NCT02501967

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 8, 2015

Last Update Submit

August 23, 2016

Conditions

Keywords

multiple chronic conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of changes made to the medication regimen

    3 Month Follow Up

  • Coding of audiotapes of primary care visit

    The primary care visit at which the patient is enrolled in the study

Study Arms (2)

COMET

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Interventions

COMETOTHER

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.

COMET

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Terri R Fried, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 17, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations