Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335953
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-22
Brief Title:
ALIGN Aligning Medications With What Matters Most Demonstration
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Demonstration of ALIGN Aligning Medications With What Matters Most
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the effectiveness of a pharmacist-led primary care-based de-prescribing intervention for people living with dementia PLWD and the persons care partners
The intervention consists of the following strategies 1 a de-prescribing educational brochure designed to activate the patient and care partner 2 a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patients medications with the patient and care partner in the context of the persons goals and preferences and 3 pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome the proportion of patients who deprescribe at least one medication by 3 months
The intervention consists of the following strategies 1 a de-prescribing educational brochure designed to activate the patient and care partner 2 a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patients medications with the patient and care partner in the context of the persons goals and preferences and 3 pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome the proportion of patients who deprescribe at least one medication by 3 months
Detailed Description:
PLWD have high rates of polypharmacy This is due to the high degree of comorbid illnesses and challenging behavioral and psychological symptoms such as apathy and agitation Guidelines written for individual conditions increase polypharmacy and potentially inappropriate medication PIM use in which risks of medications outweigh benefits or medications may not align with treatment goals PIM in PLWD include anticholingerics psychotropics and opioids which are prescribed to PLWD in rates that far exceed use in the general older adult population in spite of the association with harms such as falls negative cognitive effects cardiac conduction abnormalities respiratory suppression and death Polypharmacy and PIM use among PLWD is associated with adverse drug events emergency department visits hospitalizations and treatment burden suggesting that in some situations the cure may have become the disease
The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD In keeping with principles of person-centered care people should be on the medicines that will help achieve the persons goals but not medicines that are likely to be harmful or unhelpful
Deprescribing statins antihypertensives and psychotropic medications in older adults has been shown to be safe and may lead to improved quality of life reductions in falls and improvements in cognitive and psychomotor function Lessons from successful interventions include the need to target primary care clinicians and patients and to target more than one class of medications Most deprescribing interventions have occurred in hospitals long-term care facilities or home healthcare not in primary care - typically the first point of contact with the health care system for PLWD Few deprescribing studies have addressed care partners of PLWD despite the enormous strain faced due to medication-related tasks and the persons specific informational and decisional needs and conflicts These are gaps that the proposed research would address
The investigators previous research has shown that care partners want primary care providers PCPs to discuss medication-related goals of care as dementia progresses and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations Pharmacists are ideally suited to help address these problems by providing evidence-based individualized deprescribing recommendations without increasing demands on PCP time
The clinical trial consists of the following strategies 1 direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD 2 telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the persons goals and preferences and 3 pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patientcare partner
The trial is designed as a cluster-randomized trial with a delayed waitlist control where the unit of randomization will be the clinic The investigators will enroll 280 patients with 140 per group intervention group and waitlist control group PLWD may enroll independently or together with a care partner Care partners are not required to participate but may do so independently or with the PLWD if desired Each participant will be in the study approximately 3 months intervention period and additional follow-up
This protocol employs a pragmatic design The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model
The use of these and other medications requires nuanced decision-making to balance potential benefits and harms for PLWD In keeping with principles of person-centered care people should be on the medicines that will help achieve the persons goals but not medicines that are likely to be harmful or unhelpful
Deprescribing statins antihypertensives and psychotropic medications in older adults has been shown to be safe and may lead to improved quality of life reductions in falls and improvements in cognitive and psychomotor function Lessons from successful interventions include the need to target primary care clinicians and patients and to target more than one class of medications Most deprescribing interventions have occurred in hospitals long-term care facilities or home healthcare not in primary care - typically the first point of contact with the health care system for PLWD Few deprescribing studies have addressed care partners of PLWD despite the enormous strain faced due to medication-related tasks and the persons specific informational and decisional needs and conflicts These are gaps that the proposed research would address
The investigators previous research has shown that care partners want primary care providers PCPs to discuss medication-related goals of care as dementia progresses and to acknowledge the tradeoffs implicit in using medications for symptom management in PLWD But PCPs cite time pressure and lack of guidance of when and how to stop medications for PLWD as barriers to having these conversations Pharmacists are ideally suited to help address these problems by providing evidence-based individualized deprescribing recommendations without increasing demands on PCP time
The clinical trial consists of the following strategies 1 direct-to-consumer deprescribing educational materials designed to activate the care partner and PLWD 2 telehealth visit in which a pharmacist discusses benefits and harms of the medications with the patient and care partner in the context of the persons goals and preferences and 3 pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations that are actionable for the PCP Pharmacists will receive a laminated tip sheet and participate in a 20-minute webinar Decisions about discontinuation or continuation of medications will ultimately be made by the PCP and patientcare partner
The trial is designed as a cluster-randomized trial with a delayed waitlist control where the unit of randomization will be the clinic The investigators will enroll 280 patients with 140 per group intervention group and waitlist control group PLWD may enroll independently or together with a care partner Care partners are not required to participate but may do so independently or with the PLWD if desired Each participant will be in the study approximately 3 months intervention period and additional follow-up
This protocol employs a pragmatic design The intervention is delivered by clinical pharmacists who are integrated in primary care clinics or practice through a centralized telemedicine model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54AG063546 | NIH | None | httpsreporternihgovquickSearchU54AG063546 |