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Evaluation of a Decision Support Tool (PRIMA)

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ClinicalTrials.gov Identifier: NCT02060981
Recruitment Status : Unknown
Verified February 2015 by Jennifer Polinski, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : February 18, 2015
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Foundation for Informed Medical Decision Making
Information provided by (Responsible Party):
Jennifer Polinski, Brigham and Women's Hospital

Brief Summary:
Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.

Condition or disease Intervention/treatment Phase
Medication Adherence Hypertension Decision Making, Shared Patient-Centered Outcomes Research Behavioral: Control Behavioral: Interview Only Behavioral: Interview plus decision support tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
Study Start Date : February 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interview only
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Behavioral: Interview Only
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.

Placebo Comparator: Control
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. These patients will be asked to review the brochure, complete the survey, and mail it back to the research team using a self-addressed stamped envelope.
Behavioral: Control
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.

Experimental: Interview plus decision support tool
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension, and to provide feedback regarding a new tool for helping patients learn more about their medications. Interview plus patients' index date for follow-up is the date of the scheduled interview.
Behavioral: Interview plus decision support tool
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications.




Primary Outcome Measures :
  1. Cumulative incidence of antihypertensive medication fills [ Time Frame: 6 months ]
    The proportion of patients in each group who picked up a prescription for an antihypertensive medication in any class during the follow-up period. Investigators will calculate cumulative incidences among all patients, whether or not they successfully completed the interview or returned the paper-based survey (Intention to Treat) and among only those patients who did complete the interview or returned the paper-based survey (As Treated).


Secondary Outcome Measures :
  1. Patient Interviews [ Time Frame: 5 months ]
    One-on-one structured interviews will ask about participants' preferences, attitudes and beliefs regarding primary adherence and/or use of a decision support tool.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider.
  • High blood pressure diagnosis

Exclusion Criteria:

  • under age 25.

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): NCT02060981


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Patient-Centered Outcomes Research Institute
Foundation for Informed Medical Decision Making
Investigators
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Principal Investigator: Jennifer Polinski, Sc.D. Brigham and Women's Hospital

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Responsible Party: Jennifer Polinski, Assistant Professor and Epidemiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02060981     History of Changes
Other Study ID Numbers: 2014-P-00008959
#2013P001295/BWH ( Other Identifier: Partners IRB )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by Jennifer Polinski, Brigham and Women's Hospital:
Randomized controlled trial
Primary medication adherence
Decision-support tool
Patient-centered outcomes research
Antihypertensive medications
One-on-one patient interviews