Trials / Completed

CompletedNCT06061172

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 123 (actual)

Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex: All
Age: 65 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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: 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.

Timeline

Start date: 2023-10-02
Primary completion: 2024-08-29
Completion: 2024-08-29
First posted: 2023-09-29
Last updated: 2024-12-12

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT06061172. Inclusion in this directory is not an endorsement.