Medication Adherence With Polyglot Meducation
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2013 |
End Date: | July 2014 |
Evaluate Changes in Medication Adherence and Patient Perspective of Polyglot Systems, Inc's Meducation Technology
The investigators propose a 6 month pre-post, pilot,feasibility study with up to 25
individuals among veterans with cardiovascular disease risk factors including Hypertension
(HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the
hospital-based primary care clinics associated with Durham VAMC. The investigators will
examine veteran's perception and ease of using an innovative tool to help improve medication
adherence to cardiovascular medications. This study aims to focus on patients with multiple
chronic conditions and their caregivers to address 1) appropriate use of medications
2)maximize patient self-care and care by families and other caregivers 3) make available a
tool for medication management 4) managing complex regimens, and 5) addressing health
literacy.
individuals among veterans with cardiovascular disease risk factors including Hypertension
(HT), Diabetes Mellitis (DM) and Hyperlipidemia (HL) who receive care from the
hospital-based primary care clinics associated with Durham VAMC. The investigators will
examine veteran's perception and ease of using an innovative tool to help improve medication
adherence to cardiovascular medications. This study aims to focus on patients with multiple
chronic conditions and their caregivers to address 1) appropriate use of medications
2)maximize patient self-care and care by families and other caregivers 3) make available a
tool for medication management 4) managing complex regimens, and 5) addressing health
literacy.
Recruitment letter:
Each week, the research assistant (RA) will identify participants who have a medical
appointment scheduled 3 weeks from the current date from the statistician's list of eligible
participants. The RA will review Computerized Patient Record System (CPRS) to confirm
enrollment at the Durham VA Medical Center (DVAMC) or Raleigh Community Based Outpatient
Clinic (CBOC), identify participants' primary care provider and conduct a preliminary
medical record review of the exclusion criteria listed above.
An introductory recruitment letter signed by the patient's provider will be sent to these
participants.
Telephone Screening:
The RA will call the participants between 1 and 2 weeks later to assess interest and
eligibility using the telephone screening script. During this telephone call, the RA will
ask permission to conduct the telephone screening to further evaluate the participants'
eligibility to participate in the study. These screening questions are being asked because
exclusion criteria may not be accurately reflected in the VA medical record. If participants
agree to meet with study team to further discuss the project they will be scheduled for an
interview. If requested, participant will be sent an appointment reminder letter signed by
the study principal investigator and/or project coordinator.
All participants will be sent reminder letters up to 3 weeks prior to their scheduled 3 and
6 month follow-up appointments.
Consent Process:
At this interview, the patient will be given greater detail about the study, and if
agreeable, will provide written informed consent. Participants who consent to participate in
the study and agree to be digitally audio recorded will also have complete form 10-3203
"Consent for use of picture and /or voice" at baseline.
Interview Procedures:
RAs will obtain the participants' outcome values (i.e., BP) from the clinical record at
baseline, at 3 month follow-up. This information will be double-entered into an application
on the Health Services Research & Development (HSRD) VA Server. At baseline and 3-month
follow-up contacts, participants will also undergo an interview to determine secondary
outcome variables including self-reported medication adherence and perceptions of the
intervention. The baseline interview will be conducted in person if possible, however, at
the 3 month follow-up appointment the interview will be conducted by telephone. The RA's
will work with patients to be seen in a 6 week window around the original follow-up
appointment. Pill refill will be calculated for all individuals at 6 months.
Participant Contacts In-person meeting - Baseline After the consent process, at the baseline
interview, a research assistant(RA) will conduct the outcome assessment procedures, which
includes asking the participant questions about their age,race, medical history, self
reported adherence to cardiovascular medications and their understanding about the risk of
cardiovascular disease. The RA will also ask questions about their lifestyle, and quality of
life. Participants who qualify for enrollment and provide informed consent will meet with
the research pharmacist for education use of the Meducation Calendar.
3 month follow-up interview. A research assistant will contact participant via phone to
determine secondary outcome variables including self reported medication adherence to
cardiovascular medications. The entire interview should take no more than 30 minutes.
Optional Qualitative: 3 month phone interview: For selected intervention participants only
the RA will conduct a questionnaire about the participant's perception to determine which
aspects of the Meducation Calendar intervention were most helpful for participants and which
aspects need revision. Participants who agreed to the qualitative interview during the
consent process will be asked during the 3 month interview to confirm their continued desire
to participate in the audio recorded phone interview if selected. This visit should take no
more than 30 minutes. Those selected to participate will be scheduled to complete the
qualitative interview over the phone within 15 days from the time they complete the
intervention and interview. The qualitative interview will be audio recorded digitally on a
VA owned and configured computer and later transcribed using VA owned computer software.
Names will not be associated with the audio recordings. After all recordings have been
analyzed and coded, recordings will be destroyed in accordance with VA Information Security
procedures. This phone call for the optional qualitative interview should take no more than
30 minutes.
Each week, the research assistant (RA) will identify participants who have a medical
appointment scheduled 3 weeks from the current date from the statistician's list of eligible
participants. The RA will review Computerized Patient Record System (CPRS) to confirm
enrollment at the Durham VA Medical Center (DVAMC) or Raleigh Community Based Outpatient
Clinic (CBOC), identify participants' primary care provider and conduct a preliminary
medical record review of the exclusion criteria listed above.
An introductory recruitment letter signed by the patient's provider will be sent to these
participants.
Telephone Screening:
The RA will call the participants between 1 and 2 weeks later to assess interest and
eligibility using the telephone screening script. During this telephone call, the RA will
ask permission to conduct the telephone screening to further evaluate the participants'
eligibility to participate in the study. These screening questions are being asked because
exclusion criteria may not be accurately reflected in the VA medical record. If participants
agree to meet with study team to further discuss the project they will be scheduled for an
interview. If requested, participant will be sent an appointment reminder letter signed by
the study principal investigator and/or project coordinator.
All participants will be sent reminder letters up to 3 weeks prior to their scheduled 3 and
6 month follow-up appointments.
Consent Process:
At this interview, the patient will be given greater detail about the study, and if
agreeable, will provide written informed consent. Participants who consent to participate in
the study and agree to be digitally audio recorded will also have complete form 10-3203
"Consent for use of picture and /or voice" at baseline.
Interview Procedures:
RAs will obtain the participants' outcome values (i.e., BP) from the clinical record at
baseline, at 3 month follow-up. This information will be double-entered into an application
on the Health Services Research & Development (HSRD) VA Server. At baseline and 3-month
follow-up contacts, participants will also undergo an interview to determine secondary
outcome variables including self-reported medication adherence and perceptions of the
intervention. The baseline interview will be conducted in person if possible, however, at
the 3 month follow-up appointment the interview will be conducted by telephone. The RA's
will work with patients to be seen in a 6 week window around the original follow-up
appointment. Pill refill will be calculated for all individuals at 6 months.
Participant Contacts In-person meeting - Baseline After the consent process, at the baseline
interview, a research assistant(RA) will conduct the outcome assessment procedures, which
includes asking the participant questions about their age,race, medical history, self
reported adherence to cardiovascular medications and their understanding about the risk of
cardiovascular disease. The RA will also ask questions about their lifestyle, and quality of
life. Participants who qualify for enrollment and provide informed consent will meet with
the research pharmacist for education use of the Meducation Calendar.
3 month follow-up interview. A research assistant will contact participant via phone to
determine secondary outcome variables including self reported medication adherence to
cardiovascular medications. The entire interview should take no more than 30 minutes.
Optional Qualitative: 3 month phone interview: For selected intervention participants only
the RA will conduct a questionnaire about the participant's perception to determine which
aspects of the Meducation Calendar intervention were most helpful for participants and which
aspects need revision. Participants who agreed to the qualitative interview during the
consent process will be asked during the 3 month interview to confirm their continued desire
to participate in the audio recorded phone interview if selected. This visit should take no
more than 30 minutes. Those selected to participate will be scheduled to complete the
qualitative interview over the phone within 15 days from the time they complete the
intervention and interview. The qualitative interview will be audio recorded digitally on a
VA owned and configured computer and later transcribed using VA owned computer software.
Names will not be associated with the audio recordings. After all recordings have been
analyzed and coded, recordings will be destroyed in accordance with VA Information Security
procedures. This phone call for the optional qualitative interview should take no more than
30 minutes.
Inclusion Criteria:
- Enrolled in one of three DVAMC Primary Care Clinics affiliated with the hospital for
at least one year;
- At least one visit to a primary care provider (PCP) at Durham VAMC associated primary
care clinics in the previous 12 months;
- Outpatient diagnostic code for hypertension (> 140/90), diabetes and/or
hypercholesterolemia
- Prescription for metoprolol tartrate (twice a day beta blocker, most common 2 day
medication prescribed in the VA)
- Baseline Medication Possession Ratio (MPR) of < 80% indicating medication non
adherence
- More than 9 active medications.
Exclusion Criteria:
- diagnosed with metastatic cancer,
- diagnosed with dementia documented in medical record,
- active diagnosis of psychosis documented in medical record with admission with last
30 days
- participating in another clinical trial,
- not currently receiving care at the Durham VAMC
- resident of a nursing home,
- hard time seeing type/printing on books, magazines articles, etc.
- hard time hearing or speaking on the telephone
- limited/no access to telephone
- currently a patient in the primary care pharmacist medication management clinic at
Durham VAMC
- plans to move medical care from DVAMC in next 12 months
We found this trial at
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Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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