Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT00201201
First received: September 16, 2005
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to reduce adverse self-medication practices in older adults with hypertension.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Other: Education Intervention
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Behaviors Risk Score [ Time Frame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    Using a five-point scale from 1, "very unlikely" to 5, "very likely," a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors.

  • Blood Pressure (BP) Readings: Systolic Blood Pressure [ Time Frame: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4 ] [ Designated as safety issue: Yes ]
    BP measurements were taken by the APRN at each of 4 visits - at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.


Secondary Outcome Measures:
  • Self-efficacy for Avoiding Adverse Self-medication Behaviors [ Time Frame: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
    The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, "Not Sure" to 5, "Totally Sure"). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors.

  • Prescription/Over the Counter (Rx-OTC) Knowledge [ Time Frame: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
    The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.

  • Satisfaction With the PEP-NG [ Time Frame: Measured at 12 weeks ] [ Designated as safety issue: No ]
    The PEP-NG user Satisfaction scale is a 14-item instrument - with eight items addressing the ease of program use, program content, and suitability of program content - and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, "strongly disagree" to 5, "strongly agree") were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG.

  • Satisfaction With the APRN Provider Relationship [ Time Frame: Measured at 0, 12 weeks on visit 1 and 4 ] [ Designated as safety issue: No ]
    The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:"not at all easy" to 5: "very easy").


Enrollment: 160
Study Start Date: September 2007
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education
PEP-NG targeted and tailored education intervention
Other: Education Intervention
Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program.
Other Name: Personal Education Program - Next Generation (PEP-NG)
Control
Control, intervention is care as usual.
Other: Control
Control group receiving care as usual after interfacing with the surveys on the PEP-NG
Other Name: Control group for PEP-NG

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201201

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Patricia J. Neafsey, RD, PhD University of Connecticut
  More Information

Publications:
Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT00201201     History of Changes
Other Study ID Numbers: H02-602, R01HL084208
Study First Received: September 16, 2005
Results First Received: August 13, 2013
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Connecticut:
Older Adults
Primary Care
Hypertension
Adherence

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014