Sexual and Gender MinoritiesNCT05877391
Intervention to Collect and Utilize Sexual Orientation and Gender Identity (SOGI) Information in Hospice
A study testing SGM Communication Intervention in people with Sexual and Gender Minorities and Hospice, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual and Gender Minorities, Hospice, Alzheimer's Disease and Related Dementias
- What is being tested?
- SGM Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- 18 years and above
Who cannot join
- --People under 18, pregnant women, prisoners, and people who are decisionally challenged will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Carey Candrian, PhD
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- SGM Communication Intervention
- Medical subject headings
- Coitus, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM Communication InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SGM Communication Intervention | Other | The goal of the arm is to train hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers. Receives: Behavioral: SGM Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators to communicating with SGM older adults and perceptions and preferences for asking/disclosing 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/disclosing SOGI.
Measured: Years 1-2
Content of training
Iteratively develop content areas with a focus on facilitating conversations with patients who are different than you.
Measured: Years 2-3
Delivery of content
Determine acceptable, replicable, and scalability of content.
Measured: Year 3-4
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.
Measured: Year 5
Secondary outcomes (3)
Sources of bias and stigma
Identify sources of stigma (anticipated, internalized, and experienced) and sources of bias (e.g. community, hospice staff, culture, policies).
Measured: Years 1-2
Ongoing engagement around SOGI-informed care
Evaluate means for ongoing engagement of the SGM community for ongoing, authentic, training delivery.
Measured: Years 2-3
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.
Measured: Years 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start13 Mar 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual and Gender MinoritiesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877391
- Sponsor's protocol ID
- 212337
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05877391
- Acronym / sponsor ID
- 212337
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGM Communication Intervention | Other | Behavioral: SGM Communication InterventionThe goal of the arm is to train hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- 18 years and above
Key exclusion criteria (1 listed)
- --People under 18, pregnant women, prisoners, and people who are decisionally challenged will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGM Communication InterventionEvaluate 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. | Behavioural | SGM Communication Intervention |
Primary outcome
Barriers and facilitators to communicating with SGM older adults and perceptions and preferences for asking/disclosing SOGI
Time frame: Years 1-2
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/disclosing SOGI.
Content of training
Time frame: Years 2-3
Iteratively develop content areas with a focus on facilitating conversations with patients who are different than you.
Delivery of content
Time frame: Year 3-4
Determine acceptable, replicable, and scalability of content.
Feasibility and assessment of training
Time frame: Year 5
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.
3 secondary outcomes
Sources of bias and stigma
Time frame: Years 1-2
Ongoing engagement around SOGI-informed care
Time frame: Years 2-3
Accessibility
Time frame: Years 3-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGM Communication Intervention in people with Sexual and Gender Minorities and Hospice, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carey Candrian, PhD (3037247892, carey.candrian@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators to communicating with SGM older adults and perceptions and preferences for asking/disclosing SOGI (time frame: Years 1-2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.