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CPAP Population Management

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case Management
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea (OSA) focused on measuring Case Management (CM), Management by Exception, Continuous Positive Airway Pressure (CPAP), CPAP Adherence, Auto-monitoring, Patient Engagement, Patient Acceptance, Cost-Effective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Kaiser Permanente member
  • Moderate-Severe Obstructive Sleep Apnea diagnosis (AHI4%≥15 on home sleep apnea test [Nox T3 or WatchPAT] or polysomnography (in-lab study)
  • PAP therapy clinically recommended and prescribed for home therapy of OSA
  • Adults (age ≥ 18 years)

Exclusion Criteria:

  • Chronic respiratory failure requiring bilevel PAP ventilatory support or addition of oxygen supplementation.
  • Prior use of PAP prescribed for home therapy.
  • Inability wirelessly connect patient's PAP device.

Sites / Locations

  • Kaiser Permanente Sleep Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Case Management

Arm Description

Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year.

Patients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as <70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the case manager 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.

Outcomes

Primary Outcome Measures

PAP Adherence
Evaluate the impact each arm (Usual Care & Case Management) has on PAP adherence.

Secondary Outcome Measures

Healthcare Provider Effort
Evaluate the cost-effectiveness of each arm by evaluating the number, estimated time and cost per encounter.

Full Information

First Posted
July 7, 2020
Last Updated
July 5, 2022
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT04559737
Brief Title
CPAP Population Management
Official Title
Impact of Population Management Strategies on Continuous Positive Airway Pressure Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Untreated obstructive sleep apnea (OSA) increases patient risks and burden on the healthcare system due to its high prevalence, impact on cardiovascular health, and daytime symptoms that cause deficits on daytime functioning. The yearly economic cost of OSA in Australia, with a population of about 25 million, is estimated to be $21 billion. Unfortunately, the effectiveness of continuous positive airway pressure (CPAP) therapy on improving patient and population outcomes is limited by suboptimal adherence with literature generally reporting adherence rates of 50-70% (defined by Medicare as ≥70% nights used ≥4 hours). The development of technology-based solutions is critical towards improving adherence, and this includes the use of remote patient monitoring, automation, and population management tools. Current CPAP devices are now wirelessly connected (eg, via cellular) which enables remote access by sleep medicine providers to access patient usage. Fox et al demonstrated the utility of remote monitoring in a randomized trial. New CPAP users that were remotely identified to have suboptimal use (and underwent a telephone encounter with a sleep medicine provider) showed significantly better 3 month CPAP use compared to the control group without monitoring (321 minutes versus 207 minutes; p<0.0001). Our center also performed a randomized trial (Tele-OSA study) in which a similar process was applied but the monitoring and patient feedback was automated. Patients with <4 hours use for 3 nights in a row were automatically sent messages (typically via SMS text) encouraging use. The investigators demonstrated the cost-effectiveness of this automated approach (Auto-Monitoring), which resulted in improved CPAP adherence without an increase in manual intervention with a provider. 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 process. This process concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. In our center, the investigators intend to implement this population management process by identifying CPAP strugglers at 1 month, 2 month, and 3 months after therapy initiation although impact on outcomes is unknown. Time Motion Pilot Our center proceeded with a preliminary implementation of this automated MBE process and performed a time motion study comparing time required to deliver care utilizing the population management process with automated risk stratification versus a non-automated process. The tasks performed were as follows: 1) Risk stratification (identifying patients with moderate-severe OSA), assessing CPAP Adherence (identifying those with >50% nights used at least 4 hours), telephone encounter (to troubleshoot issues with CPAP use), and documentation. The investigators demonstrated an 83% reduction in time required to follow-up a similar population of new CPAP users at any given time point (eg, 1 month, 2 months, etc.) While the results of this pilot (unpublished data) demonstrates significant improvement in care delivery efficiency, the impact on adherence remains unclear. Population Management Study The investigators propose a study to formally compare two CPAP follow-up pathways: 1) Usual care - a control group utilizing standard care practices with no active outreach; 2) Case Management - in addition to "Usual Care", other encounters may be initiated with CPAP strugglers while successful users are passively followed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
Keywords
Case Management (CM), Management by Exception, Continuous Positive Airway Pressure (CPAP), CPAP Adherence, Auto-monitoring, Patient Engagement, Patient Acceptance, Cost-Effective

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year.
Arm Title
Case Management
Arm Type
Active Comparator
Arm Description
Patients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as <70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the case manager 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.
Intervention Type
Other
Intervention Name(s)
Case Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
PAP Adherence
Description
Evaluate the impact each arm (Usual Care & Case Management) has on PAP adherence.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Healthcare Provider Effort
Description
Evaluate the cost-effectiveness of each arm by evaluating the number, estimated time and cost per encounter.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction
Description
Evaluate measures of patient acceptance, engagement and satisfaction with Case Management intervention and care experience
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Kaiser Permanente member Moderate-Severe Obstructive Sleep Apnea diagnosis (AHI4%≥15 on home sleep apnea test [Nox T3 or WatchPAT] or polysomnography (in-lab study) PAP therapy clinically recommended and prescribed for home therapy of OSA Adults (age ≥ 18 years) Exclusion Criteria: Chronic respiratory failure requiring bilevel PAP ventilatory support or addition of oxygen supplementation. Prior use of PAP prescribed for home therapy. Inability wirelessly connect patient's PAP device.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Hwang, MD
Phone
909-427-4432
Email
dennis.x.hwang@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Arguelles, BS
Phone
909-427-3032
Email
jessica.arguelles@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Hwang, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Sleep Center
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Woodrum

12. IPD Sharing Statement

Citations:
Citation
The Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010.
Results Reference
background
PubMed Identifier
8466125
Citation
Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, Redline S, Henry JN, Getsy JE, Dinges DF. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993 Apr;147(4):887-95. doi: 10.1164/ajrccm/147.4.887.
Results Reference
background
PubMed Identifier
25243523
Citation
Iftikhar IH, Valentine CW, Bittencourt LR, Cohen DL, Fedson AC, Gislason T, Penzel T, Phillips CL, Yu-sheng L, Pack AI, Magalang UJ. Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a meta-analysis. J Hypertens. 2014 Dec;32(12):2341-50; discussion 2350. doi: 10.1097/HJH.0000000000000372.
Results Reference
background
PubMed Identifier
25700870
Citation
Iftikhar IH, Hoyos CM, Phillips CL, Magalang UJ. Meta-analyses of the Association of Sleep Apnea with Insulin Resistance, and the Effects of CPAP on HOMA-IR, Adiponectin, and Visceral Adipose Fat. J Clin Sleep Med. 2015 Apr 15;11(4):475-85. doi: 10.5664/jcsm.4610.
Results Reference
background
PubMed Identifier
22467985
Citation
Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
Results Reference
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CPAP Population Management

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