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

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ClinicalTrials.gov Identifier: NCT02501967
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Polypharmacy Other: COMET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
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.

No Intervention: Usual Care



Primary Outcome Measures :
  1. Patient Assessment of Care for Chronic Conditions (PACIC) [ Time Frame: 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 :
  1. Number of changes made to the medication regimen [ Time Frame: 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.

  2. Coding of audiotapes of primary care visit [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501967


Locations
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United States, Connecticut
VA Connecticut Healthcare
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
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Principal Investigator: Terri R Fried, MD Yale School of Medicine
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02501967    
Other Study ID Numbers: 1410014812
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by Yale University:
multiple chronic conditions
Additional relevant MeSH terms:
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Disease
Pathologic Processes