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Optimizing Medication Therapy for Patients Recently Discharged From Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02888782
Recruitment Status : Terminated (Program Restructured)
First Posted : September 5, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Kelly, Memorial University of Newfoundland

Brief Summary:

Patients who are discharged from hospital can be overwhelmed when they suddenly have to manage new conditions or medications. These changes can be particularly difficult for people on many medications or with multiple health conditions. There is a real risk that this will lead to emergency room visits, hospital readmission, and even death. In addition to endangering patients, these adverse events are very costly to the healthcare system. The good news is that these events can be preventable if patients receive care that is better coordinated.

Patient-oriented research will be conducted to determine if a pharmacist-led medication therapy management service can improve health outcomes of 'medically complex' patients transitioning from acute to primary care in Newfoundland and Labrador (NL). This a more comprehensive service than their community pharmacist would normally provide. The program will use a new Pharmacist Clinic service to provide care and support which does not currently exist for patients in NL after they leave hospital. After discharge, patients will be randomly divided into two groups: one group will receive care as usual from their doctor; the other group will have their medications assessed by a clinic pharmacist within one week of hospital discharge along with their usual care from their doctor. The two groups will be compared to determine whether specialized pharmacist services after hospital discharge is satisfactory to patients/providers, improves patient health, and reduces emergency room visits, hospital readmissions, and repeat trips to the doctor. If successful, this project will help ensure that patients are taking the right medications in the right way, improving individual health and making better use of healthcare system resources.


Condition or disease Intervention/treatment Phase
Chronic Disease Other: Pharmacist Consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Optimizing Medication Therapy Outcomes for Complex Patients Transitioning From Acute to Primary Care
Actual Study Start Date : December 8, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacist Consultation
Meet with pharmacist for consultation in addition to regular physician follow up
Other: Pharmacist Consultation
No Intervention: Control
Receive regular physician follow up



Primary Outcome Measures :
  1. Composite Hospital Utilization Rate [ Time Frame: 30 days post discharge ]
    A composite score of hospital readmission rate and ER visits


Secondary Outcome Measures :
  1. Number of Emergency Room Visits [ Time Frame: 30 days post discharge ]
  2. Number of Emergency Room Visits [ Time Frame: 60 days post discharge ]
  3. Number of Emergency Room Visits [ Time Frame: 90 days post discharge ]
  4. Rehospitalization Rate [ Time Frame: 30 days post discharge ]
  5. Rehospitalization Rate [ Time Frame: 60 days post discharge ]
  6. Rehospitalization Rate [ Time Frame: 90 days post discharge ]
  7. Mortality Rate [ Time Frame: 30 days post discharge ]
  8. Mortality Rate [ Time Frame: 60 days post discharge ]
  9. Mortality Rate [ Time Frame: 90 days post discharge ]
  10. Frequency of Family Physician Visits [ Time Frame: 30 days post discharge ]
  11. Frequency of Family Physician Visits [ Time Frame: 60 days post discharge ]
  12. Frequency of Family Physician Visits [ Time Frame: 90 days post discharge ]

Other Outcome Measures:
  1. Patient Satisfaction Survey [ Time Frame: Collected 3 - 6 months after study enrollment ]
    Measured using a Likert scale questionnaire

  2. Pharmacist Satisfaction Survey [ Time Frame: Collected at the end of study period (12-15 months) ]
    Measured using a Likert scale questionnaire

  3. Physician Satisfaction Survey [ Time Frame: Collected at the end of study period (12-15 months) ]
    Measured using a Likert scale questionnaire

  4. Patient quality of life Short Form Health Survey [ Time Frame: Collected at time of hospital discharge ]
    Measured using a Short Form Health Survey (SF-36)

  5. Patient quality of life Short Form Health Survey [ Time Frame: Collected at 30, 60 and 90 days post hospital discharge ]
    Measured using a Short Form Health Survey (SF-36)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years of age or older
  2. Admitted to a General Medicine ward
  3. Take 5 or more chronic medications

Exclusion Criteria:

  1. Discharge to a long term care facility
  2. Life expectancy less than 3 months
  3. Have entered palliative care
  4. Cognitive impairment (unless a responsible caregiver can provide consent and assist in participation)
  5. Non-English speaking
  6. Unable to provide informed consent

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): NCT02888782


Locations
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Canada, Newfoundland and Labrador
Health Sciences Center
Saint John's, Newfoundland and Labrador, Canada
St. Clares Mercy Hospital
St. John's, Newfoundland and Labrador, Canada
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
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Principal Investigator: Deborah Kelly, PharmD Memorial Univeristy of Newfoundland

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Responsible Party: Deborah Kelly, Associate Professor and Special Advisor of Innovation, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT02888782    
Other Study ID Numbers: HREB-2016.221
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes