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Minnesota Inclusive LTSS for LGBTQ Seniors (MILLS)

Primary Purpose

Alzheimer Disease, Dementia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training to Serve (TTS) in person training
Training to Serve online training (eTTS)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring LGBTQ+, Sexual and gender minorities, Long-term support and service facilities, Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • licensure in Minnesota to provide nursing and/or as a housing with services establishment
  • Willingness to undertake a policy and environment review at baseline and 6 months later
  • having at least 5 managers/ supervisors and 5 staff.

Exclusion Criteria:

  • Participants who cannot speak and read English

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Training to Serve (TTS) in person training

Training to Serve online training (eTTS)

Waitlist control

Arm Description

Participants are provided access to the pretest one week before the training. On the day of training, when the trainers arrive, participants have a final opportunity to complete the baseline survey before the intervention. Tablets will be available to complete pre- and post- surveys. The training for management takes 3-4 hours, and for staff, one hour. For consistency and feasibility, both trainings are conducted by the same trainers at the same visit. Immediately after the intervention, participants complete the post-intervention seminar evaluation assessing knowledge and attitudes/comfort in serving SGM clients.

Participants are provided a unique identifier to access the online website. The opening page welcomes them to the study, then directs them to the chunked consent materials and baseline survey. As soon as they have completed this, they receive access to the intervention, which for management is expected to take 1-2 hours and for staff, 30-45 minutes (i.e., the online equivalent of 3-4 and 1 hour, respectively). After completion of the required modules, participants receive access to the optional modules as well as the posttest survey to evaluate the training. Once the post-test is complete, they are thanked for their involvement and informed they will receive an e-mail to access a follow-up survey in six months' time.

Participants complete the baseline survey, then they receive a note thanking them for completing all activities and informing them the intervention will be available in 6 months' time.

Outcomes

Primary Outcome Measures

Environment change
Access to sexual and gender minority (SGM) providers, gender neutral intake forms
Skills assessment
Ability to conduct 7 skills key to providing competent care to SGM
Skills assessment
Ability to conduct 7 skills key to providing competent care to SGM
Competence in SGM Care
Competent scale when it comes to providing care to SGM

Secondary Outcome Measures

SGM with AD/ADRD referenced explicitly in policies
Human Resources policies and intake forms
SGM with AD/ADRD referenced explicitly in policies
HR policies and intake forms
SGM knowledge
10-item review of key content in training
SGM knowledge
10-item review of key content in training
SGM knowledge
10-item review of key content in training
SGM attitudes
Homonegativity scale
SGM attitudes
Homonegativity scale
SGM attitudes
Homonegativity scale
Health care empathy
Jefferson Physician Empathy student version
Health care empathy
Jefferson Physician Empathy student version
Health care empathy
Jefferson Physician Empathy student version

Full Information

First Posted
July 22, 2022
Last Updated
April 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05530590
Brief Title
Minnesota Inclusive LTSS for LGBTQ Seniors
Acronym
MILLS
Official Title
Training the Long-Term Services and Supports Dementia Care Workforce in Provision of Care to Sexual and Gender Minority Residents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is designed to help improve the care of sexual and gender minority (SGM) with Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD) in long-term services and supports (LTSS) by training the state's LTSS workforce in SGM culturally responsive care. The randomized controlled trial will rigorously test the effects of an in person versus an online training program on improving SGM culturally responsive care with a waitlist control.
Detailed Description
The study involves conducting a 3-arm, stratified (management/staff), group (agency) randomized controlled trial (RCT) of the in-person vs. online intervention vs. waitlist control on organizational factors (i.e., environment and policy) and on staff knowledge, attitudes, and skills.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
LGBTQ+, Sexual and gender minorities, Long-term support and service facilities, Alzheimer Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study involves conducting a 3-arm, stratified (management/staff), group (agency) randomized controlled trial (RCT) of the in-person vs. online intervention vs. waitlist control on organizational factors (i.e., environment and policy) and on staff knowledge, attitudes, and skills.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training to Serve (TTS) in person training
Arm Type
Experimental
Arm Description
Participants are provided access to the pretest one week before the training. On the day of training, when the trainers arrive, participants have a final opportunity to complete the baseline survey before the intervention. Tablets will be available to complete pre- and post- surveys. The training for management takes 3-4 hours, and for staff, one hour. For consistency and feasibility, both trainings are conducted by the same trainers at the same visit. Immediately after the intervention, participants complete the post-intervention seminar evaluation assessing knowledge and attitudes/comfort in serving SGM clients.
Arm Title
Training to Serve online training (eTTS)
Arm Type
Experimental
Arm Description
Participants are provided a unique identifier to access the online website. The opening page welcomes them to the study, then directs them to the chunked consent materials and baseline survey. As soon as they have completed this, they receive access to the intervention, which for management is expected to take 1-2 hours and for staff, 30-45 minutes (i.e., the online equivalent of 3-4 and 1 hour, respectively). After completion of the required modules, participants receive access to the optional modules as well as the posttest survey to evaluate the training. Once the post-test is complete, they are thanked for their involvement and informed they will receive an e-mail to access a follow-up survey in six months' time.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Participants complete the baseline survey, then they receive a note thanking them for completing all activities and informing them the intervention will be available in 6 months' time.
Intervention Type
Other
Intervention Name(s)
Training to Serve (TTS) in person training
Intervention Description
Participants receive in person training.
Intervention Type
Other
Intervention Name(s)
Training to Serve online training (eTTS)
Intervention Description
Participants receive online training.
Primary Outcome Measure Information:
Title
Environment change
Description
Access to sexual and gender minority (SGM) providers, gender neutral intake forms
Time Frame
baseline and 6-months follow up
Title
Skills assessment
Description
Ability to conduct 7 skills key to providing competent care to SGM
Time Frame
Baseline
Title
Skills assessment
Description
Ability to conduct 7 skills key to providing competent care to SGM
Time Frame
Immediately post-intervention
Title
Competence in SGM Care
Description
Competent scale when it comes to providing care to SGM
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
SGM with AD/ADRD referenced explicitly in policies
Description
Human Resources policies and intake forms
Time Frame
Baseline
Title
SGM with AD/ADRD referenced explicitly in policies
Description
HR policies and intake forms
Time Frame
6 months post-intervention
Title
SGM knowledge
Description
10-item review of key content in training
Time Frame
Baseline
Title
SGM knowledge
Description
10-item review of key content in training
Time Frame
immediately post-intervention
Title
SGM knowledge
Description
10-item review of key content in training
Time Frame
6 months post-intervention
Title
SGM attitudes
Description
Homonegativity scale
Time Frame
Baseline
Title
SGM attitudes
Description
Homonegativity scale
Time Frame
immediately post-intervention
Title
SGM attitudes
Description
Homonegativity scale
Time Frame
6 months post-intervention
Title
Health care empathy
Description
Jefferson Physician Empathy student version
Time Frame
Baseline
Title
Health care empathy
Description
Jefferson Physician Empathy student version
Time Frame
immediately post-intervention
Title
Health care empathy
Description
Jefferson Physician Empathy student version
Time Frame
6 months post-intervention
Other Pre-specified Outcome Measures:
Title
Discrimination experience at work
Description
Adapted everyday discrimination scale
Time Frame
Baseline
Title
Discrimination experience at work
Description
Adapted everyday discrimination scale
Time Frame
immediately post-intervention
Title
Discrimination experience at work
Description
Adapted everyday discrimination scale
Time Frame
6 months post-intervention
Title
Social desirability at work
Description
Marlowe Crowne Social desirability scale
Time Frame
Baseline
Title
Social desirability at work
Description
Marlowe Crowne Social desirability scale
Time Frame
immediately post-intervention
Title
Social desirability at work
Description
Marlowe Crowne Social desirability scale
Time Frame
6 months post-intervention
Title
Sexual and Religious Identification
Description
Duke Religiosity Index
Time Frame
Baseline
Title
Sexual and Religious Identification
Description
Duke Religiosity Index
Time Frame
6 months follow-up post-intervention
Title
Agency demographics
Description
Agency type, size and staff
Time Frame
Baseline
Title
SGM estimate
Description
Number of SGM staff
Time Frame
Baseline and 6 month follow up.
Title
SGM estimate
Description
Number of SGM staff
Time Frame
6 months follow up post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: licensure in Minnesota to provide nursing and/or as a housing with services establishment Willingness to undertake a policy and environment review at baseline and 6 months later having at least 5 managers/ supervisors and 5 staff. Exclusion Criteria: Participants who cannot speak and read English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Rosser, PhD,MPH
Phone
612-624-0358
Email
rosser@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Rosser, PhD,MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tetyanna Shippee, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunna Kilian
Phone
612-626-8148
Email
kilian@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Minnesota Inclusive LTSS for LGBTQ Seniors

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