Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994 | Recruiting

• 1 other identifier: 01GY2109
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Whether patients have stayed at least once for at least one night in hospital during the preceding twelve months

  The outcome will be assessed by a standardised questionnaire. The patients will be asked how often they had been in hospital during the preceding twelve months and how long these stays had lasted. Before analysis, the outcome will be dichotomised.

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

Secondary Outcomes (7)

• The number of contacts with the GP during the preceding twelve months

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

• The number of contacts with outpatient specialists during the preceding twelve months

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

• 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

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

• 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

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

• Self-rated health as assessed by the EuroQoL visual analogue scale

  Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

Study Arms (2)

Control group

NO INTERVENTION

Care as usual

Intervention group

EXPERIMENTAL

GPs in the intervention arm have to use the web application gp-multitool.de. For every participating patient they have to use at least four specific questionnaires in the first six intervention months, i.e. 1a is required, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. In the following six intervention months, GPs in the intervention arm also have to use at least four specific questionnaires, i.e., 1a is required again, and either 2a or 2b, and either 3a or 3b, and either 4a or 4b or 4c. Results from the questionnaires need to be discussed between GPs and patients. Additionally, at least one medication review during the first six intervention months is obligatory.

Other: gp-multitool.de

Interventions

gp-multitool.de OTHER

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.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Related Publications (1)

• Schafer I, Menzel A, Lezius S, Krause L, Zapf A, Luhmann D, Scherer M, Paucke V, Nothacker J. Effects of a digital tool implementing the German S3 clinical practice guideline for multimorbidity in primary care (gp-multitool.de): study protocol for a cluster-randomised controlled trial. BMJ Open. 2025 Aug 3;15(8):e102086. doi: 10.1136/bmjopen-2025-102086.

  PMID: 40754332 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Coronary Disease; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Pulmonary Disease, Chronic Obstructive; Obesity; Heart Failure; Depression; Osteoporosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Behavioral Symptoms; Behavior; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases

Study Officials

• Ingmar Schäfer, Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Nothacker

CONTACT

+49-7410-57161; j.nothacker@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The project staff conducting patient interviews will be blinded regarding allocation of the patient's practices.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be made available at the time of publication. No time limit is planned.
• Access Criteria: No restrictions.

Locations

DE (1)