Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Rates of study enrollment
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 65 or older
- •Diagnosed with any stage breast, GI or lung cancer
- •Panning to receive first-line chemotherapy at MGH
- •Verbal fluency in English
Exclusion Criteria
- •Unwilling or unable to participate in the study
- •Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
Arms & Interventions
Pharmacy Intervention
Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will
- Perform detailed medication reconciliation
- Obtain allergy and vaccination history
- Evaluate and document polypharmacy (number of medications)
- Document their findings in the medical record and discuss their recommendations (in-person, phone call, email) with each patient's oncology team
Intervention: Pharmacy Intervention (Other)
Usual Care
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.
- Remind participant to complete self-report measures
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Rates of study enrollment
Time Frame: 2 years
To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
Secondary Outcomes
- Rates of Study Completion(2 years)
- Number Of Medications(Baseline to 4 weeks)
- Rates of Polypharmacy(Baseline to 4 weeks)
- Change In The Number Of Potentially Inappropriate Medications(Baseline to 4 weeks)
- Number Of Potentially Inappropriate Medications(Baseline to 4 weeks)
- Rates Of Appropriate Pneumococcal Vaccinations(Baseline to 8 weeks)
- Rates Of Appropriate Influenza Vaccinations(Baseline to 8 weeks)
- Rates of study satisfaction(2 years)
- Rates of Medication List Accuracy(Baseline to 4 weeks)
- Change In The Number Of Medications(Baseline to 4 weeks)
- Rates Of Appropriate Pneumococcal Vaccinations(Baseline to 4 weeks)
- Rates Of Appropriate Influenza Vaccinations(Baseline to 4 weeks)
Investigators
Ryan Nipp
Principal Investigator
Massachusetts General Hospital