School-based health centers addressing health equity for LGBTQ+ patients

ISRCTN	ISRCTN13844475
DOI	https://doi.org/10.1186/ISRCTN13844475

Submission date: 18/09/2024
Registration date: 20/09/2024
Last edited: 28/11/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
School-based health centers (SBHCs) provide vital behavioral, sexual, and reproductive healthcare services to youth across the United States. Young people who identify as LGBTQ+ are far more likely to deal with adverse health outcomes than their cisgender and heterosexual peers. There are several areas of practice that SBHCs can implement in order to improve services for LGBTQ+ young people and positively impact their wellbeing. These practices include (1) adopting, disseminating, and adhering to LGBTQ+ supportive policies and procedures; (2) creating welcoming physical environments; (3) systematically documenting and using sexual orientation and gender identity information; (4) training all employees in best practices for interacting with LGBTQ+ patients; and (5) developing the clinical workforce to deliver high-quality services to LGBTQ+ patients. The main goal of this study is to test the ability of a implementation model, the Dynamic Adaptation Process, to support SBHCs in putting these practices into place and to examine how these practices impact student satisfaction and engagement with care.

Who can participate?
School-based health centers serving high schools in New Mexico, their staff, and their student patients are eligible to participate in this study. Since the study is focused on improving care and services at an organizational level, individual participants are not required to have a certain health condition.

What does the study involve?
The SBHC personnel will be expected to participate in annual web-based surveys and 1 week of rapid assessment procedure-informed clinical ethnography (RAPICE). The surveys inquire into attitudes about LGBTQ+ people, perceptions of LGBTQ+ supportive guidelines, implementation climate, and work environments. RAPICE will involve direct observations and unstructured interviews.
Once an IRT member is recruited by SBHC personnel, the research team will invite this individual to join the study via email, phone, and/or in-person meetings; their involvement in research activities will entail the completion of evaluation forms related to training activities and participation in a small group interviews, brief surveys, and ethnographic observations performed by the study coach.
Per the DAP, IRT members and other SBHC personnel will collaborate with an implementation coach to complete the LGBTQ+ Practices Checklist to capture data regarding the adoption of specific guidelines. They will use data from this tool to plan for the implementation of the LGBTQ+ supportive guidelines.
High school students who use SBHC services will be asked to complete a self-administered anonymous post-clinic visit survey to assess student perceptions of SBHC settings, barriers to care, satisfaction with care, and engagement.

What are the possible benefits and risks of participating?
There are no individual benefits to participation other than temporary access to free training and technical assistance and the potential satisfaction of contributing to improved services for student patients. The main risk involved in participation is a breach of confidentiality should unauthorized individuals gain access to private information about the participants. Potential risks to participants from such breaches are primarily psychological and social. The researchers will privately collect information regarding the SOGI information from all participants, which could lead to embarrassment if disclosed in public.

Where is the study run from?
Pacific Institute for Research and Evaluation – Southwest Center (USA)

When is the study starting and how long is it expected to run for?
October 2021 to March 2027

Who is funding the study?
National Institute for Nursing Research (USA) (R01NR021019)

Who is the main contact?
Daniel Shattuck, dshattuck@pire.org

Study website

Contact information

Dr Cathleen Willging
Principal Investigator

851 University Blvd SE, Suite 101
Albuquerque
87106
United States of America

ORCID ID	0000-0001-6446-5083
Phone	+1 (0) (505) 244-3099
Email	cwillging@pire.org

Dr Daniel Shattuck
Public, Scientific

851 University Blvd SE, Suite 101
Albuquerque
87106
United States of America

ORCID ID	0000-0003-4689-863X
Phone	+1 (0) (505) 244-3099
Email	dshattuck@pire.org

Study information

Study design	Randomized stepped-wedge trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	School, Other
Study type	Other
Scientific title	Enhancing structural competency in school-based health centers to address LGBTQ+ adolescent health equity
Study acronym	SBHCs HELP
Study objectives	School-based health centers will significantly increase the adoption of LGBTQ+ supportive practices.
Ethics approval(s)	Approved 09/05/2022, Pacific Institute for Research and Evaluation (4061 Powder Mill Road, Beltsville, 20705, United States of America; +1 (0)301 755 2757; IRB@pire.org), ref: 1952485
Health condition(s) or problem(s) studied	Enhancing structural competency of school-based health centers
Intervention	Application of the Dynamic Adaptation Process, including coaching, training, and data-driven adaptation of practices and implementation strategies, to support site-specific implementation resource teams to assess, plan, and implement changes to their school-based health centers. Using a randomized stepped-wedge design, each school-based health center serves as its own control comparison as well as a comparator for other centers. All centers eventually receive the intervention. Sites were randomized into one of three cohorts. Randomization was balanced using the median population served by sites. The intervention will last one year. Follow up will occur periodically for the remainder of the study period, which is determined by when each cohort received the interventions and ranges in duration from 6 to 23 months.
Intervention type	Behavioural
Primary outcome measure	Practice adoption is measured using a structured collaborative assessment at baseline and 9-month intervals
Secondary outcome measures	1. Organizational readiness to implement evidence-based practices measured by the Organizational Readiness to Change Assessment (ORCA) at baseline and 9-month intervals 2. SBHC staff clinical preparedness and attitudinal awareness measured by the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale at baseline and 9-month intervals 3. Implementation climate measured by the Implementation Climate Scale at baseline and 9-month intervals 4. LGBTQ+ community engagement measured by the LGBTQ+ Community Engagement Subscale at baseline and 9-month intervals 5. Acceptability, feasibility, and appropriateness of intervention and implementation strategies measured by the Acceptability, Feasibility, and Appropriateness of Intervention Measure at baseline and 9-month intervals 6. Staff attitudes toward lesbians and gay men measured by the Attitudes Toward Lesbians and Gay Men Scale (ATLG) at baseline and 9-month intervals 7. Staff attitudes toward bisexual people measured by the Bisexualities: Indiana Attitudes Scale-Abridged at baseline and 9-month intervals 8. Attitudes toward transgender individuals measured by the Attitudes Toward Transgender Individuals Scale at baseline and 9-month intervals 9. Willingness to adopt interventions measured by Evidence-Based Practice Attitude Scale at baseline and 9-month intervals 10. Student Perceptions of SBHC settings, barriers to care, satisfaction with care, engagement in care measured by questions adapted from the Youth Engagement with Health Services survey instrument at baseline and 9-month intervals
Overall study start date	01/10/2021
Completion date	31/03/2027

Eligibility

Participant type(s)	Patient, Health professional, Employee, Service user, Other
Age group	Mixed
Lower age limit	13 Years
Sex	Both
Target number of participants	2,630
Key inclusion criteria	Inclusion criteria for SBHCs: 1. Must be part of the state-funded SBHC network 2. Reported willingness to convene an IRT Inclusion criteria for SBHC personnel: 1. Minimum of half-time employment as a PCP, behavioral health provider, clinic coordinator or other staff (e.g., medical assistant) in an SBHC enrolled in the study 2. Reported ability to complete study measures in English Inclusion criteria for IRT membership: 1. Minimum of half-time employment as a PCP, behavioral health provider, clinic coordinator or other staff (e.g., medical assistant) in an SBHC enrolled in the study; or identification as a high school professional (e.g., administrator, teacher, staff); or identification as a student or parent/guardian at the high school served by the SBHC 2. Reported ability to participate in meetings and data collection activities conducted in English 3. Reported willingness to engage in DAP-related activities (e.g., assessment, action planning, monitoring) Inclusion criteria for patients (students): 1. Identification as a high school student served by an enrolled SBHC 2. Ability to complete the patient survey in English or Spanish
Key exclusion criteria	Exclusion criteria for SBHCs: 1. Does not serve high school-aged students. Exclusion criteria for IRT members: 2. Lack of time to participate in periodic surveys and small group interviews (or focus groups) Exclusion criteria for patients (students): 3. Prior completion of the survey within the current semester
Date of first enrolment	01/04/2023
Date of final enrolment	15/05/2025

Locations

Countries of recruitment

United States of America

Study participating centre

Pacific Institute for Research and Evaluation - Southwest Center

851 University Blvd SE, Suite 101
Albuquerque
87106
United States of America

Sponsor information

Pacific Institute For Research and Evaluation
Research organisation

4061 Powder Mill Road
Suite 350
Beltsville
20705
United States of America

Phone	+1 (0) (301) 755-2700
Email	info@pire.org
Website	https://www.pire.org/
"ROR"	https://ror.org/01jfr3w16

Funders

Funder type

Government

National Institute of Nursing Research
Government organisation / National government

Alternative name(s): National Institute of Nursing Research National Institutes of Health, NINR
Location: United States of America

Results and Publications

Intention to publish date	01/04/2028
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	All data will be archived in an NIH repository of the funding institute. The dataset will not be archived until all data collection is completed. The PI will make the data used in publications that do not utilize the final dataset available upon request from an investigator at an institution with a current Federal Wide Assurance (FWA). Each publication will provide a statement on how to access the data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		27/11/2024	28/11/2024	Yes	No

Editorial Notes

28/11/2024: Publication reference added.
19/09/2024: Study's existence confirmed by the Pacific Institute for Research and Evaluation.