Asthma Clinical Trial
— gp-multitoolOfficial title:
Evaluation of a Digital Tool Enhancing GPs' Information Management in the Treatment of Patients With Multimorbidity - a Pilot Study (Gp-multitool)
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The number of contacts with the GP during the preceding six months | The outcome will be assessed by asking the patients how often they had used their GP during the preceding six months. | Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention) | |
Secondary | The number of contacts with outpatient specialists during the preceding six months | The outcome will be assessed by asking the patients how often they had used outpatient specialists during the preceding six months. | Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention) | |
Secondary | The number of contacts with home care services during the preceding six months | The outcome will be assessed by asking the patients how often they had used home care services during the preceding six months. | Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention) | |
Secondary | 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 | 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, 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) | |
Secondary | 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 | 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) | |
Secondary | 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) | |
Secondary | Health-related quality of life as assessed by the "EuroQoL five dimension five level scale" descriptive system, German value set | The outcome will be assessed by the "EuroQoL five dimension five level scale" (EQ-5D-5L) descriptive system (Herdman M et al. 2011, DOI: 10.1007/s11136-011-9903-x). A summary score will be calculated using the German value set (Ludwig K et al. 2018, DOI: 10.1007/s40273-018-0615-8). According to the German value set, the EQ-5D descriptive system has a possible range between 1.0 and -0.661 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) | |
Secondary | Patient satisfaction with organization of care as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire | The outcome will be assessed by subscale 'organization of care' of the European Task Force on Patient Evaluation of General Practice Care questionnaire (EUROPEP, Wensing M et al. 2000, DOI: https://doi.org/10.3109/13814780009069953). The score has a possible range between 0 and 4 points each and higher values indicate higher patient satisfaction. | Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention) | |
Secondary | Patient satisfaction with clinical performance as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire | The outcome will be assessed by subscale 'clinical performance' of the European Task Force on Patient Evaluation of General Practice Care questionnaire (EUROPEP, Wensing M et al. 2000, DOI: https://doi.org/10.3109/13814780009069953). The score has a possible range between 0 and 4 points each and higher values indicate higher patient satisfaction. | Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention) |
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