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Implementation StrategiesNCT07904078

Demographic Data Collection in Healthcare

A study testing Training, Implementation Strategy 1 and Implementation Strategy 2 in people with Implementation Strategies, run by Pacific Institute for Research and Evaluation at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Collecting and using sexual orientation and gender identity (SOGI) data are the keys to systematically assessing and addressing the health and healthcare needs of sexual- and gender-diverse (SGD) people across all domains of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Implementation Strategies
What is being tested?
Training, Implementation Strategy 1 and Implementation Strategy 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,320 participants
Where
1 siteUnited States
Study dates
Nov 2026to Jun 2030
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being age 18 or older;
  • Current employment at NMHealth/PHO at 20 hours per week or more;
  • Being proficient in English to complete study instrumentation and informed consent; and
  • Being able to provide informed consent.
  • Being age 18 and over;
  • Being proficient in English or Spanish to complete study instrumentation and informed consent;
Show all 12Show fewer
  • Being able to provide informed consent; and
  • Having used PHO services within the last six months.
  • Being age 18 and over;
  • Being proficient in English or Spanish to complete study instrumentation and informed consent;
  • Being able to provide informed consent; and
  • Having visited a PHO in the past month.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Shattuck contact

505-765-2331

dshattuck@pire.org

United States1 site, 1 recruiting
  • Pacific Institute for Research and Evaluation

    Albuquerque, New Mexico, 87106

    Daniel Shattuck, 505-765-2331, dshattuck@pire.org

    Recruiting

Other trials in United States

About this study

Official title: Statewide Implementation of Sexual Orientation and Gender Identity (SOGI) Data Collection to Advance Health Equity

Collecting and using sexual orientation and gender identity (SOGI) data are the keys to systematically assessing and addressing the health and healthcare needs of sexual- and gender-diverse (SGD) people across all domains of life. This multilevel, mixed-method study will develop resources and study strategies for implementing SOGI data collection in state-operated Public Health Offices that provide a wide range of health and social services to racially, ethnically, and geographically diverse communities in urban, rural, and frontier communities of New Mexico. Study findings will be pertinent to other states and healthcare settings interested in illuminating the nature and extent of disparities and adverse health outcomes for SGD people, encouraging patient-centered care, and advancing equity-focused evidence-based interventions to eliminate long-standing disparities.

Read the detailed description

National health authorities point to collecting sexual orientation and gender identity (SOGI) data as essential to systematically addressing the health and healthcare needs of sexual- and gender-diverse (SGD) people across all domains of life. The State of New Mexico answered this call by directing all its government agencies, including those overseeing or financing health and human service delivery, to collect voluntary self-reported SOGI data. These data are vital to (a) illuminate the nature and extent of disparities and adverse health outcomes for a minoritized population, (b) encourage patient-centered care, and (c) develop equity-focused evidence-based interventions (EFEBIs) to eliminate long-standing disparities. New Mexico is a bellwether for other states wanting to routinize processes for robust demographic analyses of SGD people, enhance coordination of health services, guide policy and funding decisions, advance EFEBIs for their varied citizenries and monitor progress toward health equity for SGD people. New Mexico's health department (NMHealth) operates 53 public health offices (PHOs)-ideal settings for analyzing the uptake and sustainment of SOGI data collection. Staffed in large part by nurses, PHOs are a critical safety net for racially, ethnically, and geographically diverse communities in New Mexico, offering a wide range of health services, from immunizations, family planning, nutritional programming, substance use harm reduction, testing and treatment for sexually transmitted infections, cancer prevention and control, and other medical care across the lifespan. This multilevel, mixed-method R01 study will test the acceptability, appropriateness, and feasibility of implementation strategies in PHOs to enable SOGI data collection with different populations and in urban, rural, and frontier contexts. Guided by the Interactive Systems Framework, the study's interdisciplinary team will (1) assess gaps in implementation readiness to engage in accurate, reliable, and usable SOGI measurement in PHOs; and apply implementation mapping to systematically select and tailor implementation strategies to address barriers; (2) deploy and evaluate identified implementation strategies to enable SOGI data collection in PHOs in a sequential multiple assignment randomized trial (SMART); and (3) use the Discover, Design, Build, and Test framework to develop an online toolkit integrating manualized implementation strategy resources to disseminate SOGI data collection in service delivery settings. The study team of researchers, healthcare providers, and patient advocates are poised to foster use of implementation strategies for inclusive SOGI data collection, so the state and nation are prepared to identify, analyze, and advance EFEBIs to intervene in the alarming disparities negatively shaping SGD health and well-being. Through the innovative use of models and methods from dissemination and implementation science, the team's overall goal is to tackle a long-running, perplexing problem-the rampant deficiencies in state-sponsored data collection systems that abet the invisibility of SGD people in public health, medical, and human service records, thwart the development of EFEBIs, and buttress poor health outcomes.

Being tested
Training, Implementation Strategy 1, Implementation Strategy 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrainingBehavioural

    Brief training on demographic data collection and entry for PHO staff.

  • Implementation Strategy 1Behavioural

    Implementation support strategy identified through implementation mapping.

  • Implementation Strategy 2Behavioural

    Implementation support strategy identified through implementation mapping.

Study groups in NCT07904078
Study groupRoleWhat they receive
Training Alone - 1ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training in phase 2 (months 5-10). Due to responding to training only, PHOs continue with training only through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training
Training Alone - 2ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training in phase 2 (months 5-10). Due to not responding to training only, PHOs are randomized to continue with training only through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training
Training + Implementation Strategy 2ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training in phase 2 (months 5-10). Due to not responding to training only, PHOs are randomized to continue with training and to receive an additional implementation strategy (implementation strategy 2) through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training; Behavioral: Implementation Strategy 2
Training and Implementation Strategy 1-1ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training and receive an additional implementation strategy (implementation strategy 1) in phase 2 (months 5-10). Due to responding to training and implementation strategy 1, PHOs continue with training and implementation strategy 1 through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training; Behavioral: Implementation Strategy 1
Training and Implementation Strategy 1-2ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training and receive an additional implementation strategy (implementation strategy 1) in phase 2 (months 5-10). Due to not responding to training and implementation strategy 1, PHOs continue with training and implementation strategy 1 through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training; Behavioral: Implementation Strategy 1
Training + Implementation Strategies 1 and 2ExperimentalPublic Health Offices (PHOs) in this arm receive training in phase 1 (months 1-4). PHOs are then randomized to continue training and receive an additional implementation strategy (implementation strategy 1) in phase 2 (months 5-10). Due to not responding to training and implementation strategy 1, PHOs are randomized to continue with training and implementation strategy 1 and to receive an additional implementation strategy (implementation strategy 2) through phase 3 (months 11-16). In phase 4 (months 17-22), implementation support is discontinued.
Receives: Behavioral: Training; Behavioral: Implementation Strategy 1; Behavioral: Implementation Strategy 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adoption - Electronic Health Records (EHR)

    Data on SOGI will be extracted from EHRs at participating PHOs by NMHealth. This data will be reviewed to calculate the percentage of patients with SOGI data collection recorded out of the total patients seen over the two months prior to the assessment. This is the outcome for which the SMART is powered.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

Secondary outcomes (9)
  1. Organizational Readiness to Change Assessment (ORCA)

    The ORCA tool measures organizational readiness to implement evidence-based practices in clinical settings. We will use five subscales of this 77-item measure to focus data collection and reduce burdens on participants: 1) the staff organizational culture subscale, 2) the leadership subscale on formal leadership and team building, 3) the subscale on evaluation of goal setting and tracking and communicating performance, 4) the readiness for change subscale on the attitudes of opinion leaders for practice change, and 5) the subscale general resources. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  2. Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS)

    This 18-item measure will assess PHO personnel's 1) clinical preparedness (e.g., LGBT training and clinical experiences), 2) attitudinal awareness (e.g., LGBT explicit bias and prejudice), and 3) basic knowledge (e.g., LGBT health and mental health disparities). The LGBT-DOCSS will be used with the ICS to examine innovation-specific capacity. Data for this measure will be collected during each phased assessment of the SMART. While the development of clinical skills is not a specific focus of the intervention, clinical skills measures by the LGBT-DOCSS may be an important confounding variable to capture.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  3. Implementation Climate Scale (ICS)

    This 18-item measure will assess the extent to which a PHO prioritizes and values the successful implementation of evidence-based practices. The ICS will be used with the LGBT-DOCSS to examine innovation-specific capacity. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  4. Acceptability, Feasibility, and Appropriateness of Intervention Measure

    This 12-item measure will be administered to PHO personnel across all sites annually to assess the extent to which implementation strategies are appealing, liked, and welcomed in their setting (acceptability); fitting, suitable, and applicable in their setting (appropriateness); and possible and doable in their setting (feasible). Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  5. Attitudes toward Lesbians and Gay Men Scale (ATLG)

    The ATLG Scale is a brief, 20-item measure of heterosexual peoples' attitudes toward gay men and lesbians. This scale and the BIAS-A, ATTI, and EBPAS will be used to examine motivation. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  6. Bisexualities: Indiana Attitudes Scale-Abridged (BIAS-A)

    This scale is used to measure associations between biphobia and sexual identity; two 5-item subscales measure attitudes toward bisexual men and attitudes toward bisexual women. This scale and the ATLG, ATTI, and EBPAS will be used to examine motivation. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  7. Attitudes toward Transgender Individuals Scale (ATTI)

    The ATTI Scale is a 20-item measure of attitudes toward transgender individuals, including transgender-related stigma among members of the general population. This scale and the BIAS-A, ATLG, and EBPAS will be used to examine motivation. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  8. Evidence-Based Practice Attitude Scale (EBPAS)

    The EBPAS is a 15-item tool developed to assess willingness to adopt an innovation given their attitudes toward using evidence-based practices. The measure has high internal consistency reliability (α=0.79). This scale and the BIAS-A, ATLG, and ATTI will be used to examine motivation. Data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

  9. Consumer Assessment of Healthcare Providers and Systems Clinician and Group Adult Survey (CG-CAHPS), v.3

    The 31-item CG-CAHPS, v.3, examines patient experiences with healthcare providers. Measures focus on getting timely appointments, care, and information; how well providers communicate and use the information to coordinate patient care; helpful, courteous, and respectful office staff; and patient rating of the provider. Its internal consistency estimates range from .77 to .89 across subscales, indicating acceptable to good reliability. Because of its acceptable psychometric properties at the individual and practice site levels, data for this measure will be collected during each phased assessment of the SMART.

    Measured: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

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
Randomised
Intervention model
Sequential
Model description
Sequential, Multiple Assignment, Randomized Trial (SMART)
Masking
None (open label)
Enrolment
1,320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904078
Sponsor's protocol ID
NR 021336
Other IDs
NR 021336
Status last verified
Oct 2026
First submitted
11 Sep 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Training, Implementation Strategy 1 and Implementation Strategy 2 in people with Implementation Strategies, run by Pacific Institute for Research and Evaluation 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 12 inclusion and 0 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 29 Oct 2026. 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 Daniel Shattuck (505-765-2331, dshattuck@pire.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption - Electronic Health Records (EHR) (time frame: Prior to randomization; then 4, 10, 16, and 22 months post initial randomization.). 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 29 Oct 2026.

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