Clinical trial NCT06831994: Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma Bronchiale
Breast Neoplasms
Coronary Disease
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Pulmonary Disease, Chronic Obstructive
Obesity
Heart Failure
Chronic Low-back Pain
Depression
Osteoporosis
Rheumatoid Arthritis
Comorbidities and Coexisting Conditions
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 660
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* participation in a disease management program (DMP); in Germany, DMPs have been implemented in outpatient care for asthma, breast neoplasms, coronary heart disease, diabetes mellitus type 1, diabetes mellitus type 2, chronic obstructive pulmonary disease, obesity, heart failure, chronic low back pain, depression, osteoporosis, rheumatoid arthritis
* at least two of the following coexisting conditions: Hypertension, Lipid metabolism disorders, Chronic low back pain, Severe vision reduction, Joint arthrosis, Diabetes mellitus, Chronic ischemic heart disease, Thyroid dysfunction, Cardiac arrhythmias, Obesity, Hyperuricemia/Gout, Prostatic hyperplasia, Lower limb varicosis, Liver diseases, Depression, Asthma/Chronic obstructive pulmonary disease, Gynaecological problems, Atherosclerosis/Peripheral arterial occlusive disease, Osteoporosis, Renal insufficiency, Cerebral ischemia/Chronic stroke, Cardiac insufficiency, Severe hearing loss, Chronic cholecystitis/Gallstones, Somatoform disorders, Hemorrhoids, Intestinal diverticulosis, Rheumatoid arthritis/Chronic polyarthritis, Cardiac valve disorders, Neuropathies, Dizziness, Dementias, Urinary incontinence, Urinary tract calculi, Anemias, Anxiety, Psoriasis, Migraine/chronic headache, Parkinson's disease, Cancers, Allergies, Chronic gastritis/Gastroesophageal reflux disease, Sexual dysfunction, Insomnia, Tobacco abuse, Hypotension

Exclusion Criteria:

* no capacity to consent
* functional limitations precluding participation in the intervention (eg, loss of vision)
* functional limitations precluding participation in telephone interviews (eg, loss of hearing)
* limited German language skills precluding participation in telephone interviews
* participation in other trials during the observation time of the evaluation study

Primary outcomes:
measure: Whether patients have stayed at least once for at least one night in hospital during the preceding twelve months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Secondary outcomes:
measure: The number of contacts with the GP during the preceding twelve months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: The number of contacts with outpatient specialists during the preceding twelve months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Quality of care as assessed by the summary score of the "GP-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Quality of care as assessed by the summary score of the "patient-reported core set of quality indicators for older adults with multimorbidity in primary care" during the preceding twelve months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Self-rated health as assessed by the EuroQoL visual analogue scale
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Health-related quality of life as assessed by the "Short-Form-Health Survey (SF-12)" questionnaire
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Patient satisfaction with chronic illness care assessed by the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Ingmar Schäfer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: