Integrating Care After Exacerbation of COPD (InCasE)
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: VA Office of Research and Development

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INtegrating Care After Exacerbation of COPD (InCasE) 
 
Protocol 
NCT02021955 
12/18/2018 

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Table of Contents 
1. 
Abbreviations ............................................................................................................................................................... 3 
2. 
Funding/Regulatory ..................................................................................................................................................... 3 
3. 
Study Investigators ...................................................................................................................................................... 3 
4. 
Background/Rationale ................................................................................................................................................. 4 
5. 
Rationale and objectives .............................................................................................................................................. 4 
6. 
Setting ............................................................................................................................................................................ 5 
7. 
Overall Design .............................................................................................................................................................. 5 
8. 
Provider Eligibility, Recruitment, and Consent ....................................................................................................... 6 
8.1. 
Eligibility: .............................................................................................................................................................. 6 
8.2. 
Recruitment: .......................................................................................................................................................... 6 
8.3. 
Consent: ................................................................................................................................................................. 7 
8.4. 
Provider clustering/randomization: .................................................................................................................. 7 
9. 
Index discharges ........................................................................................................................................................... 7 
9.1. 
International Classification of Diseases (ICD) discharge diagnosis codes:.................................................. 7 
9.2. 
Discharges with missing ICD codes: ................................................................................................................. 7 
9.3. 
Additional eligibility criteria. ............................................................................................................................. 8 
10. Intervention ................................................................................................................................................................... 8 
10.1. 
Recommendations for COPD guideline care: .............................................................................................. 8 
10.2. 
In-services: ......................................................................................................................................................... 9 
11. Blinding: ........................................................................................................................................................................ 9 
12. Outcome and Baseline Assessments.......................................................................................................................... 9 
12.1. 
Primary outcome measures .......................................................................................................................... 10 
12.2. 
Secondary measures ...................................................................................................................................... 10 
12.3. 
Other measures: .............................................................................................................................................. 11 
12.4. 
Baseline Characteristics: ................................................................................................................................ 11 
12.5. 
Remuneration: ................................................................................................................................................ 13 
13. Analytic Approach ..................................................................................................................................................... 13 
13.1. 
Models ............................................................................................................................................................. 13 
13.2. 
Sampling and non-response bias and missing data .................................................................................. 13 
13.3. 
Sample size and study power ....................................................................................................................... 14 
13.4. 
Qualitative analyses ....................................................................................................................................... 14 
14. Protection of Human Subjects .................................................................................................................................. 15 

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14.1. 
Minimal risk .................................................................................................................................................... 15 
14.2. 
Consent ............................................................................................................................................................ 15 
14.3. 
Data and safety monitoring .......................................................................................................................... 15 
14.4. 
Data management and confidentiality ........................................................................................................ 16 
15. Summary of Changes from original protocol ........................................................................................................ 16 
16. References.................................................................................................................................................................... 18 
Appendix 1: Chart abstraction template ....................................................................................................................... 20 
Appendix 2: Recommendations checklist template ................................................................................................... 24 
Appendix 3: Modified SHEP .......................................................................................................................................... 34 
Appendix 4: Provider Satisfaction Survey ................................................................................................................... 36 
Appendix 5: Provider Interview Guide ........................................................................................................................ 38 
 
 
1. Abbreviations 
• 
(CCQ) – Clinical COPD Questionnaire 
• 
(CDW) – VA Corporate Data Warehouse(ICD) - International Classification of Diseases 
• 
(DC) - Discharge 
• 
(EHR) – Electronic Health Record 
• 
(GLMM) – Generalized Linear Mixed Model 
• 
(IRB) – Institutional Review Board 
• 
(MCS) – Mental Component Summary 
• 
(PCP) – Primary Care Provider 
• 
(PCS) – Physical Component Summary 
• 
(SHEP) – Survey of Healthcare Experiences of Patients 
• 
(VA) – Veterans Affairs 
• 
(VISN) – Veterans Integrated Service Network 
• 
(VR-12) – Veterans RAND 12 Item Health Survey 
 
2. Funding/Regulatory 
• 
Funding: Veterans Affairs (VA) Health Services Research and Development IIR 12-130-2 
• 
IRB: VA Puget Sound Institutional Review Board (IRB) approved all study procedures.  
• 
Trial registration: ClinicalTrials.gov as NCT02021955. 
 
 
3. Study Investigators 
VA Puget Sound Health Care System: 
Principal Investigator 
• 
David H. Au, MD, MS; david.au@va.gov 

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Co-Investigators: 
• 
Rosemary Adamson, MB, BS; rosemary.adamson@va.gov 
• 
Douglas Berger, MD; douglas.berger@va.gov 
• 
Scott Coggeshall, PhD; scott.coggeshall@va.gov 
• 
Richard Goodman, MD; goodmanr@uw.edu 
• 
Karin Nelson, MD, MSHS; karin.nelson@va.gov 
• 
Lynn Reinke, PhD, ARNP; lynn.reinke1@va.gov 
• 
Deborah Woo, PharmD; pharmacist; deborah.woo@va.gov 
• 
Andrew Zhou, PhD; biostatistician, andrew.zhou@va.gov 
 
Boise VA Medical Center: 
Site Principal Investigator: 
• 
Paula Carvalho, MD; site principal investigator and clinical reviewer; paula.carvalho@va.gov 
 
Co-Investigator: 
• 
William Weppner, MD, MPH; co-investigator and clinical reviewer; william.weppner@va.gov 
 
4. Background/Rationale 
Hospital admission and readmission have been an interest as an important driver of healthcare costs (AHRQ – 
Au-DH).1  In 2014, CMS implemented a COPD readmission penalty with assumptions that 30-day hospital 
readmissions were in part related to quality of care received while in hospital.  Interest has focused on 
interventions to reduce COPD readmission with systematic reviews expressing doubt about the effectiveness 
of such interventions.2,3  From a patient perspective, exacerbations cause significant decrements in health-
related quality-of-life.4,5,6,7   Across health systems, exacerbations drive health care expenditures with as many 
as half of patients requiring readmission within 6 months.   The time after discharge (DC) for hospital can be 
viewed as a sensitive period where the likelihood of relapse peaks within 8 to 12 weeks after the incident 
exacerbation.  How to deliver guideline recommended services in a timely fashion is a challenge across most 
health systems.  
Within North America, the Department of Veterans Affairs provides care to Veterans at more than 1000 
primary care settings and 150 medical centers.   To meet the needs of Veterans across all instances of health 
care settings, VA needs to redesign care delivery systems regardless of locale.  VA’s current specialty care 
system reflects a fee-for-service model where specialists wait for patient referrals and do not assume 
responsibility for the health of a population of patients.  This approach does not take advantage of the VA 
integrated health system increasing risk of care fragmentation.  Specialists also are geographically 
concentrated at major medical centers that are culturally and physically separated from the patient's medical 
home. Determining how to deploy existing specialties using a primary care and patient centric approach 
represents an important opportunity to improve access, timeliness, and quality-of-care.  
 
5. Rationale and objectives  
To be successful, health systems require a pragmatic health system-level solution. In this intervention, we 
propose to realign specialty care to collaborate with primary care teams and focus on patient needs and 
guideline concordance after discharge from hospital for COPD exacerbation.  The intervention was designed to: 
1) support primary care teams in the care of patients recently discharged for a COPD exacerbation, 2) utilize 
population health methods to identify patients at risk of readmission, 3) integrate proactive collaborative care 

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with specialty care and primary care teams 4) deliver care within the context of existing services and ongoing 
care, 5) leverage data systems and virtual care to facilitate improved delivery, and 6) respect the role of primary 
care while attempting to minimize their workload.  Our goal is to improve 1) patient quality-of-life as measured 
by the Clinical COPD questionnaire and 2) reduce 180-day hospital readmission and mortality after hospital 
discharge.  
 
6. Setting 
We will conduct this trial at the VA Puget Sound Health Care System in Washington State, and the Boise VA 
Medical Center in Idaho. These are two academic medical facilities within VISN 20.  We will include their 
accompanying 10 community-based outpatient clinics. These facilities cover a wide geographic range, 
including six that are designated as rural facilities. 
 
7. Overall Design 
We will perform a modified stepped wedge clinical 
trial which is a variant of a clustered randomized 
cross-over design.8,9   Our focus will be to evaluate a 
multifaceted intervention designed to improve 
quality-of-life and decrease rate of hospital 
readmission and mortality among patients who were 
discharged from hospital with an exacerbation of 
COPD (Figure 2).  We chose a modified stepped 
wedge design for several reasons: 1) resource 
constraints require a staggered roll out of the 
intervention; 2) timing is randomized, allowing all 
providers to eventually receive the intervention; 3) 
utilizes within and across provider comparisons 
maximizing efficiency and allowing the fewest 
number of providers to be enrolled because analyses 
utilize within provider and between provider 
comparisons increasing power.   
 
In this stepped wedge design, clusters of teams transition from the control group to the intervention group 
over time.  For this trial (Figure 2), we will assemble 30 clusters of primary care teams (see Section 8.4).   Each 
primary care team consists of between 1-4 primary care clinicians.  The number of primary care teams 
allocated to each cluster will be done to ensure a balanced number of patients with COPD in each cluster.  All 
clusters of teams will start in the control group (first column of Figure 2).  At the beginning of every 30-day 
period, a randomly selected cluster of primary care teams will transition to the intervention group such that 
all clusters will be in the intervention group in the 30th period (last column of Figure 2).  The first control 
period (period 0) started on May 12, 2015. 
 
We describe the trial flow in the following sections as illustrated in Figure 2. 
Figure 2.  Transition of primary care team clusters 
from control to intervention.
1c
1c
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Clusters*
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cc
 
*1-4 providers/team and 2-13 teams/cluster such that each 
cluster had comparable number of COPD patients 

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8. Provider Eligibility, Recruitment, and Consent 
8.1. 
Eligibility: 
We will obtain names and contact information for providers from the VA Corporate Data Warehouse (CDW).10 
We will invite all PCPs (physicians, physician residents, physician’s assistants, and nurse practitioners) from 
the VA Puget Sound and the Boise VA Medical Center to participate.  The only exception will be PCPs who 
agreed to be co-investigators on this trial.   
 
8.2. 
Recruitment: 
We will approach providers using the following methods: 
Primary care team meetings:  We will introduce the study at primary care team meetings and grand rounds.  
At the end of the presentation, we will ask providers to complete an enrollment sheet indicating their 
willingness, or not, to participate and a short demographic survey.  Providers will either return the enrollment 
forms to trial staff after the meeting or mail it to us after the meeting.  For providers who do not indicate their 
willingness, we will send an email inviting them to participate (see next section).   
 
Email: We will invite providers via email if they do not return an enrollment sheet after a team meeting or if 
they are hired after the intervention launches.  The email will contain an overview of the study, and a link to a 
detailed study description and the demographic survey, as well study contact information.  The email will ask 
providers to review the material and reply if they wish to be excluded.  The email explains that we will 
consider them enrolled in the study if they do not respond within one week (default opt-in), and that they 
could withdraw at any time. 
 
 
 
Figure 2: Overll study flow 
Randomized to 
date to cross 
from control to 
intervention:
• All start in 
control
• All move to 
intervention 
over 30-
month period
Recruitment 
& Consent:
• staff 
meeting
• e-mail, or
• telephone
Patient 
DC 
with 
COPD dx
Chart 
Abstrac-
tion
Study 
Team 
Clinical 
Review
Guideline 
treatment 
recommen-
dations placed 
in CPRS 
patient record
Satisfaction 
survey; 
interview
Primary care 
post-DC visit: 
PCP accepts, 
modifies, or 
declines 
reccomen-
dations
Follow-up 
with PCP
Provider
experience
Intervention
Outcomes
Control
(Usual 
Care)
Repeat for each patient DC with COPD Exacerbation
Patient
experience
 post DC 
survyey 
(mail or 
telephone
Receives 
care as 
directed by 
PCP
Patient 
outcomes 
from 
CDW
Color
Key
Recruitment

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8.3. 
Consent: 
We will consider a provider consented once they return the enrollment sheet, respond to the invitation email 
indicating that they want to participate, or we receive no response to the email within one week.  
 
8.4. 
Provider clustering/randomization: 
We will group VA Primary care teams based on continuity and usual cross -coverage purposes.  Primary care 
teams consist of 1-4 providers.  We will group consented providers into 30 clusters.  When assembling 
provider clusters, to the extent possible, we will group teams 1) that had shared staffing (e.g. nurses, medical 
support assistants), 2) are from the same site, and 3) when combined have relatively even distributions of 
empaneled clinic patients with a COPD diagnosis.  By clustering this way, we minimize potential 
contamination of providers in the control arm by providers who had already crossed into the intervention.   
 
The trial biostatistician will randomly assign each cluster to one of 30 30-day time periods.  Each period the 
next cluster of PCP teams will transition from the control to the intervention period.  When new providers join 
a primary care team, they assume their team’s cluster and randomization time period. If providers change 
teams after randomization, they will retain their original cluster assignment.  Any new teams created will be 
randomly assigned into one of the remaining intervention time periods such that they will have at least one 
time period in the control and intervention periods.   
 
9. Index discharges  
An index discharge is the date of a hospital discharge involving care for COPD for a patient under the care of 
an enrolled provider starting May 12, 2015.  We will interrogate the CDW daily to identify all eligible 
discharges as described below.  
 
9.1. 
International Classification of Diseases (ICD) discharge diagnosis codes: 
We will define a COPD exacerbation as a primary ICD-9 primary discharge diagnosis of COPD (491%, 492%, 
493.2%, or 496%), or a primary discharge diagnosis of respiratory failure (518.51, 518.53, 518.81, 518.83, 518.84) 
with any secondary diagnosis of COPD. In October 2015, VA will switch from the ICD-9 to the ICD-10 coding 
convention (J41.0, J41.1, J41.8, J42., J43.0, J43.1, J43.2, J43.8, J43.9, J44.0, J44.1, or J44.9 for COPD and J80., J96.00, 
J96.01, J96.02, J96.10, J96.11, J96.12, J96.20, J96.21, J96.22, J96.90, J96.91, J96.92 for respiratory failure).  
 
We will exclude patients who were miscoded as having COPD discharge.  Study coordinators will review the 
electronic health record (EHR) to confirm that the patient received care consistent with a COPD exacerbation.  
A single coordinator will review discharges where COPD is the primary discharge diagnosis.  For cases of 
uncertainty, a second coordinator will review.  If discordant, a study clinician will adjudicate and make the 
final decision.  
Discharges for respiratory failure with a secondary COPD diagnosis are often more complicated. In this 
situation, two coordinators will independently review and adjudicate with a clinician when discordant.   
 
9.2. 
Discharges with missing ICD codes: 
For discharges with a missing ICD discharge code, we will employ a Natural Language Processing algorithm 
to identify potential index discharges.  This algorithm identifies discharges with pre-defined keywords 
(%COPD%, %Bronchitis%, %Bronchiectasis%, %Bronchospasm%, %Emphysema%, %Acute% and %Bronc%, 
%SOB% and %Bronchitis%, %Chronic% and %Bronc%, %Chronic% and %Pulm%, %Chronic% and 

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%Obstruct%, Obstructive Pulmonary Disease, or Reactive Airway Disease) contained within the admission 
diagnosis or discharge summary text. Once identified, coordinators will review the EHR to confirm the 
hospitalization covered treatment for a COPD exacerbation.   
 
9.3. 
Additional eligibility criteria.   
• 
A patient may have more than one index discharge if the 180-day outcomes period for the prior index 
discharge is completed and was with a provider in the control group.  Once a patient has a discharge with 
a provider in the intervention group, they cannot have additional index discharges.  We will include each 
patient’s first discharge only in primary analyses. 
• 
We will exclude patients for whom we would not be able to provide recommendations including those 
discharged to a domiciliary unit, a nursing home, respite care, or to hospice.  
• 
We considered patients discharged and readmitted within 12 hours to have a continuous hospital 
admission.   
 
10. Intervention 
10.1. Recommendations for COPD guideline care: 
Each week, for patients with a new index discharge and under the care of a provider in the intervention group, 
we will perform the following: 
Chart abstraction: A study coordinator will cut and paste pertinent sections of the EHR into an abstraction 
template (Appendix 1).  These abstractions will include notations from emergency care, discharge summaries, 
primary care, pulmonary/sleep, social work, advanced directives, post-discharge telephone calls, and 
procedures and imaging studies.   
 
Clinical review: The intervention team, consisting of pulmonary, primary care, and pharmacy providers, and 
study coordinators will convene to prepare recommendations for each patient with an abstraction as follows: 
• 
Clinical lead:  
o A pulmonologist or PCP team member will be designated to lead the review each week 
o Reviews the abstractions, and/or EHR as needed, to draft a recommendations checklist 
(Appendix 2).  The checklist will include: 
 
Recommendations for diagnostic testing, medications, therapies/referrals, and/or 
follow-up, addressing any gaps in contemporary COPD guideline recommended 
care4,11 and related co-morbidities. 
 
Draft of the recommendations note that will be placed into the EHR for the PCP’s 
review.    
• 
Review meeting: 
o Moderator: clinical lead. 
o Attendees: a clinical team consisting of at least one pulmonologist and one PCP, with input by 
the pharmacist as needed, and coordinators. 
o Review: the clinical team will discuss each patient’s history, consulting the abstraction and 
EHR as needed, and identify any gaps in guideline COPD/comorbidity care. 
• 
Recommendations: 
o Final recommendations: modify draft recommendations checklist as appropriate per team 
review 
o Language/content: ensure that notations will be acceptable to primary care providers.  For 
example, smoking cessation counseling:   

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 
Do not recommend if there have been notations reflecting previous discussions.  
 
Do offer recommendations such as addition of pharmacotherapy for smoking cessation 
if none has been previously offered. 
o No recommendations: if a patient is receiving all guideline care, reinforce the excellent work. 
 
Entering recommendations and/or orders into EHR: We will provide recommendations to the PCP timed to 
coincide with the patient’s post-discharge clinic follow-up (usually within two weeks of discharge) as follows: 
• 
EHR notation:  
o Enter note: a study coordinator will cut and paste the finalized recommendations note into the 
EHR as an E-Consult note for the lead clinician to sign.   
o Lead study clinician signs: once entered, the clinician will receive an EHR alert that they have 
a note ready for signature.   
o Additional signers: To ensure awareness, we will add the patient’s PCP and pulmonologist, if 
any, as additional signers. If the PCP is a resident, we will add the attending physician as a 
signer.  
o Questions: The note will encourage the PCP to ask any questions about the recommendations, 
or any other elements of their OPD care, by responding with an addendum to the note, 
through encrypted email, or telephone. 
• 
Enter unsigned orders:   
o A study coordinator will enter any recommended orders notated on the finalized. 
recommendations checklist as an unsigned order on behalf of the PCP to sign.  
o For any questions that arise, the coordinator will seek guidance from the lead clinician. 
• 
PCP reviews recommendations:  
o View alert: once entered, the PCP will receive an EHR alert that an order is awaiting signature.   
o Signs, modifies, or cancels orders: the PCP may choose to sign the order as is, modify the 
order, or decline the order as appropriate given their personal knowledge of the patient’s 
clinical condition.   
o Autonomy: this process ensures the PCP maintains autonomous care of the patient.   
• 
Recommendations requiring more clinical context:  
o We will elaborate on recommendations that require more clinical context in the E-consult note 
but will not enter any related orders on behalf of the PCP.  
 
10.2. In-services: 
The study pharmacist will provide periodic training to residents on correct use of inhalers available in the VA 
formulary. 
 
11. Blinding: 
Because we will only review for recommendations patients whose PCP was in the intervention, it is not 
possible for anyone on the study team to be blinded for the intervention.  Patient self-report outcomes 
collected over the telephone were collected by a coordinator blinded to the patient’s intervention status. 
 
12. Outcome and Baseline Assessments  
We will assess the following using a combination of data extracted from CDW, EHR chart review, and self-
report surveys (Table 1).  For patient self-report, we will mail an invitation to complete surveys six weeks after 
their index discharge.  The mailing will include a cover letter informing them that their provider is taking part 
in the study and asking for their input about their satisfaction with their COPD care and COPD-related health.  

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The mailing also will include an Information Statement with detailed information about the study.  The letter 
will ask them to either return completed surveys by mail, or to return a postcard indicating they do not want 
to participate or that they want more information through a telephone call.  For those who do not respond 
after two weeks, we will follow up with a telephone call.  For those who prefer, we administered the surveys 
over the telephone.   We describe provider self-report methods below. 
 
12.1. Primary outcome measures 
Hospital readmission and mortality:  assess 180 days after the index discharge with a composite measure of 
any hospital readmission or death. 
COPD specific health status:  measured with the Clinical COPD Questionnaire (CCQ),12-14 which consists of 10 
items that encompass three domains (symptoms, functional state, mental state).  Scores range from 0-to-6 with 
higher scores indicating better health. The minimally important difference (MID) is 0.39 with a standard error 
of 0.21.     
 
12.2. Secondary measures 
Secondary outcomes - patient-reported: 
General health status: measure using the Veterans RAND 12 Item Health Survey (VR-12),15,16 which consists of 12 
items yielding a Physical Component Summary (PCS) and Mental Component Summary (MCS) score of 0-100, 
with higher scores reflecting better health.  Our outcome is the PCS score, which has a national mean of 27.0 
(SD=8.4) among Veterans admitted for COPD.17 
Patient satisfaction:  assess patients’ satisfaction with respect to the post-discharge primary care follow-up visit 
using sections of the Patient Care Medical Home Survey of Healthcare Experiences of Patients (SHEP) (Appendix 3).  
We will use the 6-item communication, 3-item medication decisions, and the 2-item self-management 
composite scores, as well as single-item questions covering coordination of care, information, and provider 
rating.   
Secondary outcomes - provider experience and perception:  
To assess providers’ experience and perception of the intervention, we will use a convergent mixed methods18 
approach, concurrently using quantitative and qualitative measures.18 For quantitative measures, we 
developed a brief 10-item survey (Appendix 4), based on our work with the VA Office of Specialty Care 
Transformation evaluation, that assessed topics directly relevant to our intervention including satisfaction 
with the consultation process, workload, patient access to specialty care, and quality of care delivered.  Within 
two weeks of posting recommendations for their first intervention patient, we will email providers asking 
them to complete this survey on-line.  For those who do not respond, we will mail the survey with a return 
inter-office envelope.     
 
For the qualitative approach, coordinators will conduct semi-structured interviews using scripted, open-ended 
questions and semi-structured prompts (Appendix 5) to elicit thick descriptions that capture the depth and 
breadth of providers’ experiences including: acceptability; fit with practice; feasibility and satisfaction with the 
intervention; and its perceived effectiveness.  We will invite providers to participate in the interview after their 
first intervention patient is discharged. We anticipated needing to interview no more than 30 providers to 
reach thematic saturation, the point at which no new or novel insights are provided 19 
 

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12.3. Other measures: 
Uptake of care recommendations:  A coordinator will use the finalized recommendations checklist to enter 
recommendations into the study database.  A second coordinator, blinded to the first coordinator’s entries, 
also will enter the recommendations.  The coordinators will discuss any discrepancies, clarifying with that 
week’s lead clinician as needed to resolve. Six weeks after an index discharge for a patient of an intervention 
provider, two study coordinators will independently conduct EHR chart reviews to determine which of the 
care recommendations have been endorsed and completed by the PCP.  They will discuss any determination 
for which they did not agree and consult with a study investigator for resolution as appropriate.   
 
Quality of COPD care:  
Using a composite measure of quality metrics  endorsed by the National Quality Forum20, we will use a 
combination of data from CDW and EHR chart review to assess the overall quality of COPD care 180 days 
after discharge.  Similar to the approach used by Lindenauer21 et al., our measure will dichotomized those 
patients who achieved all of the recommended care processes for which they were eligible (score =1) versus 
those who did not (score =0).  Individual measures may be assessed individually or grouped based on whether 
they are generic (tobacco use, vaccinations) or COPD specific (medications, spirometry). These recommended 
processes include: 
• Assessment of smoking status  
• Referral/counseling for smoking cessation, if current or recent quitter (within 1 year) 
• Assessment of resting O2 saturation or PaO2  
• Provision of O2 for long-term continuous therapy for patients with SpO2<88% or PaO2<55mhg 
• Addition of at least one controller agent (LABA, LAMA, ICS, Roflumilast) when appropriate  
• Confirmation of COPD by lung function assessment  
• Offer, confirmation or administration of influenza vaccination during appropriate season 
• Offer, confirmation or administration of pneumococcal vaccination 
• Other inhaled therapy types--date filled 
• Systemic corticosteroid therapy types--date filled 
• Antibiotic therapy types--date filled 
• Other therapy types--date filled 
 
 
12.4. Baseline Characteristics:  
• Sociodemographic: patient and provider characteristics at enrollment using a combination of CDW 
and self-report.  
 
We will use CDW to identify/calculate the following: 
• COPD and medications: results from patients’ most recent pulmonary function tests and pulmonary 
medication prescriptions over the past 12 months.    
• Days exposed to steroid: number of days a patient was prescribed an oral corticosteroid in the year 
prior to index admission. 
• COPD exacerbations not requiring hospitalization: number of outpatient exacerbations over the year 
prior to the index discharge, defined by a primary outpatient ICD-9 or ICD-10 diagnosis associated 
with a clinical event and prescription for an antibiotic and systemic corticosteroid within 2 days of 
the diagnosis. 

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• Comorbidities and health status indicators: collected information on common comorbidities that 
comprised the health inventory checklist used in previous intervention studies22,23 for the year prior 
to and through the index admission:  
o diagnoses for COPD and common co-morbidities such as diabetes, liver disease, chronic heart 
failure, vascular disease, and the like to include diagnoses that comprise the Charlson 
comorbidity index24 
o number of all-cause admissions 
o number of inpatient COPD exacerbations 
o number of COPD outpatient exacerbation 
o length of admission 
o Intensive care unit hours during index admission 
 
Table 1.  Summary and timing of data elements. 
 
Data element 
Source 
Timing 
Primary 
Outcomes 
Hospital readmission 
Record review, CDW, 
patient self-report, CMS 
(on early participants) 
180 days post index 
discharge 
Mortality 
Record review, CDW 
Clinical COPD Questionnaire 
Patient self-report 
6 weeks post index 
discharge 
Secondary 
Outcomes and 
other measures 
VR-12 
Patient satisfaction / smoking status 
Care recommendations 
EHR chart review 
Quality of COPD care  
EHR chart review, CDW, 
patient self-report 
180 days post index 
discharge 
Provider satisfaction 
Provider self-report 
survey 
2 weeks after receiving 
recommendations for 
intervention discharge 
Interview 
After receiving 
recommendations for 
intervention patient 
Key 
Characteristics 
Patient sociodemographic 
Patient self-report and 
CDW 
6-weeks post index 
discharge 
Provider sociodemographic 
Provider self-report and 
CDW 
Enrollment 
Comorbid diagnoses 
CDW 
1 year prior to index 
discharge 
All cause hospital admissions 
Inpatient and outpatient 
exacerbations 
-Days exposed to steroid 
Additional COPD treatments 
-Oral corticosteroid use prior to 
admission 
-Oral corticosteroid dosage at 
admission 
-Inhaled medications  
-LTE inhibitors 
-PDE-4 inhibitor 

12/30/2020 
 
P a g e  | 13 
 
12.5. Remuneration: 
We remunerated participant $20 for survey completion.  We did not pay providers.   
 
13. Analytic Approach 
Our modified stepped wedge design, through its randomized intervention allocation, offers several 
advantages to interval validity compared to observational approaches. However, our clustered design also 
requires additional analytic evaluation compared to a simple two-arm randomized trial.9  The primary 
outcome measure is COPD hospital readmission/mortality within 180 days as assessed through the CDW.  
Time zero for intervention patients is the start of the period when the provider cluster is randomized to 
receive the intervention.  Time zero for control patients is the start of each 30-day period (wedge) while the 
provider cluster remained unexposed to the intervention.  Provider clusters randomized to receive the 
intervention at later time periods will accrue fewer patients than clusters randomized to earlier periods.  We 
will present the analysis for hospital readmission as the example for the analytic approach that would also 
apply for our secondary outcome measures.  
 
13.1.  Models 
We will use mixed-effects linear regression or logistic regression as appropriate for the outcome of interest25 
(180-day readmission or death, CCQ Total Score, VR-12 PCS) with clustering by provider: 𝑔𝑔ቀE൫𝑦𝑦𝑖𝑖ห𝐗𝐗𝑖𝑖, 𝛼𝛼𝑗𝑗[𝑖𝑖]൯ቁ=
𝐗𝐗𝑖𝑖𝛃𝛃+ 𝛼𝛼𝑗𝑗[𝑖𝑖], where 𝑦𝑦𝑖𝑖 is the outcome for patient i and 𝛼𝛼𝑗𝑗[𝑖𝑖] is a random effect for provider j seen by patient i such 
that, across providers, the 𝛼𝛼𝑗𝑗[𝑖𝑖]’s are assumed independently and identically distributed (i.i.d.) Normal(0, 𝜎𝜎𝛼𝛼2). 𝛃𝛃 
is a 7 × 1 vector of fixed effects regression coefficients, and 𝐗𝐗𝑖𝑖 is a 1 × 7 vector containing the following fixed 
effects terms for patient i: a constant term (identical across patients), an indicator for patient i’s receipt of the 
intervention (X𝑖𝑖
𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖= 1 if patient i received the intervention, X𝑖𝑖
𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖𝑖= 0 otherwise), three time-
based restricted cubic spline terms for patient i, the number of days in the past year that patient i was exposed 
to systemic corticosteroids, and the number of COPD exacerbations not requiring admission experienced by 
patient i in the past year. The logistic link function was used for the 180-day readmission or death GLMM such 
that E൫𝑦𝑦𝑖𝑖ห𝐗𝐗𝑖𝑖, 𝛼𝛼𝑗𝑗[𝑖𝑖]൯= 𝜋𝜋𝑖𝑖= ൫𝑒𝑒𝐗𝐗𝑖𝑖𝛃𝛃+𝛼𝛼𝑗𝑗[𝑖𝑖]൯൫1 + 𝑒𝑒𝐗𝐗𝑖𝑖𝛃𝛃+𝛼𝛼𝑗𝑗[𝑖𝑖]൯
ൗ
. The identity link function was used for the CCQ Total 
Score and VR-12 PCS GLMMs such that E൫𝑦𝑦𝑖𝑖ห𝐗𝐗𝑖𝑖, 𝛼𝛼𝑗𝑗[𝑖𝑖]൯= 𝜇𝜇𝑖𝑖= 𝐗𝐗𝑖𝑖𝛃𝛃+ 𝛼𝛼𝑗𝑗[𝑖𝑖]. 
 
13.2. Sampling and non-response bias and missing data 
We will perform an intention-to-treat analysis.  The analysis will include all patients in the groups and time 
period which they were randomly assigned to begin receiving treatment, regardless of their adherence with 
the treatment and/or subsequent participation. An adjusted odds ratio will be estimated to compare control 
and intervention group odds of 180-day readmission or death, and adjustment mean differences will be 
estimated to compare control and intervention group means for CCQ Total Score and VR-12 PCS. In the event 
of missing outcome data, the primary analysis of the respective outcome will be based on outcome data 
imputed under a multiple imputation using chained equations procedure, with inference from 70 models of 
imputed data combined using Rubin’s Rules. Sensitivity complete-case analyses will be performed for 
outcomes with missing values to assess whether direction of association or statistical significance is impacted 
by a change in missing data approach. 
 

12/30/2020 
 
P a g e  | 14 
13.3. Sample size and study power  
For the sample size calculation,9 let the design have I clusters, T time points, and N individuals sampled per 
cluster per time interval.  Assume the model, 𝑌𝑌𝑖𝑖𝑖𝑖= 𝜇𝜇+ 𝛼𝛼𝑖𝑖+ 𝛽𝛽𝑗𝑗+ 𝑋𝑋𝑖𝑖𝑖𝑖𝜃𝜃+ 𝑒𝑒𝑖𝑖𝑖𝑖, where 𝛼𝛼𝑖𝑖 is a random effect for 
cluster i such that 𝛼𝛼𝑖𝑖~𝑁𝑁(0, 𝜏𝜏2), 𝛽𝛽𝑗𝑗 is a fixed effect corresponding to time interval j, 𝑋𝑋𝑖𝑖𝑖𝑖 is an indicator of the 
treatment mode in cluster i at time j (1=intervention; 0=control), 𝜃𝜃 is treatment effect and 𝑒𝑒𝑖𝑖𝑖𝑖= ∑𝑒𝑒𝑖𝑖𝑖𝑖𝑁𝑁
⁄
𝑘𝑘
 are 
independent and identically distributed 𝑁𝑁(0, 𝜎𝜎2) and 𝜎𝜎2𝑒𝑒𝑁𝑁
⁄ .  Let 𝑌𝑌𝑖𝑖𝑖𝑖 be the mean for cluster i at time j.  
Assume testing the hypothesis 𝐻𝐻0: 𝜃𝜃= 0 versus 𝐻𝐻𝐴𝐴: 𝜃𝜃= 𝜃𝜃𝐴𝐴, where 𝜃𝜃𝐴𝐴 is the treatment effect size.  The 
approximate power for conducting a two-tailed test of size alpha is 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝= Φ ൭ቆ𝜃𝜃𝐴𝐴ට𝑉𝑉𝑉𝑉𝑉𝑉൫𝜃𝜃෠൯
ൗ
ቇ−𝑍𝑍1−𝛼𝛼2
⁄ ൱ 
where Φ is the cumulative standard normal distribution function, 𝑍𝑍1−𝛼𝛼2
⁄  is the (1 −𝛼𝛼2
⁄ )𝑡𝑡ℎ quantile of the 
standard normal distribution function and 𝜃𝜃෠ is the estimated treatment effect size.  Let 𝑋𝑋𝑖𝑖𝑖𝑖= 0 if cluster i 
receives the control at time j and let 𝑋𝑋𝑖𝑖𝑖𝑖= 1 if cluster i receives the intervention at time j.   Thus with this 
matrix 𝑿𝑿 and assuming equal N per cluster per time interval, then assume 𝑉𝑉𝑉𝑉𝑉𝑉൫𝜃𝜃෠൯=
[𝐼𝐼𝜎𝜎2(𝜎𝜎2 + 𝑇𝑇𝜏𝜏2)] [(𝐼𝐼𝐼𝐼−𝑊𝑊)𝜎𝜎2 + (𝑈𝑈2 + 𝐼𝐼𝐼𝐼𝐼𝐼−𝑇𝑇𝑇𝑇−𝐼𝐼𝐼𝐼)𝜏𝜏2]
⁄
 where 𝑈𝑈= ∑𝑋𝑋𝑖𝑖𝑖𝑖
𝑖𝑖𝑖𝑖
, 𝑊𝑊= ∑൫∑𝑋𝑋𝑖𝑖𝑖𝑖
𝑖𝑖
൯
2
𝑗𝑗
 and 𝑉𝑉=
∑൫∑𝑋𝑋𝑖𝑖𝑖𝑖
𝑗𝑗
൯
2
𝑖𝑖
. This variance equation is used in the power calculation.  We have approached the power estimates 
conservatively allowing for a lower proportion of subjects who may experience hospital readmissions, 
allowing for regression to the mean.  
We assume 30 unidirectional movements from control to intervention among 30 clusters (clinics) and 15 
individuals sampled per cluster per time interval. We assume a significance level of alpha = 0.05. We assume 
baseline hospital readmission of 0.40 with a 10% relative reduction to 0.36, baseline CCQ of 0.40 with a 10% 
relative reduction to 0.36, and baseline SF-12 of 0.35 with an 11% relative increase to 0.39. We assume each 
outcome to have a coefficient of variation equal to 0.1. Under these assumptions, our power is estimated for 
hospital readmission, CCQ, and SF-12 analyses to be 0.874, 0.874, and 0.889, respectively. 
 
13.4. Qualitative analyses   
We will conduct qualitative data collection and analysis concurrently. We will conduct data analysis using 
simultaneous deductive and inductive content analysis26. We will upload transcripts to ATLAS.ti.17 13 for 
coding and data management. Coding will use audio recordings and transcriptions simultaneously to ensure 
transcription fidelity, and capture participant inflection not contained in written transcripts. We will conduct 
deductive content analysis through the identification of quotes and phrases that fit within pre-identified and 
defined a-priori categories. A-priori categories to be included: acceptability, feasibility, provider satisfaction, 
sustainability, barriers, facilitators, intrusions, collaboration, engagement and perceived patient outcomes. 
Inductive content analysis will be conducted through open/unstructured coding, allowing for the 
identification of emergent, previously unidentified or unexpected themes. This will allow us to capture data 
that did not fit into a-priori categories. Coding will continue until thematic saturation: the point at which 
subsequent data failed to produce new findings 19.  
 
An important component of mixed methods is the ability to compare and contrast the findings from each data 
source.27 “Triangulation” describes a process by which data collected from multiple data sources are used 
comparatively, broadening and validating the definition and understanding of complex constructs. We will 
compare the survey derived satisfaction ratings from the full sample with the coded constructs that we have 
identified from the qualitative data.  We will assess if there is concordance or discordance between these 
scores/constructs with a particular focus on whether the qualitative constructs offer some mechanism for 
understanding sources or satisfaction or dissatisfaction.  
 

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P a g e  | 15 
14. Protection of Human Subjects 
14.1. Minimal risk 
Since the intervention will be at the provider level and represents an encouragement of a variant of standard 
of care, the IRB determined that the study intervention presents minimal risks. 
 
14.2. Consent 
Using methods described above we will consent PCPs to receive guideline care recommendations (Section 8)  
for their patients discharged with COPD and to complete self-report surveys and interviews  (Section 12.2) 
under a Waiver of Documentation of Informed Consent.  The IRB does not require informed consent for 
activities that do not directly engage the patient by the study team; therefore, we will collect information about 
patients under Waiver of Informed Consent.  For patient reported outcomes, we will provide an information 
sheet and opportunity to address questions.  We will invite patients to complete self-report surveys (Section 
12) approximately six weeks after their index discharge under a Waiver of Documentation of Informed 
Consent. 
 
14.3. Data and safety monitoring 
Adverse events: 
Although all clinical decisions will be left with the patient’s primary care clinician, there is an unlikely, but 
small chance for unanticipated adverse events.  For example, recommendations may not consider a unique 
patient circumstance that is not well documented in the chart, yet the provider accepts the recommendations 
without review, resulting in worse outcomes.  As such, our monitoring entity consists of Dr. David Au, the 
study Principal Investigator, and a clinical researcher with expertise in pulmonary medicine and not part of 
the study team, Dr. Kristina Crothers.  We will not have a formal data and safety monitoring committee or 
board.   
 
Based on previous work with a cohort of 3764 patients hospitalized for COPD, we identified diagnoses 
affecting at least 1% of patients during their initial hospital admission and subsequent admissions and 
outpatient visits over the year following their initial hospitalization.  We will consider any occurrence of these 
events to be expected.  All deaths and all-cause re-admissions will be considered expected.  
 
Systematic adverse event review will occur after a patient’s 180-day outcomes period when a coordinator will 
review the EHR for urgent care notes, hospital admissions, and PCP visits. A coordinator will prepare reports 
summarizing events involving urgent care, admissions, or respiratory symptoms, along with event outcomes 
and any study recommendations. A member of the monitoring entity will review for expectedness, 
relatedness, and severity.   We will reported serious, unexpected events to the IRB within five days, and other 
events at annual review. We will process ad hoc events discovered during the six-week review of which study 
intervention recommendations were adopted in the same way. 
 
Given that the intervention is a variant of normal care and that the likelihood for unanticipated adverse events 
is low, we will not have formal stopping rules for safety, efficacy, and futility are not proposed.   
 
Care recommendation fidelity:  
Prior to study launch, the study team will conduct mock reviews using actual patients discharged with a 
COPD diagnosis.  We will continue reviews until the team has reached consensus about types of 
recommendations, orders, and standardized language we will use for providers in the intervention.   

12/30/2020 
 
P a g e  | 16 
We will prepare a detailed “how-to” guide to entering notes and orders in the EHR for coordinators to follow.  
Using the guide, coordinators will enter orders into the EHR for a test patient until they have demonstrated 
100% accuracy as assessed by a study clinician.  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. 
 
14.4. 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) regular review of questionnaire response rates, reported respondent burden, and missing items to identify 
and correct problem areas; 4) validation and verification of all data, and 5) 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 IRB approved 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 study staff.  
Chart abstracted notations will not be entered into the study database. 
 
We will store data in strong password protected SQL and ACCESS relational databases that reside on a secure 
VA network server.  To reduce errors in data entry with participant self-report data elements, we will use 
double data entry and field valuation checks wherever possible.   
 
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.  Providers will belong to a 
Windows group, which allows access to the database.  Roles and the provider’s login credentials restrict them 
to records associated only with themselves.  They will not be able to see any other provider’s records, 
regardless of the application used to connect to the database. 
 
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.   
 
 
 
15. Summary of Changes from original protocol 
• 
2/12/2014: VA CDW:  
o Used instead of Veterans Integrates Service Network (VISN) 20 data warehouse because of 
changes in VA policy. 
• 
2/12/2014: Remuneration 
o Patient participants were remunerated $20 instead of $25 based on budget and IRB application. 

12/30/2020 
 
P a g e  | 17 
• 
3/5/2015: Provider enrollment 
o Modified to passively consent providers who had not responded to invitation after one week. 
• 
4/2/2014: Outcomes  
o Used VR-12 instead of the SF-12 because VR-12 is the SF-12 modified for a Veteran population.  
• 
2/12/2014: Wedge interval length/outcomes period:  
o Wedges consisted of 30-day wedge intervals instead of 1 month to maintain standard interval 
length. 
o 30-day intervals resulted in 180-day outcomes period instead of six months. 
• 
5/6/2014: Number of wedges  
o Used 30 wedges over 30 months instead of 36 wedges over 36 months;  
o Recalculated power estimates based on actual numbers of consented providers and COPD 
exacerbation discharge data.  To maintain 0.90 power assuming an alpha of 0.95 and coefficient 
of variation of 0.1, we would require 30 clusters in lieu of 36.   
• 
5/21/2015: Smoking status self-report 
o Added short smoking status questionnaire with patient outcomes, as smoking status around the 
time of discharge is an indicator of quality of COPD care. 
• 
8/4/2016: COPD Training for inpatient discharge and primary care teams   
o After several attempts to coordinate in-services to inpatient and primary care teams, we were 
unable to develop a practical and mutually agreeable schedule because of logistical and 
scheduling constraints.  
• 
7/23/2015: Mailed patient outcomes 
o Added option for patient participant to complete surveys via mail instead of telephone. 
• 
3/22/2016: E-cigarettes and vaping 
o Included a question about e-cigarette and vaping use, as these devices’ popularity increased 
and many Veterans had adopted these practices over cigarette smoking. 
• 
7/27/2017: Qualitative interviews  
o Initially targeted providers after three intervention discharge; because of low response rate we 
reduced to one in attempt to include more providers. 
• 
1/12/18: Correlation of measures within patient/used participants first DC only  
o We did not correlate measures within patient, because we used only the first index discharge 
per patient. Given the small number of patients with > 1 index discharge, the additional 
complexity of modeling within-patient correlation would not be cost-effective with respect to 
degrees of freedom. 
• 
7/27/18: VR-12 PCS  
o demoted from primary to secondary because COPD intervention studies have not shown effects 
on QoL so no good rationale that there will be any significant effect– we will not adjust for it. 
• 
12/28/18: Analyses  
o Modeling time: we originally wanted to model (k – 1) fixed effects for the k wedges in the 
stepped-wedge design. However, each wedge only had ~10 discharges, on average, and it 
would be expensive (and likely not very informative) to model all of the wedges individually. 
Therefore, we modeled time using a 3-knot restricted (or natural) cubic spline for flexibility and 
lower degrees of freedom cost. 
o Medicare data: not used because of insufficient time/resources to pull and merge with current 
data.  
 

12/30/2020 
 
P a g e  | 18 
16. References 
1. 
Elixhauser A, Au DH, Podulka J. Readmissions for Chronic Obstructive Pulmonary Disease, 2008: 
Statistical Brief #121. 2006. 
2. 
Aboumatar H, Naqibuddin M, Chung S, et al. Effect of a Program Combining Transitional Care and 
Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive 
Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2018;320(22):2335-2343. 
3. 
Prieto-Centurion V, Markos MA, Ramey NI, et al. Interventions to reduce rehospitalizations after 
chronic obstructive pulmonary disease exacerbations. A systematic review. Ann Am Thorac Soc. 
2014;11(3):417-424. 
4. 
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary 
Disease. Global Initiative for Chronic Obstructive Lung Disease. Available at: 
https://goldcopd.org/2021-gold-reports/. Published 2020. Accessed December, 2020. 
5. 
Niewoehner DE. The impact of severe exacerbations on quality of life and the clinical course of chronic 
obstructive pulmonary disease. Am J Med. 2006;119(10 Suppl 1):38-45. 
6. 
Miravitlles M, Ferrer M, Pont A, et al. Effect of exacerbations on quality of life in patients with chronic 
obstructive pulmonary disease: a 2 year follow up study. Thorax. 2004;59(5):387-395. 
7. 
David A, Corlateanu A. Influence of COPD exacerbations on health related quality of life. 
2012;40(Suppl 56):P4821. 
8. 
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC medical research 
methodology. 2006;6:54. 
9. 
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemporary 
clinical trials. 2007;28(2):182-191. 
10. 
Corporate Data Warehouse (CDW), VA Informatics and Computing Infrastructure. U.S. Department of 
Veterans Affairs. https://www.hsrd.research.va.gov/for_researchers/vinci/cdw.cfm. Accessed Feburary 
6, 2020. 
11. 
VA/DoD Clinical Practice Guideline for Management of Outpatient Chronic Obstructive Pulmonary 
Disease. Version 3.0 Web site. https://www.healthquality.va.gov/guidelines/CD/copd/. Accessed 
December, 2020. 
12. 
van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, 
validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003;1:13. 
13. 
Trappenburg JC, Touwen I, de Weert-van Oene GH, et al. Detecting exacerbations using the Clinical 
COPD Questionnaire. Health Qual Life Outcomes. 2010;8:102. 
14. 
Stallberg B, Nokela M, Ehrs PO, Hjemdal P, Jonsson EW. Validation of the clinical COPD Questionnaire 
(CCQ) in primary care. Health Qual Life Outcomes. 2009;7:26. 
15. 
Selim AJ, Rogers W, Fleishman JA, et al. Updated U.S. population standard for the Veterans RAND 12-
item Health Survey (VR-12). Qual Life Res. 2009;18(1):43-52. 
16. 
Jones D, Kazis L, Lee A, et al. Health status assessments using the Veterans SF-12 and SF-36: methods 
for evaluating otucomes in the Veterans Health Administration. J Ambul Care Manage. 2001;24(3):68-86. 
17. 
Kazis L. Health Status of Veterans: Physical and Mental Component Summary Scores Veterans SF-12. 
Veterans Health Administration Medical Center, Bedofrd MA.: Veterans Health Administration; 1998 
1998. 
18. 
Creswell JW, Klassen AC, Plano Clark VL, Smith KC. For the Office of Behavioral Social Sciences 
Research: Best practices for mixed methods research in the health sciences. 2011. 
19. 
Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995;18(2):179-183. 
20. 
National Quality Forum. http://www.qualityforum.org/Measures_List.aspx. Accessed Decemeber 01, 
2011. 

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21. 
Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Quality of care for patients 
hospitalized for acute exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 
2006;144(12):894-903. 
22. 
Au DH, Udris EM, Engelberg RA, et al. A Randomized Trial to Improve Communication about End-of-
Life Care among Patients with COPD. Chest. 2011. 
23. 
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. 2004;116(4):241-248. 
24. 
Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM 
administrative databases. J Clin Epidemiol. 1992;45(6):613-619. 
25. 
McCullagh P, Nelder JA. Generalized Linear Models 2nd Ed. ed. London: Chapman and Hall; 1989. 
26. 
Elo S, Kyngas H. The qualitative content analysis process. Journal of advanced nursing. 2008;62(1):107-
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Denzin NK. Moments, mixed methods, and paradigm designs. . Qualitative Inquiry. 2010;16(6):419-427. 
 
 
 

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Appendix 1: Chart abstraction template  
 
 
 
 
 
 
 
(back to intervention) 
Date of abstraction: Click for date. 
Abstractor: Click here. 
Links: 
Patient Information 
DC Summary and/or H&P Template 
Advanced Directive 
Dates/Diagnoses 
HPI 
Hospital Course 
Disposition 
Smoking History 
Prior Admissions 
PMH 
Condition On DC 
Follow-up/Post DC call 
Home CPAP/BIPAP/O2 
Prior ER Visits 
Social History 
Activity Restrictions 
Instr. and Education 
Prior Primary Care Visit 
Consultations 
Review of Systems 
Diet 
Competency 
Prior Pulmonary Visit 
Procedures 
Physical Exam 
Medications/Allergies 
Code Status 
Social Work Notes 
 
 
 
 
Immunizations 
 
 
 
 
Sleep Study 
 
Patient:  
 
Station: 
Choose an 
item. 
 
 Age: 
 
Sex: Click here. 
Ht (in):  
Wt (lb):  
BMI: 
 
 
Discharge Summary: 
Back to top 
 Current DC DATES/DIAGNOSES: (from Clinical Reports/Visits/Admissions/Discharge Diagnoses): 
 
  
  
DC summary DC diagnoses text: 
 
  
  
PRIOR ADMISSIONS (click for details) 
 
Back to top 
  
 
 PRIOR ER Visits (click for details) 
Back to top 
  
CONSULTATIONS (click for details of consults up to 1 year prior) 
 
Back to top 
  
DC summary text: 
 
  
PROCEDURES/IMAGING (during or most recent to this hospitalization):    
 
Back to top 
  
Click here for copy of most recent report: PFT;  CXR;  CT; ECHO 
DC summary text: 
 
  
HISTORY OF PRESENT ILLNESS: 
 
Back to top 
  
  
HOSPITAL COURSE: 
 
Back to top 
  
  
PAST MEDICAL HISTORY: 
 
Back to top 
  
  
SOCIAL HISTORY (incl smoking):   
 
Back to top 
   
 

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REVIEW OF SYSTEMS: 
 
Back to top 
  
  
PHYSICAL EXAM (click for details) 
 
Back to top 
  
CONDITION ON DISCHARGE: 
 
Back to top 
 Choose an item. 
  
ACTIVITY RESTRICTIONS: 
 
Back to top 
 Choose an item. 
  
DIET: 
 
Back to top 
 Choose an item. 
  
DISCHARGE MEDICATIONS (click for details) 
 
Back to top 
  
DISPOSITION: 
 
Back to top 
 Choose an item. 
  
FOLLOW UP/Post DC Follow-up call:  
 
Back to top 
  
  
DISCHARGE INSTRUCTIONS AND EDUCATION: 
 
Back to top 
  
  
COMPETENCY: 
 
Back to top 
 Choose an item. 
 
  
CODE STATUS: 
 
Back to top 
 Choose an item. 
 
 
 
 
Allergies: 
Back to top 
  
 
Medications:  
Back to top 
Prior Hospital Discharges: 
Back to top 
Back to DC Summary 
 
 
Prior ER Visits past year (not resulting in hospital admission): 
Back to top 
Back to DC Summary 
 
 
 
 
 
 
 
 
 
 

12/30/2020 
 
P a g e  | 22 
Back DC Summary 
 
 Active medication list at discharge: 
  
 
 
Meds filled over last year (from Pharmacy Outpatient Medications) , now not on Active list (above): 
  
 
 
MEDICATION CHANGES: 
From DC summary: 
 
From Pharmacy Discharge Note: 
 
 
PFT:  
Back to top 
Back to DC Summary 
  
CXR:  
Back to top 
Back to DC Summary 
  
CT Scan:  
Back to top 
Back to DC Summary 
        
Echo:  
Back to top 
Back to DC Summary 
  
 
Physical Exam/labs: 
Back to top 
Back to DC Summary 
  
 
Consultations/findings (through 1 yr prior to DC): 
Back to top 
Back to DC Summary 
  
 
 
Prior Primary Care Visit : 
 
Back to top 
  
 
Prior Outpatient Pulmonary Visit:  
Back to top 
  
 
Social Work Notes 
 
Back to top 
  
 
Home CPAP/BIPAP/O2: 
Back to top 
  
Date: 
Settings (inpt/outpt) 

12/30/2020 
 
P a g e  | 23 
 O2: 
 
 
 BiPap:   
 
 CPAP:  
 
 
Sleep Study: 
Back to top 
 
 
 
Advanced Directive: 
Back to top 
 
 
 
 
Immunizations 
Back to top 
 
  
 
 
 

12/30/2020 
 
P a g e  | 24 
Per IRB approval, save this document only in the InCasE 
secure network folder.  
\\VHAPUGFPC30.v20.med.va.gov\Projects$\InCasE-
MIRB\InCasE Clinical Reviews
Appendix 2: Recommendations checklist template   
 
 
 
 
  
(back to intervention) 
RECOMMENDATIONS CHECKLIST: InCasE   
   
Patient ID: «Patient_ID»/«PatientLastName»/«PatientSSN»/«DischargeStation» 
PCP: «Provider_Name»Institution: «InstitutionCode» «InstitutionName» 
Attending Physician:  
Pulmonologist: 
Completed by: Clinician’s name    Meeting Date: Click here to enter a date.    
1. PCP VISIT SCHEDULED PRIOR TO THIS MEETING? 
No 
☐  
Yes 
☐  
Follow up scheduled for : 
2. DIAGNOSIS AND ASSESSMENT RECOMMENDATIONS:   
ADD 
☐1 
Consider 
☐3 
☐3 
☐3 
☐3 
PFT 
☐ spirometry before and after bronchodilator 
☐ lung volumes 
☐ DLCO 
☐ MIP/MEP 
☐1 
☐3 
6-minute walk 
☐1 
☐3 
Ambulatory/Exercise Oximetry 
☐1 
☐3 
Chest X-ray  
☐1 
☐3 
Chest CT  
☐1 
☐3 
ECHO 
☐1 
☐3 
ABG  
☐1 
☐3 
PSG/sleep study 
☐1 
☐3 
Serologies 
☐1 
☐3 
IGE levels 
3. PHARMACOLOGIC TREATMENT RECOMMENDATIONS: 
Add 
Remove 
Consi- 
Sider* 
Cont. 
*check this box if the add or remove is not definitive, but we want the PCP to 
consider the change and we did not enter a consult for this 
3.a. Short-acting beta-agonist (SABA) 
3.a.1. by Metered Dose Inhaler (MDI) 
☐1 
☐0 
☐3/4 
☐2 
Albuterol 
☐1 
☐0 
☐3/4 
☐2 
Levalbuterol (non-formulary at VA, second line to Albuterol) 
☐1 
☐0 
☐3/4 
☐2 
Metaproternol (no longer manufactured, only available as tablet and syrup, non-formulary at VA) 
3.a.2 by Nebulization 
☐1 
☐0 
☐3/4 
☐2 
Albuterol 
☐1 
☐0 
☐3/4 
☐2 
Levalbuterol 
☐1 
☐0 
☐3/4 
☐2 
Metaproternol (no longer manufactured, only available as tablet and syrup, non-formulary at VA) 
3.b. Short-acting antimuscarinic agents (SAMA)  
3.b.1. by Metered Dose Inhaler (MDI) 
☐1 
☐0 
☐3/4 
☐2 
Ipratropium  
3.b.2. by Nebulization 
☐1 
☐0 
☐3/4 
☐2 
Ipratropium, Inhl 0.02% 
3.c. Combo 
3.c.1. by Respimat 
☐1 
☐0 
☐3/4 
☐2 
Ipratropium /Albuterol (Combivent) 
3.c.2. by Nebulization 
☐1 
☐0 
☐3/4 
☐2 
Ipratropium /Albuterol (DuoNeb) 

12/30/2020 
 
P a g e  | 25 
3.d. Long-acting beta-agonist (LABA) 
☐1 
☐0 
☐3/4 
☐2 
Olodaterol  
☐1 
☐0 
☐3/4 
☐2 
Salmeterol  
3.e. Long-acting antimuscarinic (LAMA) 
☐1 
☐0 
☐3/4 
☐2 
TIOTROPIUM 
3.f. Long-acting antimuscarinic (LAMA)/ Long-acting beta-agonist (LABA) (combination) 
☐1 
☐0 
☐3/4 
☐2 
Olodaterol/Tiotropium (Stiolto Respimat) 
3.g. Inhaled corticosteroid (ICS) 
☐1 
☐0 
☐3/4 
☐2 
Beclomethasone Dipropionate Inhl (non-formulary at VA after mometasone and symbicort) 
☐1 
☐0 
☐3/4 
☐2 
Budesonide (not available at VA) 
☐1 
☐0 
☐3/4 
☐2 
Flunisolide (not available at VA) 
☐1 
☐0 
☐3/4 
☐2 
Fluticasone (non-formulary at VA, after mometasone, symbicort, and beclomethasone) 
☐1 
☐0 
☐3/4 
☐2 
Mometasone  
☐1 
☐0 
☐3/4 
☐2 
Triamcinolone no longer manufactured 
3.h. Inhaled corticosteroid (ICS)/ Long-acting bronchodilator (LABA) (combination) 
☐1 
☐0 
☐3/4 
☐2 
Budesonide /Formoterol (Symbicort) 
☐1 
☐0 
☐3/4 
☐2 
FLUTICASONE/Salmeterol (non-formulary at VA) 
☐1 
☐0 
☐3/4 
☐2 
Formoterol / Mometasone (non-formulary at VA) 
☐1 
☐0 
☐3/4 
☐2 
Modified Titration of inhaled glucocorticoid (mometasone) 
3.i. Phosphodiesterase-4 inhibitor 
☐1 
☐0 
☐3/4 
☐2 
Roflumilast (non-formulary at VA) 
3.j. Methylxanthine 
☐1 
☐0 
☐3/4 
☐2 
Theophylline 
3.k. Mucolytic 
☐1 
☐0 
☐3/4 
☐2 
Acetylcysteine 
3.l. Oral Corticosteroid 
☐1 
☐0 
☐3/4 
☐2 
Methylprednisolone 
☐1 
☐0 
☐3/4 
☐2 
Dexamethasone 
☐1 
☐0 
☐3/4 
☐2 
Hydrocortisone 
☐1 
☐0 
☐3/4 
☐2 
Prednisolone (not available at VA) 
☐1 
☐0 
☐3/4 
☐2 
Prednsone 
☐1 
☐0 
☐3/4 
☐2 
Prednisone, burst taper prn home use 
3.m. Antibiotics 
☐1 
☐0 
☐3/4 
☐2 
Antibiotics 
☐1 
☐0 
☐3/4 
☐2 
Antibiotics, prn home use 
3.n. Leukotriene modifier 
☐1 
☐0 
☐3/4 
☐2 
Montelukast 
3.o. Smoking Cessation 
☐1 
☐0 
☐3/4 
☐2 
Nicotine replacement  patch, gum, lozenge, (nasal spray non-formulary at VA) 
☐1 
☐0 
☐3/4 
☐2 
Varenicline 
☐1 
☐0 
☐3/4 
☐2 
Buproprion 
3.p. Other 
☐1 
☐0 
☐3/4 
☐2 
 
4. PHARMACY EDUCATION:        
Add 
Consi- 
sider* 
*check this box if the add is not definitive and we did not enter a consult for this 
☐1 
☐3 
Inhaler technique 
☐1 
☐3 
Spacer 
☐1 
☐3 
Pharmacy Other (ie med review, peak flow meter):  

12/30/2020 
 
P a g e  | 26 
5. THERAPIES/REFERRALS: 
Add 
Consi- 
Sider* 
*check this box if the add is not definitive and we did not enter a consult for this 
☐1 
☐3 
Pulmonary rehabilitation 
☐1 
☐3 
Respiratory Therapy 
☐Oxygen titration evaluations 
☐ Nocturnal oximetry 
☐ home oxygen evaluation  
☐1 
☐3 
Smoking cessation   
☐ 1-800 quit line 
☐Behavioral Health/Pharmacy Counseling 
☐1 
☐3 
Pulmonary specialty care evaluation 
☐1 
☐3 
Palliative care 
☐1 
☐3 
Weight loss:  ☐ MOVE!     ☐ TELE-MOVE! 
☐1 
☐3 
Nutritional eval 
☐1 
☐3 
PT/OT 
☐1 
☐3 
Social Services 
☐1 
☐3 
Dental 
☐1 
☐3 
Vaccinations: 
☐1 
☐3 
OTHER Recommendations:  
6. DIFFERENTIAL DIAGNOSIS: 
This hospitalization was due to COPD exacerbation: 
Yes 
☐ 
Probably Yes 
☐ 
Probably No 
☐ 
No 
☐ 
If COPD Dx is questionable, list probable differential diagnosis:  
 
********************************************************************** 
CPRS RECOMMENDATIONS TEMPLATE  
DRAFT completed by lead reviewer PRIOR to team meeting, then finalized and copied into 
CPRS after team discussion            
********************************************************************** 
----------------------------------------------------------------------------------- 
This patient's medical record was reviewed by the INtegrating Care After Exacerbation of 
COPD (InCasE) collaborative review team on [date].  Team members include the following 
primary care physicians and pulmonary specialists:  
Seattle: Rosemary Adamson, David Au, Douglas Berger, Richard Goodman, Karin Nelson, Lynn 
Reinke, Deborah Woo.  
Boise: Paula Carvalho, William Weppner, Theodore Lange 
 
For your convenience, we have entered unsigned orders for you to review and accept, 
modify, or discontinue based on your clinical judgment and personal knowledge of 
this patient. 
 
SUMMMARY: 
 
DIAGNOSTICS: 
Recommended: 
-  
-  
Consider: 
-  
-  

12/30/2020 
 
P a g e  | 27 
 
MEDICATION(S):  
Recommended: 
-  
-  
Consider: 
-  
-  
 
PHARMACY USE/EDUCATION: 
Recommended: 
-  
-  
Consider: 
-  
-  
 
THERAPY(S)/REFERRALS(S): 
Recommended: 
- <<Per DAU, discuss Pulm Rehab for all pts>> 
-  
Consider: 
-  
-  
 
FOLLOW-UP: 
Recommended: 
-  
-  
Consider: 
-  
-  
 
 
We are happy to address any of these recommendations with you based on your preference by 
encrypted e-mail (InCasEStudy@va.gov), CPRS, Pulmonary SCAN-ECHO, E-Consult, 
and/or phone.  
 
*********** 
We have made COPD-specific recommendations based on the: 
*Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative 
for Chronic Obstructive Lung Disease (GOLD) 2014, available from: 
http://www.goldcopd.org/uploads/users/files/GOLD_AtAGlance_2014_Jun11.pdf, and 
 
*VA/DOD Clinical Practice Guideline for the Management of Outpatient Chronic Obstructive 
Pulmomary Disease, Version 3.0, 2014, available from: 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDCPG.pdf (full). 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDClinicianSummary.pdf 
(summary). 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDPocketCard.pdf (pocket card). 
 
----------------------------------------------------------------------------------- 
 
 

12/30/2020 
 
P a g e  | 28 
********************************************************************************* 
STANDARD PHRASES 
********************************************************************************* 
DIAGNOSTICS:  
CXR 
        -Follow up 2-view chest x-ray in 6-8 weeks to evaluate... 
- Follow-up 2-view chest X-ray in approximately one month to evaluate areas of  
infiltrate/atelectasis evident on admission films. 
PFT 
        -Pulmonary function testing – spirometry before and after bronchodilator, lung 
volumes and DLCO.  Needs updating. 
 
- Pulmonary function testing with bronchodilator response, volumes, DLCO, 6-MWT, exercise 
oximetry with titration. Functional assessment should be performed when the patient is at 
or approximating his respiratory baseline. 
 
        -Minimum of spirometry with and without bronchodilator.  If no airflow 
obstruction is found by spirometry, focus evaluation of <dyspnea> on <list other 
diagnoses> issues as he is not likely to have COPD. 
 
MIP and MEP 
- Although the admitting diagnosis was Acute Respiratory failure related  
to COPD exacerbation we do not think this is COPD. To verify diagnosis,  
we suggest obtaining an updated pulmonary function test including MIP  
and MEP to evaluate for neuromuscular dysfunction. 
 
MRI 
        -Follow-up on previously ordered MRI. 
 
Obesity 
        -The team is unclear if the symptoms are driving by weight vs copd.   
 
 
MEDICATIONS: 
COPD 
        -Agree with current medication management.  However, if pt. does not stabilize, 
would consider addition of Symbicort 160/4.5 mcg q12 and discontinuation of mometasone. 
        -If he has COPD, consider adding as needed albuterol by nebulization as rescue 
therapy.  
        -Agree with albuterol mdi and neb, and tiotroprium 
        -Discontinue duoneb because patient is already on tiotroprium  
        -Consider discontinue symbicort because of potential side effect of PNA  
                from steroid component  
        -Consider replacing with combination of mometosone and formoterol with  
                plan to titrate off mometasone as described (we have arranged  
                pulmonary follow up for patient) 
-LABA/ICS or LAMA/LABA:  
- simplify regimen with LABA/ICS (budensonide/formoterol) or LAMA/LABA  
(tiotropium/oldaterol) if he becomes willing. As you are aware, tiotropium and  
ipratropium should not be used together - ipra outcompetes tio for binding sites 
 
LABA 
- Starting Olodaterol 2 actuations daily. Long-acting bronchodilator (in this case a Long-acting beta-agonist) is the preferred 
controller therapy approach for symptomatic patients with COPD. 
 
Opiate titration for dyspnea 
- We also recommend consideration of an opioid to help with the sensation of dyspnea. The 
Canadian Thoracic Society guidelines on the management of dyspnea in COPD are extremely 
useful and include a regimen for the initiation of morphine for dyspnea. This guideline 
provides very clear recommendations for how to initiate opioids for the management of 

12/30/2020 
 
P a g e  | 29 
dyspnea in COPD using morphine solution. This allows you to start at an extremely low 
dose, such as 1mg and then titrating extremely slowly. Such low doses are unlikely to 
cause respiratory depression. Marciniuk et al. Managaing dyspnea in patients with 
advanced COPD: A Canadian Thoracic Society clinical practice guideline. Can Respir J 
2011;18(2):69-78 
 
Suggested protocol for managing dyspnea with opioid therapy in advanced chronic 
obstructive pulmonary disease patients: 
• Initiate opioid therapy with oral immediate-release morphine syrup – 
titrate slowly at weekly intervals over a 4- to 6-week period 
• Start therapy with morphine 0.5 mg orally twice daily for 2 days, and then 
increase to 0.5 mg orally every 4 h while awake for remainder of week 1 
• If tolerated and indicated, increase to morphine 1.0 mg orally every 4 h 
while awake in week 2, increasing by 1.0 mg/week or 25% dosage 
increments/week until the lowest effective dose that appropriately 
manages the dyspnea is achieved 
• Once a stable dosage is achieved (ie, no significant dose change for 
2 weeks and dyspnea managed), a sustained-release preparation at a 
comparable daily dose could be considered for substitution 
• If patients experience significant opioid-related side effects such as nausea 
or confusion, substitution of an equipotent dose of oral hydromorphine 
could be considered (1 mg hydromorphine = 5 mg morphine) 
• Stool softeners and laxatives should be routinely offered to prevent 
opioid-associated constipation 
 
Titrate methadone/opiates: 
-Titrate methadone and opiates:  from a pulmonary standpoint based on 
pharmakinitics and risk these can repress breathing.  Please discuss with patient 
the need to reduce these medications.  
Step down on inhaled corticosteroids once resolved.  
 
Titrate glucocorticoid: 
- Modified Titration of glucocorticoid medications based on the NEJM article found here: 
http://www.nejm.org/doi/full/10.1056/NEJMoa1407154 to comply with medications available 
at VA. At least eight (8) weeks after the patient started the high potency high dose 
regimene they are currently on reduce the dose by half.  Six(6) weeks later cut the dose 
in half again and six (6) weeks after that discontinue the medication completely.  
 
For Mometasone: Beginning at highest dose than the patient is currently on usually 
Begin at 220 mgm BID 2 puff 
after 8 weeks reduce it to 110mgm bid, 
after 6 weeks reduce it to 110 mgm QD 1 puff OD, 
after 6 weeks off  
For steroid: beginning at the high dose that the patient is currently on 
 
Begin flovent at 500 BID 
 
After 8 weeks cut flovent in half (flovent 250 BID) 
 
After 6 weeks cut in half again (flovent 125 BID) 
 
After 6 weeks off 
 
Smoking Cessation 
Nicotine lozenges: 
        -Consider prescribing nicotine lozenges as use for replacement of cigarettes, 
                which is effective even among precontemplators.. 
 
Bupropion 
Bupropion is recommended along with a tobacco cessation program to provide the patient with additional 
support and educational materials.  
http://www.publichealth.va.gov/smoking/professionals/treatment/pharmacotherapy.asp 
 
GERD: 

12/30/2020 
 
P a g e  | 30 
- GERD controlling medication (H2 blocker or PPI) and GERD education 
 
PHARMACY USE/EDUCATION:         
         - To maximize inhaler teaching we are entering a return to clinic order for PCC 
pharmacy teaching.  This can be done on a day he is already at VA. 
 
THERAPIES/REFERRALS 
Smoking Cessation 
- Refer to behavioral health for assistance with smoking cessation  
- Consider a warm hand-off to behavioral health at next visit to address smoking 
cessation and oxygen compliance. 
- Consider behavioral health referral for assistance in smoking cessation, as it 
is evident that prior attempts to offer assistance with smoking cessation has 
been declined. 
- Continue to encourage smoking cessation, consider referral to behavioral medicine or 
home telemonitoring if patient willing. 
 
Smoking Cessation-inconsistent pt report of status 
- In reviewing chart, we noticed patient inconsistent in reporting of smoking  
status (told PCP none x3 mo, reported 2 cigs/day to admitting resident).  
Encourage continued attention to smoking, as you are doing. 
 
Co-Smoking Cessation and Mental Health 
-Dr. Saxon and colleagues have demonstrated that co-treatment of mental health 
and tobacco concomitantly is effective for smoking cessation. 
 
Marijuana 
-Encourage patient to not smoke marijuana 
 
Palliative Care 
-Consider focusing on palliation of symptoms and clarifying goals of care. 
-Consider a Palliative care consult to address goals of care and symptomatic treatment of 
dyspnea. 
 
Pulmonary Rehab 
-Pulmonary rehabilitation: Demonstrated to reduce readmission and improve quality of life 
by improving functional ability and improving dyspnea management. 
 
-Pulmonary rehabilitation – we will enter a non-VA care consult given patient lives > 40 
miles from the Seattle VA 
 
- Pulmonary rehabilitation: randomized evidence reduces readmission and improves functional status. 
 
Rule out DVT-BLE venous duplex exam 
- Consider ruling out DVT- BLE venous duplex exam. Patient has sufficiently elevated 
pulmonary arterial pressures thus increasing the morbidity factor of PE if he does have 
DVT. Further diagnostics for PTE would depend on results of duplex.  
-If clinically indicated at this time, further assessment for cardiac ischemia with 
cardiac stress test could be considered. 
 
O2*** 
-Needs reevaluation for use of long-term oxygen therapy. 
- Consider a warm hand-off to behavioral health at next visit to address oxygen 
compliance. 
- Respiratory therapy for 6 minute walk test, exercise oximetry, o2 titration  
evaluation, and home oxygen evaluation (order entered) 
 
***Seattle Reevaluation does not have the staff for us to be able to do the evaluations routinely. Alice Hansen may 
complete some on Thursdays if the Provider requests her, otherwise it is up to the PCP to re-assess. When Norco does 

12/30/2020 
 
P a g e  | 31 
the every 90 day concentrator check, she will write a progress note and have the PCP co-sign when a discrepancy is 
noted. Per A. Hanson 4/2016 
 
 
MOVE! 
Lung specialists agree that obesity is likely the driving factor in this 
patient’s disease process, and weight reduction may be the most beneficial 
therapy; therefore encouragement to participate in MOVE! or TeleMOVE! is 
recommended.  
 
Dental 
        -Agree with dental and nutrition consult 
 
Nutrition 
        -Agree with dental and nutrition consult 
 
Non-compliant patient 
Based on this review, patient has received excellent care in the hospital and in  
follow-up. He is receiving guideline concordant care for COPD and any co-  
morbidities; therefore, we have only minor suggestions to consider adding to  
your management of this patient. We understand the difficulties providing care in this 
apparently reluctant participant with recommend Rx. 
 
Other: 
- If the patient completes smoking cessation for 6 months and pulmonary rehabilitation, 
he may be considered for lung transplantation. 
 
Question of if patient actually has COPD: 
This patient has a number of complex comorbid issues of which respiratory 
problems are prominent.  The etiology of his symptoms includes both potential 
cardiac and pulmonary etiologies.   Although the pretest probability is 
reasonable that the patient has COPD, we were unable to find records of PFT to 
confirm the diagnosis.  Some of the below recommendations are based on whether he 
actually has COPD.   
 
Good job-minor suggestions: 
Based on this review, patient has received excellent care in the hospital and in  
follow-up. He is receiving guideline concordant care for COPD and any co- 
morbidities; therefore, we have only minor suggestions to consider adding to  
your management of this patient. 
 
We agree thus far with excellent inpatient and outpatient management, with the following 
recommendations to further the plan that has been initiated.  
 
This patient with typical COPD exacerbation is receiving guideline concordant 
care in primary care and through his hospitalization. His disease is obviously 
very severe COPD. Appreciate attention to his goals of care/discussion with DPOA. 
 
********************************************************************************* 
GOOD Job - NO RECOMMENDATIONS: 
----------------------------------------------------------------------------------- 
Based on this review, your patient is receiving guideline concordant care for 
COPD and any co-morbidities; therefore, we do not have additional 
recommendations. We agree with your excellent management of this patient. 
 

12/30/2020 
 
P a g e  | 32 
If you have any questions about COPD treatments for this patient, please feel 
free to contact us via e-mail (InCasEStudy@va.gov), CPRS, Pulmonary SCAN-ECHO, E-
Consult, and/or phone [insert study number], whichever is easiest for you.  
 
COPD guideline recommendations may be found here: 
*Global Strategy for the Diagnosis, Management and Prevention of COPD, Global 
Initiative for Chronic Obstructive Lung Disease (GOLD) 2014, available from: 
http://www.goldcopd.org/uploads/users/files/GOLD_AtAGlance_2014_Jun11.pdf, and 
 
*VA/DOD Clinical Practice Guideline for the Management of Outpatient Chronic 
Obstructive Pulmomary Disease, Version 3.0, 2014, available from: 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDCPG.pdf (full). 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDClinicianSummary.pdf 
(summary). 
http://www.healthquality.va.gov/guidelines/CD/copd/VADoDCOPDPocketCard.pdf 
(pocket card). 
----------------------------------------------------------------------------------- 
 
 

12/30/2020 
 
P a g e  | 33 

12/30/2020 
 
P a g e  | 34 
Appendix 3: Modified SHEP 
(Back to Secondary Measures) 
 
Our records show that you received care from  [insert name of post DC PCP] after your hospital discharge on 
[insert discharge date].   
The questions in this survey will refer to [insert name of post DC PCP] as “this provider.” Please think of that 
person as you answer the survey. 
1. Did this provider explain things in a way 
that was easy to understand? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
2. Did this provider listen carefully to you? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
3. Did this provider give you easy to 
understand information about your health 
questions or concerns? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
4. Did this provider seem to know the 
important information about  your 
medical history? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
5. Did this provider show respect for what 
you had to say? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
6. Did this provider seem informed and up-
to-date about the care you got from 
specialists? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
7. When you talked about starting or 
stopping a prescription medicine, how 
much did this provider talk about the 
reasons you might want to take a 
medicine? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
8. When you talked about starting or 
stopping a prescription medicine, how 
much did this provider talk about the 
reasons you might not want to take a 
medicine? 
 Not at all 
(0) 
 A little (1) 
 Some (2) 
 A lot (3) 
9. When you talked about starting or 
stopping a prescription medicine, did this 
provider ask you what you thought was 
best for you? 
 Yes (1) 
 No (1) 
 
 
10. Did you and anyone in this provider’s 
office talk about all the prescription 
medicines you were taking? 
 Yes (1) 
 No (1) 
 
 
11. Did anyone in this provider’s office talk 
with you about your specific goals for 
your health? 
 Yes (1) 
 No (1) 
 
 
12. Did anyone in this provider’s office ask 
you if there are things that make it hard 
for you to take care of your health? 
 Yes (1) 
 No (1) 
 
 
13. Did this provider’s office give you 
information about what to do if you 
needed care during evenings, weekends, 
or holidays? 
 Yes (1) 
 No (1) 
 
 

12/30/2020 
 
P a g e  | 35 
14. Did this provider spend enough time with 
you? 
 Yes (1) 
 No (1) 
 
 
15. Using any number from 0 to 10, where 0 
is the worst provider possible and 10 is 
the best provider possible, what number 
would you use to rate this provider? 
(please only mark one box) 
0   1   2   3   4   5   6   7   8   9   
10 
Worst 
Best 
 
 
 

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Appendix 4: Provider Satisfaction Survey  
 
 
 
 
 
(Back to Secondary Measures) 
 
Provider Survey   
 
 
 
 
 
 
 
 
 
Study ID: 
This survey is intended for primary care providers involved in the INtegrating Care After Exacerbation of COPD 
(InCasE) intervention. The purpose of this survey is to evaluate how the intervention is working for patients 
discharged from your facility for a COPD exacerbation. For each item below, please rate the strength of your 
agreement or disagreement with the statement. If you intentionally do not answer a question, please indicate 
the question number in #10 so that we will not contact you for a missing answer. 

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strongly 
disagree 
disagree 
neither 
agree 
nor 
disagree 
agree 
strongly 
agree 
not 
applicabl
e 
1. Training for the InCasE intervention 
has been adequate. 
 
 
 
 
 
 
2. The InCasE intervention has 
increased my workload. 
 
 
 
 
 
 
3. The intervention was helpful to me. 
 
 
 
 
 
 
4. I feel that the InCasE intervention 
process respects the role of the 
primary care provider in patient 
management. 
 
 
 
 
 
 
5. InCasE clinicians respond to my 
questions about their 
recommendations in constructive 
ways. 
 
 
 
 
 
 
6. The InCasE intervention has 
improved patient access to 
specialty care. 
 
 
 
 
 
 
7. The InCasE intervention has 
improved coordination of care 
between primary and specialty 
care providers. 
 
 
 
 
 
 
8. The InCasE intervention has 
improved the quality of care for our 
patients. 
 
 
 
 
 
 
9. As a provider, I find participating in 
InCasE to be a satisfying 
component of my role in patient 
care. 
 
 
 
 
 
 
10. Please provide any additional comments or insights into the InCasE intervention below: 
 
 
 
 

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Appendix 5: Provider Interview Guide 
 
 
 
 
 
 
(Back to Secondary Measures) 
Interview Guide 
 
Interviewer Name: 
 
Date: 8/21/17 
#301 
 
Time Start: 
Time End: 
 
Hello [Dr./Mr./Ms. interview participant name],  
 
My name is [interviewer name]. We are interviewing providers of patients who have participated in the InCaseE 
intervention in order to get your perspective on the program.  
 
We won’t identify you as a participant, nor will we identify your site in any of our reports. 
 
The call will take approximately 30 minutes. 
 
Your participation in this interview is voluntary.  You can stop the interview at any time, and let me know if you’d rather 
not answer a particular question. 
 
Do you have any questions? 
 
In order to make sure we capture all of the information you give us, we would like to record this call.  The audio-file for 
the recording will be stored directly to a restricted access file on the VA secure network. Is this okay with you?  Since we 
are recording, please do not refer to specific patients by name. [Hit record button.]  Okay, to confirm, I’m starting the 
recording.  Is this ok with you? 
 
[Generic 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. Can you tell me more about  ____________ ? 
3. Can you give me an example of ____________ ? 
4. Can you tell me about a time when ____________ ?] 
 
   
1.  Are you familiar with the INCasE Program?  
    
IF YES: Please describe the program for me.  
 
IF NO:  The InCasE study began in May 2015.  The intervention was developed by a team of primary care,  
pulmonary, pharmacy, and palliative care providers to decrease rates of hospital readmissions and mortality among 
Veterans discharged for COPD exacerbations. 
 
After patients are discharged for a COPD exacerbation, the study team reviews the patient’s CPRS record and 
provides a summary of recommended COPD treatments, medication, and follow-up through a CPRS note.  They also 
enter any recommended orders for the provider to review, and then sign, modify, or decline. 
 
a.  Are you familiar with this program? 

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Note: if still not familiar with this program, PAUSE RECORDER and list patients seen as part of the intervention. 
Our records indicate that you have received InCasE recommendations for some of your patients. Do you recall 
this? 
 
 
IF NO  Provide patient full name & last 4. 
1.  
2. _________________  
3. _____________________________________  
I am now going to turn the recorder back on, remember that because we are recording, please do not refer to any 
patients by name.  RESUME RECORDER 
 
If provider is still not familiar with the program, skip to question 8. 
 
2. Please tell me about your experience with the InCasE.  
3. [As needed] How well does the InCase intervention fit with your practice? [Acceptability] 
a. [If needed] What, if anything, about the InCasE intervention fit with your work flow? 
b. [If needed] Was there anything about the InCasE intervention that did not fit with your work flow? 
4. [As needed] How easy or difficult was it to implement the InCasE recommendations? [Feasibility] 
a. [If needed] Were there any challenges to implementing the InCasE recommendations? 
b. [If needed] What, if anything, helped to implement the InCasE recommendations?  
5. [As needed] How satisfied have you been with InCasE? [Satisfaction] 
a. [If needed] Was there anything about InCasE that you found satisfying?  
b. [If needed] Was there anything about InCasE that you were dis-satisfied with? 
6. [If needed] Can you tell me about InCasE’s effect on patient care. [Effectiveness] 
7. [If needed] What future do you see for InCasE?  [Feasibility & Sustainability] 
8. Would you like to see the approach used in InCasE extended to other disciplines? 
9. Do you have any questions for us, or is there anything else you would like to add? 
 
Thank you for participating in this interview. 
 
 
 

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