Digital Tool Enhancing GPs' Information Management for Patients with Multimorbidity - a Pilot Study
NCT ID: NCT06061172
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2023-10-02
2024-08-29
Brief Summary
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Detailed Description
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This cluster-randomized controlled pilot study examines the feasibility of the gp-multitool.de study, i.e., intervention and evaluation in GP practices. Specifically, the aims of the pilot study are 1. to pilot the gp-multitool.de intervention over six months and to test acceptance, functionality, reliability and usability in general practices under real world conditions, 2. to assess feasibility of the study design, i.e., recruitment of practices and patients, baseline data acquisition, randomization, implementation of the intervention, and outcome data acquisition, and 3. to provide data for the final sample size calculation of the evaluation study.
GPs in the intervention group receive access to the digital tool, together with a brief introduction to its functionalities, a written manual, and contact data of a telephone support hotline, which can be called in case of any technical or organizational problems in relation to the digital tool. 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 gp-multitool.de 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 negative-binomial regression model, and secondary outcomes will be analyzed by multilevel mixed-effects linear and negative-binomial regression models.
In addition to quantitative data collection, a qualitative process evaluation with all participating GPs and one patient from each practice will be conducted based on a pre-defined semi-structured interview guide. The process evaluation will focus on compliance with the study protocol, problems with functionality, usability and reliability of the tool and possible sources of bias in the study. The interviews will be digitally recorded, transcribed verbatim and analyzed by qualitative content analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Care as usual
No interventions assigned to this group
Intervention group
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.
gp-multitool.de
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.
Interventions
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gp-multitool.de
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Ingmar Schäfer, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Countries
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Other Identifiers
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2022-100786-BO-ff
Identifier Type: -
Identifier Source: org_study_id