Medication-taking Preferences & Practices of Patients With Chronic Conditions

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Washington State University
Sponsor:
Collaborator:
Providence Medical Research Center
Information provided by (Responsible Party):
Roxanne Vandermause, Washington State University
ClinicalTrials.gov Identifier:
NCT01614353
First received: June 1, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

"Patients can easily be overwhelmed, confused and many times don't fully understand their need for new medications, or when the dosages are to be administered" (patient research partner quote). The long-term goal of this study is to refine medication science by developing patient-centered assessment, monitoring and management guidelines for patients and health professionals. The objective is to advance knowledge about the medication-taking perspectives, experiences, and behaviors of older adults with multiple chronic medical conditions (MCMC) to inform future research related to patient-centered medication prescribing, monitoring and management. This pilot study addresses the following PCORI interest area: "evaluating methods that can be used to assess the patient perspective when researching behaviors and choices within the patient's control that may influence outcomes." The rationale that underlies the proposed study is that medication-taking practices are wholly within patients' control, and are foundational to reducing complications and improving outcomes for those with MCMC. To meet the overall objective of this application, the following specific aims will be pursued: 1) identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC; and 2) generate an interpretation of the meaning of medication-taking among older adults with MCMC. To achieve these aims, data will be obtained in "real time" from patients (N=30) receiving a new prescription using smart phone technology. The smart phones will include prompts to help participants record thoughts about medication use throughout the day for 30 days. Findings from electronic diaries will be logged, analyzed and qualitatively analyzed. Some patients (n=15) will provide in-depth hermeneutic interviews to provide rich descriptions and interpretive commentary about the experience of receiving a new medication prescription. The objective is to uncover previously unidentified areas of common experience in older persons with multiple chronic conditions who have received a new prescription. Common experiences and patterns of influences, that are often surprising or unexpected, will be categorized and assessed. The expected outcomes of this pilot study are improved knowledge of medication-taking perceptions, experiences, and practices of older adults with MCMC—knowledge that is critical to advance patient-centered medication science.


Condition Intervention
Any Condition in N73.0 Specified as Chronic
Adult Disease
Pharmacological Action
Other: Electronic Diaries
Other: Hermeneutic Interviews

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medication-taking Preferences & Practices of Patients With Chronic Conditions

Further study details as provided by Washington State University:

Primary Outcome Measures:
  • Identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC. [ Time Frame: Daily electronic diaries for a duration of 30 days ] [ Designated as safety issue: No ]
    Data will be obtained in "real time" in that patients will audio record thoughts as they arise in the course of each day using an electronic device, over 30 consecutive days, and will answer questions related to medication use. Findings from end of day prompts will be logged using tables that compare participant demographic characteristics, whether or not the new medication or all prescribed medication was taken, and self-assessed level of wellness.

  • Generate an interpretation of the meaning of medication taking among older adults with MCMC. [ Time Frame: 2 Interviews: 1 at enrollment and 1 at 30 days ] [ Designated as safety issue: No ]
    In-depth hermeneutic interviews and interpretive phenomenological analyses will be conducted for 15 of the 30 enrolled participants. Patterns and themes that capture common experiences revealed in these data provide language for further investigation and new discussion in areas that have been studied traditionally. Such findings are the characteristic "phenomenological contribution" of qualitative research. Interpretive commentary in the context of social and cultural evidence and extant literature on medication use will be generated.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Cohort
All participants (N=30) will be asked to identify perceptions and behaviors surrounding the medication-taking process using technology-assisted prompts and recordings. Half (n=15) of the participants will participate in two hermeneutic interviews using an interpretive phenomenological approach to generate an interpretation of the meaning of medication taking.
Other: Electronic Diaries
Participants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days.
Other: Hermeneutic Interviews
Half of the enrolled participants (n=15) will participate in 2 hermeneutic interviews conducted in an interpretive phenomonological approach to generate an interpretation of the meaning of medication taking.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Persons seen at the Providence Kidney Disease and Hypertension Clinic, aged 60 years or older, with 3 chronic conditions, taking 5 or more medications, and who receive a prescription for a NEW medication will be invited to participate in the 30 day study.

Criteria

Inclusion Criteria:

  • 60 years of age or older
  • Diagnosis of at least 3 chronic medical conditions
  • Receiving 5 or more medications
  • Receipt of a new prescription medication at enrollment
  • Ability to speak English

Exclusion Criteria:

  • Any individual that does not meet the 5 inclusion criteria listed above
  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: NCT01614353

Contacts
Contact: Roxanne K Vandermause, PhD 509-324-7281 rvandermause@wsu.edu

Locations
United States, Washington
Washington State University Recruiting
Spokane, Washington, United States, 99210-1495
Contact: Joshua J Neumiller, PharmD    509-368-6756    jneumiller@wsu.edu   
Principal Investigator: Roxanne Vandermause, PhD         
Sub-Investigator: Cynthia F Corbett, RN, PhD         
Principal Investigator: Joshua J Neumiller, PharmD         
Sub-Investigator: Prabu David, PhD         
Providence Medical Research Center Recruiting
Spokane, Washington, United States, 99201-4813
Sub-Investigator: Katherine Tuttle, MD         
Sub-Investigator: Gail Burton, RN         
Sub-Investigator: Duane Sunwold         
Sponsors and Collaborators
Washington State University
Providence Medical Research Center
Investigators
Principal Investigator: Joshua Neumiller, PharmD Washington State University
Principal Investigator: Roxanne Vandermause, PhD Washington State University
  More Information

No publications provided

Responsible Party: Roxanne Vandermause, Associate Professor, Washington State University
ClinicalTrials.gov Identifier: NCT01614353     History of Changes
Other Study ID Numbers: PI-12-001
Study First Received: June 1, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington State University:
Multiple Chronic Conditions
Older Adults
New Prescription

ClinicalTrials.gov processed this record on August 26, 2014