| Project Name: Automated Virtual Follow-Up to Reduce Premature Treatment Discontinuation |
| Grant Number: U19MH092201 (Pilot study under MHRN II) |
| Principal Investigator: Robert Penfold, PhD |
| Principal Investigator Contact Information: robert.b.penfold@kp.org |
| Funder NIMH |
| Funding Period: 07/2017 – 06/2019 |
| Abstract: Recent developments in health informatics have created the potential for more efficient and more targeted outreach programs to address dropout from depression treatment. First, electronic medical records databases allow real-time evaluation of patients who are “overdue” for prescription refills and follow-up visits. Second, increasing use of standardized depression severity measures (such as the PHQ9), allow efficient identification of those at risk for unfavorable outcomes. Third, increasing use of patient-provider online messaging will permit much more efficient outreach communication. We are conducting a pilot study of a semi- automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy). Participants with missed antidepressant refills or missed psychotherapy sessions are emailed a short questionnaire to ask about their intentions for treatment as well as a PHQ9, GAD2, and AUDIT-C. Feedback on patients’ answers is delivered immediately in a web-based format. |
| Participating Sites: Kaiser Permanente Washington (Lead Site) Kaiser Permanente Colorado |
| Investigators: Robert Penfold, PhD Arne Beck, PhD |
| Major Goals: Conduct a pilot study of a completely automated outreach program for adult outpatients who appear to have dropped out of acute-phase depression treatment (either pharmacotherapy or psychotherapy). |
| Description of study sample: The study population will include up to 2400 adult patients in participating health systems who initiate medication or psychotherapy treatment for depression. |
| Current Status: Health record data were used to identify KP adult members eligible for outreach with a new depression diagnosis who have started therapy and appear to have discontinued prematurely, but do not have a recorded good outcome (most recent PHQ9 on record total score is >=10). A secure outreach message, including a link to an externally hosted questionnaire in Research Electronic Data Capture (REDCap) was sent to identified subjects through kp.org (i.e., MyChart). The study questionnaire was comprised of (2) standard assessments used for depression and suicide risk screening and a number of treatment- specific questions.PHQ9- standard assessment measuring depression severityCSSR-S- standard assessment measuring severity of suicidal ideation/ behavior. Depression Treatment Discontinuation QuestionsSubjects who returned the questionnaire were provided tailored feedback, ranging from “glad to hear that you are planning to continue care” to “we’d like to see you feeling better/we want to make sure that you are receiving the care you need- please consider scheduling an appt.” The web-based consent process and survey were hosted on KPCO’s internal instance of Research Electronic Data Capture (REDCap)All patient recruitment and outreach activities are complete. Data collection is complete. During the recruitment phase we identified and enrolled 988 subjects meeting study criteria for initiating psychotherapy. After ongoing monitoring of enrolled subjects, 657 subjects were flagged as potentially discontinuing psychotherapy treatment early. Subjects flagged by the automated algorithm as potential ‘early discontinuers’ were manually reviewed for meeting ‘discontinuation of treatment’ study criteria. After manual review, 518 qualified subjects were outreached through the electronic health record with an invitation to complete the depression treatment questionnaire. 70 of the 518 qualified subjects who were sent an invitation to complete the depression treatment questionnaire- responded.63 fully completed AND 7 people who consented but did not fully complete all components of the questionnaire. |
| Study Registration: N/A – study hasn’t started yet |
| Publications: N/A |
| Resources: N/A |
| Lessons Learned: N/A |
| What’s next? N/A |
Tag: Pragmatic trials
Behavioral Activation for Perinatal Depression
| Project Name: Feasibility of Behavioral Activation for Perinatal Depression |
| Principal Investigator: Arne Beck, PhD |
| Principal Investigator Contact Information: arne.beck@kp.org |
| Principal Investigator institution: Kaiser Permanente Colorado, Denver, CO |
| Funder: NIMH |
| Funding Period: 07/2010 – 07/2014 |
| Abstract: At four MHRN sites (Group Health, HealthPartners, KP Colorado, and KP Georgia) women with moderate or greater symptoms of depression were identified either by visit-based screening (by OB clinic staff at first prenatal visits) or mailed screening (of all pregnant women during the first and/or second trimester). Those identified were offered participation in a randomized trial comparing continued care as usual to Behavioral Activation (BA) Psychotherapy added to care as usual. The BA program was adapted for the specific needs of mothers (including delivery by telephone) and for delivery by a range of clinicians (including OB clinical staff). The project also took advantage of the MHRN’s centralized online survey platform for administration of standard assessments at baseline and follow-up. |
| Grant Number: U19MH092201 |
| Participating Sites: Kaiser Permanente Colorado, Denver, CO (Lead Site) Group Health Cooperative, Seattle, WA HealthPartners, Minneapolis, MN Kaiser Permanente Georgia, Atlanta, GA |
| Investigators: Arne Beck, PhD – KPCO Sona Dimidjian, PhD – University of Colorado Boulder Greg Simon, MD – GH Nancy Sherwood, PhD – HP Sherryl Goodman, PhD – KPGA Evette Ludman, PhD – GH |
| Major Goals: Demonstrate the feasibility of innovative and efficient methods for multi-site comparative effectiveness trials in mental health, using perinatal depression as an example, including: Screening for depression at the point of care and via low-cost mail and web surveysTraining real-world clinicians to deliver a structured behavioral activation intervention. Delivering a structured psychotherapy intervention via telephone contacts and in-person visitsAssessing outcomes via low-cost web-based interactive voice response surveys. In a population-based sample of pregnant women with current depression, conduct a randomized comparison of a structured Behavioral Activation intervention to care as usual in order to evaluate feasibility and acceptability – and make a preliminary comparison of effectiveness. |
| Description of study sample: Women with moderate or greater symptoms of depression were identified either by visit-based screening (by OB clinic staff at first prenatal visits) or mailed screening (of all pregnant women during the first and/or second trimester). Using various methods of recruitment, women were randomized into this study to usual care or to the intervention. For all participating sites, 163 women participated in the randomized trial. Follow-up surveys were completed for all participating sites with the completion of the last 3-month post-partum surveys. Only 9 participants out of the 163 women who were enrolled at all the sites were lost to follow-up (filled out the baseline but did not complete any follow-ups), 6 in the intervention group and 3 in the usual care group. |
| Current Status: Nurse practitioners, nurse midwives, and mental health therapists were trained to deliver 10 telephonic sessions of behavioral activation (BA) therapy to women screening positive for depression at prenatal visits who are randomized to the BA arm of the trial. An efficient web-based survey using the DatStat platform was developed and used to collect data on several measures from participants at enrollment, 5 and 10 weeks, and 3 months post-partum. |
| Study Registration: NCT01401231 |
| Publications: Dimidjian, S, Goodman, SH, Sherwood, NE, Simon, G, Ludman, S, Gallop, R, Welch, SS, Boggs, JM, Metcalf, CM, Hubley, S, Beck, A. (2016) A Pragmatic Randomized Clinical Trial of Behavioral Activation for Depressed Pregnant Women. Journal of Consulting and Clinical Psychology. In Press. |
| Resources: N/A |
| Lessons Learned: The most efficient recruitment procedure was developed and implemented at HP, involving large mailings of PHQ9 surveys to women scheduled for prenatal visits. Recruitment is also being done at the point of care at KPCO, GHC, and KPGA, when women are given the PHQ9 or EPDS to assess their level of depression symptoms. Nurse practitioners and midwives can be trained to deliver BA with an acceptable level of fidelity. Telephonic BA is feasible and acceptable to participants. Compared to treatment as usual, patient randomized to the behavioral activation group, had significantly lower depressive symptoms and higher remission rates. Behavioral activation also showed significant reductions in symptoms of anxiety and perceived stress. |
| What’s next? Following this trials demonstration of the acceptability and effectiveness of behavioral activation delivered by allied health providers, the study teams approached the OB-GYN departments at each institution regarding implementation of a BA intervention in the OB-GYN setting. While there was recognition of the effectiveness of the BA model for perinatal depression, implementation of an operation program was met with hesitancy regarding financial and logistical hurdles. Specific barriers included a lack of continued funding for the BA clinicians employed during the study and coordination hurdles surrounding nurses or other allied health professionals taking time away from their current job roles to provide BA for women with depression. Therefore, the study team took this feedback and Sona Dimidjian proposed a new study using peer specialists who would be trained in BA combined with research to practice engagement methods. This R34 was funded in September, 2016 for 3 years. The goals of this study are to engage all stakeholders in the design of a Peer BA intervention for perinatal and post-partum depression using research to practice frameworks to better facilitate successful adoption following the trial. Stakeholders include patients, OB-GYN, Behavioral Health, and other relevant departments at KPCO. |
Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
| Project Name: Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt |
| Principal Investigator: Greg Simon, MD, MPH |
| Principal Investigator Contact Information: Gregory.E.Simon@kp.org |
| Principal Investigator institution: Kaiser Permanente Washington |
| Funder NIMH |
| Funding Period: 09/2014 – 07/2020 |
| Abstract: Suicide ranks 10th among all causes of mortality in the US, accounting for over 38,000 deaths in 2010. Non-fatal suicide attempts result in 600,000 emergency room visits and nearly 200,000 hospitalizations each year. Recent developments have opened new opportunities to develop and evaluate population-based selective prevention programs for suicidal behavior. First, increasing use of standard depression severity measures and recording of results in electronic medical records will allow timely and efficient identification of people at risk for suicidal behavior. Second, efficient and scalable interventions (both structured risk assessment/care management programs and low-intensity emotion regulation skills training) have shown promise for reducing risk of suicide attempt in at-risk populations. Third, the NIMH-funded Mental Health Research Network has established an infrastructure to adequately evaluate population-based prevention. We will conduct a large, pragmatic trial to examine two specific selective prevention programs. Both programs are based in a re-conceptualization of suicidal ideation as an enduring vulnerability rather than a short-term crisis. The trial will be conducted in 4 large, integrated health care systems. We propose to enroll up to 19,500 adults for whom responses to item 9 of the PHQ depression scale (regarding thoughts of death or suicide) indicate elevated risk. Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: An outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways. An online psychoeducational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence. Both programs are supplements to usual care. Both programs will capitalize on existing electronic records to improve efficiency and assure quality. The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records. A pragmatic trial of selective prevention would fill a major gap in current suicide prevention efforts. Methods developed in this trial should dramatically accelerate future suicide prevention research. |
| Grant Number: UH3007755 |
| Participating Sites: Kaiser Permanente Washington Kaiser Permanente Northwest Kaiser Permanente Colorado HealthPartners |
| Investigators: Greg Simon, MD Rebecca Rossom Arne Beck Greg Clarke |
| Major Goals: To conduct a large, pragmatic trial to examine two population-based programs to prevent suicide attempt. Participants will be randomly assigned to continued usual care or usual care supplemented by one of the two prevention programs: an outreach and care management program (via secure messaging and telephone) including structured assessment linked to specific care pathways, or an online psycho-educational program focused on development of emotion regulation skills and prevention of suicidal behaviors, supported by coaching to promote engagement and adherence. The primary outcome will be suicide attempt (fatal or non-fatal) during 18 months following enrollment – ascertained automatically from computerized records. The trial will be conducted in 4 health systems: Kaiser Permanente Washington, Kaiser Permanente Colorado, Kaiser Permanente Northwest and HealthPartners. |
| Description of study sample: Adult outpatients who completed a PHQ depression questionnaire in the previous week and reported thoughts of death or self-harm “most of the days” or “nearly every day.” |
| Current Status: A total of 18,887 participants were enrolled, intervention procedures will continue through Fall 2019. |
| Study Registration: NCT02326883 |
| Publications: Shortreed SM, Rutter CM, Cook AJ, Simon GE. Improving pragmatic clinical trial design using real-world data. Clin Trials. 2019 Jun;16(3):293-282. Simon GE, Beck A, Rossom RC, Richards JR, Kirlin B, Shulman L, King D, Ludman EJ, Penfold R, Shortreed SM, Whiteside US. Population-Based Outreach Versus Care As Usual To Prevent Suicide Attempt: Study Protocol for a Randomized Controlled Trial. Trials. 2016 Sep 15;17(1):452.Whiteside U, Lungu A, Richards J, Simon GE, Clingan S, Siler J, Snyder L, Ludman E. Designing messaging to engage patients in an online suicide prevention intervention: survey results from patients with current suicidal ideation. J Med Internet Res. 2014 Feb 7;16(2):e42. |
| Resources: Specifications for defining suicide attempts are available at: https://github.com/MHResearchNetwork/MHRN-Central |
| Lessons Learned: Transferring registry tools between health system Epic EMRs was more complicated than anticipated. |
| What’s next? The target for completing primary analyses is Summer 2020. |
Reducing Excess Cardiovascular Risk in People with Serious Mental Illness
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Project Name: Reducing Excess Cardiovascular Risk in People with Serious Mental Illness |
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Principal Investigator: Rebecca Rossom, MD, MS |
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Principal Investigator Contact Information: Rebecca.C.Rossom@HealthPartners.com |
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Principal Investigator institution: HealthPartners, Minneapolis, MN |
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Funder NIMH |
| Funding Period: 08/2014 – 06/2019 |
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Abstract: People with serious mental illness (SMI) (schizophrenia, schizoaffective disorder, bipolar disorder) die, on average, 20 years earlier than their peers. Cardiovascular (CV) disease is the predominant cause. Primary care clinicians are often unaware of increased risk in patients with SMI and, even when they do identify elevated CV risk factors, often do not take appropriate clinical actions. Electronic health record-based clinical decision support can identify at-risk patients with SMI and systematically prompt more effective treatment of their CV risk factors, but its potential has been largely untapped. |
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Grant Number: U19MH092201 |
| Participating Sites: HealthPartners, Minneapolis, MN (Lead Site) Essentia Health, Duluth, MN Park Nicollet, Minneapolis, MN |
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Investigators: Rebecca Rossom, MD, MS Steve Waring, PhD Patrick O’Connor, MD, MS, MA JoAnn Sperl-Hillen, MD Lauren Crain, PhD Kris Kopski, MD Stephanie Hooker, PhD |
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Goals: The objectives of this project were to improve CV risk factor care in patients with SMI through a pragmatic trial of a point-of-care electronic health record-based clinical decision support system (referred to as “CV Wizard”). The trial was conducted in over 80 primary care clinics in three large healthcare systems. |
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Description of study sample: Patients enrolled in the study were ages 18-75 with diagnoses of schizophrenia, schizoaffective disorder or bipolar disorder (i.e. serious mental illness (SMI)) and were not at goal for at least one of the following reversible cardiovascular risk factors: BMI, tobacco use, LDL, blood pressure, A1c or aspirin use. |
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Current Status: The project was implemented in all 3 sites and completed patient enrollment in September 2018. A total of 11,046 patients with SMI made at least one primary care visit during the study period, and 8937 patients made at least 2 primary care visits. |
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Study Registration: ClinicalTrials.gov # NCT02451670 |
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Publications: Rossom RC, O’Connor PJ, Crain AL, Waring S, Ohnsorg K, Taran A, Kopski K, Sperl-Hillen JM. Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness. Contemp Clin Trials. 2020 Feb 20;91:105964. doi: 10.1016/j.cct.2020.105964. PubMed PMID: 32087336. Sperl-Hillen JM, Rossom RC, Kharbanda EO, Gold R, Geissal ED, Elliott TE, Desai JR, Rindal DB, Saman DM, Waring SC, Margolis KL, O’Connor PJ. Priorities Wizard: Multisite Web-Based Primary Care Clinical Decision Support Improved Chronic Care Outcomes with High Use Rates and High Clinician Satisfaction Rates. EGEMS (Wash DC). 2019 Apr 3;7(1):9. doi: 10.5334/egems.284. Review. PubMed PMID: 30972358; PubMed Central PMCID: PMC6450247. |
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Resources: N/A |
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Lessons Learned: N/A |
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What’s next? Analyses and manuscript development are in progress. |
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. |