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

Asthma Clinical Trial

— gp-multitool  

Official title:

Evaluation of a Digital Tool Enhancing GPs' Information Management in the Treatment of Patients With Multimorbidity - a Pilot Study (Gp-multitool)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061172
• Other study ID #: 2022-100786-BO-ff
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Julia Nothacker, M. Sc.
• Phone: +49-40-7410-57161
• Email: j.nothacker[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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: preferences (including a. treatment goals, and b. involvement of other persons in decision making); activities (including a. activities and participation, and b. social support); treatment (including a. problems with medication, and b. treatment burden); 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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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)