PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Phase: NA
Conditions: Depression
Sponsor: University of Massachusetts, Worcester

 
 
 
 
 
 
 
PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology  
Clinics (PRISM) 
 
NCT02760004  
 
Document Date:5/9/23 
 
 

 
 
1) Title 
 
PRogram In Support of Moms (PRISM): Phase 2 
 
2) IRB Review History* 
 
We will be involving external IRBs and will submit modifications as the external study sites agree to participate.  
 
 
3) Objectives* 
 
Aim 1 (Phase 2) To compare the effectiveness of PRISM vs. enhanced usual care to improve depression severity and 
treatment participation in pregnancy through 12 months postpartum (primary outcomes) among 340 patients (n=170 per 
group) via a cluster RCT.  
 
Aim 2: To examine provider/staff fidelity to PRISM (secondary outcome).   
 
Aim 3: To estimate costs of PRISM and enhanced usual care and indicators of potential savings. 
 
 
 
4) Background*  
 
The primary goal of this study is to refine, evaluate, and disseminate a new low-cost and sustainable stepped care 
program for Obstetrics/Gynecology (Ob/Gyn) clinics that will improve perinatal women’s treatment rates and outcomes. 
There is a tremendous public health need for this research as depression is the leading cause of disability among women 
of reproductive age worldwide.  Upwards of 1 in 7 women suffer from perinatal depression. It has deleterious effects on 
birth outcomes, infant attachment, and children’s behavior/development. Maternal suicide causes 20% of postpartum 
deaths in depressed women.  
 
Although the vast majority of perinatal women are amenable to being screened for depression, screening alone 
does not improve treatment rates or patient outcomes. Our research has found that barriers at the patient, provider, 
and systems levels prevent women from receiving the care they need.  Addressing these barriers across the nation will 
ultimately require a practical and sustainable platform. Such a model is offered by our Massachusetts (MA) Child 
Psychiatry Access Project (MCPAP), a successful population-based model for delivering psychiatric care in primary care 
settings that has been widely disseminated and implemented in 32 states across the U.S.  We recently adapted this 
model to create a new program, MCPAP for Moms. MCPAP for Moms provides Ob/Gyn clinics throughout MA access to 
immediate resource provision/referrals and psychiatric telephone consultation to help them address perinatal 
depression.  MCPAP for Moms is within grasp of most Ob/Gyn clinics/practices and health systems because it only costs 
$8.31 per perinatal women per year ($0.39 per month).  Our exciting new program now needs to be strengthened to 
proactively work with Ob/Gyn clinics to help them develop a systematic stepped care approach to ensure their patients 
do not fall through cracks in the depression care pathway. 
 
To build on and address the limitations of MCPAP for Moms, we developed and pilot tested the Rapid Access to 
Perinatal Psychiatric Care in Depression (RAPPID) Program (IRB Docket #H-00004195) to create a more comprehensive 
intervention that is proactive, multifaceted, and practical. RAPPID aims to improve perinatal depression treatment and 
treatment response rates through: (1) access to the immediate resource provision/referrals and psychiatric telephone 
consultation for Ob/Gyn providers via MCPAP for Moms; (2) clinic-specific implementation of stepped care, including 
training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment 
response to depression screening/assessment.  RAPPID was developed using formative data and feedback from key 
stakeholders.  Our pilot work in real-world settings suggests RAPPID is feasible and improves depression detection and 
treatment in Ob/Gyn settings.  

 
We propose to compare two active interventions, Enhanced usual care (access to MCPAP for Moms) vs. PRISM 
in a cluster randomized controlled trial (RCT) in which we will randomize 12 Ob/Gyn clinics to either PRISM or enhanced 
usual care.  A stratified sampling mechanism will be used to ensure representation of women with different times of 
depression onset.  We will compare differences in depression severity and treatment participation among 340depressed 
women (n=170 per group) that receive care from PRISM or enhanced usual care clinics (effect size=0.377). 
 
Taking the same basic approach as we did with MCPAP, PRISM will be poised for national dissemination if 
proven effective in our cluster RCT. Our interdisciplinary team with substantial experience in perinatal depression and 
cluster-randomized methodology combined with our close working relationship with Ob/Gyn clinics and providers bodes 
well for implementation success.  Our proposal has potential to have a tremendous impact on the many mothers, 
families, and babies affected by perinatal depression. 
 
Comparison Group: Enhanced Usual Care. The comparison group will consist of access to psychiatric consultation and 
resources and referrals through MCPAP for Moms – MCPAP for Moms is available free of charge to all Ob/Gyn clinics in 
Massachusetts.  However, in contrast to the clinics enrolled in PRISM, the clinics in the enhanced usual care group will not 
receive the training, clinic-specific implementation support, proactive patient monitoring and engagement, and stepped 
care procedures that PRISM clinics will (Table 1). Statewide provider access to MCPAP for Moms is essential to maintain 
ethical standards. This is enhanced usual care1 because most Ob/Gyns in other states do not have access to this level of 
psychiatric consultation and resource provision/referrals.2  Our pilot data suggest that the additional support provided to 
the PRISM clinics is needed to ensure treatment participation by perinatal women with depression and thereby is needed 
to improve depression outcomes among these women.   
 
Enhanced usual care will include: Access to immediate resource provision/referrals and psychiatric telephone consultation 
for Ob/Gyn providers via MCPAP for Moms.    The enhanced usual care practices will receive one 30-60 minute 
presentation by a MCPAP for Moms perinatal psychiatrist on perinatal depression in which we will recommend screening 
for perinatal depression twice during pregnancy and once in the postpartum period. The clinics/practices will have access 
to the MCPAP for Moms Provider Toolkit which includes assessment and treatment protocols (available at 
www.mcpapformoms.org). Real time telephonic consultation with the MCPAP for Moms consulting perinatal psychiatrist 
will also be available for practices. Consultations address many topics including diagnostic support, guidance in regards to 
medication treatment (when indicated), advice on psychotherapy and community supports, treatment planning, and 
medication concerns regarding preconception, pregnancy and lactation. The MCPAP for Moms perinatal psychiatrist will 
work with the provider to assist him/her in addressing their patient's mental health concerns. The MCPAP for Moms 
perinatal psychiatrist will also be available to see patients for one time face-to-face consultation, after which they will 
send a detailed written assessment that will include treatment recommendations to the Ob/Gyn provider.  This will be 
available for all patients regardless of insurance status.  MCPAP for Moms Care Coordinators can also provide mental 
health resources and referrals to providers and patients.  The Care Coordinators can assist providers in arranging ongoing 
mental health support for patients by providing resources and referrals for psychotherapy groups, mental health 
treatment (including prescribers), and family based treatments that are geographically convenient for the patient. In some 
cases the Care Coordinator can call the patient/family and provide referrals for follow-up mental health care directly to 
the patient.  
 
 
Table 1  Characteristics of Comparison and Intervention Groups 
Enhanced Usual Care/MCPAP for Moms 
PRISM 
Access to MCPAP for Moms  
 30-60 minute presentation on perinatal depression 
 Access to telephonic psychiatric consultation with 
MCPAP for Moms perinatal psychiatrist for Ob/Gyns 
 Access to one-time face-face evaluation with patient 
by a MCPAP for Moms psychiatrist  for assessment 
and treatment recommendations for Ob/Gyn 
provider  
 Access to MCPAP for Moms  
o See left column 
 Provide PRISM Toolkit with Stepped Care Algorithms 
 Support clinic specific implementation using the 
Addressing Problems Through Organizational Change 
(APTOC) implementation platform3,4 
1. Engage clinic providers, leaders and staff 

 
 
 
Intervention Group:  PRISM.  The implementation of systematic screening and treatment response to depression 
screening/assessment will be customized to each practice based on their specific processes and needs.  PRISM will also 
include proactive treatment engagement and patient monitoring of all depressed practice patients to ensure that patients 
initiate, receive and respond to treatment. 
 
Access to immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn providers. 
As in the enhanced usual care clinics, the PRISM clinics will have access to psychiatric consultation and resource 
provision/referrals available through MCPAP for Moms (details above).  
 
Implementation support specific to each Ob/Gyn clinic.  Step-by-step implementation support will be provided to 
help implement all the PRISM components in obstetric clinics/practices.  We will use several core implementation 
strategies from Addressing Problems Through Organizational Change (APTOC) 4model: (1) engage clinic providers, leaders 
and staff; (2) identify champion(s) and prepare for change; (3) assess readiness to implement PRISM; (4) identify steps to 
achieve goals; (5) implement PRISM components into the clinic; (6) support, encourage and sustain change.3   
 
Engage clinic providers, clinic leaders and staff.  We will meet with clinic providers and staff and articulate a vision 
for change.  We will lead meetings and activities to empower and support Ob/Gyn providers and staff to brainstorm and 
develop approaches for addressing perinatal depression in their practice and prepare for implementation of PRISM 
components. 
 
Identify champion(s) and prepare for change.  Practice champions will be identified and a work group will be 
formed that will implement the practice’s change plan and achieve their goals through specific strategies and tactics. Each 
practice will identify a physician champion and a non-physician champion (navigator).  The physician champion will serve 
as a leader and advocate for PRISM implementation at the practice site.  The non-physician champion (navigator) will be 
the true practice and patient advocate ensuring PRISM implementation in the clinic site, enforcing stepped care 
management and tracking of patients, and interfacing with the study team.  Each practice site will select the non-physician 
champion (navigator) based on knowledge of their practices’ logistics, needs, roles, etc.  It is anticipated that this role 
could be performed by medical assistants, nurses, social workers, research assistants, and other persons within practices.  
For the remainder of the document, this person will be referred to as the ‘champion’ as compared to ‘physician champion.’  
For each practice, the physician champion who will work directly with the champion and practice leadership to support 
and advocate PRISM implementation. 
 
Assess readiness to implement PRISM.  A baseline assessment to determine readiness and the best approach for 
implementing PRISM will be conducted.  The assessment will involve detecting early signs of opportunities and threats to 
implementing PRISM components and documenting the practice work flow, current screening practices or lack thereof.   
Implementation strategies will then be customized to each clinic. 
 
Identify steps to achieve goals, including policy changes (universal screening). We will meet with the work group 
to identify steps needed to implement PRISM. We will invest in the education, skills training, and tools necessary for 
Ob/Gyn providers and staff to be effective in implementing PRISM components. 
 Access to Provider Toolkit which includes assessment 
and treatment protocols (available at  
www.mcpapformoms.org and see Appendix) 
 Resource provision/referrals 
2. Identify Champions and prepare for change 
3. Assess readiness to implement PRISM 
4. Identify steps to achieve goals 
5. Implement PRISM components into the clinic 
6. Support, encourage and sustain change 
 Develop approach to depression screening 
customized for each practice. 
 Proactively engage and track all women who 
screened positive on the EPDS 
 Employ  psychoeducation and Motivational 
Interviewing to engage patients who screened 
positive on the EPDS 
 Establish and maintain communication between the 
non-physician champion (navigator) and psychiatrist 
every two weeks to review cases  
 Stepped care treatment response to depression 
screening/assessment 
 

 
Implement PRISM components.  On-site consultation, including work flow assessment and training and ongoing 
technical assistance with implementation of PRISM will be provided.  We will work with the clinics/practices to determine 
the most efficient approach to implementing PRISM. 
 
Support, encourage and sustain change. In person and telephone consultations and emails to provide ongoing 
technical assistance will be provided.  Monthly meetings with provider representatives and the champions to review 
quantitative data and qualitative experiences implementing PRISM, to identify obstacles, and to propose solutions will be 
held.  We will also provide monthly iterative feedback about performance to allow for continuous improvement of PRISM 
based on clinic-wide data and provider experience.  The designated on-site physician champion will reinforce trainings, 
consult with peers, and give feedback to peers based on the non-physician/champions tracking of cases.   
 
Proactive patient engagement and monitoring, and stepped treatment response to depression 
screening/assessment.  Stepped care involves initial determination of treatment based on illness severity followed by 
intensification of care as necessary (such as stepwise increases in dose of antidepressant medication) for those with 
persistent illness.  The following strategies will be used to implement screening:  training, toolkits, systematic screening, 
proactive engagement and monitoring, and stepped care protocols. 
 
Training.  Each provider group with receive a total of 3, 2-hour trainings.  Each of these trainings will be specifically 
tailored to the target audiences which will be: (1) physicians and licensed independent practitioners; (2) nurses, and 
medical/patient care assistants; and, (3) clinical administrative support staff.   We will train and assist the PRISM clinics to 
provide population based care for depression, including systematic screening and monitoring for depression, telephone 
monitoring of adherence to the care plan, symptom reduction and side effect monitoring when applicable. Providers will 
be trained how to use  our stepped care approach (Figure 1) to screen and assess depression, to include depression in 
treatment plans, and to discuss the risks and benefits of antidepressant use during pregnancy and lactation. Providers also 
will receive training in how to de-stigmatize depression and activate women to seek help.  non-physician champion 
(navigator)Training for the non-physician champion (navigator) will include behavioral health methods such as 
Motivational Interviewing, evidence based depression care management, and team-based approaches to behavioral care.   
 
Toolkits. Practices will be provided with stepped care screening, referral and treatment protocols.  Stepped 
care protocols will have specific instructions for specific ranges of scores on the Edinburgh Postnatal Depression Scale 
(EPDS) that will prompt subsequent assessment and treatment steps (see Figure 1).   The EPDS is a ten-item scale validated 
for depression during pregnancy and the postpartum period.5 Practices will also be provided with psychoeducational 
resources to give to women.    
 
Systematic screening. We will work with each practice to develop an individualized approach to depression 
screening. This will include establishing office prompts and procedures for screening.  We will determine the timing, 
location, and setting for screening and discussion of screening/treatment/referral.  We will work with clinic providers/staff 
to tailor screening procedures to be acceptable and helpful. 
 
Proactive patient monitoring and care coordination. We will train the /non-physician champion (navigator) 
from each PRISM clinic to proactively engage and track all women who have screened positive on the EPDS (i.e. keep a log 
or registry that can be used for follow-up).  The /non-physician champion (navigator)’s role will be to facilitate treatment 
success through patient outreach, offering additional referrals and ensuring patients engage in recommended medication 
treatment and attendance at mental health appointments.  This will also include ensuring that patients who screen 
positive receive monthly follow up calls.  The /non-physician champion (navigator) will call patients if they miss their 
follow-up Ob/Gyn appointment to reengage them in depression and obstetric care (see Patient Engagement description 
below).  The proactive patient monitoring process will also include timely referrals to community mental health providers 
and actionable feedback to Ob/Gyn providers. To ensure adequate and reliable referral sources for psychotherapy 
treatment, the /non-physician champion (navigator) will develop relationships with local mental health clinics/practices 
and individual providers.  Our research team will provide guidance and consultation for the /non-physician champion 
(navigator) in how to develop relationships, and reliable and efficient referral pathways for psychotherapy, as part of 
implementation assistance. 
 
Patient monitoring will also include ongoing monitoring of symptoms which will allow providers to determine 
whether a higher level of stepped care is warranted at any stage in the treatment process.  A psychiatrist from 
UMMHC/MCPAP will be available to review cases with the /non-physician champion (navigator) every two to six weeks 
during a case review meeting.   The goal of the meeting will be to ensure that no cases are missed and to provide expert 
supervision and feedback on management and treatment engagement.  The /non-physician champion (navigator) will 
work closely with the Ob/Gyns and patients to assure continuity and follow-up.  The /non-physician  

champion will be responsible for communicating with the Ob/Gyn provider in regards to changes in treatment status (e.g. 
patient self-discontinued therapy medication).   
 
Patient engagement.  The /non-physician champion (navigator) will be trained to provide psychoeducation 
and Motivational Interviewing. The non-physician will deliver psychoeducation and/or Motivational Interviewing when 
women screen positive for depression as part of the stepped care treatment response and when he/she calls patients to 
follow-up regarding treatment participation as part of the proactive patient monitoring.   During follow-up calls the non-
physician will offer referral to therapy if the patient is not engaged in psychotherapy or behavioral health treatment.   
 
Psychoeducation for depression emphasizes instruction and education on a variety of topics relating to 
depression, including symptoms, the expected clinical course and prognosis, treatment options and strategies, and signs 
of relapse.6,7  Motivational Interviewing is an approach to exchanging information with patients that increases their 
engagement with care by allowing them to resolve their ambivalence about taking steps to improve their health.  
Motivational Interviewing is commonly used and has been shown to be effective as it: (1) encourages patients to set and 
achieve goals for health maintenance and disease management; (2) addresses issues of problematic alcohol, opiate, and 
other drug use; (3) improves patient's medication adherence; and, (4) promotes engagement in other evidence based 
behavior change approaches, such as Cognitive-Behavioral Therapy.8  Psychoeducation and Motivational Interviewing will 
thus be delivered by the non-physician as a major part of our stepped care approach.  The non-physician and providers 
will also be equipped with verbal and written materials and web-based educational resources about perinatal depression 
to use during feedback interventions.   
 
 
Stepped Care Protocols.  We will match the severity and complexity of patients' disorders to the appropriate level 
of care. We will develop a guided work flow and information flow, specifying when to screen, how to stratify patients to 
stepped interventions, and how to track outcomes. These guidelines will be flexible and modifiable for individual patients 
based on the obstetric provider’s clinical judgment and patient preference.  We will also integrate comorbid anxiety 
illnesses such as PTSD and bipolar disorder into the stepped care approach.  Women that score ≥ 10 on the EPDS and for 
bipolar disorder with the Mood Disorder Questionnaire (MDQ).11  If deemed feasible by practices, women will also be 
screened for PTSD with the    PTSD Screen-Civilian version (PCL-C)9,10  We will work with each clinic site to tailor these 
screening processes into their practice.  We will also provide training in how to administer and interpret the screens.    
 
Psychopharmacology, when indicated, will be provided by the Ob/Gyn providers and licensed independent 
practitioners guided by a MCPAP for Moms perinatal psychiatrist as needed.  Psychoeducation, motivational interviewing, 
and resource provision will be offered during perinatal visits according to the stepped care protocol.  Patients with severe, 
complex, or treatment refractory illness will be referred to a psychiatric provider according to stepped care protocol and 
clinical judgment of the Ob/Gyn.  Referral to psychiatrists or psychiatric nurse will be facilitated by the PRISM non-
physician.  During subsequent follow-ups visits, patients will be stepped up to a higher level of care if there is evidence of 
clinical deterioration or lack of improvement.  Lack of clinical improvement will be defined as no improvement in subjective 
clinical symptoms and EPDS score at 1 month follow-up.  Clinical deterioration will be defined as subjective worsening of 
clinical symptoms and/or ≥2 point increase in EPDS score at 1 month follow-up.  
 
 
Summary.  PRISM will provide an integrated service (one treatment plan with obstetric and behavioral 
aspects, rather than two separate depression and obstetric treatment plans) that will be customized at each participating 
clinic.   We will integrate depression in obstetrical care in every way possible including scheduling, information about the 
services provided to patients, screening using validated EPDS for all patients, and our PRISM stepped care approach.  We 
will also include proactive patient monitoring and treatment engagement of all depressed patients in the clinic to ensure 
that patients initiate treatment, receive adequate treatment, and respond to treatment.  PRISM will change perinatal 
mental health service delivery in Ob/Gyn practices to target multiple gaps in treatment and ensure the patients' 
depression improves.  
 
REFERENCES1. Gross D. On the merits of attention-control groups. Res Nurs Health 2005;28:93-4.2. 
Delatte 
R, Cao H, Meltzer-Brody S, Menard MK. Universal screening for postpartum depression: an inquiry into provider 
attitudes and practice. Am J Obstet Gynecol 2009;200:e63-4.3. 
Ziedonis DM, Zammarelli L, Seward G, et al. 
Addressing tobacco use through organizational change: a case study of an addiction treatment organization. J 
Psychoactive Drugs 2007;39:451-9.4. 
Guydish J, Ziedonis D, Tajima B, et al. Addressing Tobacco 
Through Organizational Change (ATTOC) in residential addiction treatment settings. Drug Alcohol Depend 
2012;121:30-7.5. 
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 
10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987;150:782-6.6. Lin MF, Moyle W, Chang HJ, 
Chou MH, Hsu MC. Effect of an Interactive Computerized Psycho-education System on patients suffering from 

depression. J Clin Nurs 2008;17:667-76.7. Dowrick C, Dunn G, Ayuso-Mateos JL, et al. Problem solving 
treatment and group psychoeducation for depression: multicentre randomised controlled trial. Outcomes of 
Depression International Network (ODIN) Group. BMJ 2000;321:1450-4.8. 
Rubak 
S, 
Sandbaek 
A, 
Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract 
2005;55:305-12.9. 
McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical 
review. Clin Psychol Rev 2010;30:976-87.10. 
Weathers F, Litz B, Huska J, Keane T. PTSD checklist—
civilian version. In. Boston: Nation Center for PTSD. Behavioral Sciences Division. ; 1994.11. Hirschfeld 
RM, Williams JB, Spitzer RL, et al. Development and validation of a screening instrument for bipolar spectrum 
disorder: the Mood Disorder Questionnaire. AJ Psychiatry 2000;157:1873-5.12. 4PS. 
(Accessed 
at 
13.
 
Thombs BD, Benedetti A, Kloda LA, et al. The diagnostic accuracy of the Patient Health Questionnaire-
2 (PHQ-2), Patient Health Questionnaire-8 (PHQ-8), and Patient Health Questionnaire-9 (PHQ-9) for detecting 
major depression: protocol for a systematic review and individual patient data meta-analyses. Syst Rev 
2014;3:124.14. 
Smith MV, Gotman N, Lin H, Yonkers KA. Do the PHQ-8 and the PHQ-2 accurately 
screen for depressive disorders in a sample of pregnant women? Gen Hosp Psychiatry 2010;32:544-8.15.
 
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen 
Intern Med 2001;16:606-13.16. 
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. 
Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987;150:782-6.17. Gaynes 
BN, Gavin N, Meltzer-Brody S, et al. Perinatal depression: prevalence, screening accuracy, and screening 
outcomes. Evid Rep Technol Assess (Summ) 2005:1-8.18. Delucchi KL, Tajima B, Guydish J. Development of 
the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues 2009;39:347-64.19.
 
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: 
the GAD-7. Arch Intern Med 2006;166:1092-7.20. Swanson LM, Flynn HA, Wilburn K, Marcus S, Armitage 
R. Maternal mood and sleep in children of women at risk for perinatal depression. Arch Womens Ment Health 
2010;13:531-4.21. 
Clement S, Brohan E, Jeffery D, Henderson C, Hatch SL, Thornicroft G. Development and 
psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill 
health. BMC Psychiatry 2012;12:36.22. 
Tajima B, Guydish J, Delucchi K, Passalacqua E, Chan M, Moore 
M. Staff Knowledge, Attitudes, and Practices Regarding Nicotine Dependence Differ by Setting. J Drug Issues 
2009;39:365-84.23. 
Joseph AM, Arikian NJ, An LC, et al. Results of a randomized controlled trial of 
intervention to implement smoking guidelines in Veterans Affairs Medical Centers. Medical Care 2004;42:1100-
10.24. Simpson JM, Klar N, Donnor A. Accounting for cluster randomization: a review of primary prevention 
trials, 1990 through 1993. Am J Public Health 1995;85:1378-83.25. 
Donner A, Birkett N, Buck C. 
Randomization by cluster. Sample size requirements and analysis. Am J Epidemiol 1981;114:906-14.26. Harvey 
ST, Fisher LJ, Green VM. Evaluating the clinical efficacy of a primary care-focused, nurse-led, consultation 
liaison model for perinatal mental health. Int J Ment Health Nurs 2012;21:75-81.27. 
Donner A, Klar N. 
Statistical considerations in the design and analysis of community intervention trials. J Cin Epidemiol 
1996;49:435-9.28. 
Baron RM, Kenny DA. The moderator-mediator variable distinction in social 
psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986;51:1173-
82.29. Karlson K, Holm A. Decomposing primary and secondary effects: A new decomposition method. 
Research in Social Stratification and Mobility 2011;29:221-37.30. Comparing regression coefficients between 
models using logit and probit: a new method. Available online at Social Science Research Network, 2010. 
(Accessed Accessed August, 2011, at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1436349.)31. Total, 
direct, 
and 
indirect 
effects 
in 
logit 
models. 
2010. 
(Accessed 
Accessed 
August, 
2011, 
at 
http://papers.ssrn.com/sol3/papers.cfm?abstractid=1730065.)32. 
Heitjan DF. Annotation: what can be done 
about missing data? Approaches to imputation. Am J Public Health 1997;87:548-50.33. Little R. Statistical 
Analysis with Missing Data. New York: John Wiley and Sons; 1987.34. 
Byatt N, Moore Simas T, Lundquist 
R, Johnson J, Ziedonis D. Strategies for Improving Perinatal Depression Treatment in North American Outpatient 
Obstetric Settings. Journal of Psychosomatic Obstetrics & Gynecology 2012 (in press). 
 
5) Inclusion and Exclusion Criteria* 
 
Provider and staff participants will be enrolled to participate if they meet the following inclusion criteria: 

1. Prenatal care providers and support staff including physician, advanced practice nurse, nurse, patient care 
assistant, social workers, office research staff, administrative support staff and others serving women at the 
recruited clinical sites  
Provider and staff subjects will be excluded from the study for any of the following: 
1. Not a prenatal care provider or support person as indicated above from one of the study designated sites.  
 
Provider and staff subjects will participate in either PRISM or Enhanced Usual Care, depending on what group 
their clinic/provider is assigned to. Clinics will be randomly assigned to either the PRISM group or the Enhanced 
Usual care group. 
Women subjects will be enrolled to participate if they meet the following inclusion criteria: 
1. Female 
2. Age 18-55 years 
3. English speaking 
4. >4 weeks gestational age (GA) until 4 months postpartum 
5. Receiving care from one of the 10 participating clinics (five will participate in PRISM (intervention group) and 
five will have access to enhanced usual care (comparison group)) 
6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10 
7. Able to communicate in written and spoken English; and 
8. Cognitively able to participate in informed verbal consent 
 
Women subjects will be excluded from the study for any of the following: 
1. Lack of verbal and written English fluency 
2. Under age 18 or over age 55 
3. substance use disorder (as determined by substance use disorder questions in4P’s) 
4. Screen positive for bipolar disorder via the MDQ (Mood Disorder Questionnaire) 
5. Prisoner 
6. Women participating in ‘Moms do care’ study in participating sites 
 
6)   Study-Wide Number of Subjects* 
We will be comparing 10 clinic sites in which women (n=340) participate in the study, (5 clinics/group, n (women) = 
170/group, 34/per clinic). Fourteen (14) clinics will be recruited anticipating that 2 will drop out during the run-in phase.  
Equal number of women will participate in PRISM vs. Enhanced Usual Care.  The total number of subjects will include 
340 perinatal women. This is a multi-site study, and all 340 subjects will be recruited across all the 10 participating 
clinics/sites.  
 
 
7) Study-Wide Recruitment Methods* 
 
Provider and staff participants: Recruitment will be through email and direct contact with potential provider and staff 
participants through faculty meetings, and personal communications.  The PI, Co-Is and RCs will facilitate recruitment 
efforts to be performed by the research coordinator (see Figure 1). Once the practice conveys their willingness to 
participate in the PRISM study, we would request them to provide contact information for all staff from their practice. 
Then study staff will contact providers and/or staff by phone, email, online or in person and inform them about the study 
opportunity   The study staff will provide information regarding the study procedures (see Fact Sheet), inform them that 
their participation is voluntary, and provide the baseline survey (see attached) to be completed if they are interest in 
participating. The providers and staff will be informed that completing the survey indicates their consent to participate in 
the study.  The study staff will send weekly reminder emails to the providers/staff if they have not completed the survey 

sent to them electronically. The providers who would like to opt out of participation (even if their clinic is involved in the 
study) can inform the study staff by email or phone about their decision to not participate in the study. 
 
 

Figure 1 Recruitment of Providers and Staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment of patient participants: 
We have designed a stratified sampling mechanism to ensure representation of women with differential depression 
onset times during the perinatal time period.  We will use a telephone-based recruitment approach.  This approach will 
allow us to: (1) estimate depression prevalence among all clinic patients, including those not screened in the clinic; (2) 
recruit all clinic patients, including those not screened in the clinic; and (3) have an enhanced usual care comparison 
group that does not necessitate implementation support to initiate screening in the clinic setting.   
 
We will: (1) compile a list of potential patient participants; (2) obtain consent to screen for study eligibility; (3) screen 
patients for eligibility criteria; and (4) invite eligible patients to participate.  Once informed verbal consent is obtained, 
we will interview the patient.  In addition, at the time of survey, we will seek permission from patients to access their 
medical records. 
 
 
 
 
 
 
Recruitment for run-in phase (see Figure 2): 
 
1.  Patient identification.  We will work with the Ob/Gyn clinics/practices to obtain lists of pregnant women. The list will 
be compiled in different ways at various participating practices.  Practices will transfer listings to study staff in one of 
several ways, 1. electronically using a secure file transfer protocol (sftp) such as MoveIT DMZ,  Accellion, or others, 2. 
Provider Eligibility 
 
 Obstetric physician, advanced practice nurse, nurse, patient care assistant, or administrative 
support staff serving women at the recruited clinical sites for the cluster RCT. 6 clinics will be 
assigned to the RAPPID group and 6 will be assigned to the Enhanced Usual Care group. 
 
Initial recruitment efforts through email, direct contact with potential participants through faculty 
meetings, informational sessions and personal communications 
Study staff informs the providers and/or staff by phone, 
email or in person of study opportunity. Study staff also 
informs that participation is entirely voluntary and shall 
continue only if they are interested 
Study staff provides study information and baseline survey by email, 
online, phone or in person. The providers and/or staff are informed that 
answering the survey indicates their consent to participate in the study. 
The providers can opt out if they are not interested in participating by 
informing the study staff by email or phone. 
Conduct baseline assessments and proceed with study protocol 
Provider & 
Staff 
Experience 

mailing completed forms via U.S. Postal Service, or 3. placing forms in a sealed envelope marked confidential for study 
staff to pick up and transport to the study office in a locked box. 
 
A. Approach at the practice level for opt-in to be contacted: Some practices (e.g. Reliant Medical Group) prefer to use an 
opt-in approach (form attached).  During a prenatal visit the practice staff will give the patient the opt-in form along with 
study brochure for patients to review. If the prenatal visit is done by phone, practice staff will tell patients about their 
involvement in the study and asks for patient verbal consent to share their contact information with the study team. If 
the patient agrees, the practice staff will then fill out the opt-in form and send it to the study team. By filling out the opt-
in form, patients indicate their approval for their contact information to be provided to the PRISM study staff. These 
practices will then send only the list of patients who agreed for their information to be shared with PRISM research staff. 
Anytime the list is modified at the practice level to indicate patients’ willingness to be contacted (opt-in), then the study 
staff will mail out the study brochure, fact sheet, HIPAA authorization and a letter inviting them to participate in the 
study (letter attached). The research staff will wait for one week after mailing the letter and then contact the women by 
phone to tell them about the study. 
 
B. Approach at the practice level for opt-out of being contacted: Some practices prefer the study brochure to have 
verbiage about opting out of being contacted by PRISM study staff (brochure sample attached).  During prenatal visit the 
practice staff will hand over the study brochure for patients to review. The patients have the opportunity to sign the opt-
out form in the last page of the brochure to indicate that they do not want to be contacted by the study staff. These 
practices will send the list of patients who did not opt-out of being contacted by study staff.  
 
C. Opt-out of being contacted after snail mail from study staff: Some practices will be providing the list of all patients 
without any modification to the list at the practice level.  
 
For B & C options: From the list received from the practices, the RC will compile a list of potential patients for inclusion 
from each practice (check for age, gestational age, etc.). Once identified as potentially eligible, study staff will send out a 
study brochure along with a letter from the clinic directors, study fact sheet, and HIPAA authorization details by email 
(only those sites that have opted to provide, as part of their, patients email addresses instead of their mailing address 
since those sites primarily use email for communicating with their patients) or along with a business reply card by 
standard postal mail, explaining the study and informing the patient about how to opt out of the study if not interested 
in participating (by mailing the letter back, by inserting the enclosed post card in the enclosed business reply envelope 
and mailing it back, by calling the study number, or by emailing study staff).  This gives potential participants enough 
time to review the study details before the RC’s call to get consent for the study.  If the patient does not contact the 
study team to “opt out” within two weeks of when the letter was mailed or after 3 days of when the email was sent then 
staff will contact the women by phone or text them (script attached) to tell them about the study. Once the RC has a list 
of potential patients who haven’t opted out then he/she will randomly sort the call list to determine the order in which 
they are contacted to ensure that patients are selected randomly. Emails will be sent secure (by typing “secure” in the 
subject line) and UMMS IT confirmed that they are sent through a HIPAA compliant server. UMMS IT also confirmed that 
the email is retained in an encrypted state in the secure portal for seven days and then are permanently deleted. The 
providers from those sites may mention to their patients about their collaboration with UMass for a research study. The 
subject line in those emails will have “UMass and [Participating site’s name] collaborating for PRISM” (ph: 774-502-5058) 
in order for participants to identify it is from their provider and they can reach out to the research team for more 
information. To participants from Brigham and Women’s clinic an email will be sent to their email id (not using secure 
portal) with the cover letter and opt out information from their clinic director in the body of the email [(letter attached – 
PRISM email letter with link).  This letter will not contain any reference to pregnancy or postpartum status and will 
contain a link that has all the other details (fact sheet, brochure & HIPAA authorization) about the study. The 
participants will be directed in the body of the email to click on the link to see more details about the study.  
We got approval from the director of the clinic to send out emails using this method.  
2.  When the study staff is able to connect with the women by phone, they will go over the content of the fact sheet 
mailed to the patient earlier and get their verbal consent to participate in the study. The study staff will then go over 
HIPAA authorization.  Then they will get verbal consent to administer the EPDS by phone, (see attached script and EPDS)  
then a bipolar disorder screen will be conducted using the well-validated Mood Disorder Questionnaire (see attached 
script and MDQ)11 along with a screen for substance use disorder using the screening question in 4 P’s.  Along with these 

3 questionnaires participants will be asked a few demographic and health questions. If eligible from the 3 screening 
questionnaires, the RC will administer the GAD 7, PCL-C, BACE, DSQ short version (14) and PARC-D surveys In addition, at 
the time of survey, the RC will seek permission from the patients to access their medical records as described in section 
30. If  participants are not eligible after the screening questionnaires then they will be asked a few demographic and 
health questions to get information on the socio-economic and current mental health status then participants will be 
informed that from the screening questions done, they are not eligible to continue with further questions.  
3. Perinatal women who are eligible to be in the run-in phase will be compensated with a $20 gift card after the 
assessment is completed.  
 
Figure 2 Patient Recruitment for the Run-in Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Recruitment for the RCT (see Figure 3 and selection flow chart)) 
 
1. See above step 1 & 2 (Recruitment for run-in phase) for recruitment description for RCT.   
 
2. When the study staffs are able to connect with the women by phone, they will first get verbal consent for 
administering EPDS by phone (see attached script) followed by a bipolar disorder screen using the well-validated 
Mood Disorder Questionnaire (MDQ)11 along with a screen for substance use disorder using the screening question in4 
4P’s, to determine eligibility.   
 
3.  Once eligibility has been determined: 
 
If not eligible for study: 
If the participant is not eligible for the study because of positive MDQ or substance use disorder the study staff will 
explain that they do not meet the inclusion criteria for the study and thank the patient for their time  
 For those who did the initial screening by phone but then declined to participate or were deemed ineligible to 
participate, we will maintain a file with their names and keep that information separate from and not linked to the 
potential holding pool (so that study staff will make sure not to send them study information again) until the end of 
study recruitment. The identifiers will be destroyed once recruitment is completed for the study If the participant is not 
Patient Eligibility 
 
 
1) Female ages 18-55 years  
 
 
 
2) > 4 weeks Gestational age until 4 months postpartum 
 
 
3) English speaking/reading  
 
 
 
4) Receiving OB care from one of the 12 participating clinics  
Study staff will mail study info flyers, fact sheet, HIPAA authorization and intro letter from clinic 
director to pregnant and postpartum women from all participating clinics and asks them to opt out 
if not interested. 
Study staff will contact by phone those women who did not opt out of the study 
 
Explain about the study and obtain informed verbal consent to participate in the run-in phase 
 
If patient meets eligibility, then RC will administer EPDS () via phone after verbal consent and then complete with 
MDQ and 4P’s questionnaires and demographic and health questions 

eligible because of negative EPDS then their name will be entered in the holding pool and they will be contacted by 
phone or text message (script attached) at different recruitment time periods to check if they become eligible (if they 
become depressed) at a later time. 
If eligible for study: 
 For participants who are eligible and interested in participating, during the first study phone meeting for the RCT, we 
will obtain informed verbal consent.  The study staff will then go over HIPAA authorization. The RC will also seek 
permission from the patients to access their medical records. The RC will administer the surveys and standardized 
questionnaires listed in the procedure section. We will ask the participant to confirm her phone number and mailing 
address and provide any additional phone numbers and email address she may use. We will ask for several sources of 
contact information in order to facilitate their continued participation in the study.  We will ask for the contact 
information for up to 3 family/friends that know the patient well and will be able to help us contact them should their 
contact information change.  After obtaining permission from the participant (see informed consent), we will keep in 
contact with the participants by mail, email, text message or phone in order to facilitate their continued engagement in 
the study.  For example, we will send them a card to congratulate them on the birth of the baby. We will also send 
patients cards on their own birthday or major pregnancy milestones and date baby will turn year old are good times too.  
We will also keep in contact with participants in order to ensure that we keep track of any changes in their contact 
information and to remind how they can contact study staff should they wish to. 
 
Perinatal women who are in the RCT phase of the study will be compensated with a $25 gift card after every assessment 
is completed and $30 gift card after the last assessment has been completed. Women will be recruited during 4-20 
weeks, 20-40 weeks of pregnancy or 0-4 months postpartum. Depending on when they are recruited they will be 
followed up 2 or 4 more times until 13 months postpartum. Data will be collected specifically for research purposes.  
Sources for both women and provider subject material will include: self-report data on surveys, semi-structured 
interviews and data abstracted from MCPAP for Moms database and medical record chart reviews.  Sources for provider 
material only will include training and consult log, and procedure checklist. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3 Recruitment of Patients for PRISM Phase 2 Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
PATIENT  
 
  
EXPERIENCE 
 
 
 
 
 
Patient Eligibility Aim 1  
 
 
 
1) Female ages 18-55 years  
 
 
 
2) < 4 weeks Gestational age until 4 months postpartum 
 
 
 
3) English speaking/reading 
 
 
 
4) Receiving OB care from one of the 12 participating clinics  
      5) EPDS score ≥ 10 
          6) MDQ and 4Ps scales negative 
          7) Cognitively able to participate in informed verbal consent 
Study staff will mail study info flyers, study fact sheet, HIPAA authorization and intro letter from clinic director to 
pregnant and postpartum women from all participating clinics and asks them to opt out if not interested. 
Study staff will contact by phone those women who did not opt out of the study 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Explain about the study (provide fact sheet info) and obtain informed verbal consent to participate in the study  
Then RC will proceed with study protocol  
If patient meets eligibility after RA administers EPDS, MDQ and 4P’s via phone after verbal consent,  
 
 
 
No consent 
Opt out response 
Patients in practice who received their 1st trimester ultrasound 
Mail fact sheet and HIPAA authorization 
Do not opt out  
Pre-screen for eligibility  
Consented 
(potential pool) 
 
 
Complete EPDS 
    <10 
Holding pool 
Potentially  
eligible at later 
trimester or 
postpartum 
Meet selection criteria 
(Balance characteristics of 
study population) 
P
i i
d
ll
d
        no  
               yes   
No data collection 
PRISM Research Study Participant Selection Flow Chart 
Prescreened not eligible 
Call to consent 
  
Unable to contact 
Eligible 
 
EPDS ≥ 10 

 
 
8) Study Timeline 
 
As shown in the table 2 below, we will enroll and conduct pre-assessments for providers and staff over several months.  
We will then work with the 5 intervention clinics to prepare for the implementation of PRISM over a four month period.  
We will then implement PRISM and recruit women to participate in the study.  We will recruit, enroll, and perform pre-, 
post- and longitudinal assessments on 2-4 women per week over 2 years. Longitudinal and post-assessments will also be 
conducted with providers/staff over 3 years. We will then complete analyses of study data. 
 
 
 
 
 
 
 
9) Study Endpoints* 
 
To compare the effectiveness of PRISM vs. enhanced usual care to improve depression severity and treatment 
participation in pregnancy through 12 months postpartum (primary outcomes) among 340 patients (n=170 per group) via 
a cluster RCT.  
 
To examine provider/staff fidelity to PRISM (secondary outcome).   
 
 
10)    Procedures Involved* 
 
Run-in Phase.  During the run-in phase (Figure 4), we will collect data on depression prevalence and severity and 
socioeconomic status from clinic/practice patients to inform restricted randomization.  The run-in phase will also allow us 
to confirm feasibility of study procedures for the practices.   
 
During the run-in phase, the study team will work with the clinics to implement the study protocol for 
systematically identifying research participants. Each clinic will be required to have 10-50 patients successfully screened 
for depression as part of the run-in phase to be able to move to the next study phase.  Clinics not able to implement the 
protocol or provide the required number of enrolled patients will be withdrawn from the study.  
Table 2 Staffing and Time Table for Phase 2  
 
         Year 1 
      Year 2 
     Year 3 
     Year 4 
     Year 5 
Quarter   
1 
2 
3 
4 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Conduct run-in phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct Cluster RCT 
 
 
 
 
 
 
P H A S E 2  
 
 
 
 
 
 
 
Baseline assessment of clinics, 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Work with clinics to prepare for implementation of PRISM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provider/staff training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Implement PRISM and usual care 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit and enroll women 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct longitudinal and post assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop and disseminate findings/recommendations  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze data 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Estimate PRISM costs & indicators of potential savings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Present findings to stakeholders/develop recommendations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disseminate findings/recommendations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
If a clinic is withdrawn, we will replace the withdrawn clinic/practice with another clinic that has agreed to 
participate yet was not selected for the run-in phase. 
Patients will be identified from clinic visit logs provided securely by the practices. Potentially eligible patients identified 
via visit logs will be contacted and invited to participate in the run-in phase of the study for enrollment in the study run-
in phase. After consenting participants, we will proceed with the study procedures and data collection as described below.  
 
During the run-in phase, we will also implement and Beta-
test PRISM components and products in one practice site. 
The practice site will each individually test the PRISM 
components with patients who obtain obstetric care from 
their practice and complete a process checklist for each 
component.  The provider participants (working group 
members) will not be reporting back any data about 
patients (not even anonymous data).  They will be reporting 
their experiences using the PRISM intervention 
components.  
Prior to employing the PRISM components, the providers 
participating in the Beta testing will provide an overview of 
the study to the patient and let the patient know that they 
are evaluating the tools the study has developed by utilizing 
them during patient care.  If a patient indicates that they do 
not wish to be involved in the evaluation of the PRISM 
components, the provider participants will provide the 
usual standard of care.  No identifiable data will be 
collected from any patients. The provider participants members/subjects will tell the patients that they will not be 
collecting any identifiable data from patients.    A chart review of the patients see during the Beta test will be conducted.  
This will include a collection of the data listed in the pilot chart extraction form. 
 
 
Procedures for clinics/practices.  As outlined in Table 3 participation data, adherence, and fidelity (see attached 
Measures of Intervention Fidelity and Checklists V2.8-6-16) will be collected longitudinally. All other provider/staff and 
systems-level data will be collected at baseline and after PRISM participation (annually after initiation). We will conduct 
a baseline clinic assessment which will allow us to tailor our implementation approach and restricted randomization 
based on practices' readiness to implement PRISM (see attached environmental scan). We will obtain pre, longitudinal- 
and post-intervention data through individual surveys to evaluate depression screening practices, acceptability of 
screening, perceived gaps in screening/referral supports, and attitudes, and practices towards perinatal depression. The 
post-implementation surveys will measure acceptability of PRISM components. 
 
Modification 06/2021 
Current provider participants who are still working at the practices and providers who are new to the practice since the 
practice mid-assessment was completed will be asked to complete the survey.  We estimate there will be 75 providers 
and clinical staff who will be asked to complete the final survey.  We will know once we approach the practices how 
many providers and clinical staff who completed the mid-assessment remain in the practices and how many are new.  
Providers and clinical staff will receive $50 as gift cards via email for completion of the final survey. 
 
 
 
Figure 4 PRISM Refinement and Effectiveness Testing 
 
Conduct run-in phase 
 
Conduct Cluster RCT 
(Phase 2) 
 
Randomize 12 Ob/Gyn clinics 
 
6 clinics                                                 6 clinics 
 
         PRISM    
                               Enhanced  Usual Care 
 
Random selection of perinatal patient study 
participants from clinic patient roster 
 
Follow patients longitudinally until 12 months 
postpartum and assess depression and treatment 
participation 

 
Table 3  Clinic and Provider/staff-level Measures 
Outcome/endpoint
Measure 
Administration 
Time Points 
 
Base-
line 
Annual 
Annual 
Post 
 
PARTICIPATION 
 Obstetric provider and staff 
participation 
in 
Training 
Curriculum, 
 
Stepped 
Care 
Treatment Response, Telephone 
Consult service.23  
Training log, consult 
log, and  chart 
review  (RC to 
collect) 
Ongoing  
 
ADHERENCE 
AND 
FIDELITY 
 Appropriateness of stepped care 
treatment response, screening 
and referral rates, medication 
prescription 
rates, 
documentation of depression in 
plan, 
referral 
rate 
to 
psychotherapy.   
 Procedure 
checklist: 
clinic 
policies/procedures, 
environmental scan. 
Consult log (nature 
of calls), medical 
records, procedure 
checklist (RC to 
collect) 
Ongoing  
 
KNOWLEDGE, 
ATTITUDES, 
ACCEPTABILITY  AND  
PRACTICES 
• 
Knowledge, 
Attitudes, 
and 
Practices Instrument (S-KAP):22 
46 items adapted for depression 
in obstetric settings.  
Online survey 
(attached) 
√ 
√ 
√ 
√ 
 
Procedures for Perinatal Women: As outlined in table 4, several assessments will be collected via the telephone at 
different time points longitudinally.  The interviews will be audiotaped. Women will be informed that the interview is 
being audiotaped before proceeding.  Women may also be asked to complete 10-20 minutes of questionnaires 
(excluding the EPDS) via a secure web form via REDCap.  Assessments will be pre-tested to ensure the time burden is 
about60 minutes.  To minimize participant time burden and increase efficiency, we will pre-screen for depression using  
the EPDS.    The primary measure of depression severity (primary outcome) will be the Edinburgh Postnatal Depression 
Scale (EPDS), the most commonly used scale to assess depression during pregnancy and the postpartum period. The 
Edinburgh Postnatal Depression Scale (EPDS) is a validated, self-administered 10-item screening questionnaire that is 
widely used to assess depression during pregnancy and the postpartum period.16 The intensity of depression is rated for 
the preceding 7 days by answering 10 multiple-choice items.5  Each item is scored on a 4-point scale for a total score 
range of 0-30 with higher scores reflecting a greater severity of symptoms.16   
 
As shown in Table 4, we have chosen standardized or psychometrically validated tools to screen for other comorbid 
psychiatric illnesses, as opposed to a diagnostic interview, in order to limit respondent burden and maintain the 
practicality and feasibility that is imperative for this real-world study.  We will screen for PTSD with the well-validated  
PTSD Screen-Civilian Version (PCL-C).9,10  We will screen for generalized anxiety using the Generalized Anxiety Disorder 
Assessment (GAD-7), a 7-item tool that is used to screen for and assess the severity of generalized anxiety disorder).19,20 
We will screen for bipolar disorder with the well-validated Mood Disorder Questionnaire (MDQ).11  We will screen for 
infant mother bonding with the S-PBQ as an indicator of postpartum depression.  Access to care will be measured using 
the Barriers to Access to Care Evaluation scale (BACE), a 30 item tool that assesses barriers to accessing mental health 
care and includes a ‘treatment stigma’ subscale.21 We will assess participants’ beliefs and supports using the 30-item 
version of the Patient Attitudes towards and Ratings of Care for Depression (PARC-D), which allows the interviewer to 
explore the likelihood that a patient would use specific therapies for depression. We will use the short version of the 
DSQ - Defense Style Questionnaire (14 questions) to screen for immature defenses which correlates with persistent 
depression. A structured interview will be conducted to assess utilization of depression treatment and barriers and 
facilitators to treatment participation (see attached). At certain time points there will be other relevant survey questions 
[e.g. demographics at baseline, obstetric and delivery outcomes at first postpartum visit and traumatic life events 
questions (Table 4)].   

 
To quality check data that will be collected using electronic data capture, all interviews will be audiotaped using a digital 
recorder attached to the telephone.  At the start of each call, participants will be informed that the interview is being 
recorded for quality purposes.  If participants request not to be recorded, the digital recorder will be turned 
off.  Recordings will be identified using the date of the interview and participant’s ID and stored in a secure 
server.  Recordings will be destroyed at the conclusion of study data analysis. 
 
 
 
 
 
Cost of PRISM and Enhanced Usual Care (MCPAP for Moms) and Indicators of Potential Savings.  In collaboration with 
our health economist, we will estimate cost and indicators of potential savings as outlined in Table 5.  We will utilize 
regular data reporting that will allow us to assess PRISM and enhanced usual care on both the cost of implementing the 
intervention and full operational costs.  
 
 
 
 
 
 
 
 
 
 
 
 
Table 4 Patient Level Measures 
Outcome/endpoint 
Measure 
Admin- 
istration 
Time Point 
     
4-20 
wks 
GA 
  20-40 
wks 
GA 
0-12 
wks 
PP 
5-7 
mos 
PP 
  11-13 
mos 
PP 
DEPRESSION SEVERITY 
• 
EPDS 
 
RC 
administered 
√ 
√ 
√ 
√ 
√ 
COMBORBID ANXIETY 
DISORDERS 
• 
GAD-7 
• 
PCL-C 
RC 
administered  
√ 
√ 
√ 
√ 
√ 
KNOWLEDGE, 
ATTITUDES, AND   
TREATMENT 
PARTICIPATION 
 
• 
Structured interview assessing mental 
health 
treatment 
initiation 
and 
sustainment and barriers and facilitators 
to treatment participation  
 
Structured 
interview with 
RC  
 
√ 
√ 
√ 
√ 
√ 
HELP-SEEKING 
• 
BACE 
• 
PARC-D 
RC 
administered  
√ 
√ 
√ 
√ 
√ 
INFANT BONDING 
• 
S-PBQ 
RC 
Administered 
 
 
√ 
√ 
√ 
IMMATURE DEFENSES 
• 
DSQ (14 questions) 
RC 
Administered 
 
√ 
 
 
 
INDICATORS OF COST 
SAVING POTENTIAL 
• 
Structured interview assessing birth 
outcomes: (e.g. birth weight, preterm 
delivery) and infant outcomes:  
hospitalizations (e.g. NICU, special care 
nursery) 
Structured 
interview with 
RC  
 
 
 
√ 
√ 
√ 
TRAUMATIC EVENTS 
• 
Structured questions assessing 
experiences with violence 
Structured 
interview with 
RC  
 
Will be asked at one time at one of the time 
periods listed above 

 
One of the ways in which we will determine the costs and costs effectiveness of Enhanced Usual Care is to link study 
data with that of external MCPAP for Moms utilization data. The data for this analysis will combine data from the 
Enhanced Usual Care arm (MCPAP for Moms) of the PRogram In Support of Moms (PRISM) trial (RCT) and MCPAP 
for Moms program data (referred to as the MCPAP database from this point forward). The PRISM database contains 
outcomes data for patients who have been served by practices/providers enrolled in MCPAP for Moms. The MCPAP 
database contains utilization data for providers (and, thus, practices) who have been served by MCPAP for Moms. Thus, 
linking the data will allow us to examine individual-level practice and provider utilization data, to link to costs and 
efficacy.  
 
UMass will link the PRISM and MCPAP databases using provider names to know which practices/providers interacted 
with MCPAP for Moms. The specific data to be linked from the MCPAP for Moms program data is limited to the 
aggregate number and type of encounters by year for each of the PRISM providers. The final dataset provided to 2 
external CDC collaborators will be deidentified and they will have no way of accessing any related PHI. 
 
 
11) 
Data and Specimen Banking* 
 
NA- we are not banking data or specimens.  
 
12) 
Data Management* 
 
Data will be collected specifically for research purposes.  Sources for both women and provider subject material will 
include: self-report data on surveys, semi-structured interviews, MCPAP for Moms database and medical record chart 
reviews.  Sources for provider material will include the training and consult log, environmental scan and procedure 
checklist. Collection of subject’s contact information including patient name, address, email address, telephone numbers 
with numbers for family /friends to contact if needed (if patient is willing to provide).  Subject privacy will be maintained 
during the course of the study by identifying participant data by code, data will only be entered according to the 
participant’s code, and all identifying data will be kept in a locked file cabinet in a secured office or in a password 
Table 5 Cost of PRISM and Indicators of Potential Savings 
Outcome/endpoint 
Measure 
Data Source 
COST OF PRISM AND 
ENHANCED USUAL 
CARE 
 
• 
Startup costs 
• 
Cost of implementation includes initial training 
(including the opportunity costs incurred by training 
participants) and other investments necessary for 
implementation.  
• 
Operational costs: Cost of MCPAP for Moms (already 
in place) and staff costs of operating the program at 
full capacity. 
• 
Track number and length of implementation 
meetings, trainings to prepare for PRISM 
implementation; Identify and include other 
costs (e.g. new tracking software) 
• 
Time Medical Assistant spends calling patients  
• 
Non-physician tracks hours per week spent 
implementing  PRISM (Time Sampling, email 
script attached) 
• 
Time Ob/Gyn spends on behalf of patients overall, 
time spent per patient with negative screen, time 
spent per patient with positive screen  
• 
Provider will report time spent with patients 
using a PDA/smart phone application (e.g. 
Hours, LifeHacker). No patient identifying 
information will be mentioned in such report. 
(Time Sampling, email script attached) 
INDICATORS OF COST 
SAVING POTENTIAL 
 
• 
Compare hospitalization rates (medical, obstetric and 
psychiatric) for perinatal women receiving care from 
PRISM versus enhanced usual care 
 
• 
Self-report during structured interview with 
patients 
• 
Reporting protocol for Ob/Gyn clinics. 
• 
Cost per hospitalization based on average 
cost, obtained from Mass. Health Policy 
Commission, a publicly available de-identified 
database  
• 
Birth outcomes: birth weight, preterm delivery 
• 
Infant outcomes:  hospitalizations (NICU, special care 
nursery) 
• 
Self-report during structured interview with 
patients. 

protected computer file.  The interviews with women patient participants will be audiotaped. They will have no 
identifying information and will be kept in a locked cabinet.  Access to tapes and data will be limited to the PI, the Co-Is 
and the research coordinator.   
 
 This Study will be using both QuickBase and Redcap for data collection, data storage and data management. Contact 
information and calling attempts and other study management data will be managed in a QuickBase database designed 
and built specifically for this study.  Security for remote users is handled with HTTPS protocols and role-based security in 
both REDCap and QuickBase.  QuickBase employs industry-standard, Secure Socket Layers (SSL) protocol to ensure 
information is neither intercepted nor corrupted during transmission over the Internet. In addition, QuickBase uses 
encryption technology to help protect data stored on disk.  For both of these systems the study will be using the 
principle of Least Privileges, where users are given the lowest level of access that will enable them to fulfill their role in 
the study.  QuickBase and The University of Massachusetts Medical School have a Business Associate Agreement that 
specifies that our QuickBase projects will be stored securely and separately from those of other users. 
 
The patient registry to be used by the navigator to track and follow-up all depressed patients in the clinic/practice has 
been designed and developed in Quickbase database. The data manager and study project director will have access to 
the registry for trouble shooting purposes. De-identified registry data will be analyzed to look for patterns and/or  
progress in patient profiles, patient engagement in mental health treatment, mental health treatment referral and 
proactive monitoring. 
 
 All de-identified data will be captured and stored in Redcap at the University of Massachusetts Medical School by the 
Research Coordinator. The use of latest technology will limit the use of paper for data collection and reduce the chances 
of unauthorized personnel obtaining access to the research information. All analyses will be completed by trained staff 
at the University of Massachusetts Medical School in coordination with trained biostatisticians.  
 
To quality check data that will be collected using electronic data capture, all interviews will be audiotaped using a digital 
recorder attached to the telephone. Recordings will be identified using the date of the interview and participant’s ID and 
stored in a secure server.  Recordings will be destroyed at the conclusion of study data analysis. 
 
MCPAP for Moms Data collection:   
 
MCPAP for Moms utilization data will be collected for all clinic sites.  Each discrete activity (e.g., perinatal psychiatric 
consultation, face to face assessment, care coordination event, follow-up inquiries) performed by a member of the 
MCPAP for Moms team is considered an encounter.  Each encounter is logged into a secure, web-based, Health 
Insurance Portability and Accountability Act (HIPAA)-compliant structured-query language database. MCPAP for Moms 
staff enter data into a central server via a secure web-based portal.  Data for statistical analysis are transmitted securely 
to the central server with identifying information accessible only to the members of the MCPAP for Moms team. The 
data received by the PRISM research team will be de-identified.   The MCPAP for Moms database has been added to the 
PHI on HIPPAA Authorization form.    
 
For sample size calculation and data analysis plan please see pages 22-23 of grant proposal.   
 
We plan to analyze the data collected from participants who were placed in the holding pool for rescreening, 
to determine eligibility at a later time. Those in the holding pool were screened for eligibility two more times 
later in their perinatal period to see if they developed depression symptoms. They never became full study 
participants and retained a holding pool designation since depression screen was negative at all screening 
time periods. The specific data to analyze include the screening data, mental health diagnosis &  treatment 
initiation data. These data are not linked to the identity of the subject. These data were provided through self-
report by the subjects. These participants consented to take part in the study and verbally agreed to the 
HIPAA authorization. We plan to analyze de-identified data from this pool and report in aggregate. The 
participants were told their information would be used for research purposes in the study entitled: PRogram 
In Support of Moms (PRISM) 

 
a. The research involves no more than Minimal Risk to the subjects.- Any analyses would use de-identified 
screening data, thus would not pose any additional risk to the subjects. 
b. The waiver or alteration will NOT adversely affect the rights and welfare of the subjects.- This alteration will 
not adversely affect the rights and welfare of the subjects 
c. The research could NOT practicably be carried out without the waiver or alteration.- Analyses using holding 
pool data will allow us to examine differences between those who were and were not eligible for the full 
study. Such analyses are not possible with the holding pool data and will help understand the study population 
and inform future studies. 
 
d. The research could NOT practicably be carried out without using Identifiable Private Information - – Any 
new analyses using holding pool data will not use Identifiable Private Information. 
 
e. Confirm that in the event it becomes appropriate to provide subjects with additional pertinent information 
after participation, you will seek the guidance of the IRB.- Yes, we will seek IRB’s guidance in the event that it 
is deemed necessary to provide additional pertinent information to the study participants. 
 
 
  
13) 
Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
 
We will conduct dual quality assurance (QA) and quality control (QC) reviews of all data throughout the study. These 
reviews will be conducted by trained QA/QC staff. The first control will include a review of data collected. The second 
review will include a review of data identified for correction by the initial review. We will use the standard operating 
procedures for quality assurance.  Staff will be trained and provided clear guidance on data collection and quality issues 
as well as the standardized methods to transmit data in accordance to protocol and consultation with the CDC. We will 
program the QuickBase system with validation rules and comprehensive edits at the time of entry.  Edits will check for 
validity, consistency, logic checks, appropriate skip patterns and normal range values. 
 
 
 
 
Data and Safety Monitoring Board (DSMB) 
 
We will have a Data and Safety Monitoring Board (DSMB) whose charge is to monitor patient safety and assure study 
integrity for the study protocols that will be undertaken as a result of the project. The board will be comprised of several 
persons not otherwise affiliated with the overall grant or any of its research or education projects.  DSMB membership 
will be based on professional experience, extensive knowledge of clinical trial methodology, participation on other 
monitoring boards and the absence of apparent conflicts of interest, including financial, professional, propriety or 
scientific.  A document with detailed information on DSMB charter, its members, responsibilities and meeting schedule 
is attached. 
 
Monitoring Progress and Safety. All adverse events occurring during the course of the study will be collected, 
documented, and reported to the IRB by the PI according to IRB procedures. All adverse events, serious and non-serious, 
will be fully documented on the appropriate case report forms. For each adverse event, the PI will provide information 
on the onset, duration, intensity, treatment required, outcome, and action taken. She will determine the relationship of 
the medical or behavioral intervention to all adverse events.  
 
 
The CDC (PRISM funder) and UMMS IRB will be notified immediately in the event of a serious adverse event that is 
unanticipated occurrence of physical or psychological harm or unexpected threat to privacy (e.g., lost records) or safety 
of participants. Any death of a study participant will be reported to the CDC and UMMS IRB whether or not it appears to 
be related to the study. Any temporary or permanent suspension of this research by the UMMS IRB will be reported by 

the PI to the CDC grant program director within 24 hours of that action.  Following all such telephone reports, the PI will 
provide a written report of the adverse event and any sequelae to CDC and the IRB.  These narratives will confirm the 
information collected by telephone and may give additional information not available at the time of the initial report 
 
 
Non-serious unanticipated and anticipated adverse events will be reviewed by the PI. H/She will evaluate the frequency 
and severity of the adverse events and determine if modifications to the protocol or consent form are required.   
 
 
Periodic assessments of participant recruitment, accrual and retention and of data quality and timeliness will be 
performed. Any scientific developments external to the study that bears on participant safety and on the legitimacy of 
the trial will be considered.  Adverse events will be monitored during assessments with participants. A summary of the 
adverse events will be reported to the IRB periodically, or, at minimum, during the annual re-approval of the protocol. 
The summary will include the number of subjects enrolled and a summary of graded adverse events to date.  
 Detailed document about the Safety protocol has been uploaded to the IRB. 
 
14) 
Withdrawal of Subjects* 
 
. Subjects may be withdrawn if they show uncooperative behavior towards study staff which hinders further completion 
of study activities.  
 
15) 
Risks to Subjects* 
 
Risks to Provider and Staff Subjects:  It is possible that providers may feel uncomfortable while answering survey 
questions.  Providers may feel uncomfortable about the possibility of having what they say repeated.  The other risk is 
the loss confidentiality.  The research records will be confidential to the extent possible as described in section 26.  
 
Risks to Patient Subjects: PRISM Phase 2 will use commonly used assessment techniques and empirically validated 
forms of screening, self-report questionnaires and semi-structured interviews. There is a small risk that during the 
survey or interviews in PRISM Phase 2 participants may feel uncomfortable or emotional. To address the risk of 
confidentiality breaches, in both studies subject privacy will be maintained by identifying participant data by code, data 
will only be entered according to the participant’s code, and all identifying data will be kept in a locked file cabinet in a 
secured office or in a password protected computer file.  Audiofiles from audio taped sessions will be stored 
electronically in a secure drive.  Access to recordings and data will be limited to the PI, her mentoring team, and 
research coordinator. We anticipate a minimal likelihood of occurrence of a confidentiality breech. 
 
1. Self-report questionnaires and interview assessments:  Self-report questionnaires and interviews are non-
invasive.  The primary disadvantage is the time necessary to complete these surveys and assessments.  We 
anticipate that the semi-structured interviews with women patients (study participants) will take approximately 
45 minutes.  Our estimate of time for provider and staff subjects are 45 minutes each for baseline and post 
assessments. It is anticipated that survey completion may take vary depending on the assessment (Table 4). 
 
2. Audiotaping:  We will audiotape the interviews with women patient (study participants). Steps to assure the 
confidentiality and protection of subjects with respect to audiotaping are described in the “Protection against 
Risk” section below. 
 
3. Screening:  Women will be screened for depression with the EPDS as part of the study protocol.  During 
screening, we expect that women will be identified if they answer 2 or3 on the EPDS suicide question (#10) and 
therefore have created the below Safety Plan to minimize the risk of harm to participants in both the PRISM 
group and Enhanced usual care control group.  
 
The research plan is designed to provide additional protections for pregnant women and meets the following conditions: 
 
1. Ensuring the least possible risk for women for achieving the objectives of the research. 

2. The research plan holds out the prospect of direct benefit to the pregnant subjects. 
3. Subjects’ consent is obtained in accord with the informed consent provisions.  
4. No inducements, monetary or otherwise, will be offered to terminate a pregnancy. 
5. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures 
used to terminate a pregnancy. 
6. Individuals engaged in the research will have no part in determining the viability of a neonate. 
 
Screening.  Women will be screened for depression with the EPDS by research staff as part of the study procedure. The 
PRISM and Enhanced usual care screening protocols are designed to ensure that a safety plan is in place for women who 
answer sometimes (2) or yes, quite often (3) to question 10 which ask about thoughts of self-harm. The qualified health 
care professional (listed as qualified to submit an involuntary hospitalization form- Section 12 in the state of MA) or a 
post-doctoral psychology fellow under the supervision of a psychiatrist will be available during all potential screening 
times to ensure participant safety when this situation arises.   
 
If a subject answers 2 or 3 on the EPDS self-harm question (#10) during study phone call, the RC will stay on the phone 
until the patient is assessed by a qualified health care professional (listed as qualified to submit an involuntary 
hospitalization form- Section 12 in the state of MA) or a post-doctoral psychology fellow under the supervision of a 
psychiatrist (via the telephone) .  The interviewer will stay on the phone until the subject is assessed (via telephone) by 
the qualified health care professional, who will determine if there is any safety concern. If there is no safety concern, 
then the qualified health care professional will drop off the phone line for the interviewer to continue.  
If there is safety concern the qualified professional will arrange for the participant to be transported to the nearest 
emergency room according to Massachusetts General Law Chapter 123, Section 12 while the interviewer will remain on 
the phone with the participant until emergency personnel arrive on the scene.   A similar safety protocol has been in 
place for other perinatal depression studies such that Obstetric and Psychiatry providers are familiar with urgent 
intervention/referral processes when required.  
 
During the phone screening if there is a safety concern for the patient, the study staff will contact the PI or her delegate 
immediately for further assessment and action. 
 
The expected risk to subjects is minimal. Risks include the utilization of the time it takes to complete the 
questionnaires. An additional risk is that of revealing confidential psychiatric information.  However, if subjects are 
identified as having mental health issue, they will benefit from being offered appropriate referral and/or 
consultation.  We feel that the potential benefit of the increased outcomes of depression screening and treatment 
outweighs the minimal expected risks related to participation in this study.  
 
Risks of this study are primarily psychological.  Occasionally the questions asked in the surveys may prompt adverse 
emotional responses from participants, thus bringing attention to underlying depression/anxiety. There is a risk that 
subjects may experience discomfort or anxiety as a result of being asked questions about their experience with mental 
health concerns or mental health treatment. One structured way to address potential discomfort will be to assure 
subjects during the initial consenting process and again, as needed, that it is their right to decline to answer any or all 
questions asked of them. They will also be reminded that it is their right to withdraw from the study for any reason, at 
any time, without consequence or penalty.  During the assessments, if there are any indications of distress, and at the 
conclusion of the interview, the RCs will "check in" and ask how the participant is feeling. If the participant is 
comfortable, the RC will proceed with the interview. If the participant shows or voices any distress, the participant will 
be reminded that she is free to discontinue participation in the interview at any time. The study RC will be trained to 
identify signs of distress. The Research Coordinator will contact the study PI or her delegate should any subject exhibit 
significant distress. The study PI or her delegate will determine whether emergency assessment is needed and will take 
responsibility for arranging urgent evaluation of the subject. The subject’s Ob-Gyn attending will be notified and the 
research staff will page the PI or her delegate (another physician) immediately.  The PI or her delegate will determine 
whether emergency assessment is needed and will take responsibility for arranging urgent evaluation of the subject.  

Recruiting will only take place during periods when the PI or the PIs delegates available to ensure subject safety should 
this situation arise.   
 
A way to address potential discomfort while answering psychologically related questions is to reassure subjects 
during the initial consenting process and again, as needed, that it is their right to refuse to answer any or all 
questions asked of them. They will also be reminded that it is their right to withdraw from the study for any reason, 
at any time, without consequence or penalty. If a subject does report depressive symptoms or experiences an 
exacerbation of depressive symptoms during the study, she will be offered mental health services via her obstetric 
provider or/and a mental health physician or prescriber or referred for treatment if not already connected to a 
mental health physician or prescriber.  
 
 
16) 
Potential Benefits to Subjects* 
 
The PRISM protocol has been thoughtfully proposed based on our preliminary data and recent literature review34 that 
suggests that the PRISM components will improve depression severity and treatment participation among perinatal 
women. In addition, we propose to address depression throughout the perinatal period, including depression beginning 
in pregnancy.  The proposed research plan has the potential to benefit provider and staff subjects by building their 
capacity to screen, refer and manage women with perinatal depression.  Subjects whose providers participate in the 
PRISM group will likely benefit from the enhanced training and resources their providers will have received and have 
access to as part of the PRISM group. Subjects in the Enhanced Usual Care control group may also benefit because this is 
active control group that offers screening and referral which is more than what many obstetricians are currently doing.2 
 
 
17) 
Vulnerable Populations* 
 
This study involves the recruitment of a vulnerable population of pregnant women.  These women are expected to be 
able to give verbal informed consent.  The study is of minimal risk and provides no risk to the fetus.  This study cannot be 
done without recruiting pregnant women as the subject under study is specific to this population and is being performed 
with the ultimate goal of improving depression treatment for women during pregnancy.  No inducements, monetary or 
otherwise, will be offered to terminate a pregnancy. Individuals engaged in the research will have no part in any 
decisions as to the timing, method, or procedures used to terminate a pregnancy. Individuals engaged in the research 
will have no part in determining the viability of a neonate. We may collect some data on neonates of uncertain viability 
to examine the extent to which improving maternal health can impact baby’s outcome. As previsouly mentioned, 
individuals engaged in the research will have no part in determining the viability of a neonate, as we are solely collecting 
data on the baby from the mother via verbal assessments (there will be no interaction and/or intervention with the 
neonate). Furthermore, the purpose of the research is the development of important biomedical knowledge which 
cannot be obtained by other means, and there will be no added risk to the neonate resulting from the research. Lastly, 
the mother providing consent will be fully informed regarding the reasonably foreseeable impact of the research on the 
neonate. 
 
18) 
Multi-Site Research* 
 
This is a multi-site study and it involves 10 clinics participating in the study. Once the clinic director expresses interests 
and agrees to study participation, and we will submit modifications to the IRB in order to add the clinic to the research 
study.  One research coordinator is coordinating all the communication (either phone or email) with regards to IRB 
process and procedures.  
 
19) 
Community-Based Participatory Research* 
 
NA- this is not a community-based participatory research study.  

 
20) 
Sharing of Results with Subjects* 
 
The fact sheets will indicate that research staff may notify the subject’s Ob/Gyn provider verbally or via secure email of 
their EPDS score if 10 or greater as well as of any interventions/referrals made. 
 
21) 
Setting 
 
All patient subjects will be recruited from one of the participating Ob/Gyn clinics. 
 
UMMHC’s Memorial Campus houses the clinical, educational, research and academic resources of the Department of 
Obstetrics and Gynecology. They have and will continue to support use of space, patients and other resources for 
research initiatives. The Ob/Gyn research division currently includes an administrative assistant, 1 research nurse, 2 
clinical research assistants, 1 biostatistician/analyst., and 1 division director  Each member of the research division and 
proposed site investigators have dedicated office space includng locked drawers, locked filing cabinets, fire-wall and 
password protected computers.  The research division includes 778 sq ft of office space which includes 2 rooms where 
research files can be retained in confidential locked areas.  There is ‘research swing space’  in the basement of the 
Jaquith building, room B050.  The space totals 315 square feet and contains 4 desks, 4 chairs, 4 telephones, 4 
computers, 1 printer and locked filing spacing that can be utilized by visiting supervisory study staff as needed.  
Additionally, in each of the outpatient faculty and resident clinics, thus providing a quiet and private place for study 
subjects to consider protocol enrollment, ask questions and undergo study-specific activities.   
 
The On-site Ob/Gyn Ambulatory Out-patient ‘Community Women’s Center’- CWC Prenatal Care Clinic of the 
UMMHC/UMMS Department of Ob/Gyn is the frequent site of subject identification and enrollment for studies.   
This clinic site  along with the faculty private practices serves ethnically and socioeconomically diverse populations 
resulting in approximately 16,000 obstetric visits per year and care for approximately 1,550 new prenatal care visits per 
year.  These practices have been the site of successful recruitment of study subjects for numerous study protocols.   The 
UMMHC clinic sites include 12 Ob/Gyn attending physicians, 2 nurse practitioners, 20 Ob/Gyn residents that rotate 
through the clinic, 4 nurses, 1 patient care assistant, and 3 clinical administrative support staff.  In fiscal year 2013-2014, 
the clinic site served 691 obstetric patients; among the prenatal care population, approximately 20.4% are Latina, 13.8% 
are Black, 53.7% are non-Latina white, 5.7% Asian and 6.4% are other race/ethnicities.  The clinic population was insured 
by Medicaid (69%), commercially insured (23%), Medicare (4%), and self-pay/free care (4%).  
 
UMass Memorial - HealthAlliance Hospital is a not-for-profit, full service, acute care hospital that serves the 
communities in North Central Massachusetts and Southern New Hampshire. Montachusett Women’s Health of 
Leominster is part of HelathAlliance Hospital that fully support research initiatives. They approximately do more than 
800 deliveries per year. The Montachusett site include 6 Ob/Gyn attending physicians, 1 nurse midwife, 4 nurses, 2 
ultrasound technicians and 8 medical assistants. 
Systems and Psychosocial Advances Research Center (SPARC) in the Department of Psychiatry    
A Massachusetts Department of Mental Health (DPH) Center of Excellence, SPARC is an internationally recognized 
academic center conducting research on the development, implementation, and effectiveness of mental health services.  
SPARC provides a collaborative environment within which to conduct multifaceted research. An interdisciplinary faculty 
and staff including psychiatrists, psychologists, sociologists, rehabilitation professionals, statisticians, and attorneys, 
participate in research at this location.  
 

 
22) 
Resources Available 
 
 
Principal Investigator (PI):  
 
The PI will have ultimate managerial and administrative oversight of the study, and will be the identified liaison with the 
funding agency. She/he will work in partnership with her Co-PIs to co-lead all aspects of the study. She/he will have 
ultimate responsibility for ensuring the integrity of the research, including developing materials for the IRB and working 
with UMMS and developing and executing participant recruitment strategies.  
 
Co-Principal Investigator (Co-PI 1): He will provide oversight on implementation science and methodology training, with 
a focus on pilot studies and cluster RCTs, and will review methodology for future grant proposals and manuscripts. He will 
work in partnership with his Co-PIs to co-lead all aspects of the study.  He will provide oversight of the management and 
administrative aspects of the project, particularly as it relates to the cluster RCTs, data collection and data security. He will 
contribute to the development and submission of the IRB, and work collaboratively with his Co-PIs and CDC investigators 
on protocol development, participant recruitment and retention strategies, as well as data security measures to protect 
the confidentially of all participants.  
 
Co-Principal Investigator (Co-PI 2): Se will work in partnership with her/his Co-PIs to co-lead all aspects of the study. She 
will provide oversight of the management and administrative aspects of the project, particularly as it relates to interfacing 
with site clinics and participant recruitment. She will contribute to the development and submission of the IRB, and work 
collaborative with the Co-PIs and CDC investigators on protocol development, and participant retention strategies.  She 
will work with her Co-PIs to ensure safeguards for protecting the rights and confidentiality of all patient data. She will work 
collaboratively with her Co-PIs and CDC staff on the design, analyses and dissemination of study results, and will actively 
participate in all manuscript preparation. She will participate in monthly conference calls with CDC collaborators and 
provide progress updates.  
 
Co-Investigator (Co-I 1): She will work in close partnership with the Co-PIs on the management and administrative 
oversight of the project.  Specifically she/he will supervise the Research Coordinator II and Research Coordinators, all of 
whom will be co-located at the UMMS Systems and Psychosocial Advances Research Center.  She will actively participate 
in developing all materials for the IRB submission, and will work collaboratively with the Co-PIs, and Co-I and CDC 
personnel on developing the research protocol. She will actively participate in all manuscript preparation. 
 
Co-Investigator (Co-I 2):  She will work collaboratively with the Co-PIs and Co-I on developing all materials required for 
the IRB submission including protocols, consent forms, data collection materials and recruitment materials.  She will work 
collaboratively with PIs and Co-I on protocol development. She will actively participate in all manuscript preparation. 
 
Application Database Developer: 
Database developer and programmer in the Department of Quantitative Health Sciences will be responsible for developing 
the patient tracking system in Quickbase for this project, so that research staff can schedule patient visits, track 
completed/missed visits, track complete/incomplete forms, and provide immediate reports and dashboard-like views on 
patient visit status.  
 
Senior Development Engineer:  
Senior Development Engineer will be responsible for monitoring the main study database, provide maintenance activities 
as needed (such as update and test new versions of forms, modify edit logic checks during data entry, etc.) and work with 
the statistical analysts on the project to generate analysis files from the main study database. He can also provide 
descriptive statistical analysis to validate data entry ranges, consistency, etc. 
 
Database developer and programmer: will be responsible for all data management activities of the study including 
building the contact and study databases on the RedCap platforms, specifications for variables within the data entry 
system, tracking of data quality steps, data security, and data archival.  All data management activities will be performed 
under the umbrella of reproducible research and according to standard operating practices of the QMC. 

 
 
A. Other Personnel 
 
Research Coordinator II: S/he will be supervised by the PIs and will be co-located at the UMMS Systems and Psychosocial 
Advances Research Center. S/he will meet regularly with the project team and assist in organizing materials for team 
meetings and activities. The Research Coordinator II will oversee the Research Coordinators, and will facilitate all 
recruitment activities, and liaising with the clinic sites.  S/he will work closely with all Investigators to coordinate project 
activities, develop project work plans, and manage their execution.  S/he will monitor all relationships with project 
participants and stakeholder groups, supporting these relationships via active communication. S/he will prepare materials 
for the UMMS Institutional Review Board with oversight and guidance from the Co-PIs and Co-I.  S/he will oversee and 
participate in data collection and telephone interviews with study participants.  
 
Research Coordinator I(RCs) and Research Assistants/Interns: All RCs will be supervised by the PI and Co-Is and will be 
co-located with one of the Co-Investigators at the UMMS Systems and Psychosocial Advances Research Center. They will 
meet regularly with the project team and assist the Research Coordinator II in organizing materials for team meetings and 
activities. The Research Coordinators will work closely with the Research Coordinator II on all recruitment activities, and 
interfacing with clinic sites.  They will assist the Research Coordinator II in all project activities. They will assist in the 
preparation of materials for the UMMS Institutional Review Board with oversight and guidance from the PI and Co-Is.   
 
MD/PhD Student: S/he will be supervised by the PI and Co-Is and will be co-located with one of the Co-Investigators at 
UMMS Quantitative Health Sciences department. S/he will meet regularly with the project team for team meetings and 
activities. S/he will assist in all project activities, recruitment activities and interfacing with clinic sites. S/he will participate 
in data collection and telephone interviews with study participants. S/he will be assisting in data management, analyses 
and manuscript preparation. 
 
Post-doctoral fellow: S/he will be supervised by the PI and Co-Is and will be co-located at the UMMS Systems and 
Psychosocial Advances Research Center. S/he will meet regularly with the project team for team meetings and activities. 
S/he will participate in data collection and telephone interviews with study participants. S/he will be assisting in data 
management, analyses and manuscript preparation. 
 
Content Experts 
Stepped Care Expert: Will provide expert consultation in regards to the implementation of our stepped care model, PRISM.   
 
Implementation and Organizational Change Expert: Will provide expert guidance on how to refine the implementation 
of PRISM in Ob/Gyn clinics. Will also provide guidance on how we can refine and evaluate our clinic-tailored 
implementation assistance using an organizational change platform.  
 
Health Economist:  Will work with PI, co-PIs, and co-Is of the research team to develop theoretically sound and 
methodologically rigorous methods for measuring the cost of PRISM and for assessing the potential for cost savings.  
 
Site PI: Site PI from all sites will be responsible for overseeing the activities of the PRISM study at their respective sites. 
 
Site Champion: Can be MA’s, PCA’s, RN’s or administrative staff (identified at each practice) will be responsible for 
coordinating and transmitting the patient list to PRISM study staff at UMass. 

 
23) 
Prior Approvals 
 
NA- no prior approvals.  
 
24) 
Recruitment Methods 
 
See details in #7. 
 
25) 
Local Number of Subjects 
As described in question 6, we plan to recruit 340 pregnant women to participate in the study. 
 
26) 
Confidentiality 
 
Confidentiality will be protected by providing all subjects with a numbered code. All study data referring to that subject 
will be addressed by the code, rather than by identifying information. All personal information will be coded and stored 
in a locked cabinet to protect confidentiality. Neither the subjects' names nor any other personal identifying information 
will appear on the questionnaires.  Subjects’ names will appear only on a consent form and “key” form kept by the PI. 
These documents will be kept in a locked file cabinet separate from participant data files or in a password protected file. 
For those who did the initial screening by phone but then declined to participate or were deemed ineligible to 
participate, the information gathered will be stored as described in #10, Procedures Involved. Some data collection 
(questionnaire completion) will be accomplished by electronic data capture in REDCap.  No identifying information of 
any subject will be included in the published or presented results of these studies.  These procedures have been 
effective in past research studies conducted at UMass to protect subject confidentiality. 
 
To assure the confidentiality and protection of participants with respect to audiotaping, the following steps will be 
taken: The interviewer will conduct the taping.  All taping will take place at the designated research setting.  Audiofiles 
will be labeled with the ID code on the recorder which is also included in documentation of the call in the Quickbase 
recruitment tracking application. The audiotaped calls will take place in a private setting.  Audiofiles of those who 
consent will be stored in a secure server and identified only by recorder ID code. Access to the audiotapes will be limited 
to the PI, relevant mentors, and trained research associates.  Audiotapes of those not consenting to participate will be 
deleted from the recorder immediately after the call. 
 
To ensure assure the confidentiality and protection of participants with respect to linking data to the MCPAP for Moms 
program data, the following steps will be taken:  
(1) the UMass PRISM team will provide the names only of providers that have participated in the PRISM study to the 
MCPAP for Moms program data team electronically via secure file transfer protocol (sft – MOVEIT DMZ). 
(2) MCPAP for Moms program data team will send the UMass team the aggregate number and type of encounters by 
year for each of the PRISM providers, also by sft. This will be broken down by PRISM provider.  
(3) a UMass RC will link the PRISM and MCPAP for Moms program data, deidentifying of any PHI. Using the PRISM 
provider names, the aggregate number and type of encounter will be matched to the provider’s existing PRISM de-
identified ID. Subsequently, all PHI (i.e., names) will be stripped from the data, thus, de-identifying this information.  
(4) a second UMass RC will check the linked data, to ensure that all PHI is removed. At this step, the data will be 
considered completely de-identified.   
(5) the UMass team will send de-identified data to the designated CDC collaborators by sft. There will be no way for the 
CDC collaborators to access PHI related to this dataset.    

 
27) 
Provisions to Protect the Privacy Interests of Subjects (HIPAA) 
 
Once potential subjects are approached, they will be reminded that it is their right to decline to enter or withdraw from 
the study for any reason, at any time, without consequence or penalty.  Research staff will also obtain consent from the 
subject to notify their Ob-Gyn provider of their EPDS score and the interventions/referrals made.  We are requesting a 
HIPAA waiver to prescreen the electronic medical record for potential subjects, screen the electronic medical records of 
enrolled subjects and to be able to access the minimal necessary PHI. Clinic patients who enroll in the study will receive 
a HIPPA authorization form by mail and study staff will review the entire HIPAA authorization form by phone before 
starting the survey questionnaires. We are requesting a HIPAA waiver to look through medical records and collect PHI 
via study assessments  of enrolled patient since the nature of data collection (only by phone) does not allow us to get 
the HIPAA authorization signed by the patient 
 
28) 
Compensation for Research-Related Injury 
The study does not involve more than minimal risk. In the unlikely event of injury, subjects or their insurance will 
be responsible for coverage.  
29) 
Economic Burden to Subjects 
Subjects will not be responsible for any costs involved in this study.  
30) 
Consent Process 
Subjects will only be enrolled after obtaining informed and voluntary verbal consent.  Informed consent will be obtained 
in accordance with HRP-802 INVESTIGATOR GUIDANCE: Informed Consent.  We will be obtaining a/verbal consent from 
patient participants interested over the phone since all the surveys in the study are going to be administered over the 
phone. The patient participants will be provided (mailed) with a Fact Sheet (see attached for Participant Run in Phase; 
Participant; and Provider Fact Sheets) explaining the procedures about the study and contact information of study staff. 
We are requesting a waiver of written documentation of the consent process for patients participating in the study. We 
are requesting a waiver of written documentation of the HIPAA authorization process. The patient participants will be 
provided (mailed) with the HIPAA authorization.  No sooner than two weeks after the mailing, patients will be contacted 
by phone to consider participation.  Calls to participants will be audiotaped. The person who obtains verbal consent will 
explain all the aspects of the study in lay language and answer all questions regarding the study.  It is always 
emphasized to the subject that giving consent is not a binding.  Consent is an ongoing process, and it is their right to 
withdraw that consent at any time.  The consenting study team member will explain to the subject the goals and 
structure of the study in general, as well as risks and alternative treatments, before going through the details of the 
consent form.  The subject will be given the opportunity to ask questions of the study staff. If the subject appears 
hesitant or reluctant, we will recommend that the patient review the information before making a decision.   If the 
questions are answered to the individual’s satisfaction and they give a clear indication that they wish to participate in 
the study, then the RC will proceed with the protocol. No study procedure will be performed prior to getting verbal/oral 
consent.  
We are requesting a waiver of written documentation of the consent process for providers. The request is made because 
the research presents no more than minimal risks of harm to subjects. The fact sheet containing study information is 
going to be provided to them in person, by phone or via email.  Written information will be provided on paper or 
electronically.  The research involves no procedures for which written consent is normally required outside of the 
research context. 
We will only consent English speaking/reading women. 
We will only consent adults 18 years or older.   
We will not be recruiting or consenting cognitively impaired adults. 
We will not be recruiting adults that are not able to consent, nor will we be using a HUD. 

 
In the event it becomes appropriate to provide subjects with additional pertinent information after participation, we will 
seek the guidance of the IRB. 
 
31) 
Process to Document Consent in Writing 
 
We are requesting a waiver of written documentation of the consent process for providers. The request is made because 
the research presents no more than minimal risks of harm to subjects. The consent disclosure information is going to be 
provided to them in person, by phone or via email.  Written information with elements of consent disclosure will be 
provided on paper or electronically.  The research involves no procedures for which written consent is normally required 
outside of the research context. 
 
We are also requesting a waiver of written documentation of the consent process for patients participating in the run-in 
phase and RCT phase of PRISM Phase 2 study. The request is made because the research presents no more than minimal 
risks of harm to subjects, as the research solely involves data collection.  Also, written information describing the study 
will be explained to the patients over phone and mailed to subjects as a fact sheet. The research involves no procedures 
for which written consent is normally required outside of the research context. 
 
32) 
Drugs or Devices 
NA- no drugs or devices will be used.