ClinicalTrials.gg
RecruitingNCT07904078Updated Oct 29, 2026

Demographic Data Collection in Healthcare

An interventional study of Training and Implementation Strategy 1 in Implementation Strategies, sponsored by Pacific Institute for Research and Evaluation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Pacific Institute for Research and Evaluation · Not applicable, Interventional, and Health services research

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,320
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Implementation Strategies
03

In context

Lead sponsor

Pacific Institute for Research and Evaluation is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria for NMHealth/PHO professionals in Aims 1 and 3:

  • Being age 18 or older;
  • Current employment at NMHealth/PHO of at least six months at 20 hours per week or more;
  • Being proficient in English to complete study instrumentation and ; and
  • Being able to provide informed consent.

Inclusion criteria for NMHealth/PHO professionals in Aim 2:

  • 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.

Inclusion criteria for PHO patients in Aim 1:

  • 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 used PHO services within the last six months.

Inclusion criteria for PHO patients in Aim 2:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,320 participants (estimated)

Study arms

  • Experimental
    Training Alone - 1

    Public 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.

    Behavioral: Training

  • Experimental
    Training Alone - 2

    Public 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.

    Behavioral: Training

  • Experimental
    Training + Implementation Strategy 2

    Public 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.

    Behavioral: Training · Behavioral: Implementation Strategy 2

  • Experimental
    Training and Implementation Strategy 1-1

    Public 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.

    Behavioral: Training · Behavioral: Implementation Strategy 1

  • Experimental
    Training and Implementation Strategy 1-2

    Public 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.

    Behavioral: Training · Behavioral: Implementation Strategy 1

  • Experimental
    Training + Implementation Strategies 1 and 2

    Public 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.

    Behavioral: Training · Behavioral: Implementation Strategy 1 · Behavioral: Implementation Strategy 2

Interventions

  • BehavioralTraining

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

  • BehavioralImplementation Strategy 1

    Implementation support strategy identified through implementation mapping.

  • BehavioralImplementation Strategy 2

    Implementation support strategy identified through implementation mapping.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

1 of 1 sites recruiting
  • Pacific Institute for Research and Evaluation
    Albuquerque, New Mexico 87106, United States
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07904078
Lead sponsor
Pacific Institute for Research and Evaluation
Responsible party
Daniel Shattuck (Research Scientist, Pacific Institute for Research and Evaluation) — Principal investigator
First posted
Oct 29, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2029 (estimated)
Completion
Jun 2030 (estimated)
Last update
Oct 29, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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