Deprescribing

STAR Caregivers – Virtual Training and Follow-up

Grant Details

Funder: NIMH

Grant Number: R01AG061926

Grant Period: 9/30/2018 – 5/31/2023

Narrative: Alzheimer’s Disease and related Dementias (ADRD) are debilitating conditions affecting more than 5 million Americans in 2014. It is projected that 8.4 million people with be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than $1.2 trillion by 2050. Behavioral interventions such as STAR-Caregivers are efficacious first-line treatments for managing BPSD endorsed by the Administration on Aging. However, the programs have not been implemented widely – partly due to the intensity/cost of the programs and difficulty conducting outreach. No study has investigated CG willingness to reduce or discontinue antipsychotic use. We propose a Stage III clinical trial to ascertain the feasibility and acceptability of STAR Virtual Training and Follow-up (STAR- VTF) in which (a) training materials are delivered electronically and learning is self-directed, (b) caregivers have two in-home visits with a social worker and (c) where caregivers receive support from a social worker via secure messaging (email) within a web-based portal. We will compare outcomes in the STAR-VTF group to an attention control group (mailed material plus generic secure messages). Our specific aims are: (1) Assess the feasibility and acceptability of STAR-VTF to caregivers; (2) Assess the feasibility and acceptability of the program from the payer perspective; and (3) Test the hypotheses that (H1) caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group; and (H2) PWD participants in STAR-VTF will have lower rates of daily antipsychotic medication use at 6 months compared to attention control. We propose to recruit 100 CG-PWD dyads (50 in each arm). This will be the first study to test a low intensity, self-directed caregiver training program with secure message support from social workers. It will also be the first study to measure changes in antipsychotic medication use by PWD after CG training. The study is also innovative because it brings together leading experts in caregiver training, health information management, and care management. Third, this will be the first study to use automated data and natural language processing to identify potential caregivers in need of education/support at a time when antipsychotic medication use begins. Results of this study will inform a future multi-site trial in the Mental Health Research Network.

Lead Site: KPWA (PI Rob Penfold)

Participating Sites: N/A

Current Status

Currently enrolling person-living-with-dementia – Caregiver dyads. Recruitment will end December 2022.

Summary of Findings

none yet

Publications

Ramirez M, Duran MC, Pabiniak CJ, Hansen KE, Kelley A, Ralston JD, McCurry SM, Teri L, Penfold RB. Family Caregiver Needs and Preferences for Virtual Training to Manage Behavioral and Psychological Symptoms of Dementia: Interview Study. JMIR Aging. 2021 Feb 10;4(1):e24965. doi: 10.2196/24965. PMID: 33565984; PMCID: PMC8081155.

Evaluating the Impact of Changes in Opioid Prescribing across Health Systems Implementing Zero Suicide

Project Name:
Evaluating the Impact of Changes in Opioid Prescribing across Health Systems Implementing Zero Suicide

Principal Investigator:
Brian Ahmedani PhD (Contact PI)

Principal Investigator Contact Information:
BAHMEDA1@hfhs.org

Principal Investigator Institution:
Henry Ford Health System

Funder:
NIMH

Funding Period:
09/08/2018 – 09/07/2019

Abstract:
Suicide is a major public health concern – it is the 10th leading cause of death and number one cause of injury-related death in the United States (US). Suicide rates have risen over 25% in the last 15 years. In parallel, the nation is struggling with an opioid epidemic. Opioid prescribing, heroin use, and opioid-related overdose deaths have risen substantially. Approximately 15% of all suicide deaths are due to drug overdose, and prescription opioids specifically, are commonly used among people who attempt suicide. Health systems across the country have made decisions to tackle both of these public health crises – implementing policies to dramatically reduce opioid prescribing as well as clinical processes within the Zero Suicide model to improve suicide prevention for their patients. The parent award for this supplement is focused on evaluation of Zero Suicide implementation, including fidelity to each of these clinical processes and suicide outcomes, across 6 large, diverse Mental Health Research Network-affiliated Learning Healthcare Systems providing healthcare for over 9 million individuals each year. Given the overlap, significant reductions in opioid prescribing as part of newly implemented policies should lead to a reduction in the availability of opioids. These reductions may result in a public-health level means reduction approach to reduce suicide. Means reduction is among the interventions recommended within Zero Suicide. The concurrent implementation of these new opioid prescribing policies in the context of implementation of Zero Suicide allows the opportunity to evaluate how changes in opioid prescribing impacts suicide outcomes in health care. This supplement project seeks to accomplish three specific aims: 1) Evaluate changes in opioid prescribing patterns during the period of NZSM implementation across health systems, 2) Investigate whether changes in opioid prescribing patterns reduce suicide attempt and mortality, and 3) Investigate whether changes in opioid prescribing patterns reduce opioid-related suicide attempt and mortality poisonings. Overall, we propose to use an Interrupted Time Series Design, consistent with the parent award, to measure changes in prescribing patterns and suicide outcomes.

Grant Number:
U01MH114087-02S2

Participating Sites:
Henry Ford Health System
Kaiser Permanente Washington
Kaiser Permanente Colorado
Kaiser Permanente Northern California
Kaiser Permanente Northwest
Kaiser Permanente Southern California

Investigators:
Gregory Simon, MD, MPH (co-PI)
BobbiJo Yarborough, PsyD
Stacy Sterling, DrPH
Karen Coleman, PhD
Arne Beck, PhD

Major Goals: Evaluate changes in opioid prescribing patterns during the period of NZSM implementation across health systems. Investigate whether changes in opioid prescribing patterns reduce suicide attempt and mortality. Investigate whether changes in opioid prescribing patterns reduce opioid-related suicide attempt and mortality poisonings.

Description of study sample:
N/A

Current Status:
06/26/2019 – We have finalized the study protocol and methods, including finalizing the data metrics. We have drafted the specifications for the program to extract the electronic health record data from the participating sites.

Study Registration:
N/A

Publications:
N/A

Resources:
N/A

Lessons Learned:
N/A

What’s next?
We will finalize the program specifications, write/test/distribute the program, and collect the final data for analyses

Pathways from Chronic Prescription Opioid Use to New Onset Mood Disorder

Grant Details

Funder: NIH, NIDA

Grant Number: R01ActDA043811

Grant Period: 4/1/2019 – 3/31/2023

Narrative: Research on the association between psychopathology and prescription opioid analgesic use (OAU) has established that mental illness influences risk of chronic OAU (i.e. >90-days), high dose OAU and misuse. We explored the reverse direction of association and found longer OAU and higher opioid doses are associated with increased risk of new onset depression (NOD), independent of pain. Using Veterans Health Affairs (VA) patient data revealed >90-day OAU was associated with a 35% (in VA patients) to 105% (in private sector patients) increased risk of NOD compared to patients with 1-30 day OAU. Our additional studies revealed that OAU is associated with depression recurrence and treatment resistant depression. If these results are confirmed in the present proposal, results have potential to greatly inform interventions to reduce chronic OAU (e.g. treating depression), elucidate pathways to OAU misuse, and generate a body of evidence that informs safe opioid prescribing. To reveal pathways from OAU to NOD and related depression phenotypes (i.e. dysthymia, bipolar, anhedonia, vital exhaustion) we must measure the patients’ pre-existing risk factors and post-OAU events. We will obtain diagnoses and symptom level data and covariates that are not available in the medical record data used in our R21 and strengthen the temporal relationships between OAU and NOD. The central hypothesis driving this research is that pre-OAU risk factors such as a history of depression and post-OAU events such as onset of opioid misuse contribute to NOD.
If NOD is explained by OAU alone and not by pre-existing risk factors, then the opioid epidemic is generating new cases of depression in a large population of middle-aged adults, otherwise not at risk for NOD. Findings will disentangle consequences or correlates of chronic pain per se from those of chronic, high dose OAU. We test whether the OAU-NOD association is moderated by pre-existing depression, substance use disorder (SUD), including opioid use disorder and trauma exposure. We next propose that post-OAU opioid misuse, SUD, poor functioning, low social support and poor sleep quality promote NOD. Using 12 monthly brief assessments, we will determine if change in OAU, independent of change in pain influences, depression trajectories and determine if there is a reciprocal relationship among these variables over time. We will determine if OAU is associated with different depression phenotypes and last determine which subtypes of depression contribute to incident opioid use disorder.

Lead Site: St. Louis University (PI Jeffrey Scherrer)

Participating Sites: HFHS (Site PI Brian Ahmedani)

Current Status:

Summary of Findings:

Publications:

Safer Use of Antipsychotics in Youth (SUAY)

Project Name:
Safer Use of Antipsychotics in Youth (SUAY)

Principal Investigator:
Robert Penfold, PhD

Principal Investigator Contact Information:
Robert.B.Penfold@kp.org

Principal Investigator institution:
Kaiser Permanente Washington Health Research Institute

Funder
NIMH

Funding Period:
Base period: 04/25/16 – 12/24/16
Option period 1: 12/25/16-12/24/17
Option period 2: 12/25/17-06/24/2021

Abstract:
This study proposes to test a quality improvement research program. The project is inspired by the Partnership Access Line (PAL) and Second Opinion program operated for the Washington State Medicaid program. PAL was established to bring rapid child mental health consultation access into underserved areas of WA State. Under the program, a mandatory Second Opinion review protocol is triggered for new antipsychotics prescriptions when a set of pre-established criteria are met. SUAY is a step-wise research contract with 3 separately-funded phases: (1) planning and development, (2) feasibility pilot study at 2 sites, and (3) full-scale pragmatic effectiveness trial at 4 sites. The usual care arm is primarily observational only. The only change from standard usual care is a best practice alert reminding providers of Choosing Wisely® guidelines when prescribing antipsychotics for youth. The interventional arm consists of a more robust best practice alert informing prescribers that the case will be reviewed by a child and adolescent psychiatrist and offering a provider-to-provider consultation for the prescriber and behavioral health access support for the patient. Patients with an intervention arm prescriber will be offered 6 months of behavioral health navigation to support access and engagement with therapy in the health system and up to 9 sessions of brief telemental health (clinic-to-home) therapy to bridge wait times to access in-person therapy in the delivery system. Outcomes will be assessed at 6 months.

Contract Number:
HHSN271201600002C

Participating Sites:
Kaiser Permanente Washington (KPWA)
Seattle Children’s Hospital (SCH)
Kaiser Permanente Colorado (KPCO)
Henry Ford Health System (HFHS) (base period and option period 1)
Kaiser Permanente Northwest (KPNW) (option period 2)
Nationwide Children’s Hospital (NCH) / Partners for Kids (PFK)
University of Washington (UW)

Investigators:
Robert Penfold, PhD – Kaiser Permanente Washington Health Research Institute
Greg Simon, MD, MPH – Kaiser Permanente Washington Health Research Institute
James Ralston, MD, MPH – Kaiser Permanente Washington Health Research Institute
Clarissa Hsu, PhD – Kaiser Permanente Washington Health Research Institute
Rebecca Yates Coley, PhD – Kaiser Permanente Washington Health Research Institute
Tobias Dang, MD – Kaiser Permanente Washington Behavioral Health Services
Robert Hilt, MD – Seattle Children’s Hospital
Kathleen Myers, MD – Seattle Children’s Hospital
Kelly Kelleher, MD – Nationwide Children’s Hospital (NCH) /Partners for Kids (PFK)
Brian Ahmedani, PhD – Henry Ford Health System (base period and option period 1)
Arne Beck, PhD – Kaiser Permanente Colorado
Bobbi Jo Yarborough, PhD – Kaiser Permanente Northwest
Andrea Hartzler, PhD – University of Washington (base period and option period 1)
Paul Fishman, PhD – University of Washington

Major Goals:
Base period (8 months): Develop a treatment algorithm and step-by-step clinical workflow that aims to promote the safer use of antipsychotics in youth aged 3-17 years who do not have a psychotic disorder, mania, autism spectrum disorder, or intellectual disability. Base period activities include convening a consensus panel of national experts to develop the treatment algorithm; interviewing youth, parents, and prescriber clinicians; conducting user-centered design sessions with prescribing clinicians and psychiatrists; and preparing for an option period 1 pilot study. Option period 1 (12 months): Conduct a pilot study to test the feasibility, acceptability, reproducibility and implementation of the intervention and workflow in two health systems (up to 20 patients per clinical site). Kaiser Permanente Washington and Nationwide Children’s Hospital will participate in the pilot. Option period 2 (3 years, 6 months): Conduct a full-scale pragmatic effectiveness study comparing usual care to the interventional arm at four health systems (up to 800 patients enrolled across the 4 clinical sites). Kaiser Permanente Washington, Nationwide Children’s Hospital, Kaiser Permanente Northwest, and Kaiser Permanente Colorado will participate in the pragmatic trial.

Description of study sample:
Provider-subjects: The study will pre-randomize clinicians credentialed to prescribe medications in the health systems’ internal electronic medical record. Providers will be randomized to one of two arms: (1) usual care control and (2) intervention. Patient-subjects: Patients between the ages of 3 and 17 not ordered an outpatient antipsychotic in the health system during the prior 6 months and not suffering from a psychotic disorder, mania, autism spectrum disorder or intellectual disability. Patient subjects will be added to a study log when a randomized provider enters an antipsychotic medication order for them in Epic.

Current Status:
The pragmatic trial fielded at Kaiser Permanente Washington in March 2018, Kaiser Permanente Colorado in June 2018, and at Nationwide Children’s Hospital in July 2018. Henry Ford Health System was unable to field the protocol and the contract was modified to add Kaiser Permanente Northwest as a fourth recruitment site. Kaiser Permanente Northwest fielded the trial in May 2019. The end date of the contract may be extended to allow for a longer recruitment period given delays to fielding. The study had enrolled a total of 500 subjects as of July 1, 2019 (63% of the target 800 subjects).

Study Registration:
The trial is registered in ClinicalTrials.gov under record number NCT03448575.

Publications:
Hartzler A, Ralston J, Penfold R, Kelleher K, Hannan T. Designing safer use of antipsychotics in youth: A human centered approach. Accepted by Psychiatric Services for publication.Schoenfelder-Gonzalez E, Myers K, Thompson E, King D, Glass A, Penfold R. Developing Home-Based Telemental Health Services for Youth: Practices from the SUAY Study. Accepted by the Journal of Telemedicine and Telecare for publication.

Resources: Clinical guidelines developed by a national panel of experts for the safer prescribing of antipsychotic prescribing in youth. EPIC build package. Study protocol and manual of procedures.

What’s next?
Recruitment for the large pragmatic effectiveness study will continue into Spring 2020 and intervention delivery and follow-up through Fall 2020. Data and safety monitoring board reports will continue to be prepared and delivered three times per year.