Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II

Polypharmacy Clinical Trial

— COMET  

Official title:

Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501967
• Other study ID #: 1410014812
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: August 23, 2016
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Veterans age 65 years and older.

• Patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications.

• Patients receiving primary care at the West Haven campus of VA Connecticut Healthcare System.

Exclusion Criteria:

• Unable to manage own medications because of cognitive impairment.

• Medications prescribed by physician outside of the VA.

• Severe vision or hearing impairment.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Polypharmacy

Intervention

Other:
• COMET
The intervention consists of completion of the tool by means of a telephone interview prior to the primary care visit and provision of the tool's output to the patient and PCP.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Assessment of Care for Chronic Conditions (PACIC)	A modified version of the Patient Assessment of Care for Chronic Conditions (PACIC) will be used. The original tool is a 20 item instrument (100 points total) designed to assess a patients perception of one's health care (for chronic conditions). A higher score indicates a more favorable rating.	Immediately following the primary care visit at which the patient is enrolled in the study	No
Secondary	Number of changes made to the medication regimen	A chart review will be completed of the 3 months following the clinic appointment at which the patient is enrolled in the study to document any changes that were made to the medication regimen.	3 Month Follow Up	No
Secondary	Coding of audiotapes of primary care visit	The Active Patient Participation Coding Scheme (APPC) is a validated instrument to assess indicators and facilitators of patient participation. Audio recordings will also be coded for evidence of providers' partnership building in the form of verbal encouragement to ask questions, express opinions, talk about their feelings, and participate in decision making.	The primary care visit at which the patient is enrolled in the study	No