Clinical trial NCT00201201: Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
Official title: Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Keywords: Older Adults
Primary Care
Hypertension
Adherence
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 client's self-medication practices before beginning the face-to-face interview. Thus, the PEP-NG will make optimal use of the client's waiting time and the APRN's 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 APRN's 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.

Eligibility criteria: Inclusion Criteria for Older Adults:

* Older adult diagnosed with hypertension
* Health literacy score (REALM) of 44 or greater
* Independent physical and cognitive functioning
* Visual acuity of at least 20/100, with corrective lenses

Exclusion criteria for Older Adults:

* less than age 60
* health literacy score below 44 (6th grade)
* not currently prescribed antihypertensive medication
* visual acuity of less than 20/100 (with corrective lenses, if needed)
* inability to meet independent-living and cognitive-functioning ability.

Inclusion Criteria for APRNs:

* Affiliated with ProHealth Physicians, Inc. practice site in CT and/or
* Affiliated with APRN practice sites in CT

Exclusion Criteria for APRNs:

* Not affiliated with primary care practice sites in CT

Primary outcomes:
measure: Behaviors Risk Score
timeFrame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4
measure: Blood Pressure (BP) Readings: Systolic Blood Pressure
timeFrame: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4
Secondary outcomes:
measure: Self-efficacy for Avoiding Adverse Self-medication Behaviors
timeFrame: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4
measure: Prescription/Over the Counter (Rx-OTC) Knowledge
timeFrame: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4
measure: Satisfaction With the PEP-NG
timeFrame: Measured at 12 weeks
measure: Satisfaction With the APRN Provider Relationship
timeFrame: Measured at 0, 12 weeks on visit 1 and 4
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Patricia J. Neafsey, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alicea-Planas, J., Neafsey, P.J., & Anderson, E. (2012). Using an e-health intervention to enhance patient visits for hypertension; The nurse practitioner perspective. Journal of Communication in Healthcare, 5(4), 239-249.
citation: Lin CA, Neafsey PJ, Anderson E. Advanced practice registered nurse usability testing of a tailored computer-mediated health communication program. Comput Inform Nurs. 2010 Jan-Feb;28(1):32-41. doi: 10.1097/NCN.0b013e3181c0484e.
citation: Neafsey PJ, Anderson E, Coleman C, Lin CA, M'lan CE, Walsh S. Reducing adverse self-medication behaviors in older adults with the Next Generation Personal Education Program (PEP-NG): Design and methodology. Patient Prefer Adherence. 2009 Nov 29;3:323-34. doi: 10.2147/ppa.s7906.
citation: Lin CA, Neafsey PJ, Strickler Z. Usability testing by older adults of a computer-mediated health communication program. J Health Commun. 2009 Mar;14(2):102-18. doi: 10.1080/10810730802659095.
citation: Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.
citation: Neafsey PJ, M'lan CE, Ge M, Walsh SJ, Lin CA, Anderson E. Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial. Ageing Int. 2011 Jun;36(2):159-191. doi: 10.1007/s12126-010-9085-9. Epub 2010 Dec 8.
citation: Anderson EH, Neafsey PJ, Peabody S. Psychometrics of the computer-based Relationships with Health Care Provider Scale in older adults. J Nurs Meas. 2011;19(1):3-16. doi: 10.1891/1061-3749.19.1.3.
citation: Alicea-Planas J, Neafsey PJ, Anderson E. A Qualitative Study of Older Adults and Computer Use for Health Education: "It opens people's eyes". J Commun Healthc. 2011 Apr 1;4(1):38-45. doi: 10.1179/175380611X12950033990179.
citation: Strickler, Z., Lin, C., Rauh, C. & Neafsey, P.J. (2008). Educating older adults to avoid harmful self-medication. Journal of Communication in Healthcare, 1(1), 110-128.