Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rates of study enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: 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
干预措施: Usual Care (Other)
结局指标
主要结局
Rates of study enrollment
时间窗: 2 years
To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
次要结局
- 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)
研究者
Ryan Nipp
Principal Investigator
Massachusetts General Hospital