Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

Last updated: March 16, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Osteoporosis

Depression

Treatment

gp-multitool.de

Clinical Study ID

NCT06831994
01GY2109
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • participation in a disease management program (DMP); in Germany, DMPs have beenimplemented in outpatient care for asthma, breast neoplasms, coronary heart disease,diabetes mellitus type 1, diabetes mellitus type 2, chronic obstructive pulmonarydisease, obesity, heart failure, chronic low back pain, depression, osteoporosis,rheumatoid arthritis

  • at least two of the following coexisting conditions: Hypertension, Lipid metabolismdisorders, Chronic low back pain, Severe vision reduction, Joint arthrosis, Diabetesmellitus, Chronic ischemic heart disease, Thyroid dysfunction, Cardiac arrhythmias,Obesity, Hyperuricemia/Gout, Prostatic hyperplasia, Lower limb varicosis, Liverdiseases, Depression, Asthma/Chronic obstructive pulmonary disease, Gynaecologicalproblems, Atherosclerosis/Peripheral arterial occlusive disease, Osteoporosis, Renalinsufficiency, Cerebral ischemia/Chronic stroke, Cardiac insufficiency, Severehearing loss, Chronic cholecystitis/Gallstones, Somatoform disorders, Hemorrhoids,Intestinal diverticulosis, Rheumatoid arthritis/Chronic polyarthritis, Cardiac valvedisorders, Neuropathies, Dizziness, Dementias, Urinary incontinence, Urinary tractcalculi, Anemias, Anxiety, Psoriasis, Migraine/chronic headache, Parkinson'sdisease, Cancers, Allergies, Chronic gastritis/Gastroesophageal reflux disease,Sexual dysfunction, Insomnia, Tobacco abuse, Hypotension

Exclusion

Exclusion Criteria:

  • no capacity to consent

  • functional limitations precluding participation in the intervention (eg, loss ofvision)

  • functional limitations precluding participation in telephone interviews (eg, loss ofhearing)

  • limited German language skills precluding participation in telephone interviews

  • participation in other trials during the observation time of the evaluation study

Study Design

Total Participants: 660
Treatment Group(s): 1
Primary Treatment: gp-multitool.de
Phase:
Study Start date:
February 26, 2025
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

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