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Research ArticleOriginal Research

Intervention Stage Completion and Behavioral Health Outcomes: An Integrated Behavioral Health and Primary Care Randomized Pragmatic Trial

Kari A. Stephens, Constance van Eeghen, Zihan Zheng, Tracy Anastas, Kris (Pui Kwan) Ma, Maria G. Prado, Jessica Clifton, Gail Rose, Daniel Mullin, Kwun C. G. Chan and Rodger Kessler
The Annals of Family Medicine January 2025, 23 (1) 35-43; DOI: https://doi.org/10.1370/afm.230576
Kari A. Stephens
1Department of Family Medicine, University of Washington, Seattle, Washington
PhD
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  • For correspondence: kstephen@uw.edu
Constance van Eeghen
2Department of Medicine, University of Vermont, Burlington, Vermont
DrPH, MHSA, MBA
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Zihan Zheng
1Department of Family Medicine, University of Washington, Seattle, Washington
MS
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Tracy Anastas
1Department of Family Medicine, University of Washington, Seattle, Washington
PhD
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Kris (Pui Kwan) Ma
1Department of Family Medicine, University of Washington, Seattle, Washington
PhD
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Maria G. Prado
1Department of Family Medicine, University of Washington, Seattle, Washington
MPH
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Jessica Clifton
2Department of Medicine, University of Vermont, Burlington, Vermont
3Parhelia Wellness, Santa Rosa, California
PhD
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Gail Rose
4Department of Psychiatry, University of Vermont, Burlington, Vermont
PhD
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Daniel Mullin
5Department of Family Medicine and Community Health, UMass Chan Medical School, Worcester, Massachusetts
PsyD
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Kwun C. G. Chan
6Department of Biostatistics, University of Washington, Seattle, Washington
PhD
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Rodger Kessler
7Department of Family Medicine, University of Colorado, Denver, Colorado
PhD
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    Figure 1.

    CONSORT Diagram

    CONSORT = Consolidated Standards of Reporting Trials.

  • Figure 2.
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    Figure 2.

    Adjusted Effect of Intervention Stage Completion on Patient Health Outcomes

    GAD-7 = Generalized Anxiety Disorder 7-item scale; PHQ-9 = Patient Health Questionnaire 9-item scale; PROMIS-29 = Patient-Reported Outcomes Measurement Information System-29.

    Note: P values are not corrected for multiple comparisons. Positive estimates indicate that the completion of each additional intervention stage is associated with a higher outcome score; negative estimates indicate that the completion of each additional intervention stage is associated with a lower outcome score.

    a P < .05.

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    Figure 3.

    Adjusted Effect of Intervention Stage Completion on Integration Level

    PIP = Practice Integration Profile.

    Note: P values are not corrected for multiple comparisons. Positive estimates indicate that the completion of each additional intervention stage is associated with a higher outcome score; negative estimates indicate that the completion of each additional intervention stage is associated with a lower outcome score.

    a P <.05.

    b P <.01.

    c P <.001.

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    Table 1.

    Patient Characteristics and Outcomes at Baseline

    Overall (N = 2,945)Active site (n = 1,190)Control site (n = 1,755)P Value
    Age, y, mean (SD)61.8 (13.3)61.7 (12.8)61.8 (13.6).90
    Sex, No. (%).11
        Female1,884 (64.0)742 (62.4)1,142 (65.1)
        Male1,054 (35.8)448 (37.6)606 (34.5)
    Race, No. (%).001a
        American Indian or Alaskan Native30 (1.0)12 (1.0)18 (1.0)
        Asian94 (3.2)51 (4.3)43 (2.5)
        Black or African American356 (12.1)160 (13.4)196 (11.2)
        Native Hawaiian/other Pacific Islander42 (1.4)23 (1.9)19 (1.1)
        Other/prefer not to say202 (6.9)91 (7.6)111 (6.3)
        White2,215 (75.2)849 (71.3)1,366 (77.8)
    Ethnicity, No. (%).70
        Hispanic240 (8.1)103 (8.7)137 (7.8)
        Non-Hispanic2,660 (90.3)1,068 (89.7)1,592 (90.7)
        Prefer not to say29 (1.0)12 (1.0)17 (1.0)
    Marital status, No. (%).06
        Never married489 (16.6)186 (15.6)303 (17.3)
        Married1,286 (43.7)550 (46.2)736 (41.9)
        Living as married76 (2.6)26 (2.2)50 (2.8)
        Separated81 (2.8)23 (1.9)58 (3.3)
        Divorced638 (21.7)260 (21.8)378 (21.5)
        Widowed366 (12.4)141 (11.8)225 (12.8)
    Employment, No. (%).02a
        Full-time562 (19.1)249 (20.9)313 (17.8)
        Part-time240 (8.1)85 (7.1)155 (8.8)
        Retired1,029 (34.9)407 (34.2)622 (35.4)
        Disabled783 (26.6)316 (26.6)467 (26.6)
        Homemaker107 (3.6)39 (3.3)68 (3.9)
        Student20 (0.7)2 (0.2)18 (1.0)
        Unemployed/looking for jobs94 (3.2)33 (2.8)61 (3.5)
        Other4 (0.1)1 (0.1)3 (0.2)
    Annual household income, No. (%).02a
        <$15,000871 (29.6)344 (28.9)527 (30.0)
        $15,000-$29,999625 (21.2)249 (20.9)376 (21.4)
        $30,000-$44,999333 (11.3)121 (10.2)212 (12.1)
        $45,0000-$59,999215 (7.3)81 (6.8)134 (7.6)
        $60,000-$74,999219 (7.4)85 (7.1)134 (7.6)
        ≥$75,000533 (18.1)253 (21.3)280 (16.0)
    Education, No. (%).98
        <9th grade84 (2.9)36 (3.0)48 (2.7)
        9th-12th grade, no diploma271 (9.2)110 (9.2)161 (9.2)
        High school graduate (including GED)1,217 (41.3)485 (40.8)732 (41.7)
        Associate degree450 (15.3)185 (15.5)265 (15.1)
        Bachelor degree446 (15.1)186 (15.6)260 (14.8)
        Graduate or professional degree406 (13.8)162 (13.6)244 (13.9)
    Chronic condition, No. (%)
        Arthritis1,239 (42.1)505 (42.4)734 (41.8).77
        Asthma650 (22.1)276 (23.2)374 (21.3).24
        Chronic obstructive pulmonary disease422 (14.3)162 (13.6)260 (14.8).36
        Chronic pain2,037 (69.2)824 (69.2)1,213 (69.1).17
        Diabetes (nongestational)1,335 (45.3)512 (43.0)823 (46.9).04a
        Heart failure243 (8.3)96 (8.1)147 (8.4).80
        Hypertension2,434 (82.6)999 (83.9)1,435 (81.8).13
        Irritable bowel syndrome127 (4.3)61 (5.1)66 (3.8).08
        Anxiety1,016 (34.5)420 (35.3)596 (34.0).48
        Depression1,418 (48.1)570 (47.9)848 (48.3).85
        Insomnia734 (24.9)314 (26.4)420 (23.9).14
        Substance use disorder714 (24.2)299 (25.1)415 (23.6).38
        Tobacco use574 (19.5)233 (19.6)341 (19.4).92
        Alcohol use disorder201 (6.8)88 (7.4)113 (6.4).32
        No. of chronic conditions, mean (SD)4.4 (1.7)4.5 (1.7)4.4 (1.6).17
    Neighborhood characteristic (home census tract)
        Social Deprivation Index, mean (SD)53.5 (27.8)52.4 (29.1)54.2 (27.0).09
        Urban, No. (%)2,329 (79.1)989 (83.1)1,340 (76.4)<.001a
        Population density, persons/square mile, mean (SD)3,900 (6,670)5,130 (9,510)3,090 (3,350)<.001a
        Food insecurity, No. (%)366 (12.4)130 (10.9)236 (13.4).04a
        Housing insecurity, No. (%)97 (3.3)37 (3.1)60 (3.4).68
        Financial insecurity, No. (%)697 (23.7)266 (22.4)431 (24.6).14
    Drinking category, No. (%).78
        Nondrinker1,264 (42.9)466 (39.2)798 (45.5)
        Drinker673 (22.9)240 (20.2)433 (24.7)
        Unsafe drinker205 (7.0)78 (6.6)127 (7.2)
    Primary outcomes – PROMIS-29 T-scores, mean (SD)
        Anxiety54.1 (10.1)54.2 (10.1)54.0 (10.1).77
        Depression53.0 (9.8)52.9 (9.7)53.0 (10.0).85
        Fatigue52.7 (10.4)52.5 (10.3)52.8 (10.4).42
        Sleep disturbance53.2 (8.9)53.3 (9.0)53.2 (8.9).64
        Pain interference58.3 (10.1)58.3 (10.0)58.4 (10.2).77
        Pain intensity4.5 (2.8)4.5 (2.8)4.5 (2.8).98
        Social participationb48.1 (10.0)48.1 (10.0)48.1 (10.1).85
        Physical functionb43.2 (9.5)43.5 (9.4)43.0 (9.5).17
    Secondary outcomes, mean (SD)
        PHQ-9 total score6.6 (6.1)6.6 (6.2)6.5 (6.1).84
        GAD-7 total score4.7 (5.3)4.8 (5.4)4.6 (5.3).38
    • GAD-7 = Generalized Anxiety Disorder 7-item scale; GED = General Educational Development test; PHQ-9 = Patient Health Questionnaire 9-item scale; PROMIS-29 = Patient-Reported Outcomes Measurement Information System-29.

    • ↵a P < .05. P value for 2-sample t test used for continuous variables and χ2 tests used for categorical variables.

    • ↵b Higher score is better.

    • View popup
    Table 2.

    Practice Characteristics and Outcomes at Baseline

    Overall (N = 42)Intervention arm (n = 20)Control arm (n = 22)P Value
    Practice specialty, No. (%).85
        Internal medicine7 (17)3 (15)4 (18)
        Family medicine20 (48)9 (45)11 (50)
        Mixed15 (36)8 (40)7 (32)
    Organization type, No. (%)
        Community health center15 (36)8 (40)7 (32).82
        Hospital20 (48)10 (50)10 (46).77
        Private4 (10)1 (5)3 (14).67
        Academic19 (45)10 (50)9 (41).78
        Resident training site, No. (%)16 (38)9 (45)7 (32).58
        Nonprofit, No. (%)37 (88)19 (95)18 (82).40
    Geographic region, No. (%).88
        Pacific Northwest3 (7)1 (5)2 (9)
        Mountain8 (19)4 (20)4 (18)
        South8 (19)4 (20)4 (18)
        New England9 (21)3 (15)6 (27)
        Mid-Atlantic and Great Lakes6 (14)3 (15)3 (14)
        West Coast and Hawaii8 (19)5 (25)3 (14)
    Urban by RUCA, No. (%)35 (83)18 (90)17 (77).49
    County Social Deprivation Index, mean (SD)44.9 (22.0)46.4 (23.3)43.5 (21.1).68
    Patients cared for by practice each year, mean (SD)9,285 (5,066)9,138 (4,549)9,419 (5,599).86
    Baseline BHP FTE, mean (SD)1.5 (1.1)1.7 (1.4)1.3 (0.7).18
    Baseline PCP FTE, mean (SD)6.0 (3.2)5.9 (2.7)6.1 (3.6).83
    Baseline BHP FTE:PCP FTE, mean (SD)0.30 (0.26)0.35 (0.28)0.26 (0.24).27
    Baseline PIP total, mean (SD)61.0 (17.4)60.4 (15.6)61.7 (19.1).62
    PIP–workflow, mean (SD)50.3 (21.9)48.7 (20.8)51.9 (23.0).35
    PIP–clinical services, mean (SD)60.4 (21.1)61.8 (19.8)59.0 (22.5).41
    PIP–workspace, mean (SD)87.6 (18.2)87.3 (15.2)87.9 (20.9).82
    PIP–integration, mean (SD)53.6 (23.3)52.1 (21.6)55.1 (24.9).42
    PIP–patient identification, mean (SD)66.8 (22.6)65.4 (21.4)68.1 (23.8).46
    PIP–patient engagement, mean (SD)47.5 (22.8)46.8 (21.1)48.2 (24.5).70
    • BHP = behavioral health provider; FTE = full-time equivalent; PCP = primary care physician; PIP = Practice Integration Profile; RUCA = Rural Urban Commuting Area Codes.

    • Note: P value for 2-sample t test used for continuous variables, and χ2 tests used for categorical variables.

    • a P < .05.

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  • PLAIN-LANGUAGE SUMMARY

    Original Research

    Flexible Practice-Centric Approach Improves Behavioral Health Integration in Primary Care Practices 

    Background and Goal: Many patients with mental health needs receive care in primary care settings rather than from specialized settings. Integrated behavioral health (IBH), which combines behavioral health and primary care, improves patient outcomes and experience. However, implementing IBH is challenging due to the need for practice-specific changes. This study evaluated whether a tailored, toolkit-based intervention could improve IBH and patient outcomes in primary care practices serving patients with multiple chronic medical and behavioral health conditions.

    Study Approach: The study used a cluster randomized controlled trial design. Practices were randomized into two groups. The intervention arm received a comprehensive toolkit that included four components: workbooks to guide the quality improvement project, online education tailored to specific practice personnel roles, an online learning community to facilitate collaboration, and remote coaching provided by a trained quality improvement professional paired with a psychologist experienced in IBH. The control arm continued with their usual IBH services without receiving additional support. Completion of the toolkit stages—planning, workflow redesign, and implementation—was measured. Patient outcomes, including physical and mental health, and practice integration levels, assessed through Practice Integration Profile scores, were evaluated over a two-year period.

    Main Results: A total of 42 practices were randomized in the study with one practice unable to provide eligible patient data and therefore not included in the patient-level analysis. 

    • Practices completing more intervention stages showed significant improvements in IBH integration, particularly in workflows, integration methods, and patient identification.

    • No significant clinically relevant differences were found in patient health outcomes—including depression, anxiety, fatigue, sleep disturbance, pain, pain interference, and physical function—between the intervention and control groups. 

    Why It Matters: The findings from this study suggest that a practice-centered, flexible intervention may help primary care practices tailor behavioral health integration to their specific needs, which may lead to better systems of care. 

    Intervention Stage Completion and Behavioral Health Outcomes:  An Integrated Behavioral Health and Primary Care Randomized Pragmatic Trial

    Kari A. Stephens, PhD, et al 

    Department of Family Medicine, University of Washington, Seattle, Washington

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The Annals of Family Medicine: 23 (1)
The Annals of Family Medicine: 23 (1)
Vol. 23, Issue 1
January/February 2025
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Intervention Stage Completion and Behavioral Health Outcomes: An Integrated Behavioral Health and Primary Care Randomized Pragmatic Trial
Kari A. Stephens, Constance van Eeghen, Zihan Zheng, Tracy Anastas, Kris (Pui Kwan) Ma, Maria G. Prado, Jessica Clifton, Gail Rose, Daniel Mullin, Kwun C. G. Chan, Rodger Kessler
The Annals of Family Medicine Jan 2025, 23 (1) 35-43; DOI: 10.1370/afm.230576

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Intervention Stage Completion and Behavioral Health Outcomes: An Integrated Behavioral Health and Primary Care Randomized Pragmatic Trial
Kari A. Stephens, Constance van Eeghen, Zihan Zheng, Tracy Anastas, Kris (Pui Kwan) Ma, Maria G. Prado, Jessica Clifton, Gail Rose, Daniel Mullin, Kwun C. G. Chan, Rodger Kessler
The Annals of Family Medicine Jan 2025, 23 (1) 35-43; DOI: 10.1370/afm.230576
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