Trials / Recruiting

RecruitingNCT06831994

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

Digital Implementation of the German S3 Clinical Practice Guideline for Primary Care of Older Patients With Multimorbidity - a Cluster-randomised Clinical Evaluation Study (Gp-multitool.de)

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 660 (estimated)

Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex: All
Age: 65 Years
Healthy volunteers: Not accepted

Summary

The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care by assessing and providing information relevant for the primary care of this patient group. This cluster-randomised clinical evaluation study examines the effectiveness of an intervention based on gp-multitool.de in general practitioner (GP) practices in Germany.

Detailed description

The web application gp-multitool.de study is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. The study intervention is based on this digital tool and aims to reduce the probability of hospital admissions (primary outcome) and their outpatient health care use, and to improve process quality of care, patients' health-related quality of life, and patient satisfaction (secondary outcomes). This cluster-randomized clinical evaluation study examines the effectiveness of the gp-multitool.de intervention in GP practices. GPs in the intervention group implement the intervention in consultations with participating patients for 12 months. Intervention GPs gain access to the digital tool, and get a brief introduction to its functionalities, a video tutorial, a written manual, and contact data of telephone support, which can be called in case of any technical or organizational problems in relation to the digital tool. In addition, they receive a short training in the intervention and a checklist of requirements defined in the study protocol. Moreover, each intervention practice will be provided with a mobile device, facilitating inclusion of patients without access to the internet. GPs in the control group receive no intervention and provide care as usual. Patients will be recruited from GP practices in urban and rural administrative districts in Germany. The evaluation study is based on telephone interviews of patients and their GPs. Practices will be randomized after the baseline assessment by an independent statistician who does not have access to the assessed patient and practice data. The primary outcome will be analyzed using a multilevel mixed-effects logistic regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models. The project staff conducting patient interviews will be blinded regarding allocation of the patient's practices.

Conditions

Interventions

Type	Name	Description
OTHER	gp-multitool.de	The intervention is based on the digital tool gp-multitool.de. The GPs can send questionnaires by email to patients and patients can fill out questionnaires at their home or in the waiting room of the practice using any digital device with browser and access to the internet. The digital tool also includes instructions for conducting a medication review. Results will be available from the computers of attending GPs. Decisions from talks between GPs and patients can be documented in the tool. The tool includes ten questionnaires: 1. patient preferences (including a. treatment goals, and b. involvement of other persons in decision making); 2. social life (including a. activities and participation, and b. social support); 3. treatment situation (including a. problems with medication, and b. treatment burden); 4. health complaints (including a. pain, b. psychiatric disorders, and c. other complaints). 5. resilience and protective behavior against heat.

Timeline

Start date: 2025-02-26
Primary completion: 2027-02-28
Completion: 2027-02-28
First posted: 2025-02-18
Last updated: 2025-06-29

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT06831994. Inclusion in this directory is not an endorsement.