Testing Strategies to Improve Substance Misuse Prevention Research Use in State Policy Contexts

March 3, 2025 updated by: Daniel Max Crowley, Penn State University

Building the Science of Evidence-Informed Prevention Policy: a Multi-level Model for Supporting Substance Misuse Prevention

If science is to inform effective substance misuse prevention policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence, yet our field lacks an evidence-based model designed for this purpose. Accordingly, a state-level randomized controlled trial (N = 30 states) of a formal, theory-based approach for appropriately supporting policymakers' use of scientific evidence--known as the Research-to-Policy Collaboration (RPC) Model is proposed. This work has the potential to reduce population-level substance misuse by improving the use of scientific information in policymaking, thus increasing the availability of evidence-based prevention programs and policies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

If science is to inform policy and ultimately improve public health, the field needs an effective strategy for directly supporting policymakers' use of research evidence. However, the field lacks an evidence-based model designed for supporting state policymakers' use of prevention research in crafting legislation. Instead, the field continues to largely rely on ad hoc strategies for translating prevention research (e.g., opportunistic outreach and responding to policymakers' requests if or when they are made). Accordingly, an experimental study of a formal, theory-based approach for supporting policymakers' use of scientific evidence that does not involve lobbying-the Research-to-Policy Collaboration (RPC) Model is proposed. The RPC fosters productive engagement between the policy and research communities by implementing systematic capacity building and outreach strategies. Previous experimental work on the RPC demonstrated the ability of this model to increase engagement between researchers and policymakers, increase policymakers' value for research evidence, and improve their use of scientific evidence in their policymaking.1 The study proposes a state-level randomized controlled trial of the RPC (N = 30 state legislatures) that will evaluate the model's ability to improve engagement between state policymakers' and the prevention science community, build policymakers' awareness and value of substance misuse prevention research, and subsequently their use of research evidence throughout the policymaking process. To accomplish this, the study will test three specific research aims. Aim 1 will assess historical and current use of research evidence in state legislation pertaining to substance misuse prevention. This will involve qualitative coding of bills introduced by state legislatures over the last five years. Aim 2 will compare the frequency and quality of engagement with prevention researchers between the intervention and control conditions. Additionally, the study will assess how the RPC model influences policymakers' value and awareness of substance misuse prevention over time using a validated survey across three time points. Aim 3 will evaluate the effectiveness of the RPC on legislators' actual use of research in legislation by observing and quantifying changes in legislator behavior related to research use. Improving the use of scientific information in policymaking can reduce population-level substance misuse by increasing the availability of evidence-based prevention programs and policies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel M Crowley, Ph.D
  • Phone Number: 866-905-1872
  • Email: dmc397@psu.edu

Study Contact Backup

  • Name: Jennifer T Scott, Ph.D
  • Phone Number: 864-431-2411
  • Email: jxs1622@psu.edu

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Recruiting
        • Penn State University
        • Contact:
          • D. Max Crowley, Ph.D.
          • Phone Number: 1-866-905-1872
          • Email: dmc397@psu.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • State-level public officials

Exclusion Criteria:

  • Anyone who is not a state-level public official

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Legislative offices who receive the full Research-to-Policy Model intervention.
Behavioral: Intervention: RPC Group
The RPC model entails seven interrelated steps including a capacity building and collaboration phase. Throughout the implementation, researchers are provided direct access to intermediary support from our trained RPC fellows who facilitate RPC activity at each step coordinated by an implementation supervisor. Importantly, this model does not involve any lobbying. Consistent with NIH guidelines for grantees, the RPC instead aims to "highlight and translate public health evidence…; conduct coalition building…; provide leadership and training, and foster safe and healthful environments". Specifically, implementation of the RPC model explicitly does not attempt to influence legislative actions, but instead facilitates honest brokerage in which researchers discuss evidence without indicating opinion or stance on how legislators should change specific policies, programs, or regulations.
Active Comparator: Control Group
Legislative Offices who do not receive the full RPC Model intervention.
Behavioral: Active Comparator: Control Group
Control group participants will receive "light touch" research support, similar to previous work (e.g., an RPC associate will send publicly available research materials in response to research requests). This light touch control condition will increase responsiveness of state officials to survey follow up requests.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
RPC impact on introduction of evidence-informed bills
Time Frame: Baseline, post intervention, and 6-months post intervention
Assessment of use of research evidence in bills introduced during the intervention period. It is anticipated that legislators will introduce over 5,000 bills relating to substance use are. These bills will be coded for presence of evidence markers using a validated, deductive codebook to identify how legislators use research evidence in legislative language. A subset of these bills (N = 150) will be reviewed by trained coders to identify the form (i.e. direct or indirect) and the goal of evidence use (i.e., sharing the cause of the problem, status of the problem, solving the problem, generating new knowledge, or accountability). Observed use of research evidence in bills will be quantified and analyzed in a series of multi-level models to test change across three time points.
Baseline, post intervention, and 6-months post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RPC impact on legislators' perceived use of prevention research
Time Frame: Baseline, post intervention, and 6 months post-intervention
Legislators' perceived use of research evidence will be assessed with the Reported Use of Research Evidence Scale (minimum value = 1, maximum value =5, higher scores indicate increased use of research evidence), which assesses use of research across various stages of the policy process (e.g., agenda setting, policy evaluation) and the three types of research use (i.e., instrumental, conceptual, and symbolic). Research will be defined for participants as information gleaned from scientific studies, academic investigations, or program evaluations assessing the effectiveness of an intervention. Surveys from state legislators will be analyzed longitudinally by modeling change across the two time points-including multi-level repeated measures and growth curve models (MLM).
Baseline, post intervention, and 6 months post-intervention
RPC impact on legislators' engagement with prevention researchers
Time Frame: Baseline, post collaboration, and 6 months post-intervention
The investigators will use validated quantitative survey instrument to investigate how the RPC model influences the frequency of policymakers' different types of interactions with researchers (5-pt. Likert scale; ɑ = .89). A series of multi-level models will be employed to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following the intervention. Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects. Survey data from state legislators will also be analyzed longitudinally across the three time points-including multi-level repeated measures and growth curve models (MLM) using MPlus.
Baseline, post collaboration, and 6 months post-intervention
RPC impact on state legislators' value of substance misuse prevention science
Time Frame: Baseline, post intervention, and 6 months post intervention
The investigators will use a validated quantitative survey instrument to assess how the RPC model influences legislators' perceived value of research use in their work and in policymaking more generally. It will be measured with an adapted version of the Seeking, Engaging with, and Evaluating Research (SEER) protocol. Policymakers will be asked to rate how strongly they agree with four statements assessing whether they feel they know general information pertaining to prevention programming. A series of multi-level models will be employed to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following intervention). Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects.
Baseline, post intervention, and 6 months post intervention
RPC effectiveness on legislators' awareness of substance misuse prevention science
Time Frame: Baseline, post intervention, and 6 months post-intervention
The investigators will use a validated quantitative survey instrument to investigate how the RPC model influences legislators' awareness of substance misuse prevention science. Policymakers will be asked to rate how strongly they agree with four statements assessing whether they feel they know general information pertaining to prevention programming. A series of multi-level models will be used to account for the nested structure of the study design. In addition to main effects models at each time point, this includes a three-level design that nests legislators within their state legislature across 3 time points (baseline, post intervention, and 6 months following intervention). Survey data will be modeled in terms of absolute difference and change from baseline to post-test to assess trial main effects.
Baseline, post intervention, and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021641
  • R01DA056627 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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