Sleep MAPP in the Polytrauma/TBI System of Care

NCT07886398 | Not Yet Recruiting

• 1 other identifier: RRD1-005-25W
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot implementation trial will evaluate the Sleep Disorder Management Assistance for Providers and Patients (Sleep MAPP) Care Pathway in one Veterans Health Administration Polytrauma/TBI System of Care clinic. The care pathway combines a provider-facing decision-support tool that supports pre-visit administration and documentation of the Insomnia Severity Index with training and implementation support for clinic providers to deliver Brief Behavioral Therapy for Insomnia. The study will assess the feasibility and acceptability of the care pathway; describe changes in guideline-concordant insomnia screening and behavioral treatment; and describe preliminary changes in insomnia symptoms, neurobehavioral symptoms, and participation in social roles among Veterans with mild traumatic brain injury who receive Brief Behavioral Therapy for Insomnia. Up to 30 clinic providers or staff and 50 Veterans will be invited to complete research surveys and interviews. Implementation and clinical outcomes will be obtained from routinely collected clinical data.

Conditions

Insomnia Disorder; Mild Traumatic Brain Injury

Keywords

Veterans; Insomnia Screening; Brief Behavioral Therapy for Insomnia; Clinical Decision Support; Implementation Science; Rehabilitation

Outcome Measures

Primary Outcomes (17)

• Provider-rated feasibility of Sleep MAPP decision support tool

  Provider respondents complete the four-item Feasibility of Intervention Measure for the Sleep MAPP decision-support tool. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.

  End of the 12-month implementation phase

• Provider-rated feasibility of insomnia screening with the Insomnia Severity Index

  Provider respondents complete the Feasibility of Intervention Measure for Insomnia Severity Index screening. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.

  End of the 12-month implementation phase

• Provider-rated feasibility of Brief Behavioral Therapy for Insomnia (BBTI) training

  Provider respondents complete the Feasibility of Intervention Measure for Brief Behavioral Therapy for Insomnia training. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.

  End of the 12-month implementation phase

• Provider-rated feasibility of Brief Behavioral Therapy for Insomnia (BBTI)

  Provider respondents complete the Feasibility of Intervention Measure for delivery of Brief Behavioral Therapy for Insomnia in routine care. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived feasibility.

  End of the 12-month implementation phase

• Provider-rated acceptability of the Sleep MAPP decision-support tool

  Provider respondents complete the Acceptability of Intervention Measure for the Sleep MAPP decision-support tool. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.

  End of the 12-month implementation phase

• Provider-rated acceptability of insomnia screening with the Insomnia Severity Index

  Provider respondents complete the Acceptability of Intervention Measure for Insomnia Severity Index screening. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.

  End of the 12-month implementation phase

• Provider-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI) training

  Provider respondents complete the Acceptability of Intervention Measure for Brief Behavioral Therapy for Insomnia training. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.

  End of the 12-month implementation phase

• Provider-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI) delivery

  Provider respondents complete the Acceptability of Intervention Measure for delivery of Brief Behavioral Therapy for Insomnia in routine care. The outcome is the percentage of respondents with a mean item score of 4.0 (agree) or higher. Higher percentages indicate greater perceived acceptability.

  End of the 12-month implementation phase

• Veteran-rated acceptability of insomnia screening using the Insomnia Severity Index

  Veterans complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to rate satisfaction with Insomnia Severity Index screening. Items are scored from 1 to 4 and summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. The outcome is the percentage of respondents with a mean item score of 3.0 or higher, equivalent to a total score of 24 or higher.

  Within approximately 1 month after final BBTI session; from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Veteran-rated acceptability of Brief Behavioral Therapy for Insomnia (BBTI)

  Veterans complete the 8-item Client Satisfaction Questionnaire (CSQ-8) to rate satisfaction with Brief Behavioral Therapy for Insomnia. Items are scored from 1 to 4 and summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. The outcome is the percentage of respondents with a mean item score of 3.0 or higher, equivalent to a total score of 24 or higher.

  Within approximately 1 month after final BBTI session; from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of data collection: Completion rate of Insomnia Severity Index assessments administered through Sleep MAPP

  Proportion of pre-visit Insomnia Severity Index assessments administered via Sleep MAPP that were completed by Veterans.

  From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of data collection: Rate of Insomnia Severity Index score upload to the electronic medical record

  Proportion of pre-visit ISI assessments facilitated by Sleep MAPP that were uploaded by providers into the medical record.

  From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of data collection: Availability of baseline clinical outcome data for Veterans receiving Brief Behavioral Therapy for Insomnia (BBTI)

  Proportion of Veterans initiating BBTI who report valid responses for all items on baseline clinical assessments (Insomnia Severity Index; Neurobehavioral Symptom Inventory; PROMIS Satisfaction with Social Roles; PROMIS Ability to Participate in Social Roles).

  From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of data collection: Availability of follow-up clinical outcome data for Veterans receiving Brief Behavioral Therapy for Insomnia (BBTI)

  Proportion of Veterans who engage in a final session of BBTI who report valid responses for all items on follow-up clinical assessments (Insomnia Severity Index; Neurobehavioral Symptom Inventory; PROMIS Satisfaction with Social Roles; PROMIS Ability to Participate in Social Roles).

  From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of data recruitment/retention: Implementation activity attendance

  Proportion of total number of expected attendances of implementation activities (e.g., team meetings) that were actually attended during the pre-implementation and implementation phases. Expected attendance will be calculated by summing the number of eligible team members invited to attend each meeting.

  From the start of the 6-month pre-implementation phase to the end of the 12-month implementation phase.

• Feasibility of recruitment/retention: Initiation of Brief Behavioral Therapy for Insomnia (BBTI) among eligible Veterans

  Proportion of eligible Veterans who attend ≥1 BBTI encounter.

  From the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

• Feasibility of recruitment/retention: Retention in the Brief Behavioral Therapy for Insomnia (BBTI) protocol

  Proportion of Veterans who initiate BBTI who receive ≥3 sessions, reflecting completion of protocol.

  BBTI initiation through completion of the treatment episode (time from first to last session varies but can range from 1 to 16 weeks), occurring from the start of the 12-month implementation phase to the end of the 6-month post-implementation phase.

Secondary Outcomes (23)

• Reach of insomnia screening

  Proportion of Veterans who initiate BBTI who receive ≥3 sessions, reflecting completion of protocol.

• Reach of Brief Behavioral Therapy for Insomnia (BBTI)

  Start of the 6-month pre-implementation phase to the end of the 12-month implementation phase

• Adoption of insomnia screening

  12-month implementation phase

• Adoption of Brief Behavioral Therapy for Insomnia (BBTI): Proportion trained

  12-month implementation phase

• Adoption of BBTI: Proportion delivering Brief Behavioral Therapy for Insomnia (BBTI)

  12-month implementation phase

Study Arms (1)

Sleep MAPP Care Pathway

EXPERIMENTAL

The participating Polytrauma/TBI System of Care clinic will implement the Sleep MAPP Care Pathway, which is designed to increase delivery of two guideline-recommended clinical practices: insomnia screening with the Insomnia Severity Index and Brief Behavioral Treatment for Insomnia (BBTI). Implementation will be supported by a multicomponent strategy bundle that includes deployment of the Sleep MAPP clinical decision support tool, training providers to deliver BBTI, and complementary implementation supports.

Other: Sleep MAPP Care Pathway

Interventions

Sleep MAPP Care Pathway OTHER

The Sleep MAPP Care Pathway includes four components: (1) the Sleep MAPP clinical decision-support tool, which identifies Veterans who may benefit from insomnia screening and provides clinicians with screening results and care prompts; (2) insomnia screening using the Insomnia Severity Index (ISI); (3) training PNS rehabilitation clinicians to deliver Brief Behavioral Treatment for Insomnia (BBTI); and (4) delivery of BBTI to clinically appropriate Veterans as part of routine care. BBTI is a brief, evidence-based behavioral treatment for insomnia that includes sleep education, stimulus control, sleep restriction, and strategies to support adherence and maintenance of treatment gains.

Sleep MAPP Care Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1 Provider participants (study procedures aimed at understanding feasibility and acceptability)
• \- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway (e.g., program leadership, referring clinicians, and clinicians eligible for Brief Behavioral Therapy for Insomnia training).
• Aim 1 Veteran participants (study procedures aimed at understanding feasibility and acceptability)
• Clinician-confirmed mild traumatic brain injury documented in the Comprehensive TBI Evaluation Database.
• Received the Insomnia Severity Index.
• Initiated Brief Behavioral Therapy for Insomnia at the Polytrauma Network Site and completed Brief Behavioral Therapy for Insomnia no more than 1 week before being invited to participate.
• Aim 2 Provider participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance)
• \- Multidisciplinary member of the Polytrauma Network Site who is involved in implementation of the Sleep MAPP Care Pathway, including referring clinicians and clinicians eligible for Brief Behavioral Therapy for Insomnia training.
• Aim 2 Veteran participants (study procedures aimed at understanding reach, adoption, implementation, and maintenance)
• History of mild traumatic brain injury, diagnosed during routine clinical care.
• Scheduled to receive care at the Polytrauma Network Site.
• Aim 3 Veteran participants (study procedures aimed at understanding change in clinical outcomes after Brief Behavioral Therapy for Insomnia delivery)
• History of mild traumatic brain injury, diagnosed during routine clinical care.
• Insomnia Severity Index score of 11 or higher.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Pittsburgh Healthcare System: collaborator

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Concussion

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Adam R. Kinney, PhD OTR

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam R Kinney, PhD OTR

CONTACT

(720) 857-2720; adam.kinney@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Single-site pilot implementation study evaluating a multicomponent care pathway during pre-implementation, implementation, and post-implementation phases. The study assesses feasibility, acceptability, implementation outcomes, maintenance, and preliminary clinical outcomes.

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)