Testing normalization process theory in a randomized trial of mental health clinics implementing digital...

Area of Science:

• Implementation Science
• Healthcare Management
• Health Services Research

Background:

• Normalization Process Theory (NPT) is a leading framework for understanding intervention sustainability in healthcare.
• Few NPT predictions have undergone rigorous hypothesis testing.
• This study addresses this gap by testing NPT's core tenets in a real-world trial.

Purpose of the Study:

• To test if NPT's generative mechanisms (coherence, cognitive participation, collective action, reflexive monitoring) can be modified by implementation strategies.
• To determine if greater enactment of these NPT mechanisms predicts future sustainment of complex health interventions.

Main Methods:

• A hybrid type 3 effectiveness-implementation trial randomized 21 mental health clinics to different implementation strategies.
• The Leadership and Organizational Change for Implementation (LOCI) strategy was tested against training and technical assistance alone.
• Clinicians (N=144) completed the Normalization MeAsure Development (NoMAD) questionnaire; clinic-level sustainment of digital measurement-based care was tracked for 16 months.

Main Results:

• The organizational implementation strategy significantly enhanced all NPT mechanisms (d_adj=1.08).
• Greater enactment of NPT mechanisms strongly predicted higher likelihood of sustainment (aRR=2.96) and slower decline over 16 months (b_adj=0.32, p=.032).

Conclusions:

• NPT's generative mechanisms are indeed modifiable through targeted implementation strategies.
• Increased engagement with NPT mechanisms is a significant predictor of sustained complex health intervention use.