An interventional study of Primer postcard and Control recruitment letter in Diabetes, Pharmacist-Patient Relations and Medication Adherence, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.
Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms.
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 590 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Post card; control letter; 2 calls
Behavioral: Primer postcard · Behavioral: Control recruitment letter · Behavioral: 2 phone calls
Post card; control letter; 4 calls
Behavioral: Primer postcard · Behavioral: Control recruitment letter · Behavioral: 4 phone calls
Post card; behavioral letter; 2 calls
Behavioral: Primer postcard · Behavioral: Behavioral theory-informed recruitment letter (prospect theory) · Behavioral: 2 phone calls
Post card; behavioral letter; 4 calls
Behavioral: Primer postcard · Behavioral: Behavioral theory-informed recruitment letter (prospect theory) · Behavioral: 4 phone calls
No post card; control letter; 2 calls
Behavioral: Control recruitment letter · Behavioral: 2 phone calls
No post card; control letter; 4 calls
Behavioral: Control recruitment letter · Behavioral: 4 phone calls
No post card; behavioral letter; 2 calls
Behavioral: Behavioral theory-informed recruitment letter (prospect theory) · Behavioral: 2 phone calls
No post card; behavioral letter; 4 calls
Behavioral: Behavioral theory-informed recruitment letter (prospect theory) · Behavioral: 4 phone calls
Inclusion of a mailed primer post card
a recruitment letter without any behaviorally-informed language
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
2 recruitment phone calls made by the call center
4 recruitment phone calls made by the call center
Completion of a clinical pharmacist adherence counseling appointment
rate of participants who completed their clinical pharmacist consultation
Time frame: within 8 weeks of receiving the intervention
Schedule rates for clinical pharmacist adherence counseling appointment
rate of participants who scheduled an appointment
Time frame: within 8 weeks of receiving the intervention
No-show/cancellation rates
rate of participants who did not show up to their appointment or cancelled their appointment after scheduling it
Time frame: within 8 weeks of receiving the intervention
Glucose-lowering medication adherence
proportion of days covered of a glucose-lowering medication
Time frame: 3 months after randomization
Clinical outcome - HbA1c
HbA1c levels using EHR data
Time frame: 3 months after randomization
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital