Ignite Creation Date:
2024-05-06 @ 2:30 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02056002
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2014-02-03
Brief Title:
Peer-Driven Intervention for Sleep Apnea
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Peer-Driven Intervention as an Alternate Model of Care Delivery and Coordination for Sleep Apnea
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCORI
Brief Summary:
Fragmentation of care can lead to poor treatment adherence in patients with chronic medical conditions which can in turn lead to adverse health consequences poor quality of life and patient dissatisfaction Poor treatment adherence may be due to lack of sufficient patient education time delays in delivery of care lack of adequate healthcare coordination or difficulty accessing various healthcare providers across a front desk which serves as a healthcare bottle-neck Better efficiency in healthcare delivery with greater connectivity through knowledgeable and trained peer volunteers and inexpensive cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system Specifically such community health education volunteers peer-buddies who are experienced in managing their disease condition may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session An additional important advantage is the peer-buddys ability to relate to the patient in a manner consistent with their social ethnic and cultural believes without language barriers or differences that may stem from socioeconomic strata We will use sleep apnea as an example condition to test the effect of a peer-buddy helper combined with the universal availability of personal cell phones on the problem of poor care coordination and treatment adherence to the CPAP treatment for sleep apnea Sleep apnea is a very common condition that affects 7-12 of the US population and if left untreated can lead to poor health and even death through its effects on high blood pressure heart disease stroke and motor vehicle accidents Fortunately CPAP therapy can lead to a 3-fold reduction in such consequences but patient adherence to such CPAP treatment is generally poor We have recently completed a small study that demonstrated improved usage of CPAP treatment by patients receiving help from a peer-buddy with excellent results We propose to further enhance the peer-buddy community-volunteer concept in our proposed research by combining this with cell-phone technology and a telephone exchange that improves access to healthcare providers technicians and home care companies We hope to show that active community participation by experienced lay individuals assisted by the universal availability of cheap cell-phones can improve the reach and effectiveness of our healthcare system in improving the health and well-being of our patients If successful such an innovative and community-based approach can be applied to other chronic medical conditions
Hypothesis 1 We hypothesize that patients in the peer-driven intervention with interactive voice response PDI-IVR group will experience a greater patient satisfaction measured by Likert scale6470 and PACIC7172 and perception of care coordination measured by CPCQ7273 than patients in the usual care control group
Hypothesis 2 We hypothesize that patients in the PDI-IVR group will experience a greater CPAP adherence measured by device download patient activation PAM and self-efficacy SEMSA than patients in the usual care control group
Hypothesis 3 We hypothesize that patients in the PDI-IVR group will experience greater improvements in HR-QOL measured by FOSQ vigilance psychomotor vigilance testing and blood pressure than patients in the usual care control group
Hypothesis 1 We hypothesize that patients in the peer-driven intervention with interactive voice response PDI-IVR group will experience a greater patient satisfaction measured by Likert scale6470 and PACIC7172 and perception of care coordination measured by CPCQ7273 than patients in the usual care control group
Hypothesis 2 We hypothesize that patients in the PDI-IVR group will experience a greater CPAP adherence measured by device download patient activation PAM and self-efficacy SEMSA than patients in the usual care control group
Hypothesis 3 We hypothesize that patients in the PDI-IVR group will experience greater improvements in HR-QOL measured by FOSQ vigilance psychomotor vigilance testing and blood pressure than patients in the usual care control group
Detailed Description:
COMPARATORS
1 Intervention group In order to address the proposed aims we will recruit recently diagnosed patients with obstructive sleep apnea OSA who have not been initiated on CPAP therapy and randomly assign them to the PDI-IVR system to promote adherence to CPAP therapy intervention group or be provided with educational brochures regarding OSA and CPAP therapy usual care control group In the PDI-IVR intervention group trained and experienced peers peer-buddy with sleep apnea will be paired with the newly diagnosed patients over a 6-month period As in our preliminary study the peer-buddy will be matched with the subjects with regards to age gender race ethnicity socioeconomic and educational backgrounds During this time the trained peers will share experiences on coping strategies with CPAP device and equipment promote self efficacy share their positive experiences motivational effects and outcome expectancies share their knowledge of perceived vulnerabilities due to untreated sleep apnea promote risk perception share methods for improving efficacy of CPAP equipment and interface patient education and prepare their subjects for upcoming physician or respiratory therapist appointments patient activation The interaction will occur during supervised in-person sessions two sessions at day 1 and day 7 and also telephone-based conversations through the IVR system once a week for one month followed by telephone calls on a fortnightly basis Additionally they will help the patient navigate the delivery system and effect better care coordination through the IVR system at patient-initiated request
2 Usual care description All participants will receive usual care following initiation of CPAP therapy Usual care of the newly diagnosed patient with OSA consists of attending a CPAP initiation and education class which is conducted either at the patients home or in the offices of a home care DME company by a dedicated respiratory therapist Patients are educated about the basics of the care and operation of the device mask and related equipment Following this CPAP initiation and education class they receive instructions to either mail-in the CPAP adherence monitoring card Smart card by mail to the therapist about 4 weeks following the initial visit The adherence information is evaluated and posted in electronic medical records Patients with OSA will be seen in the sleep clinic at 1 and 3 months following initiation of CPAP therapy and will have the option to call any of their care providers In order to balance the number of contacts and educational sessions between the two comparison groups educational brochures from the AASM and videos on DVD from Industry stakeholders will be mailed to participants We did not incorporate an attention-control arm requiring in-person contacts as the comparator because the overarching goal of this proposal is to make this study relevant to the real-world conditions of a well measured usual care arm to make the study findings generalizable and better inform patients decision-making Such external validity was felt to be of greater value than comparing two conditions that currently do not exist in current practice
Peer-buddy system Selection and Training of Peer-buddies Fifty peer-buddies will be recruited from the four sleep clinics who are adherent to CPAP therapy Peer buddies will be consented and compensated for their role in the research study 350 for 6 month participation per subject Each buddy may be paired with up to 12 subjects over the length of the study
Training PI and research staff will educate the peer buddy and provide them with guidelines for their interactions with the research participants They will be instructed to share their experiences and not to provide medical advice The sharing of coping strategies will fall under the following categories
i Promote self efficacy Strategies to deal with CPAP device and equipment such as pressure ramp feature humidifier settings mask and strap application and cleaning of device and related equipment ii Promote outcome expectancies Share their positive experiences with regards to effects of CPAP on energy level or vigilance sense of well-being hypertension control and other medical benefits that they possibly derived from CPAP therapy iii Risk perception Share their knowledge of perceived vulnerabilities due to untreated sleep apnea Share methods for improving efficacy of CPAP equipment and interface patient education iv Patient activation Share experiences of how to prepare for upcoming physician or respiratory therapist appointments such as what questions to ask the healthcare provider what to take with them eg CPAP adherence card or malfunctioning device humidifier or mask and what to expect at a given provider visit At the end of the training a mock interaction between the peer-buddy and PI playing the role of the patient with OSA will be undertaken before certifying or graduating the peer-buddy as competent
Potential for inter-personal conflicts and management plan The peer-buddy and research participant will be informed that they can withdraw from participation if there is a potential conflict or difficult situation they feel threatened face verbal abuse from subject individual is too demanding frequent calls or late night calls The peer-buddy and subject starting CPAP will provide the research coordinator with an availability sheet as to when they are available to take phone calls andor appear in person Each peer-buddy will be paired up with one research participant and may choose to take on up to 3 patients at a time and take on a new assignment at the end of the 6-month participation period Peer-buddy and participant will be matched by age gender race ethnicity and socioeconomic status The peer-buddies will be instructed not to offer medical advice If a medical need or problem were to arise the peer-buddies will be instructed to provide the research participant with the phone number to call the PI via call operator who will assess their medical needs and situation
Fidelity assessments Twenty percent of the telephonic communications between the peer-buddy and patient will be randomly recorded by IVR system for fidelity assessments by the behavioral therapist Haynes Co-investigator Similarly 20 of in-person visits will be assessed by the behavioral therapist Such fidelity assessments will be used to increase fidelity efficacy during study
In-person interactions In-person interaction will occur on 2 occasions 30-minutes each within the first 10 days of CPAP initiation The research coordinator will be present during this interaction but will not be facilitating or running the interaction A clean CPAP device and related supplies for the patient will need to be present during these interactions for demonstration purposes
Telephonic IVR interactions Once a week for the first month followed by 4 phone conversations over the subsequent 2 month period 8 scheduled telephonic interactions and as needed in the subsequent 3 months There will be no more than 10 such as-needed phone calls in the latter 3-months between participant and peer-buddy Therefore over the 6-months there will not be in excess of 18 phone calls per subject assigned to peer-buddy Each phone conversation will last a maximum of 30 minutes The PDI-IVR system will be programmed to recognize the peer-buddys phones cell or home and be programmed to link this with the patients phones cell or home and thereby protect the privacy of both participants The dyad of the peer-buddy and participant will introduce themselves on a first name basis and will not be required to provide other personal information However the study does not preclude them from sharing such information or developing long-lasting friendships For each dyad the research coordinator may monitor a few calls with the participants knowledge and random IVR-based recording in order to monitor the content and level of participation between the dyad however the coordinators will not direct the participation in any way Peer-buddies will share their experiences that would promote self-efficacy outcome expectations risk perception and patient activation During in-person interactions greater emphasis on promotion of self-efficacy will be placed considering the physicality of the medical device CPAP therapy masks hoses humidifiers and filters During phone interactions greater emphasis on promotion of outcome expectancies risk perception and patient activation will be undertaken The research coordinators may provide feedback to the peer-buddy regarding their performance and remind them to cover topics that were not covered in order to ensure fidelity Either the patient or the peer-buddy on behalf of the patient can initiate calls to other members of the inter-disciplinary team including obtaining CPAP adherence data through the IVR that was derived from the industry server figure 2 Call backs from any of the providers physician RT RN DME representative or sleep tech will be connected back to the initiator of the call Patient or peer-buddy IVR-initiated queries regarding CPAP device - for adherence leak and efficacy residual obstructive events data - will be faxed to the sleep physicians office or designee RN or RT by the IVR with a note for patient call back Content of interactions will pertain to OSA and CPAP therapy and related supplies mask hose filters and humidifier Content will include aspects pertaining to mask fitting using ramp function on CPAP unit using the CPAP humidification system etc Conversations regarding erectile dysfunction or a similar sensitive matter will be discouraged Both peer-buddy and subject would have provided voluntary consent for sharing their experiences with CPAP therapy and sleep apnea A checklist of content areas will be provided to the peer-buddy to ensure that such topical areas were discussed by the peer-subject pair We will refrain from writing a script for the peer-buddy as we believe that would detract from the sense of bond or trust within the dyad
1 Intervention group In order to address the proposed aims we will recruit recently diagnosed patients with obstructive sleep apnea OSA who have not been initiated on CPAP therapy and randomly assign them to the PDI-IVR system to promote adherence to CPAP therapy intervention group or be provided with educational brochures regarding OSA and CPAP therapy usual care control group In the PDI-IVR intervention group trained and experienced peers peer-buddy with sleep apnea will be paired with the newly diagnosed patients over a 6-month period As in our preliminary study the peer-buddy will be matched with the subjects with regards to age gender race ethnicity socioeconomic and educational backgrounds During this time the trained peers will share experiences on coping strategies with CPAP device and equipment promote self efficacy share their positive experiences motivational effects and outcome expectancies share their knowledge of perceived vulnerabilities due to untreated sleep apnea promote risk perception share methods for improving efficacy of CPAP equipment and interface patient education and prepare their subjects for upcoming physician or respiratory therapist appointments patient activation The interaction will occur during supervised in-person sessions two sessions at day 1 and day 7 and also telephone-based conversations through the IVR system once a week for one month followed by telephone calls on a fortnightly basis Additionally they will help the patient navigate the delivery system and effect better care coordination through the IVR system at patient-initiated request
2 Usual care description All participants will receive usual care following initiation of CPAP therapy Usual care of the newly diagnosed patient with OSA consists of attending a CPAP initiation and education class which is conducted either at the patients home or in the offices of a home care DME company by a dedicated respiratory therapist Patients are educated about the basics of the care and operation of the device mask and related equipment Following this CPAP initiation and education class they receive instructions to either mail-in the CPAP adherence monitoring card Smart card by mail to the therapist about 4 weeks following the initial visit The adherence information is evaluated and posted in electronic medical records Patients with OSA will be seen in the sleep clinic at 1 and 3 months following initiation of CPAP therapy and will have the option to call any of their care providers In order to balance the number of contacts and educational sessions between the two comparison groups educational brochures from the AASM and videos on DVD from Industry stakeholders will be mailed to participants We did not incorporate an attention-control arm requiring in-person contacts as the comparator because the overarching goal of this proposal is to make this study relevant to the real-world conditions of a well measured usual care arm to make the study findings generalizable and better inform patients decision-making Such external validity was felt to be of greater value than comparing two conditions that currently do not exist in current practice
Peer-buddy system Selection and Training of Peer-buddies Fifty peer-buddies will be recruited from the four sleep clinics who are adherent to CPAP therapy Peer buddies will be consented and compensated for their role in the research study 350 for 6 month participation per subject Each buddy may be paired with up to 12 subjects over the length of the study
Training PI and research staff will educate the peer buddy and provide them with guidelines for their interactions with the research participants They will be instructed to share their experiences and not to provide medical advice The sharing of coping strategies will fall under the following categories
i Promote self efficacy Strategies to deal with CPAP device and equipment such as pressure ramp feature humidifier settings mask and strap application and cleaning of device and related equipment ii Promote outcome expectancies Share their positive experiences with regards to effects of CPAP on energy level or vigilance sense of well-being hypertension control and other medical benefits that they possibly derived from CPAP therapy iii Risk perception Share their knowledge of perceived vulnerabilities due to untreated sleep apnea Share methods for improving efficacy of CPAP equipment and interface patient education iv Patient activation Share experiences of how to prepare for upcoming physician or respiratory therapist appointments such as what questions to ask the healthcare provider what to take with them eg CPAP adherence card or malfunctioning device humidifier or mask and what to expect at a given provider visit At the end of the training a mock interaction between the peer-buddy and PI playing the role of the patient with OSA will be undertaken before certifying or graduating the peer-buddy as competent
Potential for inter-personal conflicts and management plan The peer-buddy and research participant will be informed that they can withdraw from participation if there is a potential conflict or difficult situation they feel threatened face verbal abuse from subject individual is too demanding frequent calls or late night calls The peer-buddy and subject starting CPAP will provide the research coordinator with an availability sheet as to when they are available to take phone calls andor appear in person Each peer-buddy will be paired up with one research participant and may choose to take on up to 3 patients at a time and take on a new assignment at the end of the 6-month participation period Peer-buddy and participant will be matched by age gender race ethnicity and socioeconomic status The peer-buddies will be instructed not to offer medical advice If a medical need or problem were to arise the peer-buddies will be instructed to provide the research participant with the phone number to call the PI via call operator who will assess their medical needs and situation
Fidelity assessments Twenty percent of the telephonic communications between the peer-buddy and patient will be randomly recorded by IVR system for fidelity assessments by the behavioral therapist Haynes Co-investigator Similarly 20 of in-person visits will be assessed by the behavioral therapist Such fidelity assessments will be used to increase fidelity efficacy during study
In-person interactions In-person interaction will occur on 2 occasions 30-minutes each within the first 10 days of CPAP initiation The research coordinator will be present during this interaction but will not be facilitating or running the interaction A clean CPAP device and related supplies for the patient will need to be present during these interactions for demonstration purposes
Telephonic IVR interactions Once a week for the first month followed by 4 phone conversations over the subsequent 2 month period 8 scheduled telephonic interactions and as needed in the subsequent 3 months There will be no more than 10 such as-needed phone calls in the latter 3-months between participant and peer-buddy Therefore over the 6-months there will not be in excess of 18 phone calls per subject assigned to peer-buddy Each phone conversation will last a maximum of 30 minutes The PDI-IVR system will be programmed to recognize the peer-buddys phones cell or home and be programmed to link this with the patients phones cell or home and thereby protect the privacy of both participants The dyad of the peer-buddy and participant will introduce themselves on a first name basis and will not be required to provide other personal information However the study does not preclude them from sharing such information or developing long-lasting friendships For each dyad the research coordinator may monitor a few calls with the participants knowledge and random IVR-based recording in order to monitor the content and level of participation between the dyad however the coordinators will not direct the participation in any way Peer-buddies will share their experiences that would promote self-efficacy outcome expectations risk perception and patient activation During in-person interactions greater emphasis on promotion of self-efficacy will be placed considering the physicality of the medical device CPAP therapy masks hoses humidifiers and filters During phone interactions greater emphasis on promotion of outcome expectancies risk perception and patient activation will be undertaken The research coordinators may provide feedback to the peer-buddy regarding their performance and remind them to cover topics that were not covered in order to ensure fidelity Either the patient or the peer-buddy on behalf of the patient can initiate calls to other members of the inter-disciplinary team including obtaining CPAP adherence data through the IVR that was derived from the industry server figure 2 Call backs from any of the providers physician RT RN DME representative or sleep tech will be connected back to the initiator of the call Patient or peer-buddy IVR-initiated queries regarding CPAP device - for adherence leak and efficacy residual obstructive events data - will be faxed to the sleep physicians office or designee RN or RT by the IVR with a note for patient call back Content of interactions will pertain to OSA and CPAP therapy and related supplies mask hose filters and humidifier Content will include aspects pertaining to mask fitting using ramp function on CPAP unit using the CPAP humidification system etc Conversations regarding erectile dysfunction or a similar sensitive matter will be discouraged Both peer-buddy and subject would have provided voluntary consent for sharing their experiences with CPAP therapy and sleep apnea A checklist of content areas will be provided to the peer-buddy to ensure that such topical areas were discussed by the peer-subject pair We will refrain from writing a script for the peer-buddy as we believe that would detract from the sense of bond or trust within the dyad
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCORI | OTHER | Patient-Centered Outcomes Research Institute | None |