Reduction of Anticholinergic Medications Project (RAMP) Among Persons With Schizophrenia or Other Psychiatric Disorders Across UPMC Behavioral Healthcare Partner Organizations Using a Stepped-wedge, Randomized Trial Study Design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Reduction of Anticholinergic Medications
研究概览
简要总结
The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.
详细描述
Based on the investigator's preliminary work, the investigators will utilize a combination of administrative, prescriber and patient buy-in to reduce Anticholinergic Medication (ACM), when these medications are no longer needed, as evidence-based practice. Previously developed materials and tools from the investigator's earlier work include an ACM side-effect scale (the Pittsburgh Anticholinergic Symptoms Scale, PASS v2.0), a patient-facing information leaflet reviewing the risks of long-term ACM use, and a Clinical Guide for deprescribing. These, as well as education on the Anticholinergic Medication Burden (ACMB) reduction protocol will be provided to prescribers at initiation of each site. The clinical pharmacist on the team will train staff at each site to compute and record the Anticholinergic Cognitive Burden and use the PASS to assess ACM side effects. The investigators will train the staff members to administer the Memory Impairment Screen, a verbal working memory task.
The Principal Investigator (PI) and members of the study team will work with the healthcare teams at each site using case examples of 'how to reduce and/or stop anticholinergic medications" and maintain office hours on a scheduled basis to problem-solve, trouble-shoot and/or manage the medication reduction process and clinical issues that emerge. The PI and members of the study team will train the healthcare teams at each site to examine eligible patients for extra pyramidal symptoms and in the use of a shared decision-making approach in this effort to reduce anticholinergic medications.
Based on considerable interest from our healthcare partners, and in the absence of any randomized studies, the investigators intend to use a stepped-wedge, randomized trial study design to implement this protocol for eligible patients in each of the participating clinics. In addition to affirming earlier positive clinical outcomes in the preliminary work, the investigators intend to assess barriers to and facilitators of anticholinergic medication burden reduction implementation to inform the emerging evidence-based practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are 18 years or older
- •have a chart DSM V diagnosis of schizophrenia spectrum or schizoaffective or bipolar disorder or any other mental illness disorder
- •have received ACM and antipsychotic medications for 6 months or more
- •are considered to be clinically stable (by the patient's healthcare team) for 3 months or more
- •the ACM (e.g. benztropine and/or trihexyphenidyl) is being used to treat EPS associated with antipsychotic medications.
- •on an examination using the modified Simpson-Angus Extrapyramidal Symptoms Scale (head dropping and leg pendulousness items are dropped), no single item rated at 3 or
- •able and willing to sign the approved informed consent document.
排除标准
- •patients with ongoing Parkinsonian symptoms who require ACM meds for countering EPS side effects based on the Simpson-Angus Scale score cutoffs.
- •if the clinicians treating the potentially eligible patients consider them to be clinically unstable or if drug-addiction is the focus of treatment and participation in ACM de-prescription protocols is considered risky, the team will defer to the treating clinicians to exclude participants.
- •The same exclusions will apply to those persons undergoing medical procedures and treatments that make participation in this ACM deprescription trial unwise per the treating team.
研究组 & 干预措施
Anticholinergic Medication Reduction
干预措施: Reduction of anticholinergic medication (Other)
结局指标
主要结局
Reduction of Anticholinergic Medications
时间窗: From enrollment to final visit. The final visit can vary for each participant and can be up to 16 weeks following the first baseline visit.
For the primary outcome, reduction of anticholinergic medications (benztropine and/or trihexyphenidyl) will be computed as a percentage reduction from baseline. Those participants who discontinued fully will be considered as having a 100% reduction, and those who tapered but did not discontinue will be computed as a percentage reduction from baseline, and those participants who did not discontinue at all will be considered to have a zero-percentage reduction. This anticholinergic medication reduction will be computed at the end of the study for each participant and summed for all study participants.
Reduction of Anticholinergic Medications
时间窗: From enrollment to final visit. The final visit can vary for each participant and can be up to 16 weeks following the first baseline visit.
For the primary outcome, reduction of anticholinergic medications (benztropine and/or trihexyphenidyl) will be computed as a percentage reduction from baseline. Those participants who discontinued fully will be considered as having a 100% reduction, and those who tapered but did not discontinue will be computed as a percentage reduction from baseline, and those participants who did not discontinue at all will be considered to have a zero-percentage reduction. This anticholinergic medication reduction will be computed at the end of the study for each participant and summed for all study participants.
次要结局
- The Pittsburgh Anticholinergic Symptoms Scale v2.0 (PASS)(Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.)
- Auditory Verbal Learning and Recall(Enrollment to final visit. This can vary for each participant after Visit 1 (baseline) and be up to 16 weeks.)
- Anticholinergic Cognitive Burden Scale (ACB)(Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.)
- Auditory Verbal Learning and Recall(Enrollment to final visit. This can vary for each participant after Visit 1 (baseline) and be up to 16 weeks.)
- The Pittsburgh Anticholinergic Symptoms Scale v2.0 (PASS)(Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.)
- Anticholinergic Cognitive Burden Scale (ACB)(Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks.)
研究者
K.N. Roy Chengappa
Professor of Psychiatry
University of Pittsburgh