SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Phase: NA
Conditions: Diabetes Mellitus, Cardiovascular Disease
Sponsor: Kaiser Permanente

 
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Protocol  
 
 
SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET 
 
 
NCT02325531 
 
 
6/2/2016 
 
 
 

 
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INSTRUCTIONS: 
• 
All sections are required.  If a section does not apply to your project please enter “N/A.” The level of detail 
required for each section will vary with the complexity of your project. 
• 
If your study has multiple aims, break each section down to address each aim of the study, as appropriate. 
• 
Delete all instructions (italics). 
• 
See the Research Compliance website for guidance and information on a number of topics including 
vulnerable populations, consent, inclusion of non-English speakers, genetic research, and data sharing.  
• 
If you are doing a data-only study with no prospective or interventional components, use the Data Only 
Protocol Template instead. 
 
1. Protocol Title 
SPREAD-NET: Practices Enabling Implementation and Adaptation in the Safety Net 
 
2. Objectives 
We propose to compare the effectiveness of different 'support strategies' at helping diverse 
community health clinics (CHCs) sustainably implement an intervention shown to reduce 
patients' cardiovascular disease (CVD) event risk. Kaiser Permanente developed and 
implemented the 'ALL Initiative' (a.k.a. 'ALL'), a clinic-level intervention designed to increase 
rates of adult patients with diabetes mellitus (DM) or CVD who are prescribed cardio-protective 
medications (statins and ACE-Inhibitors) according to evidence-based guidelines. After ALL was 
shown to be highly effective in Kaiser Permanente's integrated care setting, our team 
demonstrated the feasibility of adapting it for successful implementation in 11 CHCs - with the 
help of substantial implementation support. The next step in this body of research is to identify 
the amount and type of support needed to effectively implement and sustain this intervention 
in a greater number of CHCs. To that end, we will conduct a trial in which 30 CHCs are cluster-
randomized to receive low, medium, or high-intensity support in implementing ALL. We will 
conduct this work with CHC members of OCHIN, a community health information technology 
network that hosts one of the nation's largest CHC electronic health record (EHR) platforms; 
study CHCs share a single, linked EHR. Guided by the Practice Change Model and RE-AIM 
framework, we will use mixed-methods to:  
 
Aim 1: Compare how effectively the low, medium, and high-intensity strategies support the 
CHCs' implementation of ALL, and assess change in rates of clinic patients with (i) guideline-
appropriate cardioprotective prescriptions, and (ii) controlled blood pressure and low-density 
lipoprotein, as associated with implementation supported by the different strategies;  
 
Aim 2: Assess the strategies' effectiveness at supporting intervention sustainability over 3 years; 
and  
 
Aim 3: Identify clinic characteristics associated with success at different levels of support. Our 
team includes CHC clinicians, and experts in dissemination and implementation (D&I), health 
economics, and health services research mixed-methods. Our study is designed to inform future 
implementation of ALL as well as other interventions known to improve outcomes among CHC 
patients with DM / CVD. Our results could also have high impact on D&I science, by comparing 
practical, generalizable methods for supporting the implementation of clinical innovations in 
CHCs and other ambulatory settings.  
 
Research questions: What are the characteristics of clinics that achieve sustained change even 
with less implementation support, and of those that do not achieve change even with more 
support? 

 
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3. Background 
 
A major barrier to the timely dissemination of evidence-based interventions is a lack of knowledge 
about efficient, replicable strategies for supporting the implementation of tested interventions in 
routine care. This is particularly relevant to intervention implementation in safety net Community 
Health Centers (CHCs*).1-16 
 
Disseminating successful interventions in diverse primary care settings could significantly improve the 
health of patients with DM / CVD nationwide. Yet few studies have focused on comparing effective 
strategies for supporting change in health care settings.5,79-91 Thus an important barrier to the 
widespread dissemination of evidence-based interventions such as ALL is a lack of knowledge about 
the most effective strategies for supporting sustainable implementation in diverse care settings.1,3,5,8-
11,15,21,22,24,42,44,79-88,92-97 This limitation is particularly problematic for the Community Health Centers 
(CHCs) in our health care ‘safety net’,1,13,14 which care for millions of underserved patients, and are 
expected to serve millions more through the Affordable Care Act.98-100 Rapid, effective implementation 
of interventions shown to improve care delivery and health outcomes could ensure that CHC patients 
benefit from cutting-edge clinical knowledge. Although the need is well-acknowledged, we know of no 
previous randomized trial comparing strategies for supporting consistent, reliable implementation of 
evidence-based care in CHCs.7,10,12,101 
 
This study will address the lack of knowledge about effective implementation support strategies. We 
propose to compare the effectiveness of 3 replicable strategies for supporting the implementation of 
the ALL Initiative in CHCs. These strategies have been shown to be effective and feasible in CHCs. We 
will conduct a pragmatic trial in which 30 CHCs are cluster-randomized to receive low, medium, or high-
intensity implementation support.  
 
We propose to address an important barrier to such dissemination - the lack of knowledge about the 
most effective strategies for supporting CHCs’ implementation of evidence-based 
interventions.1,13,14,45,79-91,93 This work is positioned to have broad impact. Understanding how to 
efficiently support implementing the evidence-based ALL Initiative in CHCs could reduce CVD event 
risk in patients with CVD / DM nationwide, improving health outcomes and reducing care costs. 
While this project focuses on ALL in CHCs, we will discover generalizable strategies for implementing 
ALL in other primary care settings and also for supporting CHCs’ implementation of other 
interventions shown to improve CVD /DM outcomes, and other morbidities.  
 
 
4. Study Design 
 
We will conduct a cluster-randomized, prospective, pragmatic trial with 3 arms (Figure 3). In months 1-18, 
we will collect baseline data via a survey of all study sites, and refine the toolkit. At the start of 
Implementation Year 1 (study month 19), 30 CHCs will be randomized to receive low, medium, or high-
intensity support in implementing the ALL Initiative. Guided by RE-AIM and the Practice Change Model, we 
will use mixed methods to assess how effectively the different levels of intensity support intervention 
uptake, guideline-based prescribing, and patient health (Aim 1), and sustainability over 3 years (Aim 2). We 
will identify clinic-level factors associated with each support strategy’s effectiveness and sustainability (Aim 
3), and adapt as possible. We will also conduct a cost analysis. 
 
Arm 1 (‘Low’ intensity support) components: TOOLKIT. The point person will receive the implementation 
toolkit (paper and electronic form) at the start of Implementation Year 1. Toolkit components are ready for 

 
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use except as noted. EHR-based tools, built in OCHIN’s EHR, will be activated at that time. The toolkit will 
include annual 1-hour ‘Basic Webinars’ open to the study point person, and hosted by the research team.  
 
Arm 2 (‘Medium’ intensity support) components: Arm 2 CHCs will receive the TOOLKIT as above. TRAIN-THE-
TRAINER: The study ‘point person’ will receive extensive implementation training at a 2-day in-person 
meeting in Portland, OR. Our implementation specialists will teach participants how to use the ALL toolkit 
and how to train others to use it. Training content will include necessary elements as identified by (i) our 
previous research, (ii) the baseline survey), (iii) the study team and the SPREAD-NET advisory group. 
Trainees will be asked to train staff at their clinic within 6 weeks after the in-person event. ADAPTIVE 
WEBINARS: The point people will join quarterly 1-hour webinars hosted by the research team. One webinar 
will include the content from the Toolkit’s ‘Basic’ webinars. The other three will include content to reinforce 
and augment information from the in-person training, and to address factors that the Practice Change 
Model identifies as influential on intervention implementation in primary care settings. These webinars will 
provide a forum for group discussion and best practice sharing. We will adapt the webinar’s content to 
address identified staff needs or implementation barriers we directly observe through visits and online 
diaries. This will engage staff in customizing the implementation support they receive. The webinars will be 
open to any interested clinic staff from Arms 2-3.  
 
Arm 3 (‘High’ intensity support) components: All components as in Arm 2, plus PRACTICE FACILITATION site 
visits from the study team ‘implementation specialist.’ Visits will last 2-3 days, with 2 or more visits in 
implementation year 1, and 3 or more over the course of implementation years 2-3. The specialist will 
provide support as needed; anticipated activities include staff presentations, observational coaching on how 
the tools are presented to clinic staff and used in the clinic workflow, and tailored problem-solving support 
to help address identified barriers. Clinical questions arising at these visits will be fielded by our RN practice 
facilitator, and the site clinician champion. Advisory group clinicians will be asked to provide further support 
if needed. 
 
5. Study Population 
 
a. Number of Subjects 
Quantitative: 30 CHCs will be randomized to receive low, medium, or high-intensity support in implementing 
the ALL Initiative. 
 
Qualitative: Study clinic providers and staff at OCHIN will participate in qualitative data collection efforts as 
described below.  
 
b. Inclusion and Exclusion Criteria 
Describe how individuals will be screened for eligibility and the criteria that define who will be 
included or excluded in your final study sample. 
 
Describe the plan for disposition of data collected during recruitment/screening in the event of a 
screen failure or when a potential subject is contacted but declines participation (e.g. destroyed 
immediately, destroyed at end of study, retained for separate analysis or so that subjects are not 
contacted repeatedly about participation after they have declined, etc.) 
Inclusion criteria.  
Quantitative data: ~20,000 OCHIN patients from 30 clinics. Data will be extracted monthly from 
OCHIN’s EHR including (a) Study population identification (age, CVD / DM, prescriptions); (b) Patient 
and (c) Clinic characteristics; (d) Patient outcomes (last BP, LDL results and measurement dates; 
issued prescriptions and dates); and (e) Process measures (e.g., tool use, encounters). (f) Cost 
analysis data will be collected as well. 

 
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Qualitative data: Ongoing phone calls with 30 point people. Site Visits: 18 visits in total. Breakdown: 
6 clinics per year X 3 years. Interviews: 208 in total. We anticipate 108 formal (Breakdown: 6 clinics X 
18 interviews) and 100 telephone (6 clinics X 12 interviews, plus 28 follow-up interviews). 
Exclusion. Pregnant and lactating women will be excluded, as the ALL medications are 
contraindicated for pregnancy. 
 
c. Vulnerable Populations 
Regulatory Categories:  Indicate whether you will include or exclude each of the following populations. This 
refers to subjects who are known members of these populations upon recruitment or at any time during the 
study.  You may not include members of these populations unless you describe this in your inclusion criteria.    
• 
Children  
• 
Pregnant women 
• 
Neonates  of uncertain viability or nonviable neonates (up to 28 days post birth) 
• 
Prisoners (NOTE:  The KPNW IRB does not have the appropriate membership to review research involving 
prisoners.  Consultation with KFRI will be required.) 
 
Justify the inclusion of any of these populations. Describe additional safeguards to protect the rights and 
welfare of these subjects. 
 
Neonates (i.e., newborns) of uncertain viability or nonviable: Exclude 
Children: Exclude 
Decisionally/cognitively impaired: Include 
Economically/educationally disadvantaged: Include 
Non-English Speakers: Include 
Employees who are specifically and intentionally targeted to be included in this study population because of 
their workplace and/or employee status: Include 
Elderly: Include 
Prisoners: Prisoners are excluded or not anticipated to become study subjects 
 
d. Setting 
Describe the sites or locations where your research team will conduct the research. 
 
If this is a multi-site study: 
• 
Specify what procedures are being performed at this site or by this site’s personnel (consider recruitment, 
consent process, study procedures, data analysis, etc.). 
• 
State how each site will satisfy its IRB review requirements.  Indicate if you are asking this site’s IRB to 
rely on another IRB or if another institution would like to rely on this site’s IRB and include this 
information in the eIRB IRQ. 
 
OCHIN member clinics (29 total): Winding Waters, Scappoose / OHSU, Santa Cruz County, Mosaic, 
Community HealthNet, Progressive Community Health Center, Truckee Tahoe Medical Group, Monterey 
Health Department, La Pine, Placer County, SW Montana, Neighborhood Family Practice 
 
Michigan State University (MSU) 
Mid-Atlantic Permanente Research Institute (MAPRI) – KPMAS 
 
e. Recruitment Methods 
 

 
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Describe in detail how study participants will be recruited and enrolled. For example, will you openly recruit 
through the use of advertisements, websites, or brochures? Will you do targeted recruitment through the use 
of existing records or referral? If you will contact potential participants for recruitment, include the 
method(s) of contact and number of contact attempts that may be made. 
 
Upload in the eIRB all recruitment materials, including brochures, advertisements, mailings, scripts, and 
website materials (screen shots). Note: If your materials are yet to be developed, these must be submitted to 
the IRB as a modification request and approved prior to use with study participants.  
 
Describe, by position / title, who will be recruiting and enrolling participants (providing the particular names 
of research team members is not necessary). 
 
Investigators sometimes plan to re-contact and re-recruit participants for future follow-up studies. That is, 
investigators may anticipate that participants for a currently proposed study will be logical participants in a 
future study.  If there are any such expectations or plans for the participants in the currently proposed study 
to be re-contacted for follow-up studies, describe this. (And, note that participants should be informed of this 
potential for re-recruitment during the current study’s consent process.) 
 
Clinic recruitment will be led by Chris Nelson (Co-I) at OCHIN. Chris will follow-up with each clinic (who 
agreed to participate in the study during the proposal stage) by sending them an introductory email, 
FAQ handout and MOU. Patient data will be identified by the OCHIN DM registry. Staff and providers will be 
recruited by each OCHIN clinic’s point person, specifically looking for local opinion leaders and / or as having 
strong positive or negative feelings about the intervention and support strategies used. 
 
f. Consent Process 
Describe how you will obtain and document consent, including: 
• 
Where, when and how the consent process will take place. 
• 
A process to ensure ongoing consent. 
• 
Steps that will be taken to minimize the possibility of coercion or undue influence. 
Any steps that will be taken to ensure the subjects’ understanding. 
 
 
This research will use a consent procedure which does not include, or which alters, some or all of the 
 
elements of informed consent; or waives the requirement to obtain informed consent in its entirety. We 
 
are requesting a waiver of informed consent in its entirety for the quantitative and qualitative aspects 
 
of this study.  
 
 
All of the following four statements are true: The research involves no more than minimal risk to the 
 
subjects; The waiver or alteration will not adversely affect the rights and welfare of the subjects; The 
 
research could not practicably be carried out without the waiver or alteration; and Whenever 
 
appropriate, the subjects will be provided with additional pertinent information after participation. 
 
 
Explanation of Minimal Risk Research: Quantitative data (OCHIN patient data): OCHIN's EHR will be a 
 
Limited Data Set and will not include PHI. Data collection will not affect patients. Qualitative data 
 
(OCHIN providers and staff): Regular phone calls, site visits and interviews will include questions 
 
regarding views of the ALL initiative implementation, and not about individuals’ health. Data collection 
 
will not affect providers or staff. 
 
 
Explanation of Waiver or Alteration of Informed Consent: The waiver or alteration of informed consent 
 
will not adversely affect the rights and welfare of the subjects.  

 
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Quantitative data (OCHIN patient data): consenting participants would require the release of full 
 
PHI rather than a LDS, therefore increasing their risk.  
 
Qualitative data (OCHIN providers and staff): Obtaining consent would interfere with the clinic workflow 
 
Modifications to the Consent Process  
• 
If you will not obtain consent or if you will be using only an abbreviated consent, explain how this will not 
adversely affect the rights and welfare of the subjects, why it is not practicable to obtain full consent, 
and, if appropriate, what additional pertinent information will be provided to subjects after 
participation. 
o Example 1:  If part of your study involves retrospective review of existing data for 
many individuals, it may not be practicable to collect the data you need if you had to 
contact each individual to get permission.  As long as confidentiality of the 
information is protected, such data collection poses minimal risk to the subjects and 
would not adversely impact their rights or welfare.) 
o Example 2:  Studies that require 100% participation in order to obtain valid results, 
such as studies where an entire clinic is randomized to participate in an intervention, 
may not be practicable to conduct if informed consent is required. 
• 
If you will conduct screening or any other research procedures before obtaining full informed consent, 
describe this and explain how the above criteria are met with respect to that part of the study. 
 
 
Non-English Speaking Subjects 
• 
If subjects who do not speak English will be enrolled, describe how the consent discussion will take place 
and indicate if translated consent forms or short forms will be used. 
• 
Confirm that an interpreter will assist with the initial consent process and subsequent study visits. 
 
 
Assent of Children and Parent Permission 
• 
Describe your plan for obtaining parent permission.  The permission of one parent is generally sufficient 
for minimal risk research, or for greater than minimal risk research if there is the potential for direct 
benefit to the child. 
• 
Note that for studies involving greater than minimal risk with no prospect of direct benefit to the child 
subjects, permission of both parents is required unless one parent is deceased, unknown, incompetent, or 
not reasonably available, or when only one parent has legal responsibility for the care and custody of the 
child. 
• 
Describe whether permission will be obtained from individuals other than parents, and if so, who will be 
allowed to provide permission.  
• 
Indicate whether assent will be obtained and documented from all, some, or none of the children. If 
assent will only be obtained from some children (because of very young age, severe cognitive 
impairment, etc.), indicate which children will be required to assent and which will not. 
• 
When assent of children is obtained, describe whether and how it will be documented. 
• 
When subjects might reach the age of majority during the study, describe the plan to obtain consent 
from these subjects at that time using an adult consent form. 
 
Adults Unable to Consent/Decisionally Impaired 
• 
Describe the process to determine whether an individual is capable of consent. 

 
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• 
List the individuals from whom permission will be obtained in order of priority. (E.g., durable power of 
attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.  See 
the KPNW Policy on Surrogate Consent for Research for more information.) 
• 
Describe the process for assent of the subjects. Address the following: 
o Whether assent will be required of all, some, or none of the subjects. If assent will be 
obtained from some subjects, indicate which subjects will be required to assent and which 
will not. 
o If assent will not be obtained from some or all subjects, an explanation of why not. 
o When assent is obtained, describe how it will be documented.  
• 
Describe the plan to obtain consent if subjects might regain capacity to consent during the study. 
 
HIPAA Privacy Rule Authorization – if study will use or disclose Protected Health Information 
(PHI) 
• 
Describe the plan to obtain a signed Privacy Rule Authorization from each subject. 
• 
If you will not obtain signed Privacy Rule Authorization or if you want to eliminate any required language 
from the authorization, explain: 
o Why the research could not practicably be conducted without the waiver or alteration (for example, 
you may not be able to do the research, or part of the research, if you needed to contact each 
individual for permission because of lack of contact information or a large number of individuals); 
o Why access to and use of the PHI is necessary for the research; and 
o Why the use or disclosure of PHI for the research poses no greater than minimal risk to the subjects’ 
privacy (must have an adequate plan to protect the PHI from improper use or disclosure, a plan to 
destroy identifiers at the earliest opportunity consistent with the purpose of the research, and, when 
applicable, written assurances from collaborators that PHI will not be reused or re-disclosed to any 
other entity). 
 
Not applicable. 
 
6. Study Procedures 
Describe: 
• 
All research procedures being performed and when they are performed, including timing 
and amount of all samples collected for research purposes. 
• 
Measures taken to lessen the probability or magnitude of risks (monitoring for safety, 
preventing complications, etc.). 
• 
All drugs and devices used in the research and the purpose of their use, and their FDA 
approval status. 
• 
Data collection tools (upload all surveys, scripts, and data collection forms). 
• 
What data will be collected, including long-term follow-up. 
• 
The duration of an individual subject’s participation in the study. 
 
NOTE:  It should be clear exactly which procedures will be conducted for the research as opposed to 
procedures the subjects would undergo (in the exact manner described in the protocol) even if they were 
not participating in the study.   
 
Describe procedures that will be followed when subjects withdraw from the research, including 
withdrawal from intervention but continued data collection. 
 
Describe any anticipated circumstances under which subjects will be withdrawn from the research 
without their consent.   
 

 
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If the study involves genetic testing or collection of genetic information, describe this. 
 
If the study involves anonymous or coded genetic research and consent for genetic research will NOT 
be obtained, confirm here that you will check the genetic exclusions database in order to comply with 
the Oregon Genetic Privacy Law.  
 
 
Qualitative data: 
The All Staff Survey. All staff at the SPREAD-NET (S-N) study clinics (~30 anticipated) will be asked to 
complete this paper survey, which is designed to assess each clinic’s readiness to change.  
Clinic Information Form (CIF) Survey. One person, e.g., clinic manager or quality improvement coordinator, 
at each of the study clinics will be asked to complete a paper survey which is intended to collect factual 
information about the clinic that will be used to help understand how best to support implementation of the 
ALL Initiative. 
 
Bi-weekly phone calls with point people. Once the ALL initiative has been implemented in the study clinics 
(estimated March 2015), each clinic’s study point person will participate in regular telephone calls with 
study staff at KPCHR and OCHIN. These calls will be biweekly to start; the number of calls per month may 
taper off over time. Calls are expected to last 15- 30 minutes. No PHI will be collected, nor will data be 
collected from or about patients. The format of the calls will be fairly unstructured; in general study staff will 
solicit information on barriers and facilitators to the uptake of the ALL initiative, including use of the study 
tools and fit into clinic workflows. The attached ‘Topics for point person calls’ document lists subjects that 
may be covered during these calls. Phone calls will be recorded by study staff using KPCHR-approved digital 
recorders that are encrypted and password protected for security and confidentiality, and transcribed by a 
KPCHR approved transcriptionist as necessary. Recordings and transcripts will be sent through KPCHR’s 
secure file transfer site. 
Site visits. In study years 2.5-4, we will conduct in-person observations at 6 clinics per year, to 
collect in-depth data to augment the data collected in the diary entries. We will purposively select 
CHCs for site visits that will optimize our learning, such as CHCs that are excelling with lower levels 
of support. At each visit, 2 members of our qualitative team will spend 2 days at the CHC. 
Ethnographic methods (field observation, opportunistic and semi-structured interviews) will be 
used. Such methods are uniquely suited to the study of organizational behavior as they facilitate in-
depth understanding of change processes, workflows and routines, and barriers and facilitators to 
change. At these visits, we will explore the implementation process, toolkit use and barriers and 
enablers of practice change, including understanding clinic workflow for DM / CVD patients, and 
how ALL supports medication decision-making. 
Additional interviews. In years 3-4.5, our qualitative team will conduct telephone or video-based 
semi-structured interviews with staff at each CHC that we do not visit in person. The interviews will 
be designed to elicit further information about how ALL was implemented, how effectively each 
arm’s strategy supported that implementation, and barriers to effectiveness.  We will also likely 
conduct more informal, follow-up interviews to fill in knowledge gaps identified during subsequent 
data collection and analysis. 
Other qualitative data sources. Our team will also collect ‘archival’ data related to the process evaluation 
(e.g., email / telephone discussions with CHC staff; clinic policies; concurrent QI initiatives, as well as 
conduct regular debriefings with practice facilitators (arm 3)). 
 
Quantitative data: This data will be extracted monthly from OCHIN’s EHR will include: (a) Study population 
identification (age, CVD / DM, prescriptions); (b) Patient and (c) Clinic characteristics; (d) Patient outcomes 

 
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(last BP, LDL results and measurement dates; issued prescriptions and dates); and (e) Process measures 
(e.g., tool use, encounters). Cost data will be collected as well.  
 
7. Data Analysis 
a. Analysis Plan 
Describe the data analysis plan, including any statistical procedures. 
 
When applicable, provide a power analysis. 
 
Describe any procedures that will be used for quality control of collected data. 
 
Survey data analyses. Survey results will be used for two purposes. (1) Summary results will be 
used as a ‘diagnostic tool’ to identify materials needed to train Arm 2-3 clinics at the in-person 
training and subsequent webinars. We will use descriptive statistics to summarize the responses 
to the surveys and identify prevalent aspects to be included in the trainings. (2) Results will be 
used to measure the clinics’ baseline characteristics, which will be included in longitudinal 
analyses as covariates. We will test for baseline differences in patient and clinic characteristics 
between study arm clinics using chi-square and t-tests to determine if differences exist. 
Qualitative survey results from open-ended questions will be content-analyzed by our 
qualitative team using standard methods225,226  
Specific Aim 1 & 2 analyses. For Aim 1, we will use an interrupted time-series design with three-
level hierarchical linear models to assess differences in the impact of the intervention’s 
implementation, across the 3 support strategies, on quantitative outcomes (patient health 
[Effectiveness], guideline-based prescribing [Reach]). This method is commonly used to compare 
changes in rates across time pre- and post- implementation. Time in monthly intervals will form 
the 1st level of the model, person the 2nd, and clinic the 3rd; these models do not require 
patient-level data at all time points. We will include a dummy-coded variable for study arm 
(reference group = ‘High’-intensity support) and clinic level covariates (as guided by the Practice 
Change Model components) at model level-3, and patient level covariates at level-2. The level-1 
model will be specified as a segmented regression model, to yield an estimate of the level and 
slope across time of rate of the outcomes of interest in the 2 years pre-implementation, and 
changes in the level and slope of these rates in the 12 months post-implementation. Change in 
level provides an estimate of the immediate effect of the intervention. Change in slope gives an 
estimate of effect across time. We will include a cross-level interaction of study arm with time, 
change in level, and change in slope; the interaction of change in slope by study arm tests if the 
change from pre to post intervention in the trends in the rates over time differs across arms. 
Similarly, the interaction of change in level by study arm tests if the immediate effect of the 
intervention differs across study arms. Separate analyses will be conducted for percent of 
patients with guideline-appropriate prescriptions for ACE/ARBs, statins (our primary outcomes), 
and with last BP under control, and last LDL under control (secondary outcomes) (Table 5). Aim 
2 analyses will use the same approach, adding time points through 36 months post-intervention 
[Maintenance]. The time period variable will have 3 levels (pre-intervention, 12 months post-, 
and 13-36 months post-intervention). Of interest is whether the slopes (rate of change) or level 
in the last time period differ across the 3 arms. 
Statistical power. Segmented regression is a powerful statistical technique in diverse 
applications, but formal power analyses may not be feasible as estimates of the model 
parameters are not available prior to the study. We will meet or exceed the 12 points pre- and 
post-intervention used in similar segmented regression analyses, as is adequate to detect even 
modest effect. To illustrate our power to detect changes between study arms, we conducted a 

 
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power analysis using data from our current study. At 12 months post-intervention, 60%, 63% 
and 46% of control clinic patients and 68%, 76%, and 58% of intervention clinic patients were 
appropriately on statins, ACE, and both, respectively. We can detect differences of this 
magnitude between any two arms of the study with power of .95 to .99 if the intra-class 
correlation is .01, and power of .76 to .99 if the ICC is .02 with an alpha level of .05. 
Additional analyses (Minimal support needed to achieve treatment thresholds): While our 
primary analyses will measure implementation impact as described above, we will also conduct 
secondary analyses, for both the patient health and guideline-based prescribing outcomes, in 
which we will define thresholds of intervention impact. Thresholds will be defined as a target 
percentage of clinic patients with (i) guideline-appropriate prescriptions; (ii) last LDL <100; and 
(iii) last systolic BP <135. Targets will be determined based on baseline data and in consultation 
with the SPREAD-NET advisory group, which includes CHC clinicians. We will then assess the 
minimal amount of implementation support needed to achieve threshold results. We anticipate 
based on our first study that these targets will be approximately (i) 75%; (ii) 70%; and (iii) 80%, 
respectively. Logistic regression will be used, with study arm (reference group = High support) 
predicting a binary outcome for threshold achieved by 12 months. 
Qualitative analyses (Aim 3). Led by Dr. Cohen, our expert qualitative team will analyze data 
from the weekly diaries, site visits, archival data, observation, and interviews, to gain in-depth 
knowledge of the change process. Data collection and analyses will be concurrent and iterative, 
permitting us to identify salient constructs and knowledge gaps while implementation is 
ongoing, incorporate this knowledge into subsequent data collection, and guide adaptation of 
the support strategies. A grounded theory approach coupled with an immersion-crystallization 
process will be used to identify themes and patterns in the qualitative data. The aim will be to 
understand what happens during implementation from the participants’ perspective, including 
barriers and facilitators, the extent to which toolkit elements are used or adapted [Adoption], 
and the impact of each support strategy on implementation success [Implementation]. 
Particular attention will be paid to factors leading to a given practice excelling or struggling in 
response to the offered implementation support. Our team will use Miller and Crabtree’s 5-
phase analysis strategy, as team members have previously done successfully. 
 
b. Sharing of Results with Subjects 
Describe whether results (study results or individual subject results, such as results of standard or 
research lab tests and genetic tests) will be shared with subjects or their providers. 
 
If the study carries a risk of incidental findings, describe your plan for evaluating these and determining 
whether and how subjects or their providers will be given this information. 
 
If laboratory results will be shared with subjects or their healthcare providers, verify that the laboratory 
conducting the test is CLIA certified. 
 
Not applicable.  
 
c. Data and Specimen Banking 
Indicate if specimens may be used for future research and whether that may include genetic research 
(see above regarding requirements for anonymous or coded genetic research). 
 
State if data or specimens will be sent to a separate repository.  
 

 
Page 12 of 29 
Revised: 6.2.2016 
If data or specimens will be banked in a repository for future use as part of this protocol submission, 
describe here (or in a separate document) where they will be stored, how long they will be stored, how 
they may be accessed, and who will have access to the specimens.  Describe the procedures to release 
data or specimens, including: the process to request a release, approvals required for release, who can 
obtain data or specimens, and the data to be provided with specimens. 
 
Not applicable.  
 
8. Privacy, Confidentiality, and Data Security 
Describe the steps that will be taken to protect subjects’ privacy during recruitment, consent and study 
procedures. 
 
Describe the plan for storage of data and specimens, including: 
• 
Where the materials will be stored. 
• 
How the materials will be labeled. 
• 
Any other steps that will be taken to ensure security (e.g., training of staff, authorization of 
access, password protection, encryption, physical security, and separation of identifiers from 
data and specimens, certificates of confidentiality). 
• 
Plan to destroy/archive or retain data and/or specimens at the end of the study. 
 
If you will collect any data from participants electronically (including email, website, etc.), explain: 
• 
How the data will be collected. 
• 
How the information will be secured (encryption, password protection, etc.; may require 
consultation with IT department). 
• 
Any risks to the participants’ privacy posed by using these methods (describe in consent, as 
applicable). 
• 
How you will verify the participant’s identity. 
 
If any data or specimens will be sent outside of this site, list each recipient (may list by role or category if 
the information is the same for several different entities).  For each recipient, describe: 
• 
What will be sent. 
• 
Whether the materials will be fully identifiable (PHI, if health information), a Limited Data Set, 
de-identified, or aggregate (See Types of Compliance Data – Quick Reference for more 
information). 
• 
How the materials will be transferred securely (for instance, Secure File Transfer). 
• 
NOTE:  If you are sending full PHI outside this site, you must have a RAMP review.  Complete and 
upload the Risk Assessment Tool. 
 
Quantitative data: This will be stored at OCHIN.  
Qualitative data: This will be stored at CHR.  
 
 
CHR investigators and project staff sign annual confidentiality pledges and receive IRB training and 
 
Certification every three years. Data from the community clinics will come through OCHIN, and OCHIN 
 
will use similar safeguards to ensure confidentiality when handling data. OCHIN will use unique patient 
 
identification codes and all data sources will be linked through a secure relational database at OCHIN. 
 
Data will only be shared with CHR through a secure data transfer web site. After data have been linked 
 
and transferred, they will be de-identified for analytical purposes. OCHIN and CHR will use a state-of-
 
the art file transfer application to provide secure file transfers. This application transfers data from a 
 
secured sending website to a secured receiving website. CHR’s standards meet the standards required f

 
Page 13 of 29 
Revised: 6.2.2016 
 
or DHHS level 1 security. In addition, back-end checks will be conducted periodically to ensure data 
 
reliability. 
 
9. Provisions to Monitor the Data to Ensure the Safety of Subjects 
This is required when research involves more than Minimal Risk to subjects.  Describe: 
• 
Who will monitor the study data for safety. 
• 
Who will verify data accuracy and conduct quality assessments. 
• 
How objectivity in the monitoring process will be ensured. 
• 
What data and/or events will be reported to the monitor or monitoring board and how 
frequently. 
• 
The procedures and methods that the monitor or board will use to evaluate the data. 
• 
Criteria for taking action on monitoring findings (for instance, stopping rules, reporting, 
protocol changes, changes to monitoring frequency or plan). 
• 
For studies monitored by a DSMB/C, describe the committee membership and structure, 
meeting format, and quorum requirements.  Upload the board/committee charter, if one 
exists. 
 
10. Risks and Benefits 
a. Risks to Subjects 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects 
related the subjects’ participation in the research. Describe the probability, magnitude, duration, 
and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. 
 
Risk of breach of confidentiality is common to almost all research studies. Avoid indicating that 
study participation is expected to be “risk-free” or without risk. 
 
If applicable, indicate which procedures may have risks to the subjects that are currently 
unforeseeable. 
 
If applicable, indicate which procedures may have risks to an embryo or fetus should the subject 
be or become pregnant. 
 
If applicable, describe risks to others who are not subjects and risks to Kaiser Permanente. 
 
b. Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the 
research. Include the probability, magnitude, and duration of the potential benefits. 
 
Indicate if there is no direct benefit. Do not include benefits to society or others. 
 
Note: Compensation is not considered a benefit and should not be included in this section. See 
Compensation to Participants section. 
 
11. Costs to Participants 
Describe any costs that participant may be responsible for due to participating in this study (for 
example, co-pays; paying for treatment, therapies, or other interventions, or the delivery of 
these) and how you will inform participants of these costs prior to their enrollment in this study. 

 
Page 14 of 29 
Revised: 6.2.2016 
 
12. Compensation to Participants 
Describe any compensation provided to participants, for example, for time inconvenience, 
discomfort, travel, or in the event of research related injury.  
 
If applicable, describe how you will inform participants of this prior to their enrollment in the 
study, including if payment will be prorated if the subject withdraws early from the study.  
 
 Note: payment may not be withheld as an incentive for participants to complete the study. 
 
13. Resources Available (delete if not applicable) 
Describe any special resources or expertise required to conduct the study. 
 
14. Drugs or Devices (delete if not applicable) 
If the research involves drugs or devices and is investigator-initiated, indicate whether there is 
any possibility that the results will be reported to FDA (e.g. as part of a new drug application 
[NDA] or premarket approval application [PMA]). 
 
If this is a device study and you think the device is Non-Significant Risk, include justification here 
or upload it as a separate document along with any available device information (instructions for 
use, etc.). 
 
If the drug is investigational (has an IND) or the device has an IDE or a claim of abbreviated IDE 
(Non-Significant Risk device), confirm that you will comply with all applicable FDA requirements 
for investigators.  Also see the ICH-GCP guidance for a summary of investigator and sponsor 
responsibilities in clinical trials. 
 
Address the items listed below as applicable. 
 
Drug Studies: 
• 
Confirm that you will follow applicable KP pharmacy policies and procedures. 
• 
Describe your plan for drug storage, handling, and accountability, including distribution, 
return, and destruction of the drug(s). 
• 
If applicable, upload a copy of the Investigator Brochure for each drug.  (If this is not an 
Oncology study, you must also send an additional copy to the Regional Formulary and 
Therapeutics Committee.) 
 
Device Studies: 
• 
Describe the device, the manufacturing process, and the device labeling, including safety 
instructions or warnings.  If available, this may be addressed in separately uploaded 
device information (such as instructions for use). 
• 
Describe device storage, handling, and accountability, including how access to the device 
will be limited to appropriate personnel and how you will ensure the device will be used 
only for appropriate study subjects. 
 
15. Multi-Site Coordination (delete if not applicable) 
If this site will be the coordinating center for any activities, describe those activities here or in a separate 
document. 
 
Describe the processes to ensure communication among sites, such as: 

 
Page 15 of 29 
Revised: 6.2.2016 
• 
All sites have the most current version of the protocol, consent document, and HIPAA 
authorization. 
• 
All required approvals have been obtained at each site (including approval by the site’s 
IRB of record). 
• 
All modifications have been communicated to sites, and approved (including approval by 
the site’s IRB of record) before the modification is implemented. 
• 
All engaged participating sites will safeguard data as required by local information 
security policies. 
• 
All local site investigators conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy. 
• 
Communication of problems, interim results, and study closure. 
 
16. Community-Based Participatory Research (delete if not applicable) 
Describe involvement of the community in the design and conduct of the research. 
 
Describe your plan for ensuring that community research partners are appropriately trained in 
human subjects protection. 
 
NOTE: “Community-based Participatory Research” is a collaborative approach to research that 
equitably involves all partners in the research process and recognizes the unique strengths that 
each brings. Community-based Participatory Research begins with a research topic of 
importance to the community, has the aim of combining knowledge with action and achieving 
social change to improve health outcomes and eliminate health disparities. 
 
 

 
Page 16 of 29 
Revised: 6.2.2016 
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