Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201201
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2005-09-16
Brief Title:
Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to reduce adverse self-medication practices in older adults with hypertension
Detailed Description:
BACKGROUND
Failure of older adults to take medications properly is estimated to be a factor in more than a quarter of emergency room visits and 10 percent of nursing home admissions with a total cost of over 25 billion annually It has been estimated that 10 percent of adverse drug events may be attributed to communication failure between the provider and patient Lack of adherence to prescription medication protocols and adverse self-medication practices can result in drug interactions that can be fatal In a health environment that promotes polypharmacy for older adults a group that is less well able to see hear and understand medical information than the general population a need exists to educate both older adults and their providers about the dangers of adverse drug interactions arising from self-medication
DESIGN NARRATIVE
The goal is to reduce adverse self-medication practices in older adults with hypertension A computer program developed for older adults Personal Education Program or PEP will be modified as the next generation PEP PEP-NG to include an interface to allow clients to enter self-medication behavior data independently on a wireless touch screen tablet computer Data entered on the PEP-NG will be analyzed via a secure server ProHealth and program content tailored to the specific adverse self-medication behaviors will be delivered Summaries of the reported behaviors with corrective strategies will be printed for both patient and provider so the advanced practice registered nurse APRN has a good idea of the clients self-medication practices before beginning the face-to-face interview Thus the PEP-NG will make optimal use of the clients waiting time and the APRNs clinical time
Specific aims are at three levels 1 To design an interface for the PEP-NG with a desirable characteristics for both older adults and primary care providers and b minimal user burden 2 To show that APRNs will increase a knowledge concerning potential drug interactions arising from older adults self-medication practices b self-efficacy for teaching older adults about potential drug interactions c self-efficacy for communicating with older adults about self-medication and to d demonstrate satisfaction using the PEP-NG with clients 3 To show that older adults using the PEP-NG will a increase knowledge concerning potential drug interactions arising from self-medication practices b increase self-efficacy as to how to avoid potential drug interactions arising from self-medication practice c reduce self-reported adverse behaviors associated with potential drug interactions 4 improve prescription medication adherence d achieve target blood pressure readings and demonstrate e satisfaction with the PEP-NG and f the APRN provider relationship User-sensitive inclusive design methods will be used to develop and test the patient data interface After beta-testing the PEP-NG in the primary care laboratory the PEP-NG will be piloted by 10 APRNs affiliated with ProHealth primary care practices Repeated Measures Analysis of Variance RM ANOVA with one within subjects factor TIME will be performed on APRNs outcome measures at time 0 immediate post-instruction and 3 and 6 months later APRNs will each recruit 24 clients 240 total meeting study criteria The PEP-NG software will randomly assign each APRNs clients to either control data collection only and experimental data collection plus educational intervention with targeted messages Client outcome will be assessed at 0 4 8 12 and 52 weeks and analyzed as a mixed ANOVA with NURSE and GROUP as between-subjects factors and TIME as a repeated-measures factor Healthcare utilization will be compared between the 2 groups after 52 weeks and a cost-benefit analysis conducted
Failure of older adults to take medications properly is estimated to be a factor in more than a quarter of emergency room visits and 10 percent of nursing home admissions with a total cost of over 25 billion annually It has been estimated that 10 percent of adverse drug events may be attributed to communication failure between the provider and patient Lack of adherence to prescription medication protocols and adverse self-medication practices can result in drug interactions that can be fatal In a health environment that promotes polypharmacy for older adults a group that is less well able to see hear and understand medical information than the general population a need exists to educate both older adults and their providers about the dangers of adverse drug interactions arising from self-medication
DESIGN NARRATIVE
The goal is to reduce adverse self-medication practices in older adults with hypertension A computer program developed for older adults Personal Education Program or PEP will be modified as the next generation PEP PEP-NG to include an interface to allow clients to enter self-medication behavior data independently on a wireless touch screen tablet computer Data entered on the PEP-NG will be analyzed via a secure server ProHealth and program content tailored to the specific adverse self-medication behaviors will be delivered Summaries of the reported behaviors with corrective strategies will be printed for both patient and provider so the advanced practice registered nurse APRN has a good idea of the clients self-medication practices before beginning the face-to-face interview Thus the PEP-NG will make optimal use of the clients waiting time and the APRNs clinical time
Specific aims are at three levels 1 To design an interface for the PEP-NG with a desirable characteristics for both older adults and primary care providers and b minimal user burden 2 To show that APRNs will increase a knowledge concerning potential drug interactions arising from older adults self-medication practices b self-efficacy for teaching older adults about potential drug interactions c self-efficacy for communicating with older adults about self-medication and to d demonstrate satisfaction using the PEP-NG with clients 3 To show that older adults using the PEP-NG will a increase knowledge concerning potential drug interactions arising from self-medication practices b increase self-efficacy as to how to avoid potential drug interactions arising from self-medication practice c reduce self-reported adverse behaviors associated with potential drug interactions 4 improve prescription medication adherence d achieve target blood pressure readings and demonstrate e satisfaction with the PEP-NG and f the APRN provider relationship User-sensitive inclusive design methods will be used to develop and test the patient data interface After beta-testing the PEP-NG in the primary care laboratory the PEP-NG will be piloted by 10 APRNs affiliated with ProHealth primary care practices Repeated Measures Analysis of Variance RM ANOVA with one within subjects factor TIME will be performed on APRNs outcome measures at time 0 immediate post-instruction and 3 and 6 months later APRNs will each recruit 24 clients 240 total meeting study criteria The PEP-NG software will randomly assign each APRNs clients to either control data collection only and experimental data collection plus educational intervention with targeted messages Client outcome will be assessed at 0 4 8 12 and 52 weeks and analyzed as a mixed ANOVA with NURSE and GROUP as between-subjects factors and TIME as a repeated-measures factor Healthcare utilization will be compared between the 2 groups after 52 weeks and a cost-benefit analysis conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| R01HL084208 | NIH | None | httpsreporternihgovquickSearchR01HL084208 |