The AAPP Outcomes Initiative grant was awarded during AAPP 2024. 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. In September of 2023, 6 pre-applications were received and evaluated by the taskforce. After multiple points of feedback, 2 finalists submitted their applications on April 1, 2024.
A panel of 8 researchers evaluated both applications and eventually awarded $247,352 to the winning project:
Psychiatric pharmacist management of cardiometabolic risk for adults with serious mental illness in outpatient safety-net mental health clinics in San Francisco
The primary investigator and co-investigators are Esti Iturralde, PhD, Anne Rosenthal, MD, and Hannah Van Ochten, PharmD of Kaiser Permanente Northern California Division of Research.
To learn more about the grant, download the RFP to the right and review the FAQ below.
A question and answer session was held in July 2023. All questions asked in the session are now addressed in the FAQ below.
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.
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.
Incarcerated individuals may represent a vulnerable population and care must be taken in including these individuals as research subjects. For example, federal research ethics guidelines state that prisoners cannot be used as research subjects just because it is convenient. Involuntarily committed patients also represent a vulnerable population, and in some cases their competence to provide informed consent may be impaired. Many states have state laws addressing vulnerable populations, in addition to the federal Common Rule 45 CFR 46.102 (f), and these must be addressed in considering the inclusion of such individuals. Lastly, the ability to generalize the study results to improving care of individuals with mental disorders at large must be considered.
Substance abuse disorders are included as a mental disorder in DSM-5, and psychiatric pharmacists provide care for these individuals. Patients with these disorders are an appropriate patient population for the research.
The one-page preapplication serves two purposes. It allows the investigators to know whether they have a research hypothesis, specific aims, and general methodological approach that merit the development of a full proposal. Second, it allows AAPP to know how many full proposals that they can anticipate.
No, the initial full proposal is advisory, and investigators will likely need to make revisions based upon feedback from the reviewers. Institutions with a significant volume of funded research typically have research grants offices that review and approve proposals and budgets submitted for consideration of extramural funding. If your institution has a research grants office, they must approve your final grant proposal before submission. If your institution does not have a research grants office, written approval of the final proposal should be obtained from the appropriate administrator to authorize that the research can be conducted in the institution.
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.
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.
A junior investigator must have five years or less of experience since either completing terminal training or transitioning to a research role. See “Additional Requirements” (page 3).
Final determination of whether someone is a junior investigator is up to the reviewers, but having never been PI on a large research project and/or having 0-3 original research publications are both strong indicators.
The junior investigator can participate in any role including as a site participant.
No, this was not the intent of the RFP. See “Funding Information” (page 4).
Due to the large investment of funding, only prospective studies will be considered.
The comparator group should be prospective.
This will be dependent on power analysis.
Yes. A statistician is required to provide a power analysis in the proposal design.
No. The number of outcomes should be determined by how to best address your specific aims.
Depends on specific aims. Need to be specific and measurable.
The sites can be within the same health system when distinct, separate locations.
Randomization can occur at patient or site/hospital level.
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).
Matching is an option but randomization is a stronger research design.
Implementation of a new service is allowed. (should demonstrate administrative buy-in from institutions)
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
Behavioral health sites or primary care sites are both acceptable.
One-page biosketches are preferred. Multi-page biosketches will be allowed as long as they adhere to NIH guidance, which includes a strict 5-page limit.
One-page pre-applications are encouraged, but multi-page pre-applications will still be reviewed. Short pre-application letters are meant to streamline the review process and lessen the planning requirements for researchers at this early stage.
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.
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