Introduction Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants’ place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers’ perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network? Methods and analysis In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth. Ethics and dissemination Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications. Trial registration number NCT04290286 . Protocol version 22 December 2021 (V.1.0)
Background: The provision of specialized, professionally coordinated, and interdisciplinary care is relevant for the care of transgender and gender diverse (TGD) people diagnosed with gender incongruence/gender dysphoria. In remote areas outside the metropolitan regions, however, transgender health care structures are rarely adequate or within reach. In order to improve transgender health care for TGD people, an interdisciplinary, internet-based transgender health care program (i²TransHealth) has been developed. Objective: The aim of this study was to determine the cost-effectiveness of i²TransHealth for TGD people from remote areas with no or insufficient transgender health care structures either exploring their gender identity or being in an early phase of transition from a societal perspective. Methods: This study was conducted alongside a randomized-controlled trial comparing the effectiveness of i²TransHealth with a waiting list. The i²TransHealth intervention consisted of a telehealth-based e-health intervention including 1:1 chat conversations with study therapists in combination with office-based regular care provided by general physicians and psychiatrists when needed. As health effect measures, quality-adjusted life years (QALYs) were calculated based on the EQ-5D-5L index, and reliable improvement on the Global Severity Index of the Brief Symptom Inventory-18 (BSI-18 GSI) was used. Health care service utilization was assessed using service receipt inventories. The cost-effectiveness of i²TransHealth compared to a waiting list was assessed using the adjusted incremental cost-effectiveness ratio (ICER) based on seemingly unrelated regressions. Furthermore, the uncertainty of the ICER was assessed using cost-effectiveness planes and cost-effectiveness acceptability curves. Results: Participants in the intervention group (IG; n = 88) and the control group (CG; n = 80) were on average aged 26 and 27 years, respectively. The mean QALYs of participants in the IG and CG were both 0.28 during the 4-month follow-up period. With 23.02%, participants in the IG had statistically significantly higher reliable improvement on the BSI-18 GSI compared to participants in the CG (9.21%, P=.01). The mean 4-month total costs were statistically significantly higher among the participants in the IG (+€1390, P=.002). The corresponding ICER of i²TransHealth was €254,021 per additional QALY, and €10,786 per additional reliable improvement on the BSI-18 GSI, respectively. The corresponding probability of cost-effectiveness of i²TransHealth was 20% at a willingness-to-pay (WTP) of €150,000 per additional QALY and 75% at a WTP of €15,000 per additional reliable improvement on the BSI-18 GSI. Conclusions: From a societal perspective, i²TransHealth was unlikely to be cost-effective, even at high WTP per additional QALY. However, the comparison of i²TransHealth with a waiting list could have led to a distortion of the results with regard to health care service utilization. When considering additional reliable improvement on the BSI-18 GSI as health effect measure, the probability of cost-effectiveness of i²TransHealth is unclear depending on the WTP. Clinical Trial: ClinicalTrials.gov NCT04290286; https://clinicaltrials.gov/study/NCT04290286?cond=%20NCT04290286&rank=1