[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05877391":3,"trial-entities:NCT05877391":99,"trial-summary:NCT05877391":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":53,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":75,"locations":78,"central_contacts":92,"overall_officials":96,"references":97,"see_also_links":98},"NCT05877391","212337","Intervention to Collect and Utilize Sexual Orientation and Gender Identity (SOGI) Information in Hospice","A Novel Intervention to Improve Care for Older Sexual and Gender Minority (SGM) Adults With Serious Illness and Especially Those With Alzheimer's Disease and Related Dementias (ADRD)","RECRUITING","2027-09","2024-06","2024-06-24","2023-03-13","University of Colorado, Denver","OTHER",false,"Older sexual and gender minority (SGM) patients are at risk for receiving inequitable end-of-life care; those with Alzheimer's disease and related dementias (ADRD) are at particularly high risk. Failure to collect and integrate sexual orientation and gender identity (SOGI) data to identify patients' informal support systems may have adverse health consequences for SGM older adults, particularly for those dependent on informal caregivers to provide in-home support and assist with activities of daily living. The goal of this K01 is develop a novel training for hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers.","Collecting representative and inclusive data about sexual orientation and gender identity (SOGI) is a critical component of combating the devastating health disparities affecting sexual and gender minority (SGM) older adults. This is particularly crucial for patients living with ADRD, which is widely regarded as a family disease requiring the active caregiver involvement, particularly with advanced disease. Failure to collect and integrate SOGI data to identify patients' informal support systems may have adverse health consequences for SGM older adults, particularly for those dependent on informal caregivers to provide in-home support and assist with activities of daily living. Improper identification of chosen family and caregivers contributes to incomplete care delivery and disenfranchised grief. Given the historical discrimination experienced by older SGM people, adding SOGI questions without proper training has the potential to harm patients and create staff discomfort rather than foster inclusive interactions. For this career development award, I propose to characterize SOGI data collection challenges from patients and caregivers enrolling in hospice while exploring understudied intersections, such as SGM people living with ADRD, and how they affect staff approaches to delivering person-centered care. These insights will be used to develop and pilot test an intervention to train hospice interdisciplinary team (IDT) staff to sensitively collect and utilize SOGI data to improve communication with SGM patients and caregivers.",[19,20,21],"Sexual and Gender Minorities","Hospice","Alzheimer's Disease and Related Dementias",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},80,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","SGM Communication Intervention","Evaluate the feasibility and acceptability of the SGM communication intervention by hospice staff. I will pilot test the training with hospice staff to refine the content and delivery of the training. Outcomes in the pilot clinical trial will include feasibility, acceptability, and staff satisfaction with training.",[33],[37,41,45,49],{"measure":38,"description":39,"timeFrame":40},"Barriers and facilitators to communicating with SGM older adults and perceptions and preferences for asking\u002Fdisclosing SOGI","Evaluating barriers and facilitators to creating an affirming environment where SGM patients and their caregiver feel included and safe to disclose; perceptions and preferences for asking for\u002Fdisclosing SOGI.","Years 1-2",{"measure":42,"description":43,"timeFrame":44},"Content of training","Iteratively develop content areas with a focus on facilitating conversations with patients who are different than you.","Years 2-3",{"measure":46,"description":47,"timeFrame":48},"Delivery of content","Determine acceptable, replicable, and scalability of content.","Year 3-4",{"measure":50,"description":51,"timeFrame":52},"Feasibility and assessment of training","Evaluate feasibility of training intervention through simulation with standardized patients and hospice staff. Including evaluating content and delivery of the training and assess delivery of training, feasibility, comfort and confidence the training, incorporation into practice, and evaluation of content.","Year 5",[54,57,60],{"measure":55,"description":56,"timeFrame":40},"Sources of bias and stigma","Identify sources of stigma (anticipated, internalized, and experienced) and sources of bias (e.g. community, hospice staff, culture, policies).",{"measure":58,"description":59,"timeFrame":44},"Ongoing engagement around SOGI-informed care","Evaluate means for ongoing engagement of the SGM community for ongoing, authentic, training delivery.",{"measure":61,"description":62,"timeFrame":63},"Accessibility","Evaluate accessibility of training intervention ussing simulation with standardized patients and hospice staff, pilot test the training to refine the content and delivery of the training and assess accessibility and satisfaction with training.","Years 3-5","ALL","18 Years",null,true,{"inclusion":69,"exclusion":72,"raw_text":74},[70,71],"English speaking","18 years and above",[73],"People under 18, pregnant women, prisoners, and people who are decisionally challenged will be excluded from the study.","Inclusion Criteria:\n\n* English speaking\n* 18 years and above\n\nExclusion Criteria:\n\n--People under 18, pregnant women, prisoners, and people who are decisionally challenged will be excluded from the study.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":89},"University of Colorado","Aurora","Colorado","80045","United States",[86],{"name":87,"role":88},"Carey Candrian, PhD","CONTACT",{"lat":90,"lon":91},39.72943,-104.83192,[93],{"name":87,"role":88,"phone":94,"email":95},"3037247892","carey.candrian@cuanschutz.edu",[],[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Alzheimer's Disease",[],{"nct_id":4,"found":67,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study that plans to enroll 80 participants. It is testing a behavioral intervention (SGM Communication Intervention) with hospice staff.","completed","Improving Hospice Care for Sexual and Gender Minority Individuals","This study is developing and testing a new training program called the SGM Communication Intervention for hospice staff. The goal is to help staff better understand and support older sexual and gender minority (SGM) patients, especially those with Alzheimer's disease and related dementias (ADRD). By improving how staff collect and use information about a patient's sexual orientation and gender identity (SOGI), the study hopes to ensure more personalized and supportive end-of-life care. The study aims to enroll 80 participants and is currently unclear on its recruitment status. Success will be measured by understanding the challenges and preferences for discussing SOGI with SGM older adults, and by refining the training content and delivery.","The study will assess barriers and facilitators to communication and preferences for asking\u002Fdisclosing SOGI during years 1-2, and the training content and delivery during years 2-4.",112,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]