Neurological consultations via telemedicine for specialized outpatient palliative care (SOPC) at home and in hospice (TANNE project): study protocol for a randomized controlled trial

Abstract

Abstract Background Neurological diseases cause numerous challenges in palliative care. Telemedicine may improve the access to specialized expertise in neurology for patients, their relatives, and palliative care physicians. The TANNE study offers teleconsultations by a hospital-based neuropalliative center for specialized outpatient palliative care (SOPC) and hospices. A prospective, partially randomized, controlled trial aims at generating evidence for clinical improvements, quality of life, and cost efficiency. Methods SOPC and hospice teams in Bavaria, Germany, are partially randomized to one of two study arms, namely a treatment group with teleconsultations by specialists for neurology and palliative medicine or to a control group with interventions after a 12-months delay. Individual and population-based measures are assessed with a mixed-methods design in order to evaluate the medical effects, the potential for implementation in standard care, and health economic aspects. The primary outcome consists of the mean change difference between groups in the Integrated Palliative Care Outcome Scale (IPOS), which physicians assess before and after treatment of a neurological event. Besides, several secondary outcomes are investigated, including quality of life, which is measured with the revised McGill Quality of Life Questionnaire (McGill QOL-R) as well as items regarding general and health-related quality of life. Further secondary outcomes include the concrete progress of the neurological signs and symptoms; the subjective change in well-being since the start of the treatment of the neurological diseases from the perspectives of patients, their relatives, as well as medical and nursing professionals; as well as patient, professional, and caregiver satisfaction with the teleconsultations. Moreover, a health economic evaluation compares group differences regarding hospital visits and emergency calls with utilization measurements. Discussion The TANNE trial provides a comprehensive and complex evaluation design for teleconsultations in neuropalliative care. Ethical considerations need to take the patients’ vulnerability into account. The project promises to substantially broaden the width of health care services and to improve the quality of life for deserving patients. Trial registration German Clinical Trials Register (www.germanctr.de [July 17, 2022], DRKS ID: DRKS00027436. Registered February 10th, 2022, retrospectively registered. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00027436 [July 17, 2022].