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CPAP Population Management

NCT04559737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-07-06

No results posted yet for this study

Summary

The investigators propose a study to formally compare two Continuous Positive Airway Pressure (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice and we rely on patients to reach out to us if they are struggling with therapy (there will be no active outreach); 2) Case Management - in addition to "Usual Care" visits, patients CPAP use will be monitored and further encounters may be initiated with "struggler" CPAP users while "successful" users are passively followed.

The investigators will evaluate measures of CPAP adherence, patient engagement and cost-effectiveness for the duration of 1 year.

Our hypothesis is that "Case Management" will improve CPAP adherence and cost-effectiveness compared to "Usual Care". The investigators also hypothesize that targeting "strugglers" only in a management by exception (MBE) approach will be equally effective, but require less personnel time compared to targeting "all" patients.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

OTHER

Case Management

Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up intervention. This intervention concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. Therefore, in addition to "Usual Care" we will implement this population management process by identifying CPAP strugglers only and further follow-up encounters will be triggered for these select patients for troubleshooting. Additionally, throughout the 1-year period, Q1 window of \<70% nights \>4 hours will trigger a phone call and at the discretion of the sleep provider convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Dennis Hwang, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2024-08-31
Completion
2025-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559737 on ClinicalTrials.gov