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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| University of Pittsburgh Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticholinergic Medication Reduction | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction of anticholinergic medication | Other | Shared decision making between the patient and prescriber will determine the timing and speed of reduction over a period of 12 to 16 weeks. Some patients will be discontinued from these anticholinergic medications (benztropine/trihexyphenidyl), others will be tapered from their original dosage but not completely discontinued, and some patients may not be able to taper the anticholinergic medications at all. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Anticholinergic Medications | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Verbal Learning and Recall | The Memory Impairment Screen (MIS) is being used to assess auditory verbal learning and free or cued recall memory. Lower scores are indicative of poorer learning and memory; the total scores range from 0 to 8. Scores of 5 through 8 generally indicate no memory impairment, scores of 4 or lower indicate memory concerns. | Enrollment to final visit. This can vary for each participant after Visit 1 (baseline) and be up to 16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor of Psychiatry, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Behavioral Health of the Alleghenies | Altoona | Pennsylvania | 16601 | United States | ||
| UPMC Western Behavioral Health at Safe Harbor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33878282 | Background | Lupu AM, MacCamy KL, Gannon JM, Brar JS, Chengappa KNR. Less is more: Deprescribing anticholinergic medications in persons with severe mental illness. Ann Clin Psychiatry. 2021 May;33(2):80-92. doi: 10.12788/acp.0019. Epub 2021 Feb 1. | |
| 29178683 | Background | Lupu AM, Clinebell K, Gannon JM, Ellison JC, Chengappa KNR. Reducing Anticholinergic Medication Burden in Patients With Psychotic or Bipolar Disorders. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1270-e1275. doi: 10.4088/JCP.16m11269. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2026 | May 5, 2026 |
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The investigators will use a stepped-wedge open-cohort single arm trial design, where each of the four sites is randomized 2 to 6 weeks apart.
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|
| The Pittsburgh Anticholinergic Symptoms Scale v2.0 (PASS) | This is a self-report scale guided by clinicians for participants to fill out regarding the occurrence of side effects which may be associated with anticholinergic medications like benztropine and/or trihexyphenidyl. These include symptoms such as dry mouth, blurred vision, difficulty urinating, constipation, fast heartbeat or confusion/memory problems. Each item is anchored to the last week for recall by the patient and is rated from 0 (no side effects) to 6 (all the time and every day). The total score is computed by adding the 6 items, and ranges from a score of zero (none) to 36 (maximum), higher scores indicate worse anticholinergic effects. The last two items, intensity (overall severity, considering the six individual items), and impact on day-to-day functioning, are also scored 0 (none) to 6, 6 being intolerable or unable to function. The last two items are computed separately from the top 6 individual items and range from 0 (none) to 12 (severe or intolerable). | 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) | This widely used scale provides a score of the anticholinergic medication burden in an individual participant, and the potential impact on cognition in an individual patient. The scale was developed by expert consensus and is based on clinical evidence of an individual anticholinergic medication's impact on cognition either from the literature, or in vivo or in vitro data, or available data from the manufacturer, and/or the ability to induce delirium. Each medication is scored from a minimum of 1 to a maximum of 3, with 3 indicating highly anticholinergic medications (e.g. benztropine or trihexyphenidyl). The scale authors have suggested a score of 3 or greater is clinically significant for anticholinergic impact on cognition. For purposes of this clinical study, in addition to the original list of anticholinergic medications, the investigators have added an updated medication list (following market approval of psychotropic drugs) to the original list with anticholinergic properties. | Enrollment to final visit which can vary for each participant after Visit 1 (baseline) and can be up to 16 weeks. |
| Erie |
| Pennsylvania |
| 16508 |
| United States |
| Western Behavioral Health Mon Yough | McKeesport | Pennsylvania | 16601 | United States |
| Comprehensive Recovery Services (Pittsburgh) of Western Psychiatric Hospital, Ambulatory Clinics and Residential Programs - UPMC, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15213 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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