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

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.

Study Overview

• Status: Completed
• Conditions: Polypharmacy
• Intervention / Treatment: Other: COMET

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: COMET; The intervention consists of completion of the tool (COMET) by means of a 30 minute telephone interview prior to the primary care visit and provision of the tool's output to the patient and primary care physician. The COMET tool takes information about the patient's medications and chronic conditions from the electronic health record, and then supplements this with information obtained by a telephone interview assessing the patient's cognition, social supports, medication adherence, home medication regimen, medication side effects, and health status. In addition, there is a chart review screen to record renal function, blood pressure, and hemoglobin A1C. All of this information is run through a set of algorithms to identify medication reconciliation errors and potentially inappropriate medications.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: VA Connecticut Healthcare System
• Investigators: Principal Investigator: Terri R Fried, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: multiple chronic conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 1410014812