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

Not Applicable

Completed

• Conditions: Polypharmacy
• Interventions: Other: COMET

• Registration Number: NCT02501967
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

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Exclusion Criteria

• Unable to manage own medications because of cognitive impairment.
• Medications prescribed by physician outside of the VA.
• Severe vision or hearing impairment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COMET	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.

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Care for Chronic Conditions (PACIC)	Immediately following the primary care visit at which the patient is enrolled in the study	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.

Secondary Outcome Measures

Name	Time	Method
Number of changes made to the medication regimen	3 Month Follow Up	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.
Coding of audiotapes of primary care visit	The primary care visit at which the patient is enrolled in the study	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.

Trial Locations

Locations (1)

VA Connecticut Healthcare; 🇺🇸 West Haven, Connecticut, United States