Abstract
People with severe and persistent mental illness (SPMI) frequently struggle to maintain their recovery from recurring suicidality, psychosis, and debilitating mood episodes. They also face a high risk of chronic health conditions. Traditional — often short-term — psychiatric care is ill-equipped to meet the health needs of people with SPMI. Patients often require regular and sustained follow-up to support medication effectiveness and adherence and to screen for and treat cardiovascular disease and other common health risks. Kaiser Permanente Northern California has implemented a novel telehealth-based collaborative care program, SPMI Population Care, led by advanced practice clinical pharmacists, to improve the mental and physical health of its patients with SPMI. Although the individual program components of telehealth, collaborative care, and clinical pharmacy service have been employed successfully in the past for mental health care, the SPMI Population Care model combines the components and extends this approach to individuals at the most severe end of the psychiatric illness spectrum.
More than 7 million adults in the United States have schizophrenia, schizoaffective disorder, or bipolar illness, known as severe and persistent mental illnesses (SPMIs), prevalence statistics show.1–4 These conditions are among the leading causes of disability worldwide and are associated with manifold higher risk of suicide.5–7 Well-managed pharmacotherapy can provide long-term recovery from these conditions, but successful treatment eludes many. Roughly half of individuals with SPMI do not take psychiatric medications at the prescribed frequency due to reasons including forgetfulness, adverse side effects, negative medication perceptions, low illness insight, economic barriers, and social stigma.8,9 Finding the right regimen often entails a comprehensive process of medication modifications, dose adjustments, and continuous medication-related health screening. Patients who discontinue psychotropic medications are more likely to attempt suicide and require inpatient hospitalization.10,11 A relationship with a trusted provider who regularly tracks progress and adjusts treatments based on clinical assessments can help patients persist with a lifesaving treatment.12
Better engagement with health care services can also safeguard physical health. People with SPMI face social stigma and potential clinician biases that interfere with provision of evidence-based care.13 Prevention care gaps — such as low levels of cardiovascular risk factor management — have been documented for this population across health system types.14,15 Not unlike the U.S. population as a whole, the leading causes of death among individuals with SPMI are cardiovascular disease and other natural causes, but people with SPMI face a 10- to 25-year shortened life span relative to the general population.16,17 To improve adherence to psychiatric regimens, prevent serious, adverse medication side effects, and ensure that patients receive timely disease prevention care, we developed a population-based treatment model, SPMI Population Care, which uses advanced practice clinical pharmacists to serve as care continuity navigators for patients with SPMI. This novel program extends the advantages of collaborative care and telehealth to a more psychiatrically severe population than is typically served by chronic illness management programs. Drawing on the resources of our large, integrated health care system, this program helps patients engage with services provided by a multidisciplinary clinical team (Figure 1).
FIGURE 1. Collaborative Care Led by Advanced Practice Clinical Pharmacists.
The advanced practice clinical pharmacist is at the center of the severe and persistent mental illness (SPMI) Population Care model and serves as the care continuity navigator for patients while collaborating with a multidisciplinary team on care delivery.
Source: The authors
NEJM Catalyst (catalyst.nejm.org) © Massachusetts Medical Society
Clinical pharmacists in this program have specialized psychiatric training and experience allowing them to foster rapport with patients with SPMI, manage their psychotropic medications, monitor their progress, ensure they receive recommended health screenings (such as glycemic and other cardiovascular risk factor monitoring), and facilitate patients’ engagement in evidence-based psychiatric care, primary care, and disease prevention services. By deploying advanced practice clinical pharmacists, our program also helps alleviate the care access challenges caused by a nationwide shortage of psychiatrists.18
“Because specialty psychiatric care serves as a de facto medical home for many patients with SPMI, a lack of psychiatric care engagement can also reduce the likelihood that nonpsychiatric health issues will be detected and treated.”
Reaching People with SPMI
Kaiser Permanente Northern California (KPNC) is a large, integrated health care delivery system serving more than 4 million patients within 21 medical centers in 15 service areas. Approximately 27,000 of our patients have schizophrenia, schizoaffective disorder, or bipolar disorder and are deemed at high risk for long-term, severe psychiatric illness and physical health comorbidities due to lower engagement with health care services. In our health system, clinical pharmacists have been increasingly used to manage the care of patients with chronic conditions, and we recognized an opportunity to extend this model to patients with SPMI. In late 2020, we started enrolling these patients with SPMI in Population Care, starting with six medical facility service areas. During the 6-month period starting January 1, 2021, we selected 968 of these patients for our evaluation study (Table 1).
Table 1.
Program Participants Enrolled in an Evaluation Study (N = 968)
| Characteristics at program enrollment | Number (%) |
|---|---|
| Age, yr, mean (SD) | 45.5 (16.0) |
| Sex | |
| Female | 587 (60.6) |
| Male | 381 (39.4) |
| Race and ethnicity | |
| Non-Hispanic white | 527 (54.4) |
| Hispanic | 190 (19.6) |
| Asian/Pacific Islander | 101 (10.4) |
| Non-Hispanic Black | 89 (9.2) |
| Other/multiple/unknown | 61 (6.3) |
| Lives in a low-income neighborhood* | 322 (33.9) |
| Psychiatric diagnosis | |
| Schizophrenia | 145 (15.0) |
| Schizoaffective disorder | 85 (8.8) |
| Bipolar disorder | 630 (65.1) |
| Other psychotic disorder | 108 (11.1) |
| Psychotropic medications | |
| Antipsychotic | 710 (73.4) |
| Lithium | 142 (14.7) |
| Other mood stabilizer | 550 (56.8) |
| Antidepressant | 551 (56.9) |
| Benzodiazepine | 248 (25.6) |
| Prescribed ≥3 of the above medication types | 396 (40.9) |
| Low adherence to above medications** | 470 (48.6) |
| Cardiovascular disease risk factors | |
| Diabetes | 183 (18.9) |
| Prediabetes | 241 (24.9) |
| Obesity# | 296 (59.6) |
| Dyslipidemia | 439 (45.4) |
| Hypertension | 233 (24.1) |
| Smoker, current or former§ | 363 (50.8) |
| Prior-year health care utilization | |
| Psychiatric hospitalization | 86 (8.9) |
| ED use | 302 (31.2) |
| Psychiatrist visits, any | 790 (81.6) |
| 0 | 178 (18.4) |
| 1 | 180 (18.6) |
| 2 or more | 610 (63.0) |
Percentages in the table are based on number of participants with available data, which is fewer than the 968 total where noted.
Low-income neighborhood = census-based median income less than $70,000 (data missing for 1.8% of the 968 due to invalid residential addresses).
Low adherence = days covered by dispensed medications less than 80%.
Obesity = body mass index 30 kg/m2 or higher (data missing for 48.7% of the 968 due to reduced in-person care during the Covid-19 pandemic).
Smoking history was not noted in the electronic health record for 26.1% of the 968 in the year prior to program entry. Source: The authors
Our evaluation sample reflects the characteristics of our overall population of patients with these mental health conditions: majority female (61%), significant racial/ethnic diversity (46% Hispanic, Asian, Black, or other nonwhite identity), and a sizable proportion of patients living in low-income communities (34%). Many of these program participants were prescribed medications that require close monitoring given risks for metabolic deteriorations and neurological side effects (antipsychotic medications, 73%), kidney damage (lithium, 15%), and misuse or overdose (benzodiazepines, 26%). Many patients had documented cardiovascular disease risk factors, such as prediabetes (25%) and past or current tobacco use (51%). As commonly seen among patients with SPMI, engagement with mental health care was inconsistent: 37% of these patients had limited interaction with their psychiatrist within the past year; 19% attended just one visit with their psychiatrist and 18% had attended none.
Individuals with SPMI are at high risk for severe, avoidable exacerbations of psychiatric illness. We found at baseline that 49% of our evaluation cohort had low adherence to psychotropic medications. Because specialty psychiatric care serves as a de facto medical home for many patients with SPMI, a lack of psychiatric care engagement can also reduce the likelihood that nonpsychiatric health issues will be detected and treated. Lack of consistent health care may contribute to avoidable emergency care and inpatient hospitalizations. At baseline, within the past year, 31% of our evaluation participants had visited the ED (for any reason) and 9% had been hospitalized for psychiatric conditions or self-harm.
A Novel Collaborative Care Approach
Collaborative care has long been employed to treat large populations of patients with depression or anxiety who are identified during primary care visits.19–21 Collaborative care models rely on multidisciplinary teams and health information systems to manage medications, coordinate other evidence-based services such as psychotherapy, and monitor progress. Collaborative care has not been widely offered to people with SPMI, and past models have not centered the care team around pharmacological management and medication-related health screening and follow-up.22,23 We designed a collaborative care program to be delivered by advanced practice clinical pharmacists who are trained in general and psychiatric care. These clinical pharmacists provide key support for medication adherence and optimization, disease prevention services, and coordination of other evidence-based care.
“By managing a patient caseload, clinical pharmacists take ownership of the patient’s care, increasing professional autonomy and patient-centeredness.”
SPMI Population Care builds on existing KPNC innovation and infrastructure in the areas of population management, health information systems, and telehealth services.24,25 Due to robust, longitudinal electronic health records (EHRs), KPNC can identify and reach out to even disengaged patients with SPMI, facilitating routine health screenings and other prevention-oriented care. Through telephone- and video-based visits and secure messaging via an EHR-based patient portal, patients can receive more convenient and timely care from health care providers. Patients are identified on the basis of an EHR-documented SPMI diagnosis (schizophrenia, bipolar disorder, schizoaffective disorder, or other psychosis) — with minimal exclusion criteria.
Program clinical pharmacists, who are centralized in the psychiatry department of one medical facility, work closely together serving patients across Northern California. By working from a regional hub, they can reach more patients than would be possible if they were based in local clinics. After psychiatrists provide authorization to clinical pharmacists through a collaborative care practice agreement, clinical pharmacists establish a caseload of patients with SPMI whom they follow indefinitely, pacing their telehealth appointments based on the active or maintenance treatment phase. The collaborative care practice agreement allows clinical pharmacists significant autonomy to initiate, adjust, and change treatment plans and to order and monitor test parameters. Nevertheless, program clinical pharmacists stay in close contact with patients’ psychiatrists, primary care physicians, and other health care providers. The EHR organizes team communication and handoffs. Psychiatrists are routinely copied on clinical pharmacist notes. Care team providers are notified via the EHR if input and escalation is needed, and they make note addendums to document decision-making.
Clinical pharmacists provide patient-facing assessment and supports, conduct comprehensive medication management, and coordinate care that bridges psychiatric and other forms of medical care. More than 75% of clinical pharmacist visits occur through video-based contact, with the remainder over the telephone. Patients additionally report on psychiatric status and functioning through Internet-based questionnaires, which are automatically recorded in the EHR.
A major objective of the program is to engage patients in their own care. The program hires clinical pharmacists who have demonstrated not only strong psychopharmacological knowledge, but also dedication to serving people with mental illness. Working from a list of patients with these diagnoses, clinical pharmacists prioritize for contact those individuals who have not had routine visits or health screenings. These program pharmacists are assisted by pharmacy technicians in outreaching via telephone and secure message to invite patients to enroll. Pharmacists explain that they are working alongside patients’ psychiatrists, and they use motivational interviewing, a communication approach designed to overcome patients’ ambivalence about engaging in treatment. Patients’ psychiatrists also secure-message reluctant patients, which helps increase buy-in.
Clinical Pharmacists at the Center
In SPMI Population Care, the clinical pharmacist acts as the population care manager, delivering and coordinating needed follow-up services in collaboration with the multidisciplinary care team, including, for example, a psychiatrist, primary care physician, and psychotherapist. This telehealth, clinical pharmacist–led team-based care approach is used elsewhere in Kaiser Permanente to manage a range of chronic conditions such as diabetes, hypertension, and dyslipidemia.26 As with SPMI, managing these chronic conditions requires the population managers to monitor medication effects, creating a natural fit for clinical pharmacists to assume this role.
To serve the SPMI population, clinical pharmacists need general competencies in clinical pharmacy along with psychiatry expertise. After completing their PharmD training and postgraduate year (PGY) 1, they must be board-certified or eligible in psychiatric pharmacy based on a specialized PGY2 residency or equivalent clinical experience. In 2021, KPNC started a PGY2 psychiatric pharmacy residency program based in Kaiser Permanente San Jose, the first program of its kind in any Kaiser Permanente setting. The residency’s mission is to prepare clinical pharmacists to be experts in providing patient-centered pharmacy care across an array of psychiatric settings. Graduates are board-eligible in psychiatric pharmacy with a knowledge base in up-to-date psychiatric evidence-based medicine and clinical skills acquired from direct patient care in outpatient and inpatient psychiatric settings. In addition to their psychiatric rotations, residents also receive focused training in chronic pain management, consultation liaison psychiatry, addiction medicine, and geriatric psychiatry. Current electives include hospice care, HIV treatment preexposure prophylaxis medications, and child psychiatry.
“Many psychiatrists at these sites had not previously worked with an advanced practice clinical pharmacist, much less allowed a clinical pharmacist to take the lead on patient care over an indefinite period.”
Within psychiatric care, considerable research supports employing advanced practice clinical pharmacists in direct patient care. In the management of care for patients with SPMI in inpatient and outpatient settings, clinical pharmacists have demonstrated their value in improving psychiatric outcomes, care quality, and cost-effectiveness.27 Past collaborative care models for SPMI have emphasized nonpharmacological services of care coordination, health education, and psychotherapy while usually employing psychiatrists to manage psychotropic medications.22,23 In contrast, KPNC’s SPMI Population Care model puts clinical pharmacists at the center of the collaborative care structure (Figure 2).
FIGURE 2. Severe and Persistent Mental Illness Population Care: Clinical Pharmacist Roles.
The advanced practice clinical pharmacist serves three primary roles in the severe and persistent mental illness (SPMI) Population Care model: patient assessment and counseling, medication adjustment and support, and care coordination. Examples of activities under these roles are listed.
Source: The authors
NEJM Catalyst (catalyst.nejm.org) © Massachusetts Medical Society
SPMI Population Care offers care continuity — an advantage that may not occur in other team-based pharmacy care models in which the clinical pharmacist is not the prescriber of record and does not follow the patient over time. Through regular check-ins and treatment adjustments, patients can develop a relationship with a specific clinical pharmacist. This care continuity has particular importance in mental health care, in which trust and rapport are needed to overcome potential stigma. By managing a patient caseload, clinical pharmacists take ownership of the patient’s care, increasing professional autonomy and patient-centeredness.
This consistent relationship allows clinical pharmacists to see the results of past treatment decisions and make adjustments accordingly. Program clinical pharmacists address the needs of the whole person, integrating across mental and physical health domains. For example, here are snapshots of deidentified patients we call Frank and Leena:
Frank, 54 years of age, has diagnosed schizophrenia, type 2 diabetes mellitus, and hypertension. He has successfully controlled auditory hallucinations with daily antipsychotic medication and last visited his psychiatrist more than 1 year ago. At his Population Care intake, Frank screened positive for metabolic syndrome, with elevated blood pressure, hemoglobin A1c, triglycerides, and obesity. The Population Care clinical pharmacist ordered a fasting lipid panel and started Frank on an antihypertensive medication. After meeting frequently during the next 2 months to titrate this new medication, Frank screened negative for metabolic syndrome. The clinical pharmacist scheduled follow-up in 6 months.
Leena, 36 years of age, has bipolar 1 disorder and received medication management from the Population Care clinical pharmacist. Leena also vapes 12–18 mg daily, despite previous quit attempts. After being prescribed nicotine patches by the Population Care clinical pharmacist, Leena reported during 2 months of frequent follow-up visits no longer vaping. At these visits, Leena also expressed a need for more support in coping with her bipolar disorder. The Population Care clinical pharmacist referred her to a licensed therapist for psychiatric case management. Now Leena is stable with her psychiatric medications, and she meets with her case manager monthly and attends weekly group psychotherapy. The Population Care clinical pharmacist has planned routine follow-up in 6 months (maintenance care phase).
Early Results
Program clinical pharmacists manage 350–400 patients, a typical panel for clinical pharmacists in other chronic condition management programs. Each week, about 60% of program patients are in active treatment, with follow-up every 1–4 weeks. On average, patients have rated their satisfaction with their program pharmacist at 93 out of 100. We are now conducting an evaluation of SPMI Population Care among the six demonstration sites to assess program impacts and process (Figure 3).
FIGURE 3. Key Evaluation Metrics.
All outcomes are evaluated during the 12 months after program enrollment. We will compare participants’ metrics to their own historical data and to those of approximately 8,000 similar, contemporaneous, nonprogram patients with severe and persistent mental illness who receive care in medical facilities that have not yet implemented our Population Care program.
ECG = electrocardiogram.
Source: The authors
NEJM Catalyst (catalyst.nejm.org) © Massachusetts Medical Society
During the first 6 months of our evaluation study, 840 outreached patients (87%) in our sample had attended an intake appointment by video or telephone with a program clinical pharmacist to initiate treatment, with similar rates seen across SPMI diagnosis types. Among the 7% of outreached patients who declined to attend an intake appointment, some of their commonly cited reasons were the decision not to resume psychotropic medication treatment after a period of stability off medications and a preference to follow up with their psychiatrist instead. Common needs identified during intake (Table 2) were related to psychopharmacology (55%) and cardiometabolic risk factor management (72%).
Table 2.
Selected Needs Identified at Intake (N = 840 Evaluation Participants)
| Participant need | Number (%) |
|---|---|
| Psychopharmacology | 461 (54.9) |
| Medication start, stop, adjustment, or titration | 305 (36.3) |
| Discussion and tapering of benzodiazepine or hypnotic | 64 (7.6) |
| Medication adherence support | 95 (11.3) |
| Tardive dyskinesia monitoring | 20 (2.4) |
| Other side effect or adverse drug reaction | 126 (15.0) |
| Cardiometabolic risk factor screening | 606 (72.1) |
| Metabolic syndrome screening | 564 (67.1) |
| Vitals, such as directing patient to get blood pressure or weight checked | 163 (19.4) |
| Ordering new laboratory tests | 367 (43.7) |
| Suicidality and other risk management | 49 (5.8) |
| Passive suicidal ideation | 42 (5.0) |
| Active suicidal ideation | 4 (0.5) |
| Escalated to crisis management | 11 (1.3) |
Source: The authors
As of January 1, 2022, most of these patients with intakes (73%) had attended a follow-up appointment with a program clinical pharmacist within 6 months of intake. The median number of follow-up visits was 2 (range, 1–13). The program has reengaged patients who had drifted away from psychiatric care. Of the 178 intake patients without a psychiatrist visit in the prior year, 54% attended a follow-up visit with a program clinical pharmacist. As of January 2022, 11 advanced practice clinical pharmacists are participating; we expect that to increase as the program expands.
Achieving Buy-in
Success of SPMI Population Care will depend on effective collaboration. Psychiatrists who previously assumed the main role of managing pharmacological treatment for individuals with SPMI now have had to share this responsibility with clinical pharmacist colleagues. Some psychiatrists have been reluctant to relinquish control over the care of these vulnerable patients. As clinical pharmacists work from a regional hub, this reduces the opportunity for potentially trust-building in-person interactions with patients and local care teams. To encourage buy-in and foster collaboration, facility-level leadership has been critical. Before launching the program at each demonstration site, the local Chief of Psychiatry presented the program vision to colleagues and appointed a clinical champion to manage day-to-day program participation. Many psychiatrists at these sites had not previously worked with an advanced practice clinical pharmacist, much less allowed a clinical pharmacist to take the lead on patient care over an indefinite period.
“In settings where psychiatrists are scarce, clinical pharmacists can serve a critical role as care extenders as part of a multidisciplinary team, allowing physicians and other providers to work at the top of their licenses and reach more patients.”
The implementation team has helped overcome hesitation by emphasizing the wide-ranging competencies of the clinical pharmacists, that they work under an approved prescribing protocol, and that they can relieve important but time-consuming tasks such as refilling medications, ordering health screenings, managing laboratory monitoring parameters, addressing medication side effects, and answering patient questions. Through frequent check-ins with the local clinical champion, the implementation team has supported buy-in by sharing updates on improved quality metrics and high patient satisfaction scores for program participants. Clinical pharmacists continually receive performance feedback from psychiatrists and the implementation team, driving improvements and adaptations to local clinic workflows. As trust has grown, psychiatrists have begun booking their patients into clinical pharmacists’ schedules directly. All psychiatrists in participating sites have approved patients with SPMI for enrollment in the Population Care program as part of their overall care plan, with more than 95% of patients approved by psychiatrists.
Expanding the Reach of SPMI Population Care
Informed by the ongoing program evaluation, KPNC seeks to continue implementing Population Care for patients with SPMI across the Northern California region, which covers 15 service areas, each with 1 or more medical centers. Analysis of cost-effectiveness is a goal of our follow-up work. We expect that the program costs related to providing clinical pharmacy and other collaborative care services will be offset by a reduction of avoidable ED visits and hospitalizations and by improvement in health screening quality metrics, resulting in higher health plan ratings and increased patient enrollment. Preventing and managing chronic illness among patients with SPMI has substantial implications for cost savings given these patients’ high rates of emergency and hospital use for physical health conditions.28 Higher health care costs in SPMI are strongly associated with poor medication adherence,29,30 which is why adherence interventions delivered by clinical pharmacists may also contribute to program cost-effectiveness.
The rapid transition to telehealth care for mental health during the Covid-19 era has further normalized video-based interactions with psychiatric providers.31 It will be important to observe whether specific SPMI subpopulations, such as patients with psychosis, find clinical pharmacist care via telehealth acceptable. There is potential for expansion of the Population Care model to additional psychiatric populations requiring close monitoring of medications, such as individuals with attention-deficit/hyperactivity disorder.
Population Care could be adapted for other health care delivery system types such as community-based clinics. In settings where psychiatrists are scarce, clinical pharmacists can serve a critical role as care extenders as part of a multidisciplinary team, allowing physicians and other providers to work at the top of their licenses and reach more patients. In more than 60% of all counties in the United States, there are no practicing psychiatrists.32 The telehealth approach used by Population Care can bring psychiatric expertise to individuals in these underserved areas, whether directly to patients’ homes or in local clinics serving as telehealth hubs.33 In settings with less integrated information and communication systems, psychiatrists can adapt a modified Population Care approach by maintaining more control but still benefiting from clinical pharmacist expertise. For example, a psychiatrist might delegate to clinical pharmacists after the treatment plan is solidified, receiving their help with medication monitoring and preventive health screening, while overseeing care through regular case conferences.
The Population Care model is designed to meet the needs of patients who face significant health threats in the short and long term. A team-based, multidisciplinary approach holds promise for improving the overall health of people with SPMI through responsive, individualized, and integrated care across the lifespan.
Acknowledgments
Disclosures: This project was supported by The Permanente Medical Group Delivery Science Grants Program (Drs. Fazzolari and Iturralde, Principal Investigators). Dr. Iturralde is also supported by a career development award from National Institute of Mental Health (grant number: K23MH126078). Macy Shia, Natalie Slama, Jessica Leang, Sameer Awsare, and Lily T. Nguyen have nothing to disclose.
Footnotes
Editors’ Note: Esti Iturralde and Lisa Fazzolari are co-first authors on this article.
Contributor Information
Esti Iturralde, Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.
Lisa Fazzolari, The Permanente Medical Group, Kaiser Permanente Northern California, Oakland, California, USA.
Macy Shia, The Permanente Medical Group, Kaiser Permanente Northern California, Oakland, California, USA.
Natalie Slama, Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.
Jessica Leang, Department of Psychiatry, Kaiser Permanente San Jose Medical Center, San Jose, California, USA.
Sameer Awsare, The Permanente Medical Group, Kaiser Permanente Northern California, Oakland, USA.
Lily T. Nguyen, Department of Psychiatry, Kaiser Permanente San Jose Medical Center, San Jose, California, USA.
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