JMIR Publications

ABSTRACT

Background:

Clinical practice guidelines summarize the best available evidence in a specific field. In order to improve patient-centered outcomes, guidelines have to be implemented, e.g. using information and communication technology. A strength of this approach is facilitation of complex care, e.g., for patients with multimorbidity. Multimorbidity is associated with adverse outcomes such as increased risk for hospitalizations. Although there are clinical practice guidelines (CPG) addressing multimorbidity, studies investigating their implementation are still lacking.

Objective:

To evaluate whether implementation of a CPG for multimorbidity with a digital tool is feasible and to explore possible effects of this intervention.

Methods:

A pilot cluster-randomized clinical trial based on telephone interviews was conducted from 25 October 2023 to 8 September 2024. Patients enrolled in any disease management program who were 65 years or older and had at least two additional chronic conditions, were randomly selected from 20 general practitioner (GP) practices and contacted for informed consent. Each practice was randomized after baseline data collection for every participating patient in the practice was finished. The use of a web application facilitating collection and documentation of treatment-relevant data in accordance with the CPG for multimorbidity of the German Society of General Practitioners and Family Physicians was compared with treatment as usual. Primary outcome was time spent in hospital. As secondary outcome, the number of patients with at least one hospital admission was calculated. Further secondary outcomes included outpatient healthcare use, quality of life, patient satisfaction and quality of care measured by validated indicators. Feasibility assessment included examination of sample size, participation rate, and compliance with the study protocol. Outcome measures were analyzed by linear, logistic, and negative binomial regressions with random intercepts for practices.

Results:

Of 384 patients who were contacted, 123 (32.0%) agreed to participate and were randomized and 120 patients (54 intervention, 66 control) completed baseline and follow-up assessments. Mean age was 75.4 years (SD: 6.6) and 51.7% were women. The number of patients who were treated per protocol was 48 (compliance rate: 88.9%). The incidence rate of hospital days was comparable (incidence rate ratio (IRR)=0.94,95% CI=0.09-9.42,p=0.960), but the odds of hospital admissions were almost reduced by half in the intervention group (odds ratio (OR)=0.51,95% CI=0.17-1.54,p=0.233). Incidence rate of GP contacts was higher (IRR=1.13,95% CI=0.83-1.53,p=0.428) and incidence rate of contacts with outpatient specialists was lower (IRR=0.79,95% CI=0.54-1.15,p=0.239). Quality of care was better, both, as reported by patients (mean difference (MD)=0.51,95% CI=-0.12-1.14,p=0.116) and by GPs (MD=1.19,95%CI=0.13-2.25,p=0.028).

Conclusions:

Implementation of the CPG with a digital tool was feasible. We found that the probability of hospital admissions and contacts with outpatient specialists could be reduced, and quality of care could be improved. A full-scaled cluster-randomized trial to examine these effects is warranted. Clinical Trial: ClinicalTrials.gov NCT06061172, https://clinicaltrials.gov/study/NCT06061172.