Abstract
Background:
Individuals with bipolar disorder commonly present for treatment in primary care settings. Collaborative care and colocated specialty care models can improve quality of care and outcomes, though it is unknown which model is more effective.
Objective:
To compare 12-month treatment outcomes for primary care patients with bipolar disorder randomized to treatment with collaborative care or colocated specialty care.
Methods:
We conducted a secondary analysis of 191 patients diagnosed with bipolar disorder treated for 12 months during a comparative effectiveness trial in 12 Federally Qualified Health Centers in 3 states. Characteristics and outcomes were assessed at enrollment and 12 months. The primary outcome was mental health quality of life scores (Veterans RAND 12-Item Health Survey Mental Health Component Summary), and secondary outcomes included depression and anxiety symptom scores, euthymic mood state, and recovery. T-tests and multiple linear and logistic regression models were used.
Results:
Among participants (mean age: 40 years; 73% women), the Veterans RAND 12-Item Health Survey Mental Health Component Summary increased in both arms over 12 months (baseline: collaborative care 21.99, SD 10.78; colocated specialty 24.15, SD 12.05; 12-month collaborative care 30.63, SD 13.33; colocated specialty 34.16, SD 12.65). The mean Mental Health Component Summary change did not differ by arm (collaborative care: MΔ = 9.09; colocated specialty: MΔ = 10.73; t = −0.67, P = 0.50). Secondary outcomes also improved at 12 months compared to baseline measured by the Hopkins Symptoms Checklist (MΔ = −0.75; SD = 0.85), Generalized Anxiety Disorder-7 (MΔ = −3.92; SD = 6.48), and Recovery Assessment Scale (MΔ = 0.37; SD = 0.65) and did not differ significantly by arm. The proportion of participants with euthymic mood state increased from 11% to 25% with no statistically significant difference by arm.
Conclusions:
The effectiveness of collaborative care and that of colocated specialty care were similar. Both were associated with substantial improvements in mental health quality of life and symptom reduction.
Keywords: bipolar disorder, primary care, collaborative care, integrated care
INTRODUCTION
In the United States, individuals with bipolar disorder are just as likely to present for treatment in primary care settings as in specialty mental health care settings yet are at risk of receiving lower quality of care in primary care than in mental health specialty care.1 Access to high quality of psychiatric care and outcomes can be improved through integrated care models.2 Two such models of outpatient consultationliaison psychiatry are collaborative care, a team-based model, or colocation of psychiatrists providing direct specialty care in the primary care setting. In sites lacking geographic access to psychiatrists, such as many rural Federally Qualified Health Centers (FQHCs), telehealth delivery of psychiatric care through either a collaborative care or a colocated specialty care model can make it feasible to treat patients who may otherwise go underserved.
A recent randomized trial compared these 2 remote care models in rural primary care clinics and found similarly improved mental health quality of life over 12 months in 1004 individuals screening positive for bipolar disorder and/or posttraumatic stress disorder (PTSD).3 In this trial, randomization and analyses were based on bipolar disorder screening results.4 In a prior analysis, we found bipolar disorder screening results and psychiatrist diagnosis of bipolar disorder often did not align.5 For example, over one-half of people screening positive for bipolar disorder were not diagnosed with bipolar disorder by a psychiatrist and instead were diagnosed most commonly with depressive disorders.
Because collaborative care is known to be effective in treating individuals with depressive disorders,6 it is possible that our finding that collaborative care was just as effective as colocated specialty care for patients screening positive for bipolar disorder was driven by false positives and not by outcomes of participants accurately diagnosed with bipolar disorder by a psychiatrist. Thus, we propose investigating outcomes in the subgroup of participants diagnosed with bipolar disorder.
We propose testing a superiority hypothesis for the colocated specialty care arm because the 2 treatment arms differed in intensity of psychiatrist and psychologist involvement. In collaborative care, the psychiatrist saw each patient through interactive video to evaluate diagnosis, then worked indirectly with the primary care team including a behavioral health care manager, to guide future evaluation and treatment, without any psychologist involvement. In the colocated specialty arm, psychiatrists saw patients through interactive video directly in primary care, providing ongoing direct specialty care. Furthermore, the colocated specialty arm included psychiatrists deciding on and prescribing bipolar-disorder-specific medication treatments compared to collaborative care, which relied on primary care clinicians prescribing psychiatrist-recommended medications. Colocated specialty care also included psychologists delivering specialized cognitive behavioral therapy for bipolar depression, compared to collaborative care where behavioral health care managers offered behavioral activation.4,7
Because prior analyses were based on bipolar disorder screening results not diagnosis, and because specialist treatment intensities differed in the 2 arms, we conducted a secondary analysis of trial outcomes among individuals diagnosed with bipolar disorder, to test the hypothesis that patients with psychiatrist-diagnosed bipolar disorder would have better outcomes when treated in the colocated specialty arm directly by specialists than in the collaborative care arm where psychiatric care was mostly indirect.
METHODS
Clinical Trial and Participants
The Study to Promote Innovation in Rural Integrated Telepsychiatry (SPIRIT) trial was a randomized pragmatic comparative effectiveness study conducted between October 2016 and December 2020 and was registered at ClinicalTrials.gov (NCT02738944). Twelve FQHCs (safety-net primary care clinics) in 3 states (Washington, Michigan, and Arkansas) participated.4
The study enrolled adult patients seen in FQHCs who were not currently receiving specialty psychiatric care and screened positive for bipolar disorder on the Composite International Diagnostic Interview 3.08 (positive stem question responses and scores of ≥8) and/or PTSD on the PTSD Checklist9 (score of ≥14). Participating clinics implemented bipolar disorder and PTSD screening as part of a quality-improvement initiative.10 Patients in FQHCs reporting depressive symptoms in the Patient Health Questionnaire-911 (score of 10 or more) were administered the PTSD Checklist and Composite International Diagnostic Interview 3.0 embedded in the electronic health record. There were few exclusion criteria (age younger than 18 years, unable to communicate in English or Spanish, incapacity to consent, no future FQHC visit/care planned, already being prescribed psychotropic medication treatment by psychiatrist or psychiatric nurse practitioner at baseline).
The study protocol was approved by the institutional review boards at the University of Washington. Participating FQHCs obtained a Federalwide Assurance, allowing FQHC staff to be fully engaged in research activities. Additional methods are reported.4
Procedures and Data Collection
Individuals screening positive on one or both instruments and consenting to participate were randomized to receive treatment with collaborative care or colocated specialty. Randomization used blocking and stratification by FQHC and screening results. For this secondary subsample analysis, we included only those patients who had an encounter with a psychiatrist and were diagnosed with bipolar disorder (n = 191).
For these analyses, we focused on participant demographic and clinical characteristics and outcomes assessed at enrollment prior to randomization and outcomes assessed 12 months later. Surveys were administered by trained research assistants (masked to treatment group assignment) using structured telephone or web-based surveys.4 The primary outcome was change in Veterans RAND 12-Item Health Survey Mental Health Component Summary12 scores between baseline and 12 months. The Veterans RAND 12-Item Health Survey Mental Health Component Summary is a 12-item measure used to assess health-related quality of life through mental and physical health components of quality-of-life T-scores. Secondary outcomes were depressive symptoms, proportion with euthymic mood state, anxiety symptoms, and recovery. Depressive symptoms were assessed using the Hopkins Symptom Checklist Depression Scale13 score, a 20-item measure with a 0–4 response scale, with higher mean scores indicating higher symptom levels. Euthymic mood state was classified by the Internal State Scale V2.0,14 a 15-item measure that classifies mood state. Anxiety symptoms were assessed by the Generalized Anxiety Disorder-715 score, a 7-item measure with a 0–3 response scale, with higher sum scores reflecting greater symptom levels. Recovery was measured by the mean Recovery Assessment Scale16 score, a 24-item measure of recovery from serious mental illnesses with a 1–5 response scale, with higher scores indicating better recovery.
Description of Trial Interventions
The colocated specialty arm (n = 80) included an initial clinic visit with a study telepsychiatrist from the participating state medical school to establish diagnosis and develop a treatment plan. There was no specified frequency of follow-up appointments, rather, psychiatrists could determine appointment frequency with participants based on clinical need. Psychiatrists prescribed medication treatment to participants and ordered studies through each clinic’s electronic health record. Patients referred to telepsychologists received psychotherapy treatment including cognitive behavioral therapy for bipolar depression. Measurement-based care using symptom measures11,17 was encouraged.
The collaborative care arm (n = 111) included delivery of team-based care, monitoring of the collaborative care patient population, and measurement-based care. On-site clinic behavioral health care managers provided care management, behavioral activation psychotherapy, psychoeducation, outreach, and treatment engagement. Off-site telepsychiatrist consultants from the participating state medical school conducted initial diagnostic patient assessments and subsequent systematic case reviews during weekly meetings with the behavioral health care manager and provided treatment recommendations for the primary care providers and behavioral health care manager to execute. They also helped to problem-solve system issues in collaborative care delivery. Primary care providers communicated with the behavioral health care managers about patients and were responsible for prescribing medications and providing additional workup based on the psychiatrist’s recommendations.
In both arms, psychiatrists and psychologists were credentialed to practice in the FQHCs, which included access to participants’ electronic medical records.18 Behavioral health care managers in the collaborative care arm were employed by clinics and worked within the FQHC. Study visits with psychiatrists and psychologists occurred in primary care via interactive video. Clinical diagnoses were determined at the time of initial consultation and assigned by psychiatrists in both study arms, then entered into a web-based clinical registry.5,19 No structured clinical interviews were used.
Data Analysis
Diagnosis and utilization data were extracted from the web-based clinical registry and merged with survey data. Outcome scores from baseline and 12-month survey data were used. Change scores were created for outcomes, then t-tests with a Satterthwaite correction were used to test differences between study arms. We also conducted sensitivity analyses using linear and logistic regression models to predict 12-month outcome scores or proportions. To account for randomization stratification (design effects), models were stratified by health center and screening status using proc survey reg and proc survey logistic in SAS version 9.4 (SAS Institute, Cary, NC). To address missing data (up to 37% on outcome variables), multiple imputation (100 iterations) using proc MI and proc MI analyze in SAS was used. The imputation model was stratified by health center and screening status to ensure convergence with the analytic model. All sensitivity analytic models were run adjusting for baseline scores. We also ran each model with and without race and ethnicity, gender (woman or man), gender identity (trans/nonbinary or cisgender), socioeconomic status, and rurality as covariates.
RESULTS
Baseline demographic and clinical characteristics are shown in Table 1. Participants’ mean age was 40 years, with 73% of participants self-identifying as women and 64% living below the 2016 Federal poverty threshold. Participants self-identified as African American or Black (18%), multiracial (9%), Native American or Alaskan Native (2%), White (65%), or another race (7%) and 12% as Hispanic. Many participants reported prior psychotropic medication or psychotherapy treatment (85%). Over 90% of participants were diagnosed with one or more concurrent psychiatric disorders at the time of psychiatrist evaluation. No significant differences existed between treatment groups across demographic variables.
TABLE 1.
Participant Characteristics
| Characteristic | Collaborative care (n = 111) | Colocated specialty (n = 80) | Overall (N = 191) |
|---|---|---|---|
| Age | |||
| Mean (SD) | 39.8 (12.2) | 41.1 (13.4) | 40.3 (12.7) |
| Gender, n (%) | |||
| Female | 80 (72.1) | 58 (74.4) | 138 (73.0) |
| Male | 29 (26.1) | 18 (23.1) | 47 (24.9) |
| Transgender or nonbinary | 2 (1.8) | 2 (2.6) | 4 (2.1) |
| Missing | 0 | 2 | 2 |
| Hispanic, n (%) | 10 (9.1) | 12 (15.2) | 22 (11.6) |
| Race, n (%) | |||
| African American or Black | 20 (18.0) | 13 (16.7) | 33 (17.5) |
| Multiracial | 9 (8.1) | 7 (9.0) | 16 (8.5) |
| Native American or Alaskan Native | 3 (2.7) | 1 (1.3) | 4 (2.1) |
| Other | 7 (6.3) | 7 (9.0) | 14 (7.4) |
| White | 72 (64.9) | 50 (64.1) | 122 (64.6) |
| Missing | 0 | 2 | 2 |
| Below poverty level, n (%) | 74 (72.5) | 51 (66.2) | 125 (69.8) |
| Rural, n (%) | 44 (39.6) | 37 (46.3) | 81 (42.4) |
| Education, n (%) | |||
| Eighth grade or less | 0 (0.0) | 1 (1.3) | 1 (0.5) |
| Some high school | 17 (15.3) | 13 (16.3) | 30 (15.7) |
| High school graduate | 31 (27.9) | 25 (31.3) | 56 (29.3) |
| Some college | 51 (45.9) | 30 (37.5) | 81 (42.4) |
| College graduate or postgraduate | 12 (10.8) | 11 (13.8) | 23 (12.0) |
| Marital status, n (%) | |||
| Divorced or separated | 44 (39.6) | 29 (36.3) | 73 (38.2) |
| Married or living with a partner | 34 (30.6) | 23 (28.8) | 57 (29.8) |
| Single, never married | 29 (26.1) | 24 (30.0) | 53 (27.7) |
| Widowed | 4 (3.6) | 4 (5.0) | 8 (4.2) |
| Employment, n (%) | |||
| Working full-time | 14 (12.7) | 16 (20.0) | 30 (15.7) |
| Working part-time | 15 (13.6) | 11 (13.8) | 26 (13.6) |
| Temporarily laid off, on strike, unemployed, or disabled | 65 (59.1) | 41 (51.3) | 106 (55.8) |
| Retired | 10 (9.1) | 9 (11.3) | 19 (9.9) |
| Student | 6 (5.5) | 3 (3.8) | 9 (4.7) |
| Missing | 1 | 0 | 1 |
| Physical health comorbidities | |||
| Mean (SD) | 4.4 (2.6) | 4.2 (2.6) | 4.3 (2.6) |
| Treatment history, n (%) | |||
| Past use of psychotherapy | 88 (81.5) | 70 (90.9) | 158 (85.4) |
| Past use of psychotropic medication | 94 (87.0) | 64 (83.1) | 158 (85.4) |
RUCA categorization C: dichotomization to create one “rural” category (approximate the standard metro definition but at the sub-county level).
Primary Outcome
The baseline Veterans RAND 12-Item Health Survey Mental Health Component Summary scores (collaborative care: M = 21.99, SD = 10.78; colocated specialty: M = 24.15, SD = 12.05) reflected mental health quality of life approximately 2.5 standard deviations below national mean. Overall, Veterans RAND 12-Item Health Survey Mental Health Component Summary scores improved and did not differ by arm (collaborative care: MΔ = 9.09, SD = 13.49; colocated specialty: MΔ = 10.73, SD = 13.11; t = −0.67, P = 0.50). These changes indicated one standard deviation in improvement in mental health quality of life. Baseline and 12-month outcomes are shown in Table 2.
TABLE 2.
Clinical Characteristics
| Characteristic | Baseline | 12-Month | ||||
|---|---|---|---|---|---|---|
| Collaborative care | Colocated specialty | Overall | Collaborative care | Colocated specialty | Overall | |
| VR-12 MCS | ||||||
| Mean (SD) | 21.99 (10.78) | 24.15 (12.05) | 22.89 (11.35) | 30.63 (13.33) | 34.16 (12.65) | 31.98 (13.14) |
| SCL-D | ||||||
| Mean (SD) | 2.48 (0.73) | 2.41 (0.72) | 2.45 (0.72) | 1.76 (0.89) | 1.63 (0.78) | 1.72 (0.85) |
| GAD-7 | ||||||
| Mean (SD) | 15.50 (4.94) | 14.71 (5.83) | 15.17 (5.33) | 11.95 (6.46) | 10.09 (6.57) | 11.28 (6.54) |
| RAS | ||||||
| Mean (SD) | 3.04 (0.61) | 3.06 (0.61) | 3.05 (0.61) | 3.35 (0.70) | 3.43 (0.55) | 3.38 (0.64) |
Note 3 items of the RAS were missing due to survey creation error.
GAD-7 = Generalized Anxiety Disorder-7; RAS = Recovery Assessment Scale; SCL-D = Hopkins Symptom Checklist–Depression; VR-12 MCS = Veterans RAND 12-Item Health Survey Mental Health Component Summary.
Secondary Outcomes
Secondary outcomes of symptom severity showed elevated depressive and anxiety symptoms in both arms at baseline. Depressive symptoms assessed by Hopkins Symptom Checklist Depression Scale scores improved in both arms and did not differ by arm (collaborative care: MΔ = −0.75, SD = 0.88; colocated specialty: MΔ = −0.75, SD = 0.80; t = 0.02, P = 0.98). Anxiety symptoms assessed by Generalized Anxiety Disorder-7 scores decreased and did not differ by arm (collaborative care: MΔ = −3.47, SD = 6.32; colocated specialty: MΔ = −4.73, SD = 6.75; t = 1.00, P = 0.32). Recovery assessed by Recovery Assessment Scale scores improved and did not differ by arm (colocated specialty: MΔ = −0.40, SD = 0.70; collaborative care: MΔ = 0.36, SD = 0.62; t = −0.35, P = 0.73). Individuals in euthymic mood state (classified by the Internal State Scale V2.0) increased from 11% to 25% and was similar in both groups. Sensitivity analyses using multiple imputation and adjusting for design effects and covariates also indicated no differences between arms.
Process of Care Outcomes
Collaborative Care
All participants had one or more telepsychiatrist encounters, and the mean (SD) number of telepsychiatrist encounters was 1.55 (1.03). A total of 110 participants (99.1%) had one or more behavioral health care manager encounters, and among these participants, the mean (SD) number of behavioral health care manager encounters was 11.8 (7.8). In addition, 107 participants (96.4%) had one or more systematic case review sessions conducted by the telepsychiatrist and behavioral health care manager, and of these, the mean (SD) number of systematic case review sessions was 6.7 (4.0).
Colocated Specialty Care
All participants had one or more telepsychiatrist encounters, and the mean (SD) number of telepsychiatrist encounters was 4.8 (3.3). A total of 51 (63.8%) had one or more telepsychology encounter, and of these, the mean (SD) number of encounters was 6.7 (4.6). Overall, participants in the colocated arm received 9.1 (6.8) telepsychiatry/telepsychology encounters per randomized participant.
DISCUSSION
We found that individuals diagnosed with bipolar disorder receiving treatment in primary care experienced significant improvements in mental health–related quality of life that were similar in 2 different treatment conditions—collaborative care and colocated care. Improvements in depressive symptoms occurred in both arms, and the proportion of individuals with euthymic mood state increased to about one-quarter of the sample. These findings are contrary to the hypothesis that randomization to colocated specialty care is associated with better outcomes in this sample.
Both treatment models compared in this trial are commonly used in outpatient consultation-liaison psychiatry. These results suggest that psychiatrists working in primary care settings can effectively care for individuals with bipolar disorder using either care model. This is an important clinical point because many clinicians and practices developing integrated care in primary care initially emphasize treatment of individuals with depressive and anxiety disorders although, in usual clinical practice, patients with bipolar disorder are commonly encountered.19 Clinicians in primary care now have evidence to support treating patients with bipolar disorder with collaborative care or colocated specialty care.
Notably, effectiveness of co-located care and that of collaborative care were similar in the trial3 overall and in this secondary analysis. We believe that both interventions were intensive-enough to substantially improve outcomes. Colocated specialty care offers strengths including direct clinical assessment and treatment decisions executed by psychiatrists. The current trial also included the treatment option of psychologist-delivered psychotherapy and measurement-based care. Collaborative care, in the current trial and in prior reports,6,20–23 includes strengths such as team-based assessment and care including a behavioral health care manager, use of a registry to monitor the clinical population,19 measurement-based care,24 multiple opportunities for clinical contact and treatment change, and psychiatrist involvement based on need. Three prior observational reports25–27 of collaborative care for primary care patients with bipolar disorder diagnoses illustrate different aspects of these strengths (e.g., structured team-based assessment and monitoring, multiple opportunities for assessment and treatment changes, and problem-solving of psychosocial stressors).
Additional process of care explanations for effectiveness of each treatment model include initial diagnostic assessment by psychiatrists5 at the start of collaborative care treatment (which is not routine in many collaborative care services and was done in the current trial due to recruiting individuals screening positive for bipolar disorder and PTSD) and consistent use of patient-reported symptom measures11,17 at clinical contacts. These strategies provided structured and regular assessment and monitoring linked to opportunities for treatment changes. Second, the behavioral health care managers in this clinical trial28 already worked in the FQHCs and were familiar with local practices, resources, and strategies to address patient psychosocial problems and worked effectively with psychiatrists and primary care providers in team-based care.29 Finally, the 12-month treatment duration provided sustained opportunity to frequently engage patients, monitor response to and adjust treatments, and flexibly (i.e., not prescribed by a treatment manual or policy) intensify treatment when needed such as by offering more frequent care manager visits in collaborative care, psychologist-delivered psychotherapy in colocated specialty care, or other clinic-based interventions.
We also previously explored medication treatment patterns in the current trial.30 We observed higher rates of anticonvulsant mood stabilizer prescription and lower rates of lithium prescription in this trial than data from outpatient psychiatrist practices in the United States.31 Factors possibly contributing to medication treatment patterns differing from national data include recruitment strategy, setting, and treatment delivered via interactive video. We found similar patterns of medication prescribing treatment in both arms, and prescribing patterns were guideline-concordant in both arms.30 This finding likely contributes to the similar outcomes observed in collaborative care and colocated specialty care.
Participant baseline depressive symptom severity in this trial was higher than that of participants in a depression collaborative care treatment trial25 although the magnitude of improvement was similar (e.g., reduction in Hopkins Symptom Checklist Depression Scale score of approximately 0.7). This suggests that primary care patients with bipolar disorder or major depression can experience similar degrees of improvement in depressive symptoms with sustained treatment in primary care.
This report is a secondary analysis and should be interpreted with that limitation in mind. Other aspects of the current trial, including sampling frame, must also be considered. This trial recruited patients from FQHCs, which often care for patient populations with elevated prevalence of social stressors and other markers of disadvantage such as poverty.4 Additionally, the trial included FQHCs in underserved geographic areas where access to specialty psychiatric care is limited.32 Notably one of the only exclusion criteria was receipt of current treatment by a psychiatrist or advanced practice psychiatric nurse practitioner, resulting in including patients who were previously unable or unwilling to engage in specialty psychiatric care. The 2 tested interventions may be especially applicable to such clinical groups. Also, this trial did not include a usual care or control arm. Details of psychotherapy treatment type and specific psychosocial interventions are lacking. Due to the lack of randomization on bipolar disorder diagnosis and differences in care strategies between the 2 arms, unmeasured characteristics of participants diagnosed with bipolar disorder may differ by arm. Although mean scores were used, the Recovery Assessment Scale was missing 3 items due to survey creation error.
CONCLUSION
Collaborative care and colocated specialty care were both associated with significant and substantial improvements in mental-health-related quality of life and symptoms in primary care patients diagnosed with bipolar disorder. Clinicians now have evidence to support treating patients with bipolar disorder in either primary care–based model. Clinics could implement the more feasible option or consider blended strategies in which patients who do not improve in one model receive treatment with the other, provided that the chosen approach is sufficiently resourced and well-implemented.
Funding:
This study was funded by the Patient-Centered Outcomes Research Institute (PCS-1406–19295) and in part by the National Center for Advancing Translational Sciences (NCATS; KL2 TR002317).
Footnotes
Conflicts of Interest: There are no conflicts of interest to report.
Prior Presentation: This manuscript was presented as an Oral Paper at the 69th Annual Meeting of the Academy of Consultation Liaison Psychiatry, Atlanta, GA (November 10, 2022 – November 12, 2022).
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