Implementation of the German Clinical Practice Guideline for Multimorbidity Using a Digital Tool in Primary Care: Pilot Cluster Randomized Clinical Trial

BACKGROUND: Clinical practice guidelines (CPGs) summarize the best available evidence in a specific field. To improve patient-centered outcomes, guidelines have to be implemented, using, for example, information and communications technology. Although there are CPGs addressing multimorbidity, there is still a lack of studies investigating their implementation. OBJECTIVE: This study aimed to evaluate whether the implementation of a CPG for multimorbidity using a digital tool is feasible and explore possible effects of this intervention. METHODS: A pilot cluster randomized clinical trial based on telephone interviews was conducted from October 25, 2023, to September 8, 2024. Patients enrolled in any disease management program who were aged ≥65 years and had at least 2 additional chronic conditions were randomly selected from 20 general practitioner (GP) practices and contacted for informed consent. Each practice was randomized after baseline interviews of all participating patients in the practice were finished. The use of a web application facilitating collection and documentation of treatment-relevant data in accordance with the German CPG for multimorbidity was compared with treatment as usual. The primary outcome was time spent in hospital. As a secondary outcome, the number of patients with at least one hospital admission was calculated. Further secondary outcomes included outpatient health care use, quality of life, patient satisfaction, and quality of care. Feasibility assessment included examination of sample size, participation rate, and compliance with the study protocol. Outcome measures were analyzed using linear, logistic, and negative binomial regressions with random intercepts for practices. RESULTS: Of 384 patients who were contacted, 123 (32%) agreed to participate, and 120 (31.3%, including 54/120, 45% in the intervention group and 66/120, 55% in the control group) completed baseline and follow-up assessments. Mean age was 75.4 (SD 6.6) years, and 51.7% (62/120) were women. The compliance rate, or the proportion of patients who were treated per protocol, was 89% (48/54). In our data, the incidence rate of hospital days was comparable in both groups (incidence rate ratio [IRR] 0.94, 95% CI 0.09-9.42; P=.96), but the odds of hospital admission were almost reduced by half in the intervention group (odds ratio 0.51, 95% CI 0.17-1.54; P=.23). Our data also suggest a higher incidence rate of GP contacts (IRR 1.13, 95% CI 0.83-1.53; P=.43) and lower incidence rate of contacts with outpatient specialists (IRR 0.79, 95% CI 0.54-1.15; P=.24) in the intervention group compared to usual care. Moreover, patients and GPs reported a better quality of care (mean difference 0.51, 95% CI -0.12 to 1.14; P=.12 and mean difference 1.19, 95% CI 0.13-2.25; P=.03, respectively) in the intervention group. CONCLUSIONS: Implementation of the CPG using a digital tool was feasible. Our data suggest that the probability of hospital admissions and contacts with outpatient specialists might be reduced and quality of care might be improved. TRIAL REGISTRATION: ClinicalTrials.gov NCT06061172; https://clinicaltrials.gov/study/NCT06061172.

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