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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Heart Failure; Coronary Disease; Obesity; Diabetes Mellitus, Type 2; Breast Neoplasms; Diabetes Mellitus, Type 1; Pulmonary Disease, Chronic Obstructive; Rheumatoid Arthritis; Chronic Low-back Pain; Osteoporosis; Comorbidities and Coexisting Conditions; Asthma Bronchiale
• Intervention / Treatment: Other: gp-multitool.de

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.

• Study Type: Interventional
• Enrollment (Actual): 659
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Care as usual
Experimental: Intervention group; 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; 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: patient preferences (including a. treatment goals, and b. involvement of other persons in decision making);; social life (including a. activities and participation, and b. social support);; treatment situation (including a. problems with medication, and b. treatment burden);; health complaints (including a. pain, b. psychiatric disorders, and c. other complaints).; resilience and protective behavior against heat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-rated health as assessed by the EuroQoL visual analogue scale	The outcome will be assessed by the EuroQoL visual analogue scale (Herdman M et al. 2011, DOI: 10.1007/s11136-011-9903-x), which has a possible range between 0 and 100 points. Higher scores indicate a better self-rated health.	Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
The number of contacts with the GP during the preceding twelve months	The outcome will be assessed by asking the patients how often they had visited their 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	The outcome will be assessed by asking the patients how often they had visited 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	The outcome will be assessed by the "GP-reported core set of quality indicators for older adults with multimorbidity in primary care" (Schäfer I et al. 2023, digital object identifier (DOI): https://doi.org/10.1186/s12916-023-02856-0), which has a possible range between 0 and 12 points. Higher scores indicate a better quality of primary care.	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	The outcome will be assessed by the "Patient-reported core set of quality indicators for older adults with multimorbidity in primary care" (Schäfer I et al. 2023, DOI: https://doi.org/10.1186/s12916-023-02856-0), which has a possible range between 0 and 7 points. Higher scores indicate a better quality of primary care.	Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Health-related quality of life as assessed by the "Short-Form-Health Survey (SF-12)" questionnaire	The outcome will be assessed by the "Short-Form-Health Survey (SF-12)" questionnaire (Wirtz M.A. et al. 2018, DOI: 10.1026/0012-1924/a000205), which has a possible range between 0 and 100 points. Higher scores indicate a better health-related quality of life.	Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Patient satisfaction with chronic illness care assessed by the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire	The outcome will be assessed by the "PACIC 5A" questionnaire (Rosemann T et al. 2007, DOI: 10.1111/j.1365-2753.2007.00786.x), which has a possible range between 1 and 5 points. Higher scores indicate a higher patient satisfaction with chronic illness care from patient's perspective.	Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Ingmar Schäfer, Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Heart Diseases; Chronic Disease; Disease Attributes; Arthritis; Joint Diseases; Rheumatic Diseases; Metabolic Diseases; Overnutrition; Body Weight; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Respiratory Tract Diseases; Lung Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Lung Diseases, Obstructive; Skin Diseases; Breast Diseases; Bone Diseases, Metabolic; Overweight; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Heart Failure; Obesity; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus, Type 2; Depression; Breast Neoplasms; Osteoporosis; Diabetes Mellitus, Type 1; Arthritis, Rheumatoid; Coronary Disease
• Other Study ID Numbers: 01GY2109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be included in the publication as supplementary file.
• IPD Sharing Time Frame: Data will be made available at the time of publication. No time limit is planned.
• IPD Sharing Access Criteria: No restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No