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Completed

NCT Number: NCT04193033

Evaluation of Implementing FLOW

Adequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

About this study

Our study sites requested that we pause implementation due to clinical efforts and site disruption related to COVID-19. Date of study resumption is unclear.

Adequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.

Specific aims for this proposal are:

  • To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:
  • Reach of the program: % of clinic patients transitioned to PC using FLOW
  • Effectiveness: successful transition to primary care and impact on clinic access for future patients
  • Adoption: percent of providers in the selected clinics transitioning patients to primary care
  • Implementation: use of all FLOW components
  • Maintenance: sustainment of FLOW after withdrawal of external facilitation
  • To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study uses site-level randomization
  • Sites must be VA sites with substantial numbers of mental health patients
  • VA medical centers or large or very large community based outpatient clinics

Exclusion criteria

  • Non-VA sites and CBOCs smaller than large

Treatment and study plan

FLOW intervention

Other

The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.

Primary outcomes

  1. Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care

    Time frame: Change from baseline to 12 months

    Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition

  2. Effectiveness of Intervention's Impact on Clinic Access

    Time frame: Change from baseline to 12 months

    Appointments freed up by FLOW consistent discharges from mental health clinics, by site

  3. Adoption: Percent of Mental Health Providers Who Use FLOW Intervention

    Time frame: 12 months

    Percent of mental health providers who use the FLOW intervention for at least 3 patients, compared to the total number of mental health providers in the participating clinics

  4. Implementation Fidelity to the Protocol

    Time frame: 12 months

    Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist

Secondary outcomes

  1. Maintenance of Effectiveness of Intervention's Impact on Clinic Access

    Time frame: 12-18 months

    Encounter slots 'freed up' by FLOW discharges

  2. Maintenance of Implementation Fidelity to the Protocol

    Time frame: 12-24 months

    Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months

  3. Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care

    Time frame: from 12-24 months

    Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition, during the maintenance period

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)

Acronym: FLOW

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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