Decreasing Harms and Improving Child Health: An Intervention to Reduce Inappropriate Use of Antipsychotics and Polypharmacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Feasibility
研究概览
简要总结
The investigators are doing this study because they know from research and talking with caregivers that kids can be on a bunch of medications, and it's hard to keep track of what the medications are for and whether or not they are helping.
The other thing the investigators know is that some medications have very few side effects while others have many side effects, some of which can cause real health problems (severe weight gain, diabetes). Once someone is on a medication, they often just keep taking it without thinking much about whether they still need it.
the investigators are doing this study to look at the process of reviewing medications with the help of a handout that shows basic information about the most common types of medications, making a decision about keeping medications the same or lowering one, and following people to see how it goes.
If the caregiver and youth decide to lower a medication, the investigators have created a structured process for their child's prescriber to do this slowly and safely.
Slowly means kids are not likely to have any bad reactions. This process can be used to just lower the dose of a medication or to stop it altogether.
This is called the AWARE intervention and it has 2 parts:
- Medication review using the handout & making a decision
- Prescribers' guide about lowering meds slowly for those who choose to do this The caregivers/youth do not have to lower a medication to be in the study.
详细描述
Prescriptions to children for antipsychotic medications and polypharmacy have steeply increased in recent years. Parents, schools, and clinicians may hold unrealistic expectations for these medications and desire quick relief, but do not attend to the concerning side effects or long-term morbidities. In children, the majority (75%) of antipsychotic use and 100% of polypharmacy (three or more psychiatric medications at the same time), is off-label, or not approved by the FDA for the purpose. These practices are risky, commonly leading to side effects like substantial weight gain, metabolic abnormalities, neurocognitive impairments, sedation, tremor, somnolence, and restlessness. Parents are often unaware of the risks and seldom feel fully included in decisions to use these medications. Government agencies, regulatory bodies, and media outlets have voiced significant concerns over the increased use of these medications. Clinicians and parents are interested in reducing or stopping these medications (deprescribing), but one stated barrier is the lack of guidance on how to safely deprescribe.
To address this gap, our team has developed the AWARE intervention, which incorporates two tools: 1) a patient-facing decision aid called an Option GridTM that guides both clinicians and patients/parents through a shared decision-making process about mental health treatment options; and 2) a structured protocol that provides detailed, evidence-based guidance on how to deprescribe (e.g., dose reduction rates, monitoring, safety planning) psychotropic medications in youth receiving either an off-label antipsychotic medication and/or three or more psychiatric medications concurrently. The proposed study will refine the intervention and evaluate it with 40 children receiving off-label antipsychotics or polypharmacy in two outpatient mental health clinics in the northeast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth will be aged 6-17 years;
- •They will have been prescribed an off-label antipsychotic or polypharmacy (3 or more medications) for 3 months and be stable for 3 months (i.e. no hospitalizations or residential care).
- •The parents or legal guardians of eligible children will be aged 18 years or older and capable of providing informed consent.
排除标准
- •Children with an acute clinical or medical crisis, or a major substance use disorder will not be eligible.
- •Children using an antipsychotic who have a diagnosis of psychotic disorder, bipolar affective disorder, autism spectrum disorder, or Tourette's disorder will not be eligible, as FDA approval exists for these situations.
- •Youth who are pregnant will not be eligible.
研究组 & 干预措施
AWARE Medication Review
All eligible participants and their parent/caregiver take part in the AWARE intervention - a shared decision making comprehensive medication review with the participant's clinician.
干预措施: AWARE Shared Decision Making Medication Review (Behavioral)
结局指标
主要结局
Feasibility
时间窗: Baseline through 30-week follow-up
The investigators measured feasibility by examining the number of people who were approached, enrolled, and completed data collection. The investigators also included the number of enrolled participants who activated their smartphone app account and accessed various sections/resources in the app.
次要结局
- Number of medications (baseline)(Baseline)
- Study-related adverse events(Ongoing monitoring throughout study participation (baseline through 30-week follow-up))
- Dose-weighted number of medications (follow-ups)(18- and 30-week follow-up)
- Medication-related reactions(At each clinical visit (weeks 4-18))
- Columbia Impairment Scales, Parent Version (CIS-P)(Baseline, 18-, and 30-week follow-up)
- Columbia Impairment Scales, Youth Version (CIS-Y)(Baseline, 18-, and 30-week follow-up)
- Modified Overt Aggression Scale (MOAS)(Baseline, 18-, and 30-week follow-up)
- Clinical Global Impression Scales - Severity (CGI-S)(Baseline, 18-, and 30-week follow-up)
- Clinical Global Impression Scales - Improvement (CGI-I)(Baseline, 18-, and 30-week follow-up)
研究者
Glyn Jones-Elwyn
Professor
Trustees of Dartmouth College