Intimate Partner ViolenceNCT04106193
Addressing Intimate Partner Violence Among Women Veterans
A study testing Blended Facilitation, Implementation as usual and Toolkit in people with Intimate Partner Violence, run by VA Office of Research and Development at 10 sites in United States.
Trial summary
Up to 20% of women Veterans (WV) using VHA primary care experience past-year intimate partner violence (IPV), which contributes to numerous physical and mental health conditions, including suicidality. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Blended Facilitation, Implementation as usual and Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,421 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Nov 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women Veterans age 18+
- Presenting for care at participating VA-based primary care clinics.
- Due to be screened for intimate partner violence (IPV)
Who cannot join
- IPV screen completed in past year.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
VA Gulf Coast Veterans Health Care System, Biloxi, MS
Biloxi, Mississippi, 39531
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, 32803
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
Walla Walla, Washington, 99362
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response
Up to 20% of women Veterans (WV) using VHA primary care experience past-year intimate partner violence (IPV), which contributes to numerous physical and mental health conditions, including suicidality. Despite national recommendations to screen WVs for IPV, there is low adoption of IPV screening programs in primary care. In response, VHA is spreading IPV screening programs in Women's Health Model 1 and Model 2 primary care clinics, where the majority of WV VHA primary care patients receive care. The systematic and effective implementation of IPV screening programs within primary care clinics is expected to enhance care for WVs as well as improve access to, and timeliness of, IPV-related care. Given the high prevalence of IPV among WVs and its significant negative health effects, successful implementation of IPV screening programs is expected to reduce morbidity among WV VHA patients. This stepped wedge hybrid II implementation/effectiveness study will assess efforts to implement routine IPV screening for WV VHA patients.
Read the detailed description
Background: Intimate partner violence (IPV) is common among women Veterans (WVs), with nearly 20% of WVs treated in Veterans Health Administration (VHA) primary care clinics experiencing past-year IPV. VHA's Women's Health Services (WHS), the IPV Assistance Program, and the Offices of Primary Care and Mental Health and Suicide Prevention developed recommendations for implementing IPV screening programs in primary care. More than two-thirds of WV primary care patients receive care in "Model 1" (i.e., mixed-gender primary care) and "Model 2" (i.e., separate but shared space) clinics, but uptake of screening is low in these clinics. WHS therefore plans to use Blended Facilitation (BF) to roll out IPV screening programs in Model 1 and Model 2 primary care clinics. Given the high number of these clinics throughout VHA, it is unclear whether resource-intensive BF is feasible and whether a less intensive strategy (i.e., toolkit + Implementation as Usual [IAU]) can be effective. Research is also needed on the clinical effectiveness of IPV screening programs.
Significance/Impact: Given the high prevalence of IPV among WVs and its significant health effects, successful implementation of IPV screening programs is expected to improve healthcare services and reduce morbidity among WV VHA patients, an HSR\&D priority area.
Innovation: This study will be the most comprehensive evaluation of both the implementation impact and clinical effectiveness of IPV screening programs globally. It is innovative in its inclusion of four strong VHA operations partners dedicated to successful implementation of IPV screening programs. This project capitalizes on a time-sensitive opportunity to advance IPV screening programs and implementation science.
Specific Aims: This objective of this proposal is to comprehensively evaluate two strategies for implementing IPV screening programs through achieving three specific aims.
- Evaluate the degree of reach, adoption, implementation fidelity, and maintenance achieved using two implementation strategies for IPV screening programs.
- Evaluate the clinical effectiveness of IPV screening programs, as evidenced by disclosure rates and post-screening psychosocial service use.
- Identify multi-level barriers to and facilitators of IPV screening program implementation and sustainment.
Methodology: The investigators propose a cluster randomized, stepped wedge, Hybrid Type II program evaluation design to compare the impact of two implementation strategies (BF + toolkit vs. toolkit + IAU) and the clinical effectiveness of IPV screening programs. This study will use a mixed methods approach to collect quantitative (clinical records data) and qualitative (key informant interviews) implementation outcomes (Aims 1 and 3), as well as quantitative (clinical records data) clinical effectiveness outcomes (Aim 2). The investigators will supplement these data collection methods with surveys to assess implementation strategies survey to be completed pre-BF, post-BF, and in the maintenance phase. The integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide the qualitative data collection and analysis. Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) Framework.
Next Steps/Implementation: This study's four VHA operations partners are eager to use the study results to inform future implementation strategies and clinical practices to spread IPV screening programs to all VHA primary care clinics and other clinical settings so that this vital intervention is accessible to all WV VHA patients.
- Conditions
- Intimate Partner Violence
- Being tested
- Blended Facilitation, Implementation as usual, Toolkit
- Keywords
- intimate partner violence, women Veterans, screening, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended FacilitationOther
Blended facilitation consists of an External Facilitator and Internal Facilitator to support adoption of intimate partner violence screening practices for WVs treated in primary care.
Implementation as usualOther
Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.
ToolkitOther
All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.
| Study group | Role | What they receive |
|---|---|---|
| Toolkit + Implementation as Usual | Experimental | Participating clinics assigned to this arm will receive a guiding toolkit and implementation as usual regarding IPV screening practices. Receives: Other: Implementation as usual; Other: Toolkit |
| Toolkit + Blended Facilitation | Experimental | Participating clinics assigned to this arm will receive a guiding toolkit and blended facilitation to support IPV screening practices. Receives: Other: Blended Facilitation; Other: Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reach (primary implementation outcome)
Change in proportion of WVs seen in Model 1 and 2 clinics during the last three months of each study phase who receive IPV screening
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in Disclosure Rate (primary clinical effectiveness outcome)
Change in proportion of eligible WVs who screen positive for IPV
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Secondary outcomes (5)
Change in Psychosocial Service Use (secondary clinical effectiveness outcome)
Change in proportion of WVs accepting psychosocial service referrals following a positive IPV screen who use such services within two months
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Adoption of Screening (secondary implementation outcome)
Change in proportion of PC clinics completing IPV screening with eligible WVs during evaluation periods
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in Adoption of Referrals / Resource Provision (secondary implementation outcome)
Change in proportion of PC clinics delivering IPV screening program to eligible WVs during evaluation periods, including evidence of resource provision and referral offered for those with positive screens
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in Implementation Fidelity (secondary implementation outcome)
Change in proportion of clinics for whom WVs accept referrals attend psychosocial services within two months of positive screen
Measured: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Maintenance (secondary implementation outcome)
Change in proportion of WVs seen in Model 1 and 2 clinics during the last three months of the facilitation and maintenance phases who receive IPV screening
Measured: For each site, the proportion calculated in the latter half of the facilitation phase (months 7-9) will be compared to the proportion calculated for the last three months of the maintenance phase (months 19-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Nov 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Hybrid type II implementation-effectiveness design; stepped wedge
- Masking
- None (open label)
- Enrolment
- 7,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System
- Responsible party
- Sponsor
- Investigators
- Katherine M. Iverson, PhD MA BA, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106193
- Sponsor's protocol ID
- SDR 18-150
- Other IDs
- Iverson Miller SDR
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iverson KM, Dichter ME, Stolzmann K, Adjognon OL, Lew RA, Bruce LE, Gerber MR, Portnoy GA, Miller CJ. Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial. Implement Sci. 2020 May 7;15(1):29. doi: 10.1186/s13012-020-0969-0.
PubMed 32381013Ogden SN, Dichter ME, Bazzi AR. Intimate partner violence as a predictor of substance use outcomes among women: A systematic review. Addict Behav. 2022 Apr;127:107214. doi: 10.1016/j.addbeh.2021.107214. Epub 2021 Dec 18.
PubMed 34933089Adjognon OL, Brady JE, Iverson KM, Stolzmann K, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LAE, Miller CJ. Using the Matrixed Multiple Case Study approach to identify factors affecting the uptake of IPV screening programs following the use of implementation facilitation. Implement Sci Commun. 2023 Nov 21;4(1):145. doi: 10.1186/s43058-023-00528-x.
PubMed 37990345Iverson KM, Stolzmann KL, Brady JE, Adjognon OL, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LE, Miller CJ. Integrating Intimate Partner Violence Screening Programs in Primary Care: Results from a Hybrid-II Implementation-Effectiveness RCT. Am J Prev Med. 2023 Aug;65(2):251-260. doi: 10.1016/j.amepre.2023.02.013. Epub 2023 Apr 7.
PubMed 37031032
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Intimate Partner Violence Among Women Veterans: Evaluating the Impact and Effectiveness of VHA's Response
- ClinicalTrials.gov ID
- NCT04106193
- Acronym / sponsor ID
- SDR 18-150
- Conditions
- Intimate Partner Violence
- Keywords
- intimate partner violence, women Veterans, screening, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,421 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 20% of women Veterans (WV) using VHA primary care experience past-year intimate partner violence (IPV), which contributes to numerous physical and mental health conditions, including suicidality. Despite national recommendations to screen WVs for IPV, there is low adoption of IPV screening programs in primary care. In response, VHA is spreading IPV screening programs in Women's Health Model 1 and Model 2 primary care clinics, where the majority of WV VHA primary care patients receive care. The systematic and effective implementation of IPV screening programs within primary care clinics is expected to enhance care for WVs as well as improve access to, and timeliness of, IPV-related care. Given the high prevalence of IPV among WVs and its significant negative health effects, successful implementation of IPV screening programs is expected to reduce morbidity among WV VHA patients. This stepped wedge hybrid II implementation/effectiveness study will assess efforts to implement routine IPV screening for WV VHA patients.
Detailed description
Background: Intimate partner violence (IPV) is common among women Veterans (WVs), with nearly 20% of WVs treated in Veterans Health Administration (VHA) primary care clinics experiencing past-year IPV. VHA's Women's Health Services (WHS), the IPV Assistance Program, and the Offices of Primary Care and Mental Health and Suicide Prevention developed recommendations for implementing IPV screening programs in primary care. More than two-thirds of WV primary care patients receive care in "Model 1" (i.e., mixed-gender primary care) and "Model 2" (i.e., separate but shared space) clinics, but uptake of screening is low in these clinics. WHS therefore plans to use Blended Facilitation (BF) to roll out IPV screening programs in Model 1 and Model 2 primary care clinics. Given the high number of these clinics throughout VHA, it is unclear whether resource-intensive BF is feasible and whether a less intensive strategy (i.e., toolkit + Implementation as Usual [IAU]) can be effective. Research is also needed on the clinical effectiveness of IPV screening programs.
Significance/Impact: Given the high prevalence of IPV among WVs and its significant health effects, successful implementation of IPV screening programs is expected to improve healthcare services and reduce morbidity among WV VHA patients, an HSR\&D priority area.
Innovation: This study will be the most comprehensive evaluation of both the implementation impact and clinical effectiveness of IPV screening programs globally. It is innovative in its inclusion of four strong VHA operations partners dedicated to successful implementation of IPV screening programs. This project capitalizes on a time-sensitive opportunity to advance IPV screening programs and implementation science.
Specific Aims: This objective of this proposal is to comprehensively evaluate two strategies for implementing IPV screening programs through achieving three specific aims.
- Evaluate the degree of reach, adoption, implementation fidelity, and maintenance achieved using two implementation strategies for IPV screening programs.
- Evaluate the clinical effectiveness of IPV screening programs, as evidenced by disclosure rates and post-screening psychosocial service use.
- Identify multi-level barriers to and facilitators of IPV screening program implementation and sustainment.
Methodology: The investigators propose a cluster randomized, stepped wedge, Hybrid Type II program evaluation design to compare the impact of two implementation strategies (BF + toolkit vs. toolkit + IAU) and the clinical effectiveness of IPV screening programs. This study will use a mixed methods approach to collect quantitative (clinical records data) and qualitative (key informant interviews) implementation outcomes (Aims 1 and 3), as well as quantitative (clinical records data) clinical effectiveness outcomes (Aim 2). The investigators will supplement these data collection methods with surveys to assess implementation strategies survey to be completed pre-BF, post-BF, and in the maintenance phase. The integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide the qualitative data collection and analysis. Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) Framework.
Next Steps/Implementation: This study's four VHA operations partners are eager to use the study results to inform future implementation strategies and clinical practices to spread IPV screening programs to all VHA primary care clinics and other clinical settings so that this vital intervention is accessible to all WV VHA patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type II implementation-effectiveness design; stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Toolkit + Implementation as Usual | Experimental | Other: Implementation as usual, Other: ToolkitParticipating clinics assigned to this arm will receive a guiding toolkit and implementation as usual regarding IPV screening practices. |
| Toolkit + Blended Facilitation | Experimental | Other: Blended Facilitation, Other: ToolkitParticipating clinics assigned to this arm will receive a guiding toolkit and blended facilitation to support IPV screening practices. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women Veterans age 18+
- Presenting for care at participating VA-based primary care clinics.
- Due to be screened for intimate partner violence (IPV)
Key exclusion criteria (1 listed)
- IPV screen completed in past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended FacilitationBlended facilitation consists of an External Facilitator and Internal Facilitator to support adoption of intimate partner violence screening practices for WVs treated in primary care. | Other | Toolkit + Blended Facilitation |
| Implementation as usualImplementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care. | Other | Toolkit + Implementation as Usual |
| ToolkitAll study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care. | Other | Toolkit + Blended Facilitation, Toolkit + Implementation as Usual |
Primary outcome
Change in Reach (primary implementation outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in proportion of WVs seen in Model 1 and 2 clinics during the last three months of each study phase who receive IPV screening
Change in Disclosure Rate (primary clinical effectiveness outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in proportion of eligible WVs who screen positive for IPV
5 secondary outcomes
Change in Psychosocial Service Use (secondary clinical effectiveness outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Adoption of Screening (secondary implementation outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in Adoption of Referrals / Resource Provision (secondary implementation outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Change in Implementation Fidelity (secondary implementation outcome)
Time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).
Maintenance (secondary implementation outcome)
Time frame: For each site, the proportion calculated in the latter half of the facilitation phase (months 7-9) will be compared to the proportion calculated for the last three months of the maintenance phase (months 19-21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Results publication: PubMed 32381013Iverson KM, Dichter ME, Stolzmann K, Adjognon OL, Lew RA, Bruce LE, Gerber MR, Portnoy GA, Miller CJ. Assessing the Veterans Health Administration's response to intimate partner violence among women: protocol for a randomized hybrid type 2 implementation-effectiveness trial. Implement Sci. 2020 May 7;15(1):29. doi: 10.1186/s13012-020-0969-0.
- Results publication: PubMed 34933089Ogden SN, Dichter ME, Bazzi AR. Intimate partner violence as a predictor of substance use outcomes among women: A systematic review. Addict Behav. 2022 Apr;127:107214. doi: 10.1016/j.addbeh.2021.107214. Epub 2021 Dec 18.
- Derived from this study: PubMed 37990345Adjognon OL, Brady JE, Iverson KM, Stolzmann K, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LAE, Miller CJ. Using the Matrixed Multiple Case Study approach to identify factors affecting the uptake of IPV screening programs following the use of implementation facilitation. Implement Sci Commun. 2023 Nov 21;4(1):145. doi: 10.1186/s43058-023-00528-x.
- Derived from this study: PubMed 37031032Iverson KM, Stolzmann KL, Brady JE, Adjognon OL, Dichter ME, Lew RA, Gerber MR, Portnoy GA, Iqbal S, Haskell SG, Bruce LE, Miller CJ. Integrating Intimate Partner Violence Screening Programs in Primary Care: Results from a Hybrid-II Implementation-Effectiveness RCT. Am J Prev Med. 2023 Aug;65(2):251-260. doi: 10.1016/j.amepre.2023.02.013. Epub 2023 Apr 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M. Iverson, PhD MA BA principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended Facilitation, Implementation as usual and Toolkit in people with Intimate Partner Violence, run by VA Office of Research and Development at 10 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reach (primary implementation outcome) (time frame: For each site, the proportion calculated at baseline (months 1-3) will be compared to the proportion calculated for the latter half of the facilitation period (months 7-9).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106193, which also lists 4 linked publications.
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 5 Oct 2023.