Digital Tool Enhancing GPs' Information Management for Patients with Multimorbidity - a Pilot Study

NCT06061172 | Completed

• 1 other identifier: 2022-100786-BO-ff
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The gp-multitool.de study is a cluster-randomized controlled trial that aims to enhance evidence-based and patient-centered care for patients with multimorbidity by assessing and providing information relevant for the primary care of this patient group. This pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices in urban and rural administrative districts in Germany.

Conditions

Asthma; Breast Neoplasms; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Comorbidities and Coexisting Conditions

Outcome Measures

Primary Outcomes (1)

• Time spent in hospital during the preceding six months

  The outcome will be assessed by asking the patients how often they had been in hospital during the preceding six months and how many days each hospital stay lasted. The total time in hospital will be calculated by adding the duration of all stays together.

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

Secondary Outcomes (9)

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

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

• The number of contacts with home care services during the preceding six months

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

• Process 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 six months

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

• Process 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 six months

  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 for every patient at least twice (i.e., at least once a quarter), and have to use at least four specific questionnaires at least once, i.e. 1a is required, 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 is obligatory.

Other: gp-multitool.de

Interventions

gp-multitool.de OTHER

The intervention is based on a digital tool, which implements recommendations of the S3 guideline "multimorbidity" of the German College of General Practitioners and Family Physicians. The tool includes nine questionnaires addressing four dimensions of care: 1. preferences (including a. treatment goals, and b. involvement of other persons in decision making); 2. activities (including a. activities and participation, and b. social support); 3. treatment (including a. problems with medication, and b. treatment burden); 4. complaints (including a. pain, b. psychiatric disorders, and c. other complaints). The GPs can send the questionnaires by email to the patients and the patients can fill out the questionnaires at their home or in the waiting room of the GP's practice using their own smartphones, tablets or computers. The digital tool also includes instructions for conducting a medication review. Results from talks between GPs and patients can be documented in the tool.

Intervention group

Eligibility Criteria

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

You may qualify if:

• participation in a 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, and chronic obstructive pulmonary disease
• 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/COPD, Gynaecological problems, Atherosclerosis/PAOD, 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/GERD, 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
• no access to a personal device with access to the internet (i.e., smartphone, tablet or personal computer)
• participation in other trials during the observation time of the pilot study

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Nothacker J, Paucke V, Lezius S, Zapf A, Luhmann D, Scherer M, Schafer I. Implementation of the German Clinical Practice Guideline for Multimorbidity Using a Digital Tool in Primary Care: Pilot Cluster Randomized Clinical Trial. JMIR Aging. 2025 Nov 20;8:e79767. doi: 10.2196/79767.

  PMID: 41263476 DERIVED

MeSH Terms

Conditions

Asthma; Breast Neoplasms; Coronary Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ingmar Schäfer, PD Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to intervention group and control group, respectively, in parallel for the duration of the study

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 29, 2023
• Study Start: October 2, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: December 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available from July 2025 until April 2027.
• Access Criteria: Reasonable request, non-profit organisations.

Locations

DE (1)