Adherence, MedicationBSPAPNCT03104114
Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication
A study testing pharmacist-intervention in people with Adherence, Medication, run by Boston Medical Center at 1 site in United States.
Trial summary
Boston Medical Center provides care to cancer patients on oral cancer medications through the use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in cancer treatments is relatively new and unfortunately, very little is known about adherence in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence, Medication
- What is being tested?
- pharmacist-intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment with 1 or more oral oncology agents. Oral oncology agent defined as medication taken mouth with the purpose to treat a patient's cancer
- Treatment dispensed through the BMC Specialty Pharmacy
- Age>18 years
- Life expectancy >6 months
- Patients must have ability to give written consent, or, must have a legally authorized representative
Who cannot join
- Treatment indicated for neoadjuvant, adjuvant, peri-operative treatment
- Concurrent radiation treatment
- Patients that are unable to have oral oncology agents dispense through BMC Specialty Pharmacy
- Historical Control:
- 2 controls:1 intervention match
- Matched to a patient in intervention group based on drug type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
Boston Medical Center provides care to cancer patients on oral cancer medications through the use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in cancer treatments is relatively new and unfortunately, very little is known about adherence in cancer patients. This study will evaluate the influence of a pharmacist-driven medication management program on adherence and persistence rates. Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving clinical pharmacist that will focus on educating patients about their oral cancer treatments. The program will require face-to-face counseling with a pharmacist, through the use of a proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments and, periodically thereafter, based on protocol. This study will help improve our understanding of the role of the pharmacist in cancer patients. In addition, the study will help identify independent factors that may contribute or impact adherence. The outcomes of this program will be compared to a historical control group of patients that have already received treatment for their cancer through the BMC Specialty Pharmacy.
Read the detailed description
Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP) will focus on improving adherence and persistence through the implementation of a high-touch program. In order to be eligible for the program, patients must be initiated on oral chemotherapy or targeted therapy with a life expectancy >6 months. All patients will be administered a Patient Activation Measure (PAM) 13 survey prior to consultation. Patients eligible for our program will receive a 30-60 minute pharmacist consultation prior to initiation of treatment. The pharmacy consultation includes, but is not limited to the dissemination of medical information utilizing a standardized counseling checklist, supplying of patient education materials, pharmacist-led interventions, and/or the use of other materials or devices that may improve patient adherence. All counseling checklists and monitoring will be standardized and approved by a multidisciplinary oncology team. At week 1, 2, and 4, patients will be contacted by the pharmacist for an assessment of treatment goals; monthly contacts will continue thereafter by either a specialty pharmacist or certified pharmacy technician. Scheduled follow up visits with the consulting pharmacist will be made at months 3, 6 and 12. Prior to the scheduled pharmacist consultation, patients will be administered the PAM 13 survey. Patients with a treatment gap >37 days will be referred to the consulting pharmacist for follow up. The consulting pharmacist will attempt to contact the patient via telephone for an assessment of adherence and adverse drug-related events. If patients experience a treatment gap >45, then the patient will be contacted and scheduled for a pharmacist consultation, additionally, the prescribing provider will be notified. All consultations and interventions will be documented in the hospital's electronic medical record system, EPIC®.
- Conditions
- Adherence, Medication
- Being tested
- pharmacist-intervention, Historical control
- 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-interventionBehavioural
A clinical pharmacist provides patients with motivational counseling regarding their cancer treatments. Patients will be asked to complete three different surveys throughout the study; surveys focus on social support systems and both provider- and pharmacist-patient relationships
Historical controlBehavioural
Patients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment
| Study group | Role | What they receive |
|---|---|---|
| Historical Control | Placebo comparator | Pharmacy care was standard, high-touch model where an institutional specialty pharmacy contact patients via telephone. Standard adherence and counseling was offered over the phone to patients. Receives: Behavioral: Historical control |
| Pharmacist-intervention | Experimental | In-person counseling with a clinical pharmacist prior and during treatment with an oral oncology medication. Patients meet with a clinical pharmacist prior, at month 3 and month 6 during the study. Receives: Behavioral: pharmacist-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Possession Ratio
MPR >80%
Measured: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Persistence rate
allowance of 45 day time gap
Measured: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Secondary outcomes (3)
Health-belief model
PAM-13 surveys
Measured: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Provider-patient relationship
Trust-in-physician survey
Measured: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Pharmacist-patient relationship
Pharmacist satisfaction survey
Measured: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start2 May 2017
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- More trials run by Boston 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pharmacist-led intervention group vs historical-control group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- scott gould, PharmD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104114
- Sponsor's protocol ID
- H-35671
- Acronym
- BSPAP
- Status last verified
- Jul 2019
- First submitted
- 23 Mar 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
- ClinicalTrials.gov ID
- NCT03104114
- Acronym / sponsor ID
- BSPAP / H-35671
- Conditions
- Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 2 May 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Boston Medical Center provides care to cancer patients on oral cancer medications through the use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in cancer treatments is relatively new and unfortunately, very little is known about adherence in cancer patients. This study will evaluate the influence of a pharmacist-driven medication management program on adherence and persistence rates. Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving clinical pharmacist that will focus on educating patients about their oral cancer treatments. The program will require face-to-face counseling with a pharmacist, through the use of a proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments and, periodically thereafter, based on protocol. This study will help improve our understanding of the role of the pharmacist in cancer patients. In addition, the study will help identify independent factors that may contribute or impact adherence. The outcomes of this program will be compared to a historical control group of patients that have already received treatment for their cancer through the BMC Specialty Pharmacy.
Detailed description
Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP) will focus on improving adherence and persistence through the implementation of a high-touch program. In order to be eligible for the program, patients must be initiated on oral chemotherapy or targeted therapy with a life expectancy >6 months. All patients will be administered a Patient Activation Measure (PAM) 13 survey prior to consultation. Patients eligible for our program will receive a 30-60 minute pharmacist consultation prior to initiation of treatment. The pharmacy consultation includes, but is not limited to the dissemination of medical information utilizing a standardized counseling checklist, supplying of patient education materials, pharmacist-led interventions, and/or the use of other materials or devices that may improve patient adherence. All counseling checklists and monitoring will be standardized and approved by a multidisciplinary oncology team. At week 1, 2, and 4, patients will be contacted by the pharmacist for an assessment of treatment goals; monthly contacts will continue thereafter by either a specialty pharmacist or certified pharmacy technician. Scheduled follow up visits with the consulting pharmacist will be made at months 3, 6 and 12. Prior to the scheduled pharmacist consultation, patients will be administered the PAM 13 survey. Patients with a treatment gap >37 days will be referred to the consulting pharmacist for follow up. The consulting pharmacist will attempt to contact the patient via telephone for an assessment of adherence and adverse drug-related events. If patients experience a treatment gap >45, then the patient will be contacted and scheduled for a pharmacist consultation, additionally, the prescribing provider will be notified. All consultations and interventions will be documented in the hospital's electronic medical record system, EPIC®.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pharmacist-led intervention group vs historical-control group
| Arm | Type | Receives |
|---|---|---|
| Historical Control | Placebo comparator | Behavioral: Historical controlPharmacy care was standard, high-touch model where an institutional specialty pharmacy contact patients via telephone. Standard adherence and counseling was offered over the phone to patients. |
| Pharmacist-intervention | Experimental | Behavioral: pharmacist-interventionIn-person counseling with a clinical pharmacist prior and during treatment with an oral oncology medication. Patients meet with a clinical pharmacist prior, at month 3 and month 6 during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treatment with 1 or more oral oncology agents. Oral oncology agent defined as medication taken mouth with the purpose to treat a patient's cancer
- Treatment dispensed through the BMC Specialty Pharmacy
- Age>18 years
- Life expectancy >6 months
- Patients must have ability to give written consent, or, must have a legally authorized representative
Key exclusion criteria (6 listed)
- Treatment indicated for neoadjuvant, adjuvant, peri-operative treatment
- Concurrent radiation treatment
- Patients that are unable to have oral oncology agents dispense through BMC Specialty Pharmacy
- 2 controls:1 intervention match
- Matched to a patient in intervention group based on drug type
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-interventionA clinical pharmacist provides patients with motivational counseling regarding their cancer treatments. Patients will be asked to complete three different surveys throughout the study; surveys focus on social support systems and both provider- and pharmacist-patient relationships | Behavioural | Pharmacist-intervention |
| Historical controlPatients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment | Behavioural | Historical Control |
Primary outcome
Medication Possession Ratio
Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
MPR >80%
Persistence rate
Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
allowance of 45 day time gap
3 secondary outcomes
Health-belief model
Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Provider-patient relationship
Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Pharmacist-patient relationship
Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Adherence, Medication
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Not yet recruiting
A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial
Medication Adherence, Glycemic Control for Diabetes Mellitus
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
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.
scott gould, PharmD principal investigator
Boston 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-intervention in people with Adherence, Medication, run by Boston 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 5 inclusion and 6 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 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication Possession Ratio (time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2019.