Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial
Phase: NA
Conditions: Adherence, Medication, Nonadherence, Medication
Sponsor: Vanderbilt University Medical Center

PaƟent-centered services to improve specialty medicaƟon adherence: results from a prospecƟve 
randomized controlled trial 
NCT03709277 
Protocol Date: 09/14/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background 
 
Importance: MedicaƟon nonadherence results in poor clinical outcomes and increased healthcare 
spending. Although specialty pharmacies tend to have high adherence rates, resources are needed to 
address the unique barriers associated with nonadherence to specialty medicaƟons.  
ObjecƟve: A QI study was conducted to evaluate a service designed to address paƟent-speciﬁc reasons 
for nonadherence to improve specialty medicaƟon adherence at Vanderbilt Specialty Pharmacy. This is a 
retrospecƟve review of the data collected during the QI study. As results of the QI study were posiƟve 
and we believe our ﬁndings to be generalizable for other specialty pharmacies to implement, we plan to 
analyze and report the results of the previously collected data.  
Design: A quality improvement study using a pragmaƟc, randomized controlled design, was conducted 
from May 2019 and August 2021. Eligible paƟents were randomized 1:1 to usual care or intervenƟon 
arms and straƟﬁed by historical rates of nonadherence in their clinic. IntervenƟon paƟents underwent a 
baseline adherence assessment to idenƟfy reasons for nonadherence and received paƟent-tailored 
intervenƟons and 8 months of follow up from a specialty pharmacist. A Wilcoxon test was used to test 
the diﬀerence in 6, 8, and 12-month post-enrollment PDCs between the intervenƟon and usual care 
arms.  
Main Outcomes and Measures: The primary outcome of the QI study was PDC calculated at 8-months 
post-enrollment. An exploratory analysis evaluated PDC at 6-months and 12-months post-enrollment. 
While the QI study was conducted to improve service at Vanderbilt, our ﬁndings suggest that any 
specialty pharmacies could improve adherence with exisƟng resources. 
 
RaƟonale and Speciﬁc Aims 
 
Integrated health system specialty pharmacies provide a high-touch service to their paƟents at baseline. 
Our QI study aimed to ﬁnd out if adding an addiƟonal adherence service could idenƟfy and address 
paƟent-speciﬁc reasons for nonadherence to increase adherence to specialty medicaƟons at VUMC. Few 
studies report the reasons for nonadherence to specialty medicaƟons. It is commonly accepted that cost 
is a large reason for nonadherence; however, integrated specialty pharmacies provide ﬁnancial services 
to minimize and oŌen remove the impact of cost. In the QI study, we collected each paƟent’s reason for 
nonadherence by reviewing their chart and by asking the paƟent (in the intervenƟon arm). Before this 
study, it was unknown what the reasons for nonadherence were in a broad specialty disease populaƟon 
and if those reasons could be addressed by a pharmacist. The ﬁndings of our QI study will be helpful to 
other specialty pharmacies as it demonstrated that non-labor-intensive intervenƟons could have a 
signiﬁcant impact on specialty medicaƟon adherence. 
 
Inclusion/Exclusion Criteria 
 
All data will be obtained retrospecƟvely. All nonadherent paƟents will be included in the QI project and 
paƟents with 2 or more reﬁlls in the study period will be included in the data analysis. 

 
Study Procedures 
 
This is a retrospecƟve review of data collected under IRB #181452. 
Risks 
 
The only potenƟal risk is breach of data which is stored in a HIPAA-secured REDCap and only deidenƟﬁed 
data was extracted for analysis. As data has already been extracted and stored in REDCap and 
deidenƟﬁed data extracted for analysis, there is minimal risk to the current retrospecƟve review request. 
 
ReporƟng of Adverse Events or UnanƟcipated Problems involving Risk to ParƟcipants or Others 
 
Adverse events (which may include breach of conﬁdenƟality) which are serious, unanƟcipated, and 
related (or possibly related) to the research procedures will be reported to the IRB within 7 calendar 
days of the InvesƟgator's knowledge of the event. 
 
Privacy/Confidentiality Issues 
 
Data was collected as part of the QI study and is already stored in REDCap. No additional data will be 
collected. All data will remain in the REDCap. Only KSP will have access to the data. 
 
Patient data is stored in the REDCap (a HIPAA-compliant web-based application) and only accessible to 
KSP. Access is granted as either able to view patient information or not so for example, our statisticians 
never see any patient-specific information.  
 
 
Follow-up and Record Retention 
 
Data will be destroyed no earlier than 3 years from the date the research is closed with the IRB.