Adherence, MedicationNCT03709277
Interventions to Improve Specialty Medication Adherence
A study testing Pharmacist-Driven Intervention in people with Adherence, Medication and Nonadherence, Medication, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Patients deemed nonadherent to their specialty medications will be randomized to receive 8 months of patient-tailored adherence interventions and follow up from a specialty pharmacist as needed or the standard of care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adherence, Medication, Nonadherence, Medication
- What is being tested?
- Pharmacist-Driven Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The same medication (at the Generic Product Identifier level 12) filled ≥4 times in the 12 months before date of import into the study database
- Prescription generated from one of the following Vanderbilt outpatient specialty clinics: Pediatric Rheumatology, Pediatric Gastroenterology/Inflammatory Bowel Disease, adult Vanderbilt Rheumatology clinics, Dermatology, Hematology, Adult Endocrinology, Neurology, Asthma Sinus \& Allergy, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Cystic Fibrosis, Multiple Sclerosis, Neurology, or a Lipid clinic
- Proportion of Days Covered (PDC) < 90% over the previous 4 months and 12 months
Who cannot join
- Prescription issued by a non-VUMC provider
- Planned treatment discontinuation in the subsequent eight months
- More than one unique specialty medication from the same clinic in the previous four months
- Patients with > 30 gap days in the previous four months and whose last fill was > 30 days from importing into the study database.
- Any reason for misidentified nonadherence in the previous four months
- Deceased patients
- Incarcerated patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37211
About this study
Official title: Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial
Patients deemed nonadherent to their specialty medications will be randomized to receive 8 months of patient-tailored adherence interventions and follow up from a specialty pharmacist as needed or the standard of care. Medication adherence will be measured using proportion of days covered (PDC) at 8-months post-randomization to determine if the intervention improved specialty medication adherence.
Read the detailed description
This will be a single-center, prospective, randomized controlled trial. A report of patients who use the Vanderbilt Specialty Pharmacy (VSP) will be generated daily for patients with a proportion of days covered (PDC) < 90% in the previous 4 and 12 months based on pharmacy claims. Patients who meet criteria will be randomized to receive an intervention corresponding to their specific reason for nonadherence and follow up from a specialty pharmacist or to receive usual care. For patients who are randomized to receive an intervention, the specialty pharmacist will review their medication fill history and electronic health record to identify potential reasons for nonadherence or to see if the pharmacy claims inappropriately categorized them as nonadherent (this could be due to holding treatment for a clinical reason, transferring the prescription outside of VSP or other reasons listed in Table 2). After reviewing the patient's pharmacy and medical history, if the pharmacist believes they are truly nonadherent (not taking medication as prescribed), the patient will be contacted to identify potential reasons for nonadherence and intervention(s) will be provided to combat the identified reasons for nonadherence. Adherence rates for those receiving the additional adherence interventions and those receiving standard of care will be calculated 8 months after the date of randomization. The reasons for nonadherence and the intervention to improve adherence rates will be documented in a secured REDCap database. It is important to note that the adherence pharmacist is not study staff, but a full-time employee of the health-system specialty pharmacy performing normal specialty pharmacist functions. The randomization to receive these services or not will allow for evaluation of their efficacy.
- Conditions
- Adherence, Medication, Nonadherence, Medication
- Being tested
- Pharmacist-Driven Intervention
- Keywords
- Specialty, Pharmacist Intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Driven InterventionBehavioural
The pharmacist will investigate patient assistance options for patients who cannot afford their specialty medication, reach out to prescribers when needed to address intolerance/adverse effects, improve health literacy, recommend options for forgetfulness, make every effort to reach patient, address clinical and financial barriers to unresponsiveness (lack of lab completion, not returning to clinic, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-Driven Intervention | Experimental | The study group will receive a patient-tailored, pharmacist-driven intervention(s) to overcome patient-specific barriers to adherence. Each patient in the study group will be intervened upon using a protocol that is based on their reason for non-adherence. Receives: Behavioral: Pharmacist-Driven Intervention |
| Standard of Care | No intervention | The usual care group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment
Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.
Measured: 8 months post-enrollment
Secondary outcomes (3)
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment
Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.
Measured: 6 months post-enrollment
Reasons for Nonadherence in the Intervention Arm
Reasons for nonadherence were obtained from a combination of electronic health records and patient-reported reasons. Since only intervention patients were contacted during this study, only reasons from the intervention arm are reported. Reasons were collected for each patient starting on the date of enrollment until 8-months post-enrollment starting from the date the study began (May 2019) until the study was complete (April 2022).
Measured: 35 months
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment
Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.
Measured: 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start10 May 2019
- Primary completion10 Feb 2021
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Kibbons, Vanderbilt University Medical Center
- Investigators
- Autumn D Zuckerman, Pharm.D., Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709277
- Sponsor's protocol ID
- 181452
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2018
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy. 2014 Feb 20;7:35-44. doi: 10.2147/RMHP.S19801. eCollection 2014.
PubMed 24591853Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.
PubMed 21389250Tan H, Cai Q, Agarwal S, Stephenson JJ, Kamat S. Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther. 2011 Jan;28(1):51-61. doi: 10.1007/s12325-010-0093-7. Epub 2010 Dec 6.
PubMed 21153000Jabbour EJ, Kantarjian H, Eliasson L, Cornelison AM, Marin D. Patient adherence to tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Am J Hematol. 2012 Jul;87(7):687-91. doi: 10.1002/ajh.23180. Epub 2012 Mar 31.
PubMed 22473898Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. 2010 Sep;10(9):1367-78. doi: 10.1517/14712598.2010.510508.
PubMed 20681888Butt AA, Yan P, Shaikh OS, Chung RT, Sherman KE; ERCHIVES study. Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir-based regimens: results from ERCHIVES. Liver Int. 2016 Sep;36(9):1275-83. doi: 10.1111/liv.13103. Epub 2016 Mar 24.
PubMed 26928927Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):565-74; discussion 575-7. doi: 10.1002/pds.1230.
PubMed 16514590Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Sep 21:1-11. doi: 10.1007/s40801-020-00213-8. Online ahead of print.
PubMed 32983839Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Dec;7(4):295-305. doi: 10.1007/s40801-020-00213-8.
PubMed 32955714
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03709277
- Acronym / sponsor ID
- 181452
- Conditions
- Adherence, Medication, Nonadherence, Medication
- Keywords
- Specialty, Pharmacist Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients deemed nonadherent to their specialty medications will be randomized to receive 8 months of patient-tailored adherence interventions and follow up from a specialty pharmacist as needed or the standard of care. Medication adherence will be measured using proportion of days covered (PDC) at 8-months post-randomization to determine if the intervention improved specialty medication adherence.
Detailed description
This will be a single-center, prospective, randomized controlled trial. A report of patients who use the Vanderbilt Specialty Pharmacy (VSP) will be generated daily for patients with a proportion of days covered (PDC) < 90% in the previous 4 and 12 months based on pharmacy claims. Patients who meet criteria will be randomized to receive an intervention corresponding to their specific reason for nonadherence and follow up from a specialty pharmacist or to receive usual care. For patients who are randomized to receive an intervention, the specialty pharmacist will review their medication fill history and electronic health record to identify potential reasons for nonadherence or to see if the pharmacy claims inappropriately categorized them as nonadherent (this could be due to holding treatment for a clinical reason, transferring the prescription outside of VSP or other reasons listed in Table 2). After reviewing the patient's pharmacy and medical history, if the pharmacist believes they are truly nonadherent (not taking medication as prescribed), the patient will be contacted to identify potential reasons for nonadherence and intervention(s) will be provided to combat the identified reasons for nonadherence. Adherence rates for those receiving the additional adherence interventions and those receiving standard of care will be calculated 8 months after the date of randomization. The reasons for nonadherence and the intervention to improve adherence rates will be documented in a secured REDCap database. It is important to note that the adherence pharmacist is not study staff, but a full-time employee of the health-system specialty pharmacy performing normal specialty pharmacist functions. The randomization to receive these services or not will allow for evaluation of their efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-Driven Intervention | Experimental | Behavioral: Pharmacist-Driven InterventionThe study group will receive a patient-tailored, pharmacist-driven intervention(s) to overcome patient-specific barriers to adherence. Each patient in the study group will be intervened upon using a protocol that is based on their reason for non-adherence. |
| Standard of Care | No intervention | –The usual care group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The same medication (at the Generic Product Identifier level 12) filled ≥4 times in the 12 months before date of import into the study database
- Prescription generated from one of the following Vanderbilt outpatient specialty clinics: Pediatric Rheumatology, Pediatric Gastroenterology/Inflammatory Bowel Disease, adult Vanderbilt Rheumatology clinics, Dermatology, Hematology, Adult Endocrinology, Neurology, Asthma Sinus \& Allergy, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Cystic Fibrosis, Multiple Sclerosis, Neurology, or a Lipid clinic
- Proportion of Days Covered (PDC) < 90% over the previous 4 months and 12 months
Key exclusion criteria (7 listed)
- Prescription issued by a non-VUMC provider
- Planned treatment discontinuation in the subsequent eight months
- More than one unique specialty medication from the same clinic in the previous four months
- Patients with > 30 gap days in the previous four months and whose last fill was > 30 days from importing into the study database.
- Any reason for misidentified nonadherence in the previous four months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Driven InterventionThe pharmacist will investigate patient assistance options for patients who cannot afford their specialty medication, reach out to prescribers when needed to address intolerance/adverse effects, improve health literacy, recommend options for forgetfulness, make every effort to reach patient, address clinical and financial barriers to unresponsiveness (lack of lab completion, not returning to clinic, etc.) | Behavioural | Pharmacist-Driven Intervention |
Primary outcome
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment
Time frame: 8 months post-enrollment
Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.
3 secondary outcomes
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment
Time frame: 6 months post-enrollment
Reasons for Nonadherence in the Intervention Arm
Time frame: 35 months
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment
Time frame: 12 months post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24591853Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy. 2014 Feb 20;7:35-44. doi: 10.2147/RMHP.S19801. eCollection 2014.
- Background: PubMed 21389250Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.
- Background: PubMed 21153000Tan H, Cai Q, Agarwal S, Stephenson JJ, Kamat S. Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther. 2011 Jan;28(1):51-61. doi: 10.1007/s12325-010-0093-7. Epub 2010 Dec 6.
- Background: PubMed 22473898Jabbour EJ, Kantarjian H, Eliasson L, Cornelison AM, Marin D. Patient adherence to tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Am J Hematol. 2012 Jul;87(7):687-91. doi: 10.1002/ajh.23180. Epub 2012 Mar 31.
- Background: PubMed 20681888Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. 2010 Sep;10(9):1367-78. doi: 10.1517/14712598.2010.510508.
- Background: PubMed 26928927Butt AA, Yan P, Shaikh OS, Chung RT, Sherman KE; ERCHIVES study. Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir-based regimens: results from ERCHIVES. Liver Int. 2016 Sep;36(9):1275-83. doi: 10.1111/liv.13103. Epub 2016 Mar 24.
- Background: PubMed 16514590Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):565-74; discussion 575-7. doi: 10.1002/pds.1230.
- Derived from this study: PubMed 32983839Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Sep 21:1-11. doi: 10.1007/s40801-020-00213-8. Online ahead of print.
- Derived from this study: PubMed 32955714Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Dec;7(4):295-305. doi: 10.1007/s40801-020-00213-8.
- Update on Medication Quality Measures in Medicare Part D Plan Star Ratings-2018Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Autumn D Zuckerman, Pharm.D. study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Driven Intervention in people with Adherence, Medication and Nonadherence, Medication, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment (time frame: 8 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709277, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.