AAPP is working hard to standardize and improve clinical research through various initiatives and the awarding of this grant represents a significant milestone in the AAPP Outcomes Initiative. High quality research that supports the integration of psychiatric pharmacists into mental health care teams is critical for the advancement of the profession. The primary goal of this funded research is to generate high-quality large sample size (n) data sets that evaluate the impact of integrating psychiatric pharmacists into team-based mental health care in studies with multiple research sites and investigators.
In 2023, AAPP committed up to $500,000 to directly support multi-site research related to the impact of psychiatric pharmacists on patient care through the AAPP Foundation. The first AAPP Outcomes Initiative grant was awarded during AAPP 2024.
The 2025 grant is for a prospective open label trial to compare the outcomes of patients with major depressive disorder who receive care from a BCPP with prescriptive authority (ie, CPA, VA Scope of Practice) versus those who receive standard care from a non-pharmacist primary care provider. A single site will serve as the central data collection repository and have the responsibility to summarize study results, and data will be collected from multiple sites (minimum of 2 sites) in the United States. The purpose of the RFP is to identify a primary investigator.
Application Deadline: October 1, 2025
Question and Answer Session: The session was held on July 23, 2025. All questions that are generally applicable have been added to the FAQ below. Thank you to those who came with questions!
Frequently Asked Questions (FAQ)
A question and answer session was held in July 2025.
Why is a statistician required in the research proposal?
Poor statistical design and analysis is a common reason for rejection of research manuscripts by peer reviewed journals. Similarly, the validity of study results is often questioned because of poor statistical design and analysis. Statisticians commonly state that when they are contacted after a study is completed for consultation that it is challenging to produce meaningful results because of poor study design. The projects to be funded are multi-site studies, which causes the design and analysis to become more challenging. For these reasons, organizations funding larger grants frequently require that a statistician be involved from the beginning of a funded study. If you do not have a statistician in your organization, consider reaching out to colleagues at a university who may be able to assist with connecting you with a statistician. Commercial statisticians are also available, and these organizations can be identified with an internet search. Statistician fees are allowed in the study budget, so please make sure that you appropriately budget for this expense.
How many sites is a multi-site study?
The RFP suggests 2-5 sites. Technically, two sites are multi-site. The number of sites will be limited by the logistics of coordinating multiple sites as well as the available funds in your study budget. Obviously, as the number of sites increases the costs increase along with the complexities of conducting the study.
Must IRB approval be obtained before submission of the final grant proposal?
No, IRB approval need not be obtained before submission of the final grant proposal. However, IRB approval from all sites must be obtained before grant funds will be released. Ideally, the secondary sites will accept the IRB approval of the coordinating research institution. If secondary research sites will not accept IRB approval of the coordinating research site, obtaining all necessary IRB approvals can be time consuming. Investigators are encouraged to begin the IRB review process as soon as they have a final grant proposal that can be reviewed. IRB approval and IRB approved consent forms of the funded proposals must be sent to AAPP.
How long after being notified of a successful grant proposal do the investigators have to begin the research?
Investigators should begin the research as soon as funds are received, but a maximum of six months after being notified of the award. If the investigators can show good progress toward initiating the research, consideration will be given to one three-month extension.
Can the funds be used to fund a research fellow?
No, this was not the intent of the RFP. See “Funding Information” (page 4).
Does the study need to be prospective or would retrospective study designs be considered?
Due to the large investment of funding, only prospective studies will be considered.
Does the comparator group need to be prospective or can it be retrospective?
The comparator group should be prospective.
What is considered a large N?
This will be dependent on power analysis.
Is a power analysis required for statistical analysis?
Yes. A statistician is required to provide a power analysis in the proposal design.
Is there a specific number of core outcomes that should be included in the study?
No. The number of outcomes should be determined by how to best address your specific aims.
Can the 2-5 required sites be within the same health system or does it need to be multi-system?
The sites can be within the same health system when distinct, separate locations.
Does randomization have to be at the patient level or can it be at the site/hospital level?
Randomization can occur at patient or site/hospital level. However, randomizing at the patient level can be potentially problematic for this type of study as it can be difficult for the BCPP to practice in a clinic and not interact with other clinicians, potentially influencing their patient care. Based upon local issues, matching of clinics may be acceptable, but the investigator needs to clearly explain the need for this in the proposal.
How can we include grants/administration on the budget when there needs to be a sub-contract (e.g., multiple sites involved) that would normally be covered by indirect?
This can be included as a line item or rolled into one of the investigator’s responsibilities (e.g., research technician). See “Detailed Budget” (page 12).
Is randomization required?
Matching is an option but randomization is a stronger research design.
Will organizations only be considered if they have an existing service or is this available for planning to initiate a service?
Implementation of a new service is allowed. (should demonstrate administrative buy-in from institutions)
Are there any requirements that investigators hold board certifications or organization memberships?
No. Per “Additional Requirements” (page 3), all Co-PIs need not be pharmacists, but at least one Co-PI must be a pharmacist. Sites are encouraged to have some BCPPs as Co-PIs. Study psychiatric pharmacist interventions must be performed by BCPPs
Can providers submit medical insurance claims for patients being seen during a study-related visit?
The ability to bill for services being studied will not be specified by the grant and would need to be addressed with the relevant billing departments, payers, and IRB(s). However, the task force anticipates that billing is still possible within practice-based research. Study-specific activities that would not otherwise be utilized for the patients’ care will likely be considered research administrative time and therefore not billable. However, any clinical services provided during the same visit as study-specific activities will likely still be billable within the same constraints (payer agreements, legal authorization, etc.) as the same services provided outside of the study. Some examples follow:
Some payers allow the provider to bill by time during the visit instead of procedure code. If the provider bills by time, then time that the provider spends for research procedures and not patient care would not be billable. Under procedure codes, many payers will pay for administering validated rating scales (within limits) that are completed on the day of the visit. Thus, validated rating scales administered for clinical purposes would likely be billable; however, rating scales administered purely for research purposes would not be billable.
In other words, it is probable that a study funded by this grant will not directly impact which services and providers are billable.
Are we required to use the suggested validated assessment scales?
No, these are only suggestions. However, it is important to include a patient-level outcome and a validated scale. You are strongly encouraged to refer to the Core Outcome Set for Psychiatric Pharmacists (COS-PP) for additional guidance and examples.
Does the BCPP providing the intervention need to be in the primary care clinic full-time?
No, the BCPP can either be in the primary care clinic full-time or on a part-time basis as need to provide patient care. The care can be provided either in person, through telehealth, or a combination of the two.
Does the study population have to include patients who only have MDD without other comorbidities?
The Methods outlined in the Request for Proposals document are a suggested draft. Adjustments may be considered as necessary to ensure feasibility within your system. We recommend highlighting sections that needed changing for reviewers. The following inclusion criteria are suggested: confirmed diagnosis of major depressive disorder, willingness to participate in the study, and the ability to provide informed consent. The following exclusion criteria are suggested: comorbid moderate to severe (per DSM-5-TR) substance use disorders (except in remission or nicotine), personality disorder diagnosis, psychotic depression, bipolar depression, or intellectual disability that interferes with the patient's ability to complete study procedures.
These criteria were developed with the goal of promoting a clean sample to allow for high-quality statistical analysis but may be modified as needed. You should account for potential bias if the psychiatric pharmacist tends to take on more severe/complex cases.
Where can I go with questions?
Email info@aapp.org