
Do you use any inhalers for your breathing? 
 
 
[If yes]  
a. What is the type or name of the inhalers you use? 
b. Under what circumstance do you use your inhalers(s)? 
c. How often do you use your inhaler? 
 
 
 [If no] 
a. Have you used inhalers in the past? 
b. What type or name of the inhalers did you use? 
c. Under what circumstance did you use your inhalers(s)? 
d. When did you stop using your inhaler? 
 
• 
Has there been a time you wanted an inhaler and you did not have it? 
 
• 
Has your inhaler prescription changed within the last few months? 
 
[If yes] Tell me about the change.  
 
• 
Can you tell me about a time when you got too much care? 
 
• 
Can you tell me about a time when you didn’t get enough care? 
 
• 
Is there anything we should have asked you about inhalers that we did not? 
 
• 
Do you have any questions for us, or is there anything else you would like to add? 
 

10/27/2016 4:52pm
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Confidential
Page 1 of 4
DISCUSS COPD Baseline Provider Survey
Please complete the survey below for the De-implementing Steroids to Improve Care and Safety in COPD (DISCUSS
COPD) project. Thank you!
Inhaled corticosteroids (ICS) are recommended to treat some patients with chronic obstructive pulmonary disease
(COPD). We want to better understand VA providers' perspectives on ICS use for patients with mild to moderate
COPD.
1.
In the past month, I have prescribed an inhaled
Yes
corticosteroid for one or more primary care patient
No
with mild to moderate COPD.
Experience
This section asks about the use of ICS by patients with mild to moderate COPD.
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
2.
Use of long-acting muscarinic
antagonist (LAMA) or long-acting
beta agonist (LABA) is as
effective as use of ICS in
reducing risk of COPD
exacerbation.
3.
Use of ICS by patients with COPD
results in higher risk of
pneumonia than use of a LAMA
and/or LABA.
4.
Use of LAMA and/or LABA by
patients with mild to moderate
COPD has a higher
cardiovascular risk than use of
an ICS.
5.
COPD should be treated the
same as asthma.
6.
I am unlikely to take a patient off
of ICS if another provider wrote
the prescription. 
7.
Reducing use of ICS by patients
with mild to moderate COPD is
supported by my clinical
experience.
8.

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Page 2 of 4
Reducing use of ICS for patients
with mild to moderate COPD
takes into consideration the
needs and preferences of my
patients and their family
members. 
Intention
In the next 6 months, for patients with mild to moderate COPD, I will:
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
9.
Make greater use of LAMAs
and/or LABAs.
10.
Make efforts to reduce ICS
prescriptions.
11.
Find ways of managing
breathing issues with
approaches other than
medications.
Context
In the past year, how frequently have you observed the following sets of behaviors in senior
leadership or clinical management (e.g., Clinic Director, Chief of Staff, Director) in your clinic?
Very
Infrequently
Infrequently
Neither
Frequently
Nor
Infrequently
Frequently
Very
Frequently
Don't
Know/Not
Applicable
12.
Reward clinical innovation and
creativity to improve patient
care.
13.
Promote team building to solve
clinical care problems.
14.
Establish clear goals for patient
care processes and outcomes.
15.
Encourage and support changes
in practice patterns to improve
patient care.

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Confidential
Page 3 of 4
The following questions are about improving care for primary care patients.
Very
Infrequently
Infrequently
Neither
Frequently
Nor
Infrequently
Frequently
Very
Frequently
Don't
Know/Not
Applicable
16.
How frequently have you
observed your colleagues from
the clinic exhibit a sense of
personal responsibility for
improving patient care and
outcomes?
17.
When change needs to happen
to improve patient care, how
frequently have you or your
colleagues had the necessary
resources such as budget,
training, staffing, facilities or
protected time?
Work Life
This section contains statements about job-related feelings. Please check the appropriate box
to tell us how frequently you feel this way.
Copyright © 1981 by Christina Maslach & Susan E. Jackson. All rights reserved in all media.
Published by Mind Garden, Inc. www.mindgarden.com
Never
A Few
Times Per
Year
Once a
Month or
Less
A Few
Times Per
Month
Once a
Week
A Few
Times Per
Week
Every Day
18.
I feel burned-out from my work.
19.
I worry that this job is hardening
me emotionally.
20.
I have accomplished many
worthwhile things in this job.

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Page 4 of 4
Turnover
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
21.
If I were able, I would leave my
current job.
22.
I plan to leave my job within the
next six months.
About You
23.
How long have you been with VA?
Less than 6 months
Between 6 months and 1 year
Between 1 and 2 years
Between 2 and 5 years
Between 5 and 10 years
Between 10 and 15 years
Between 15 and 20 years
More than 20 years
24.
What is your level of supervisory responsibility?
None
Team Leader (informal; not responsible for
performance ratings)
First Line Supervisor (formal; rates performance,
e.g.: Foreman, Section Chief)
Manager (formal; rates performance e.g.:
Division/Department/Service/Care Line managers)
Executive (formal; rates performance e.g.:
Associate Director, Chief of Staff, Program
Director, Nurse Executive)
Senior Executive (formal; rates performance e.g.:
Network Director, Facility Director, Chief Medical
Officer, Chief Officer, Deputy)
25.
Is there anything else you would like us to know?
 
__________________________________________
Thank you for your assistance in completing this survey.
For further questions, please contact:
Christian Helfrich, MPH PhD at
christian.helfrich@va.gov

10/11/2017 4:15pm
www.projectredcap.org
Confidential
Page 1 of 3
DISCUSS COPD Follow up Provider Survey
Please complete the survey below for the De-implementing Inhaled Steroids to Improve Care and Safety in COPD
(DISCUSS COPD) project. Thank you!
In the past 12 months, you may have received information and advice about the potential value of reducing the use
of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) for whom this therapy may
not be the best practice. Included in the information you received were details about the benefit of changing this
prescribing practice for some patients, and the potential reduction in pneumonia among this population.
We want to better understand VA providers' perspectives on inhaled corticosteroids (ICS) use for COPD.
Experience
The first questions ask about use of ICS by patients with mild-to-moderate COPD.
In the past month, I have prescribed an inhaled
Yes
corticosteroid for one or more primary care patient
No
with mild-to-moderate COPD.
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
Use of a long-acting muscarinic
antagonist (LAMA) and/or
long-acting beta agonist (LABA)
is as effective as use of ICS in
reducing risk of COPD
exacerbation.
Use of ICS by patients with COPD
results in higher risk of
pneumonia than use of a LAMA
and/or LABA.
Use of LAMA and/or LABA by
patients with mild to moderate
COPD has a higher
cardiovascular risk than use of
an ICS.
COPD should be treated the
same as asthma.
I am unlikely to take a patient off
of ICS if another provider wrote
the prescription.
Reducing use of ICS by patients
with mild to moderate COPD is
supported by my clinical
experience.

10/11/2017 4:15pm
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Confidential
Page 2 of 3
Reducing use of ICS for patients
with mild to moderate COPD
takes into consideration the
needs and preferences of my
patients and their family
members. 
 Patient Response
 In the past 6 months, have you proposed
Yes
discontinuing or reducing an ICS prescription for
No
one of your patients  with mild-to-moderate COPD
Very
Receptive
Somewhat
Receptive
Neither
Receptive nor
Unreceptive
Somewhat
Unreceptive
Very
Unreceptive
Don't
Know/Not
Applicable
 If YES, how did the patient
respond?
Continued
Reduced Dosage
Switched to another
medication
Discontinued
 For this patient was the
medication
Comments:
__________________________________
In the past 6 months, have you proposed discontinuing
Yes
or reducing other prescriptions for one of your
No
patients?
Very
Receptive
Somewhat
Receptive
Neither
Receptive nor
Unreceptive
Somewhat
Unreceptive
Very
Unreceptive
Don't
Know/Not
Applicable
If YES, how did the patient
respond?
Continued
Reduced Dosage
Switched to another
medication
Discontinued
 For this patient was the
medication
 Comments:
__________________________________

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Page 3 of 3
Provider Response
If you received information and advice about the potential value of reducing the use of inhaled
corticosteroids in patients with COPD, did you feel:
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
Irritated
Angry
Annoyed
No, Strongly
Disagree
No, Disagree
Neither Agree
nor Disagree
Yes, Agree
Yes, Strongly
Agree
Don't
Know/Not
Applicable
Did you criticize information you
received about efforts to reduce
ICS use among patients with
COPD?
Can you think of points that go
against efforts to reduce ICS use
among patients with COPD?
Are you skeptical of efforts to
reduce ICS use among patients
with COPD
Is there anything else you would like us to know?
 
__________________________________________
Thank you for your assistance in completing this survey.
For further questions, please contact:
Christian Helfrich, MPH PhD at
christian.helfrich@va.gov

10/07/2021 3:31pm
projectredcap.org
Confidential
Page 1
DISCUSS COPD Provider Survey
Please complete the survey below for the De-implementing Inhaled Steroids to Improve Care and Safety in COPD
(DISCUSS COPD) project. Thank you!
In the past 12 months, you may have received information and advice about the potential value of reducing the use
of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) for whom this therapy may
not be the best practice. Included in the information you received were details about the benefit of changing this
prescribing practice for some patients, and the potential reduction in pneumonia among this population.
We want to better understand VA providers' perspectives on inhaled corticosteroids (ICS) use for COPD.
Use of inhaled corticosteroids (ICS) by patients with mild-to-moderate COPD:
In the past month, I have prescribed an ICS for one
Yes
or more primary care patient(s) with
No
mild-to-moderate COPD.
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
Use of a long-acting muscarinic
antagonist (LAMA) and/or
long-acting beta agonist (LABA)
is as effective as use of ICS in
reducing risk of COPD
exacerbation.
Use of ICS by patients with COPD
results in higher risk of
pneumonia than use of a LAMA
and/or LABA.
Use of LAMA and/or LABA by
patients with mild to moderate
COPD has a higher
cardiovascular risk than use of
an ICS.
COPD should be treated the
same as asthma.
I am unlikely to take a patient off
of ICS if another provider wrote
the prescription.
Reducing use of ICS by patients
with mild to moderate COPD is
supported by my clinical
experience.

10/07/2021 3:31pm
projectredcap.org
Confidential
Page 2
Reducing use of ICS for patients
with mild to moderate COPD
takes into consideration the
needs and preferences of my
patients and their family
members. 
Discontinuing or reducing an ICS prescription and patients' emotional reactance to the
precription change:
 In the past 6 months, have you proposed
Yes
discontinuing or reducing an ICS prescription for
No
one of your patients  with mild-to-moderate COPD
Very
Receptive
Somewhat
Receptive
Neither
Receptive nor
Unreceptive
Somewhat
Unreceptive
Very
Unreceptive
Don't
Know/Not
Applicable
 If YES, how did the patient
respond?
Continued
Dosage Reduced
Switched to another
medication
Discontinued
 For this patient was the
medication
Comments:
__________________________________
In the past 6 months, have you proposed discontinuing
Yes
or reducing other prescriptions for one of your
No
patients?
Very
Receptive
Somewhat
Receptive
Neither
Receptive nor
Unreceptive
Somewhat
Unreceptive
Very
Unreceptive
Don't
Know/Not
Applicable
If YES, how did the patient
respond?
Continued
Dosage Reduced
Switched to another
medication
Discontinued
 For this patient was the
medication
 Comments:
__________________________________

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Page 3
We are trying to gauge emotional reaction to receiving information and advice about the
potential value of reducing the use of ICS in patients with COPD.
If you received information and advice about the potential value of reducing the use of ICS in
patients with COPD, did you feel:
Strongly
Disagree
Disagree
Neither Agree
Nor Disagree
Agree
Strongly
Agree
Don't
Know/Not
Applicable
Irritated
Angry
Annoyed
No, Strongly
Disagree
No, Disagree
Neither Agree
nor Disagree
Yes, Agree
Yes, Strongly
Agree
Don't
Know/Not
Applicable
Did you criticize information you
received about efforts to reduce
ICS use among patients with
COPD?
Are you skeptical of efforts to
reduce ICS use among patients
with COPD
Can you think of points that go
against efforts to reduce ICS use
among patients with COPD?
Is there anything else you would like us to know?
 
__________________________________________
 You missed a question! Please complete the question(s) or click Submit.
Thank you for your assistance in completing this survey.
For further questions, please contact:
Christian Helfrich, MPH PhD at
christian.helfrich@va.gov