Clinical trial NCT06061172: Digital Tool Enhancing GPs' Information Management for Patients with Multimorbidity - a Pilot Study
Official title: Evaluation of a Digital Tool Enhancing GPs' Information Management in the Treatment of Patients with Multimorbidity - a Pilot Study (gp-multitool)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Breast Neoplasms
Coronary Disease
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Pulmonary Disease, Chronic Obstructive
Comorbidities and Coexisting Conditions
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 123
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to intervention group and control group, respectively, in parallel for the duration of the study
Primary purpose: TREATMENT

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.

Detailed description: The gp-multitool.de study is a cluster-randomized controlled trial that 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. It aims to reduce the time patients spend in hospital (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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time spent in hospital during the preceding six months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Secondary outcomes:
measure: The number of contacts with the GP during the preceding six months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: The number of contacts with outpatient specialists during the preceding six months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: The number of contacts with home care services during the preceding six months
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: 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
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: 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
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Self-rated health as assessed by the EuroQoL visual analogue scale
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Health-related quality of life as assessed by the "EuroQoL five dimension five level scale" descriptive system, German value set
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Patient satisfaction with organization of care as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
measure: Patient satisfaction with clinical performance as assessed by the European Task Force on Patient Evaluation of General Practice Care questionnaire
timeFrame: Once at baseline (before randomization of practices) and once at follow-up (immediately after the intervention)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Ingmar Schäfer, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: