Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 16, 2022
Open Peer Review Period: Jun 14, 2022 - Aug 9, 2022
Date Accepted: Sep 15, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled assessor-blinded trial
ABSTRACT
Background:
Shared Decision Making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and the provider are actively involved in treatment decisions. In mental healthcare, SDM has been advocated as a mean for the patient to (re)gain control and responsibility over his/her life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, reminders etc.
Objective:
The present RCT investigated the effect of a digital tool to support patient activation and SDM.
Methods:
The trial was designed as a randomized, assessor-blinded, two-armed parallel-group, multi-center trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from nine outpatient treatment sites in the Capital Region of Denmark. The primary outcome was self-reported level of activation at post-intervention. The secondary outcomes included self-efficacy, hope, working-alliance, satisfaction, preparedness for treatment consultation, severity of symptoms and level of functioning. Explorative outcomes on the effect of the intervention at mid-intervention together with objective data on usage of the digital tool was collected.
Results:
A total of 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference = 4.39, CI: 0.99 to 7.79, d=0.33, p=0.01); confidence in communicating with one’s provider (mean difference = 1.85, CI: 0.01 to 3.69, d=0.24, p=0.05) and; feeling prepared for decision making (mean difference = 5.12, CI: 0.16 to 10.08, d=0.27, p=0.04). We found no effect of the digital SDM tool on treatment satisfaction; hope; self-efficacy; working alliance; severity of symptoms; level of functioning; use of antipsychotic medicine; number, or length of psychiatric hospital admissions.
Conclusions:
The present trial showed a significant effect of a digital SDM tool on subjective level of patient activation together with important secondary outcomes at post-intervention. The effect size was smaller than the 0.42 that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental healthcare. Clinical Trial: ClinicalTrials.gov NCT03554655
Citation
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