Change in Patient Outcomes After Augmenting a Low-level Implementation Strategy in Community Practices That Are Slow to Adopt a Collaborative Chronic Care Model: A Cluster Randomized Implementation Trial

Abstract

Background: Implementation strategies are essential for promoting the uptake of evidence-based practices and for patients to receive optimal care. Yet strategies differ substantially in their intensity and feasibility. Lower-intensity strategies (eg, training and technical support) are commonly used but may be insufficient for all clinics. Limited research has examined the comparative effectiveness of augmentations to low-level implementation strategies for nonresponding clinics.

Objectives: To compare 2 augmentation strategies for improving uptake of an evidence-based collaborative chronic care model (CCM) on 18-month outcomes for patients with depression at community-based clinics nonresponsive to lower-level implementation support.

Research design: Providers initially received support using a low-level implementation strategy, Replicating Effective Programs (REP). After 6 months, nonresponsive clinics were randomized to add either external facilitation (REP+EF) or external and internal facilitation (REP+EF/IF).

Measures: The primary outcome was patient 12-item short form survey (SF-12) mental health score at month 18. Secondary outcomes were patient health questionnaire (PHQ-9) depression score at month 18 and receipt of the CCM during months 6 through 18.

Results: Twenty-seven clinics were nonresponsive after 6 months of REP. Thirteen clinics (N=77 patients) were randomized to REP+EF and 14 (N=92) to REP+EF/IF. At 18 months, patients in the REP+EF/IF arm had worse SF-12 [diff, 8.38; 95% confidence interval (CI), 3.59-13.18] and PHQ-9 scores (diff, 1.82; 95% CI, -0.14 to 3.79), and lower odds of CCM receipt (odds ratio, 0.67; 95% CI, 0.30-1.49) than REP+EF patients.

Conclusions: Patients at sites receiving the more intensive REP+EF/IF saw less improvement in mood symptoms at 18 months than those receiving REP+EF and were no more likely to receive the CCM. For community-based clinics, EF augmentation may be more feasible than EF/IF for implementing CCMs.

Trial registration: ClinicalTrials.gov NCT02151331.

Figures

Figure 1:

Consort Diagram: Patient outcomes for ADEPT sites

Figure 2:

Predicted and raw means for Mental Health Quality of Life over study period, by first randomization Note: EF=External Facilitation; IF=Internal Facilitation. Raw means show values for non-imputed data with no adjustment. Error bars show 95% confidence interval for model predictions.

Figure 3:

Predicted and raw means for PHQ-9 over study period, by first randomization Note: EF=External Facilitation; IF=Internal Facilitation. Raw means show values for non-imputed data with no adjustment. Error bars show 95% confidence interval for model predictions.