The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.
The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
62
Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will: (1) perform detailed medication reconciliation and obtain allergy and vaccination history; (2) evaluate and document polypharmacy, potentially inappropriate medications, lack of appropriate medications; and (3) document their findings in the medical record and discuss their recommendations the oncology team.
Participants receiving usual oncology care will not meet with the pharmacist unless indicated as part of their routine clinical care. Study staff will obtain all patient-reported measures from the patient.
Massachusetts general Hospital
Boston, Massachusetts, United States
Rates of study enrollment
To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
Time frame: 2 years
Rates of Study Completion
To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study.
Time frame: 2 years
Rates of study satisfaction
To determine rates of study satisfaction, we will examine the proportion of participants who report satisfaction with the structure, timing and content of the study, using Likert-type scale responses.
Time frame: 2 years
Rates of Medication List Accuracy
Compare rates of medication list accuracy (defined as concordance between the medical record and the medication list the patient reports taking) between study arms at 4 weeks following enrollment.
Time frame: Baseline to 4 weeks
Change In The Number Of Medications
Compare change in the number of medications (defined as the number of medications a patient is prescribed) between study arms from baseline to 4 weeks following enrollment.
Time frame: Baseline to 4 weeks
Number Of Medications
Compare the number of medications (defined as the number of medications a patient is prescribed) between study arms at 4 weeks following enrollment.
Time frame: Baseline to 4 weeks
Rates of Polypharmacy
Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms.
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Time frame: Baseline to 4 weeks
Change In The Number Of Potentially Inappropriate Medications
Compare change in the number of potentially inappropriate medications between study arms from baseline to 4 weeks following enrollment.
Time frame: Baseline to 4 weeks
Number Of Potentially Inappropriate Medications
Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment.
Time frame: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 4 weeks.
Time frame: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 8 weeks.
Time frame: Baseline to 8 weeks
Rates Of Appropriate Influenza Vaccinations
Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 4 weeks.
Time frame: Baseline to 4 weeks
Rates Of Appropriate Influenza Vaccinations
Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 8 weeks.
Time frame: Baseline to 8 weeks