APHID- Primary Care Accuracy Study

Medication Review Clinical Trial

Official title:

APHID- Sensitivity and Specificity of a Medication Reconciliation Technology - A Primary Care Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135731
• Other study ID #: 08-0308
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: May 9, 2014
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2014
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

We are studying patients' abilities to correctly identify the prescription medications they are taking. We are interested in understanding what tools will help patients correctly identify their medications. People participating in this study will be asked to either review a paper printout of their medication list or a computer program with their medications. The program will show the names and pictures of the medications. In either situation, participants will be asked to indicate if they are taking the medications as prescribed. We will then compare reported adherence between each medication review process. Participation may help the program developers improve the product.

Description:

The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran with Primary Care appointment at Portland VA

• Three or more medications in medication profile

Exclusion Criteria:

• Visual impairment

• Upper extremity neuromuscular impairment

• Cognitive impairment

• Unable to speak and read English

• Never been seen at a VA

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Medication Review

Intervention

Other:
• Medication review software with pictures
The intervention is a self-service software program that displays each prescription on screen along with an image of the pharmaceutical product. Patients must use response buttons to describe adherence patterns and to advance through the questionnaire items.

Locations

Country	Name	City	State
United States	Portland VAMC	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Blake Lesselroth

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lesselroth BJ, Adams K, Tallett S, Wood SD, Keeling A, Cheng K, Church VL, Felder R, Tran H. Design of admission medication reconciliation technology: a human factors approach to requirements and prototyping. HERD. 2013 Spring;6(3):30-48. — View Citation

Lesselroth BJ, Felder RS, Adams SM, Cauthers PD, Dorr DA, Wong GJ, Douglas DM. Design and implementation of a medication reconciliation kiosk: the Automated Patient History Intake Device (APHID). J Am Med Inform Assoc. 2009 May-Jun;16(3):300-4. doi: 10.1197/jamia.M2642. Epub 2009 Mar 4. — View Citation

Lesselroth BJ, Holahan PJ, Adams K, Sullivan ZZ, Church VL, Woods S, Felder R, Adams S, Dorr DA. Primary care provider perceptions and use of a novel medication reconciliation technology. Inform Prim Care. 2011;19(2):105-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of medication discrepancies from the reference standard		Baseline	Yes