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Randomized Controlled Trial
. 2023 Nov-Dec;21(6):483-495.
doi: 10.1370/afm.3027.

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions

Benjamin Littenberg  1 , Jessica Clifton  2   3 , Abigail M Crocker  2 , Laura-Mae Baldwin  4 , Levi N Bonnell  2 , Ryan E Breshears  5 , Peter Callas  2 , Prama Chakravarti  6 , Kelly Clark/Keefe  2 , Deborah J Cohen  7 , Frank V deGruy  8 , Lauren Eidt-Pearson  9 , William Elder  10 , Chester Fox  11 , Sylvie Frisbie  2 , Katie Hekman  12 , Juvena Hitt  2 , Jennifer Jewiss  2 , David C Kaelber  13   14 , Kairn Stetler Kelley  2 , Rodger Kessler  8 , Jennifer B O'Rourke-Lavoie  2 , George S Leibowitz  15 , C R Macchi  16 , Matthew P Martin  16 , Mark McGovern  17 , Brenda Mollis  4 , Daniel Mullin  9 , Zsolt Nagykaldi  18 , Lisa W Natkin  2 , Wilson Pace  19 , Richard G Pinckney  2 , Douglas Pomeroy  2 , Paula Reynolds  2 , Gail L Rose  2 , Sarah Hudson Scholle  20 , William J Sieber  12 , Jeni Soucie  20 , Terry Stancin  13 , Kurt C Stange  14 , Kari A Stephens  4 , Kathryn Teng  13 , Elizabeth Needham Waddell  7 , Constance van Eeghen  2
Affiliations
Randomized Controlled Trial

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions

Benjamin Littenberg et al. Ann Fam Med. 2023 Nov-Dec.

Abstract

Purpose: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities.

Methods: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration.

Results: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7).

Conclusion: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

Keywords: behavioral health integration; behavioral medicine; multiple chronic conditions; pragmatic clinical trial; primary care; randomized controlled trial.

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Figures

Figure 1.
Figure 1.
CONSORT participant flow diagram. CONSORT = Consolidated Standards of Reporting Trials. a Eligible but chose not to participate. b Wanted to participate but not eligible. c Eligible but volunteered to pilot the intervention before study start.
Figure 2.
Figure 2.
Effect of active group assignment on patient and practice outcomes. PIP = Practice Integration Profile; PROMIS-29 = Patient-Reported Outcomes Measurement Information System. Note: The center point of each bar is the mean adjusted effect (regression coefficient) of the intervention on a specific outcome, with the bars representing 95% CI. Values >0 indicate that the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
Figure 2.
Figure 2.
Effect of active group assignment on patient and practice outcomes. PIP = Practice Integration Profile; PROMIS-29 = Patient-Reported Outcomes Measurement Information System. Note: The center point of each bar is the mean adjusted effect (regression coefficient) of the intervention on a specific outcome, with the bars representing 95% CI. Values >0 indicate that the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
Figure 3.
Figure 3.
Association of practice integration and patient outcomes. PIP = Practice Integration Profile. Note: The center point of each bar is the mean adjusted association (regression coefficient) of the baseline median total PIP score with specific patient outcomes, adjusting for potential confounders and using a random intercept for each practice. The bars represent 95% CI. Values >0 indicate that the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
Figure 3.
Figure 3.
Association of practice integration and patient outcomes. PIP = Practice Integration Profile. Note: The center point of each bar is the mean adjusted association (regression coefficient) of the baseline median total PIP score with specific patient outcomes, adjusting for potential confounders and using a random intercept for each practice. The bars represent 95% CI. Values >0 indicate that the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
Figure 4.
Figure 4.
Association of intervention completion in active group (n = 20) and change in practice integration and patient-reported outcomes. PIP = Practice Integration Profile; PROMIS-29 = Patient-Reported Outcomes Measurement Information System. Note: The center point of each bar is the mean adjusted effect (regression coefficient) of the completion of the intervention on a specific outcome, with the bars representing 95% CI. Values >0 indicate that completion of the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
Figure 4.
Figure 4.
Association of intervention completion in active group (n = 20) and change in practice integration and patient-reported outcomes. PIP = Practice Integration Profile; PROMIS-29 = Patient-Reported Outcomes Measurement Information System. Note: The center point of each bar is the mean adjusted effect (regression coefficient) of the completion of the intervention on a specific outcome, with the bars representing 95% CI. Values >0 indicate that completion of the intervention was associated with an increase in the outcome measured. Bars that do not cross 0 indicate statistical significance (P < .05). a Greater score indicates improved outcome.
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