NCT01614353

Brief Summary

"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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

June 1, 2012

Last Update Submit

December 19, 2012

Conditions

Keywords

Multiple Chronic ConditionsOlder AdultsNew Prescription

Outcome Measures

Primary Outcomes (2)

  • Identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC.

    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.

    Daily electronic diaries for a duration of 30 days

  • Generate an interpretation of the meaning of medication taking among older adults with MCMC.

    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.

    2 Interviews: 1 at enrollment and 1 at 30 days

Study Arms (1)

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 DiariesOther: Hermeneutic Interviews

Interventions

Participants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days.

Study Cohort

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.

Study Cohort

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence Medical Research Center

Spokane, Washington, 99201-4813, United States

RECRUITING

Washington State University

Spokane, Washington, 99210-1495, United States

RECRUITING

MeSH Terms

Conditions

DiseaseMultiple Chronic Conditions

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsChronic DiseaseDisease Attributes

Study Officials

  • Joshua Neumiller, PharmD

    Washington State University

    PRINCIPAL INVESTIGATOR
  • Roxanne Vandermause, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne K Vandermause, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 7, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations