Optimizing outreach for performance on diabetes lab monitoring

ISRCTN	ISRCTN22848294
DOI	https://doi.org/10.1186/ISRCTN22848294
Sponsor	VA Puget Sound Health Care System
Funder	Veterans Health Administration (VHA) Office of Primary Care

Submission date: 02/06/2026
Registration date: 09/06/2026
Last edited: 16/07/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Linnaea Schuttner
Principal investigator, Scientific, Public

1660 S Columbian Way (S-152)
Seattle
98108
United States of America

Phone	+1 206-277-6126
Email	Linnaea.Schuttner@va.gov

Ms Alaina Mori
Public

1660 S Columbian Way (S-152)
Seattle
98108
United States of America

Phone	+1 206-586-3374
Email	alaina.mori@va.gov

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Sequential
Purpose	Health services research
Scientific title	Optimizing veteran outreach for performance on diabetes lab monitoring
Study objectives	To determine the optimal outreach communication modality (aka "dynamic treatment regimen") to prompt diabetes laboratory monitoring among Veterans with diabetes overdue for lab monitoring and/or retinal screening, using a Multiple Comparisons with the Best (MCB) framework.
Ethics approval(s)	Ethics approval not required
Health condition(s) or problem(s) studied	Diabetes laboratory monitoring among Veterans with diabetes overdue for lab monitoring and/or retinal screening
Intervention	This 2-stage SMART trial is a prospective, adaptive, individually randomized trial consisting of two randomization rounds. Randomization is computer-generated using the R package blockrand. Stage 1: Randomization: Population: Veterans empaneled in primary care at site 663 (Puget Sound), identified on a rolling monthly basis as meeting criteria for diabetes lab monitoring or retinal eye health outreach. Specifically, eligible patients are those who appear in the denominator of at least one component eQM (dmg23h_ec subgroup, dmg31h_ec, or ked01_ec) and simultaneously fail to meet the numerator criterion for that measure (that is, they are actively due for the associated monitoring activity) at the time of monthly eligibility assessment. Randomization: Patients are randomized 1:1 to receive either: Vet-Text: Automated SMS health system alert Letter: Automated printed letter Stratification: By status of lab 'not done' for eQM dmg23h_ec in month prior to randomization (binary: done/not done), applied only among patients eligible for the dmg23h_ec subgroup at enrollment. Patients enrolled exclusively via ked01_ec or dmg31h_ec eligibility (and therefore not in the dmg23h_ec subgroup denominator) are not stratified on this variable. Outcome: The primary outcome is a patient-level binary: whether the patient met the numerator criterion for at least one component eQM for which they were eligible at enrollment, by the conclusion of the trial observation window. The Weighted and Replicated Estimator (WRE) will be used for embedded dynamic treatment regimen (EDTR) means. Stage 2: Adaptive Re-Randomization Eligibility: Patients who do not respond or complete any eligible metric numerator after a 12-week period from entry (remain as 'metric not met' in all components for which they were enrolled, and remain in the denominator of those eQMs), post-Round 1 randomization. Randomization: Patients are randomized 1:1 to low-effort or high-effort arms: Arm 1: Vet-Text + Letter (simultaneous, "Low-effort" arm) Arm 2: Nurse phone call ("High-effort" arm) Re-randomization Ratio: 1:1 Timing of Second Randomization: Onset of the 4th month eQM reporting cycle (rolling), after entry into Round 1 cohort.
Intervention type	Other
Primary outcome measure(s)	Any eligible numerator met (patient-level binary) measured using data collected on the component(s) of the electronic quality measure (eQM) for which the Veterans were eligible at enrollment (DM: HbA1c Missing, DM: Retinal Exam, Timely by Disease, and/or Kidney Health Evaluation for Patients with Diabetes) at the conclusion of the trial observation window
Key secondary outcome measure(s)	EQM component dmg31h_ec completion measured using data collected on the proportion of patients eligible for dmg31h_ec at enrollment who met the retinal exam numerator at trial conclusion EQM component ked01_ec completion measured using data collected on the proportion of patients eligible for ked01_ec at enrollment who met the kidney health evaluation numerator (eGFR + uACR) at trial conclusion EQM component dmg23h_ec subgroup completion measured using data collected on the proportion of patients eligible for dmg23h_ec subgroup at enrollment who met the HbA1c monitoring numerator at trial conclusion
Completion date	20/03/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	2500
Key inclusion criteria	1. Veterans appearing in the denominator of at least one component electronic quality measure (eQM) (dmg23h_ec subgroup, dmg31h_ec, or ked01_ec) who are not yet meeting the numerator criterion for that component at the time of monthly eligibility assessment (i.e., they are actively due for the associated monitoring activity) 2. Valid contact information 3. Assigned to participating VA site (663) 4. Ages 18-85 (note: dmg23h_ec and dmg31h_ec eligibility is restricted to ages 18-75 per eQM specification; ked01_ec eligibility extends to age 85; patients ages 76-85 may be enrolled via ked01_ec eligibility alone) 5. Have assigned primary care provider in PCMM 6. Have had at least one inpatient or outpatient encounter anywhere in VHA within the three years prior to the eQM reporting period end date
Key exclusion criteria	1. Assigned to H-PACT, GERI, SCI, or HBPC 2. Receiving hospice services in prior year (not included in eQM denominator) 3. 65 years with frailty and advanced illness (dementia medication, advanced illness definition set, or 2 instances of frailty; not included in eQM denominator) 4. Invalid/bad mailing address and invalid/non-working phone number (no valid outreach contact)
Date of first enrolment	01/08/2026
Date of final enrolment	30/09/2026

Locations

Countries of recruitment

United States of America

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Statistical Analysis Plan		08/06/2026	09/06/2026	No	No

Additional files

49638_SAP_08June2026.pdf: Statistical Analysis Plan

Editorial Notes

16/07/2026: Date of first enrolment was changed from 15/06/2026 to 01/08/2026.
03/06/2026: Study’s existence confirmed by the VACO Office of Primary Care, U.S. Department of Veterans Affairs.