PQ Program Evaluation — Pilot RCT

Protocol 2026P000564 · Slavin Academy funded · Updated May 26, 2026 ·
Johanna Lee — PI / first author Jimin Kim — BWH site PI Dan S-K — senior author
Where we are: IRB substantive review complete; pending MCA ancillary review (no protocol changes anticipated). Hoped approval by end of June. Pre-launch build proceeding now.
Latest (5/29): Johanna confirmed recruitment emails + slides are already in the initial IRB submission (files now at Projects/Scholarship/PQ Program Evaluation/Recruitment/); IRB rule = no monetary remuneration in subject line. CT.gov registration started; may not complete by 5/31 target — Johanna will route questions through Ariel then email Dan screenshots for review. MCA ancillary review still outstanding.

Milestones

Work

Hover any row for detail (owner, effort, notes). Click a group header to collapse it.

Study at a glance

PGY4 residents · MGH + BWH n ≤ 60 · optional loved-one dyad Baseline T0 SCS-SF · MBI-GS · PHQ-8 · GAD-7 Randomize 1:1 (by site) PQ program 6 wk · weekly video + daily reps Active control 6 wk · MyCap, time-matched Post T1 (~wk 8–12) Same 4 measures + feasibility / acceptability Unblinded · 1:1 · stratified by site · ~12 wk per participant
QuestionIs a 6-wk app-based mental-fitness program feasible & acceptable in anesthesiology residents, and what effect sizes does it produce?
DesignPilot RCT, 2-arm parallel, 1:1, multi-site; participants unblinded, investigators blinded
BlindingParticipants know their arm; investigators blinded via separation of duties — coord handles all PQ data transfer, not Johanna or Dan
ComparatorActive control (MyCap), matched for time + attention
Remuneration$40 (T0) + $60 (T1) = $100 via e-check (per IRB); lifetime PQ access
TargetJEPM original article (3000 words, 30 refs); present at SEA
PurposeFeasibility + effect-size data to power a future multi-site efficacy trial

Outcomes & measures

Primary Feasibility
OutcomeSpecific measure
Recruitment rate% of eligible PGY4 residents who consent
Dyadic enrollment rate% of consenting residents who enroll a loved one
Retention rate% of enrolled who complete the T1 assessment
AdherenceModule completion + daily engagement, from app/platform backend
Primary Acceptability, appropriateness & feasibility recommended set
Validated Weiner et al. triad: three 4-item scales, each rated 1 (completely disagree)–5 (completely agree), administered at T1 for both arms. Keeps acceptability cleanly separable from the efficacy signal.
Measure (4 items, 5-pt)Item stems — "The PQ program…"
AIM — Acceptability…meets my approval · is appealing to me · I like it · I welcome it
IAM — Appropriateness…seems fitting · seems suitable · seems applicable · seems like a good match
FIM — Feasibility…seems implementable · seems possible · seems doable · seems easy to use
NPS (retained)"How likely are you to recommend this program to a colleague or fellow resident?" (0–10)
Open-ended (retained)Most beneficial? · Suggested improvements? · Single biggest barrier to completion?
References. Weiner BJ, et al. Implement Sci. 2017;12:108. PMID 28851459.  ·  Proctor E, et al. Adm Policy Ment Health. 2011;38(2):65–76. PMID 20957426.
Secondary Preliminary psychological — T0→T1 change by arm (Cohen's d)
MeasureConstructFormat
SCS-SFSelf-compassion (planned primary outcome of the future trial)12 items, 5-pt
MBI-GS (abbrev.)Burnout: exhaustion, cynicism, professional efficacyLikert frequency
PHQ-8Depressive symptoms8 items, 0–3
GAD-7Anxiety symptoms7 items, 0–3
Analysis is descriptive: feasibility/acceptability as percentages; psychological change as effect sizes (Cohen's d, 95% CI). p-values exploratory only (pilot, no a priori power analysis).

Who's who

Johanna Lee, MD
PI & first author
MGH Anesthesia, Assistant PD. Owns IRB, MyCAP build, recruitment, analysis, and manuscript. Slavin grant PI.
Jimin Kim, MD
BWH site PI
Incoming BWH Anesthesiology PD (7/1/26). Advising + BWH recruitment; limited bandwidth for execution.
Dan Saddawi-Konefka, MD, MBA
Senior author / co-I
Mentor. Methodology, framing, writing, and air cover for resident recruitment via the APD team.
Ariel Mueller
ARC Director
MGH Anesthesia Research Center. Route to research coordinator + biostatistician (both Slavin-funded). Meeting 6/1.
Positive Intelligence, Inc.
Vendor
Provides the PQ platform free for this and future studies. Data Use Agreement in progress.
Shirzad Chamine
External stakeholder
PQ creator. Not on protocol (kept independent). Milestone-only updates; Dan owns that channel.