HEART RESERVE · Prospective grant dossier · October 15, 2026
GLP-1 Medicines and Pregnancy Planning
Product-specific counseling and continuity of metabolic care
Download proposal PDF · Download itemized budget PDF
Executive summary
Reproductive counseling must accompany metabolic prescribing. In a 2026 Chicago health-center study, only 11.9% of the 194 women with type 2 diabetes prescribed a GLP-1 receptor agonist reported discussing pregnancy intentions at their recent visit. These local self-reports support a counseling gap; they do not establish national prevalence or the safety of pregnancy exposure.
HEART RESERVE proposes one 60-minute enduring activity focused on the decisions that a broad obesity update cannot fully address: verify the exact product and reproductive goal, interpret exposure uncertainty, and maintain needed metabolic care during transition. Three original fictional case sequences move from a proposed plan to changed circumstances and an accepted handoff. Lisa Zahakos, RPA-C’s longitudinal teaching approach makes the communication and coordination work visible. Maternal-fetal medicine, endocrine and pharmacy review will independently assess the content.
The $71,400 prospective request includes $12,300 of defined educator revisions. Three matched first-response items measure immediate learning; proposed parallel vignettes provide a reviewable route to transfer assessment, with follow-up actions and barriers reported separately. No pregnancy or cardiovascular outcome benefit is promised. An endocrine IME route requires explicit confirmation that reproductive counseling fits current priorities, plus a separate delivery quote and provider-approved budget.
This is a developed grant-planning dossier. Funding, named faculty appointments, the legal grantee, provider participation, credit designation and native myCME acceptance require confirmation. Estimated time and any credit request must be supported by timed learner testing.
A focused reproductive-care proposal
Position this as a distinct counseling and treatment-transition activity within an appropriate endocrine education opportunity. It goes deeper into reproductive decisions than the broader obesity/diabetes course. If both are proposed, disclose overlapping material and allocate shared development costs once. Confirm the final duration through learner testing before requesting credit.
The HEART RESERVE teaching approach
History → evidence → next action → follow-up. Each case connects the patient’s story to a clinical choice, explains the reasoning and identifies the next step. Worked examples, immediate decision feedback and equivalent text and audio options connect the evidence to a practical next step.
The format draws on the one-hour, grant-supported published obesity education example: a defined audience, case-based teaching, assessment and evaluation. Its supporter relationship and credit approval belong to that program.
Needs assessment and gap analysis
Published evidence of the practice gap
A 2026 study enrolled 382 women aged 18–44 with type 2 diabetes at 38 Chicago health centers. Among 194 women prescribed a GLP-1 receptor agonist, 11.9% reported discussing pregnancy intentions and 11.4% contraception at their recent visit. These local, self-reported findings do not establish national rates or describe all people treated for obesity. They support a specific educational gap: make reproductive counseling part of the prescribing conversation and preserve diabetes care during a treatment transition.
Bailey SC et al. Journal of Women’s Health. Published August 11, 2026.
Pregnancy planning, contraception, recognized pregnancy and lactation require distinct decisions. A class-wide timing rule can miss product-specific instructions, while discontinuation without a diabetes treatment transition can interrupt needed care. The activity uses current labels, professional guidance and exposure evidence to teach counseling and coordinated follow-up without claiming either proven pregnancy safety or inevitable fetal harm.
| Practice gap | Educational response | Assessment evidence |
|---|---|---|
| One class-wide timing rule is applied across products | Verify the exact product, indication and reproductive situation | G1–G3; case 1 and 2 decisions |
| Exposure evidence is interpreted as definitive safety or inevitable harm | Explain evidence limitations and arrange individualized assessment | G4–G5; case 3 decisions |
| Stopping treatment is treated as the complete care plan | Coordinate interim metabolic care, ownership and follow-up | G6; decisions across cases |
These sources establish a clinical rationale for education. They do not establish the baseline knowledge of enrolled learners or prove that education alone removes access, insurance or staffing barriers. Collect the actual baseline and report missing data.
Audience and educational design
Intended audience: Primary care, endocrinology, obesity medicine and obstetric clinicians; pharmacists, NPs and PAs involved in preconception counseling and medication transitions.
Learning objectives
- Apply the current product-specific pregnancy and contraception instruction to a clinical situation.
- Interpret early-exposure research without claiming either proven safety or inevitable fetal harm.
- Select a coordinated medication transition and follow-up plan that preserves necessary metabolic care.
Agenda
| Component | Minutes |
|---|---|
| Overview and three baseline questions | 5 |
| Three cases, six decisions and selected media | 42 |
| Take-home clinical tool | 4 |
| Six-question posttest | 7 |
| Evaluation | 2 |
| Total | 60 |
Short videos, audio and equivalent transcripts are alternatives within the planned time; watching all formats is not required. Baseline questions have no passing score or answer feedback. Embedded decisions give feedback. The proposed posttest threshold is 65% (at least four correct answers out of six), with review and retries. Preserve first submissions separately from retries. The provider determines the final approved completion rules.
Faculty, independence and provider responsibilities
Content lead: Lisa Zahakos, RPA-C, HEART RESERVE. Proposed specialist functions cover preventive cardiology, endocrinology/obesity medicine, maternal-fetal medicine, clinical pharmacy, registered dietitian nutrition and independent clinical review. These roles are budgeted functions, not confirmed appointments.
Global Education Group is the proposed accredited-provider partner. The provider controls faculty eligibility, financial-relationship disclosures and mitigation, independent content review, final credit designation, release and expiration dates, educational-support wording, completion rules and certificate requirements. HEART RESERVE develops the educational content and media. myCME supplies services defined in the final hosting agreement. Identify the legal grant applicant, payee and contracting parties before portal submission.
Teaching is organized around patient decisions, evidence quality, benefits, harms, access and preferences. Product names identify product-specific evidence or labeling. No prescribing-volume or product-uptake goal is included. Fictional cases and AI narration must remain identified; no real patient recordings or patient identifiers are needed.
Distribution and quoted services
The $20,000 delivery line is a planning allowance informed by the October 14 myCME proposal for a cardiovascular/ASCVD/hyperlipidemia activity. This topic and primary audience require a revised, activity-specific quote. The existing quote is not approval or a guaranteed price for this course.
The source myCME proposal specifies one 60-minute enduring activity, 12 months of availability, 675 OSP Learners, 500 Post-test Finishers, one follow-up survey for each completer, and reporting of page visits, assessments, polling, evaluation, certificates and participation. These historical source terms are not commitments for this topic; this activity requires its own agreed scope and audience targets. A survey invitation is not a guaranteed survey response.
Confirm OSP definitions, unique-person counts, measurement windows, recruitment segments, exact programming and media scope, first-attempt/retry exports, accessibility, survey timing and consent, reporting access, and remedies for unmet contracted commitments. Do not add platform-wide mailing-list counts to the activity commitments.
Outcomes and evaluation plan
| Measure | Analysis and reporting |
|---|---|
| Participation · Moore level 1 | Report unique starts, OSP learners, posttest finishers, activity completions and certificates as separately defined metrics. Do not combine overlapping groups. |
| Experience · Moore level 2 | Report objective ratings, relevance, perceived bias and selected practice next step, with response denominators. Comments remain optional. |
| Knowledge · Moore level 3 | Compare only matched first responses on G1, G4, G6 (3 items before and after). Report paired n, item-level change, score change in percentage points, missingness and uncertainty. Report the full six-item posttest separately. |
| Application in fictional cases | 6 embedded selected-response decisions support practice and feedback. Analyze first choices separately from revised answers. This is not independently observed clinical competence. |
| Reported practice · exploratory Moore level 5 | One brief voluntary survey at approximately 60 days, within a 60–90-day window. Report invitations, respondents, clinical opportunities, actions and barriers separately. This is self-report, not verified performance or patient outcomes. |
Proposed educational target: a 15-percentage-point improvement on the matched three-item first-response score. This planning target is not a guaranteed result or a validated mastery threshold. Repeat items can reflect recall, the short measure has limited coverage, and the uncontrolled design cannot establish causality. Review safety-item errors separately without adding an unapproved pass gate.
Keep activity IDs and edition versions in every export. Do not pool learners across different courses or assessment versions without a prespecified analysis plan. Provide aggregate supporter reports with the provider’s small-cell suppression and privacy rules. No identifiable data transfer for marketing is proposed.
Progressive cases and transfer assessment
Each case now has a reviewable follow-up reveal, a faculty reasoning prompt and a proposed parallel application item. The exhibits use original HEART RESERVE material and make the gap-to-decision link explicit. They are prepared for validation and are not yet activated in the learner assessment.
| Original case | Changed circumstance | Clinical reasoning |
|---|---|---|
| Maya P: confirm the medicine before the calendar | The conception timeline changes after the first consultation. | Return to the exact formulation and indication before applying an interval; use teach-back for the revised plan. |
| Nora: uncertainty requires careful counseling | A patient interprets a nonsignificant observational result as proof of safety. | Ask what the study can and cannot establish; separate an imprecise relative estimate from an individual absolute probability. |
| The transition visit: a referral does not provide interim care | A specialist appointment is delayed while home glucose readings rise. | Make the interim clinical owner, assessment, treatment transition and accepted follow-up explicit; urgency depends on the actual clinical findings. |
The current baseline and first posttest share three items. Report paired n, absolute percentage-point change, item-level results and uncertainty, with retries separate. The 15-percentage-point gain is a planning target; high baseline scores may create a ceiling. Repeated items measure immediate learning with recall limitations. The proposed transfer form changes the clinical surface while preserving the mapped concept. Before using it for a Moore level 4 claim, independent clinical and assessment reviewers must approve the key, equivalence, difficulty and analysis, then pilot it with representative learners. Use it to replace matched posttest slots only after approval, preserving six final questions and the time target. It is not an additional required test in the present activity. Report unpaired data and nonresponse; do not infer causality, observed clinical performance or patient benefit.
Open the case exhibits and answer rationales · Open application narrative sections · Proposed transfer form
Funding fit and submission plan
Endocrine IME with explicit reproductive-counseling eligibility confirmation
The educational purpose is product-specific reproductive counseling while preserving necessary metabolic care. Lilly publicly lists Endocrine but does not establish reproductive counseling as a current priority on its public page. Confirm that exact scope in the current portal before selecting the funding route. Keep this focused transition activity distinct from the broader obesity/diabetes activity.
Distinct educational contribution
Provides depth on planned conception, contraception and unexpected exposure. It uses a separate objective set and should not duplicate the broader obesity course’s billing, audience counts or credit for repeated content.
Recruitment and deliverable evidence
Target clinicians who prescribe obesity or diabetes medicines and those who manage preconception transitions: primary care, endocrinology, obesity medicine, obstetrics, PAs, NPs and pharmacists. Ask the host for evidence that these segments are reachable.
All costs are planning estimates; a separate quote is needed for this audience and activity.
Application requirements and timing
For a Lilly application, confirm the current portal topic priorities, IME budget template and required attachments. Allow at least 60 days before funded work begins. Define monthly participation and quarterly outcomes responsibilities. Obtain maternal-fetal medicine/endocrine/pharmacy contributions and independent review of product-specific guidance.
Remaining submission evidence: Specific topic acceptance, separate host quote, clinical faculty commitments and allocation of any reused material.
Public requirements checked October 15, 2026. Funding source and current criteria · Submission evidence tracker · Educator fee schedule
Itemized prospective budget
$71,400 proposed total. All amounts are unquoted planning estimates. A separate activity-specific host quote is required. Existing curriculum, media, prototype development and proposal preparation are contributed. Only eligible future work after executed agreements is requested.
| Deliverable and scope | Quantity | Rate | Amount |
|---|---|---|---|
| GL01 · Activity-specific hosting, enrollment and standard reporting allowance. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Platform setup, identity/completion/certificate operations, permission-based enrollment, routine exports and standard participation report. Obtain an activity-specific itemized quote. No separate routine reporting or survey-dispatch charge is included elsewhere. | 1 package | $20,000 | $20,000 |
| GL02 · HEART RESERVE educator: curriculum and evidence revision. Lisa Zahakos, RPA-C: curriculum and evidence revision for the existing three-case activity after independent faculty review. Deliver dated revisions and a resolved review log. Scope is limited to the existing manuscript, assessment set and changed narration, with up to two consolidated review rounds. Excludes new course development, native LMS programming and independent clinical approval. Only eligible future work is requested; completed prototype work is contributed. Payment requires documented hours and accepted deliverables. | 50 hours | $150 | $7,500 |
| GL03 · HEART RESERVE educator: instructional design and assessment mapping. Lisa Zahakos, RPA-C: instructional design and assessment mapping for the existing three-case activity after independent faculty review. Deliver dated revisions and a resolved review log. Scope is limited to the existing manuscript, assessment set and changed narration, with up to two consolidated review rounds. Excludes new course development, native LMS programming and independent clinical approval. Only eligible future work is requested; completed prototype work is contributed. Payment requires documented hours and accepted deliverables. | 25 hours | $120 | $3,000 |
| GL04 · HEART RESERVE educator: narration and accessibility-text revision. Lisa Zahakos, RPA-C: narration and accessibility-text revision for the existing three-case activity after independent faculty review. Deliver dated revisions and a resolved review log. Scope is limited to the existing manuscript, assessment set and changed narration, with up to two consolidated review rounds. Excludes new course development, native LMS programming and independent clinical approval. Only eligible future work is requested; completed prototype work is contributed. Payment requires documented hours and accepted deliverables. | 18 hours | $100 | $1,800 |
| GL05 · Preventive cardiology faculty. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 4 hours | $350 | $1,400 |
| GL06 · Endocrinology / obesity faculty. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 10 hours | $350 | $3,500 |
| GL07 · Maternal-fetal medicine faculty. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 14 hours | $350 | $4,900 |
| GL08 · Registered dietitian. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 6 hours | $200 | $1,200 |
| GL09 · Clinical pharmacist. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 16 hours | $200 | $3,200 |
| GL10 · Independent clinical reviewer. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Defined specialty teaching/content review with documented revisions and deliverable acceptance; named faculty, contribution and fair-market value not yet confirmed. | 12 hours | $300 | $3,600 |
| GL11 · Activity-specific accredited-provider allowance. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Accreditation review, disclosure collection/mitigation, credit designation and required accreditation reporting only. Excludes hosting, recruitment and enhanced outcomes. Remove this allowance if those services are in the publisher quote. | 1 package | $6,500 | $6,500 |
| GL12 · Enhanced educational outcomes analysis beyond standard host reports. Prospective post-award estimate; unquoted; provider and funder eligibility review required. First-attempt matched-item analysis, missing-data reconciliation, objective-level interpretation and one limitations-aware educational narrative. Excludes platform exports, routine participation reports, survey dispatch and accreditation reporting. Remove any deliverable supplied by the host/provider. | 50 hours | $175 | $8,750 |
| GL13 · Unpaid learner timing-pilot facilitation. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Staff administration and synthesis of time-on-task/usability observations. No learner payment, travel or personal expense is requested. | 10 hours | $125 | $1,250 |
| GL14 · Patient-adviser educational planning consultation. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Proposed content-planning role: documented review of fictional case language, patient instructions and practical barriers. Not learner participation or a replacement for removed learner honoraria. Confirm this distinct role and eligibility before contracting; otherwise remove. | 8 hours | $100 | $800 |
| GL15 · Post-launch evidence and label maintenance. Prospective post-award estimate; unquoted; provider and funder eligibility review required. Scheduled release-period surveillance and clinically necessary dated updates; excludes source work already completed. Release-period maintenance is assigned to an independent reviewer and is not an additional educator fee. | 20 hours | $200 | $4,000 |
Prospective total: $71,400. Final funding and contractual amounts require approval.
Educator scope and compensation
Proposed compensation for Lisa Zahakos, RPA-C is $12,300, included in the $71,400 total (17.23%). This includes all educator payments proposed in this budget. The project limit is below 20% of the final funded total and must be recalculated if the award or scope changes.
| Educational deliverable | Hours | Rate | Amount |
|---|---|---|---|
| HEART RESERVE educator: curriculum and evidence revision | 50 | $150 | $7,500 |
| HEART RESERVE educator: instructional design and assessment mapping | 25 | $120 | $3,000 |
| HEART RESERVE educator: narration and accessibility-text revision | 18 | $100 | $1,800 |
The fee is based on defined work and estimated hours. A provider-approved agreement must establish the legal payee, eligible scope, reasonable rates, payment schedule and deliverable acceptance. Completed development is contributed. No additional personal fee is budgeted in independent review, hosting, technical production, maintenance or outcomes services. Work transferred to another contributor must be removed from the educator scope to avoid duplicate charges.
Generic management and grant-administration fees are $0. If the final award is smaller, revise the scope and all educator compensation together before contracting; do not relabel costs to meet the percentage limit. The accredited provider controls commercial-support funds and the approved payment arrangements.
Cost allocation and value
Reconcile hosting, recruitment, provider records and enhanced outcomes against the final itemized quotes. Each service must have one responsible payee and one charge. Separate routine host reports from additional analysis. Allocate reused content, templates and audience overlap across funded activities once. Confirm the scope and eligible costs before accepting partial funding.
Funding route and application requirements
Working route: independent medical education within Lilly’s Endocrine area. The current portal priorities must match the final scope. The proposal is an educational activity; it does not include a health-system implementation intervention. The HCI overhead allowance therefore is not the basis for this budget. Areas of focus · Application and budget guidance.
Plan for a 2027 program start. Submit the complete application at least 60 days before the overall program begins, including funded development. Follow the current portal limits for the narrative and attachments. The application must use one applicant/payee and consistent dates, scope and totals. Lilly’s current guidance describes monthly participation reporting and quarterly educational-outcomes reporting after award; build these into the work plan. Requirements.
The remaining submission inputs are the portal’s current priority document, final overall start/end dates, the activity-specific myCME scope, faculty commitments, provider fees and authorized organizational documents. These are application fields and agreements, not learner tasks.
Grant reporting responsibilities
For a Lilly IME award, confirm monthly participation entries, quarterly educational-outcomes entries and the final reporting, reconciliation and transparency obligations in the executed agreement. Assign one owner for each deliverable before launch. Follow contractual deadlines even when later follow-up analysis remains open.
Activity-specific reporting checklist
Schedule and release plan
| Timing | Work |
|---|---|
| Months 1–2 | Finalize applicant/payee, funding, agreements, faculty, disclosures and clinical review. |
| Month 3 | Complete media review, accessibility checks, ten-clinician timing/usability pilot, provider approval and native host acceptance; launch. |
| Months 3–14 | Twelve months of availability, recruitment and evidence maintenance. |
| Months 15–16 | Complete final follow-up window and reconcile data. |
| Months 17–18 | Complete later outcomes analysis. Financial closeout follows contractual deadlines, including earlier dates. |
About HEART RESERVE
HEART RESERVE is Lisa Zahakos’s single-member LLC and women’s health education initiative. This proposal connects pregnancy history, metabolic care and cardiovascular prevention with practical clinician decisions. It does not claim an established accreditation, a grant award or prior independently verified program outcomes.
Materials supplied
Online activity; complete downloadable media and activity package; transcript alternatives; pre/post import; case decisions with rationales; evaluation and follow-up specifications; this grant dossier; and an itemized budget CSV. The package includes a provider and host acceptance checklist.
Edition and scope
This dossier covers one standalone activity. The three-question baseline and six-question posttest are the current assessment specifications. The activity, grant narrative, budget and host imports must use the same final scope and version. Earlier editions are superseded.
Clinical references
1. ADA Professional Practice Committee. Management of Diabetes in Pregnancy. Standards of Care in Diabetes 2026. Diabetes Care. 49(Suppl 1):S321-S338. https://doi.org/10.2337/dc26-S015
11. Endocrine Society and European Society of Endocrinology. Preexisting Diabetes and Pregnancy. Joint Clinical Practice Guideline. 2025. https://www.endocrine.org/clinical-practice-guidelines/preexisting-diabetes-in-pregnancy
12. Novo Nordisk. Wegovy US Prescribing Information. Current label accessed October 14, 2026. Sections 5, 8.1, 8.2 and 8.3. https://www.novo-pi.com/wegovy.pdf
13. Eli Lilly and Company. Zepbound US Prescribing Information. Revised August 2026. Sections 5, 8.1, 8.2 and 8.3. https://pi.lilly.com/us/zepbound-uspi.pdf
14. Brown JP, et al. Continuing GLP-1 Receptor Agonists Into the First Trimester of Pregnancy and Pregnancy Outcomes. Ann Intern Med. 2026;179:929-937. https://doi.org/10.7326/ANNALS-25-04820
23. Eli Lilly and Company. Foundayo (orforglipron) US Prescribing Information. Accessed October 14, 2026. https://pi.lilly.com/us/foundayo-uspi.pdf
From the practice gap to a measurable decision
Maya P: confirm the medicine before the calendar: Return to the exact formulation and indication before applying an interval; use teach-back for the revised plan. The current baseline concept is G1; proposed transfer item TR1 remains a separate review exhibit until clinical/assessment approval and pilot.
Nora: uncertainty requires careful counseling: Ask what the study can and cannot establish; separate an imprecise relative estimate from an individual absolute probability. The current baseline concept is G4; proposed transfer item TR2 remains a separate review exhibit until clinical/assessment approval and pilot.
The transition visit: a referral does not provide interim care: Make the interim clinical owner, assessment, treatment transition and accepted follow-up explicit; urgency depends on the actual clinical findings. The current baseline concept is G6; proposed transfer item TR3 remains a separate review exhibit until clinical/assessment approval and pilot.
The active activity contains three baseline items, six formative decisions and six final items. The three repeated baseline/post items measure immediate learning with recall limitations. Link each result to its objective, retain first attempts and report retries separately. Proposed transfer cases must replace mapped final slots only after approval; they are not additional current completion requirements. Report later self-reported actions and access barriers separately from case scores.
Funding fit and accountable delivery
The educational purpose is product-specific reproductive counseling while preserving necessary metabolic care. Lilly publicly lists Endocrine but does not establish reproductive counseling as a current priority on its public page. Confirm that exact scope in the current portal before selecting the funding route. Keep this focused transition activity distinct from the broader obesity/diabetes activity.
Independent clinical faculty and the accredited provider determine content, evidence balance, assessment keys and release. Commercial supporters do not select recommendations or products. Each funded line requires an eligible future deliverable, documented hours/rate or units, and accepted work. Existing development and grant preparation are contributed. Andrea’s October 9 guidance concerns management fees above 20%; the separate user-directed ceiling aggregates all compensation to Lisa below 20% of the final funded amount. Mike’s written quote applies only to Pregnancy Is Heart History. Other courses require their own agreed scopes and quotes.