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Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285608
First Posted: November 7, 2014
Last Update Posted: November 18, 2015
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.
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton
  Purpose
Investigators are doing this study to examine if a new personalized education program for patients with mood disorders (depression and bipolar disorders) will help them take their medications as prescribed by doctors. Investigators will teach patients about how, when and why it is important for them to take their medications as prescribed. Also, investigators will ask patients why they do not take medications as prescribed. Furthermore, investigators will examine whether our education program might save money if it prevents problems related to not taking medication.

Condition Intervention
Major Depressive Disorder Bipolar Disorder Other: PIMM/SAM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Medication adherence measured by the Medication Adherence Rating Scale (MARS). [ Time Frame: Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge ]
    Medication adherence measured by the Medication Adherence Rating Scale (MARS). We will measure medication adherence at baseline and each follow up


Secondary Outcome Measures:
  • Time to re-hospitalization [ Time Frame: First time re-hospitalization any point during the 12-month follow-up period ]
    Investigators will compare the time to re-hospitalization between each study group.

  • Costs of re-hospitalization [ Time Frame: First time re-hospitalization any point during the 12-month follow-up period ]
    Investigators will adopt a healthcare system perspective and compare the costs of first re-hospitalization between each study group. When a participant is re-hospitalized for the first time at any point during the 12-month follow-up period, investigators will conduct a chart review of the entire re-hospitalization to identify all of the direct and indirect medical resources consumed during this re-hospitalization. The chart review will cover the entire length of the re-hospitalization, even if this length exceeds the 12-month follow-up period for the participant in question.


Estimated Enrollment: 166
Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PIMM/SAM
Partnership in Medication Management (PIMM): The nurse and the attending physician will meet with the patient and ask how s/he administers medication at home (i.e., blister pack). Initial education session: the nurse will teach the patient about his/her medications, dosage, purpose, when and how to take them. Nurse and patient will establish reminders to take his/her medication. Following the education session, patients will be required to notify the nurse when it is time to take their medications, where their medications are, dosage, purpose and side effects. Self-Administered Medication (SAM): Patients will transition to SAM once the clinical team feels that no further medication changes are required. SAM is also the model that the participants will follow after discharge.
Other: PIMM/SAM
The PIMM program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications.
Other Name: Partnership in Medication Management
No Intervention: Standard Prescribing Practice(SPP)
Standard prescribing practice (SPP): medication administration will proceed as standard practice. Patients will not receive a personalized medication training. The nurse will administer the patient's medications. However, patients are encouraged to ask any questions regarding his/her medications.Patients will not be provided with any tool to help them to remember when to take their medications. The nurse will record the patient's knowledge regarding his/her medications.

Detailed Description:

The efficacy of anti-depressants or lithium reported in clinical trials differs from clinical experience. Various factors such as non-adherence to treatment and poor tolerability to medications have been related to treatment non-response or treatment failure in mood disorders (major depressive disorder and bipolar disorder). Premature discontinuation of treatment for mood disorders is common. The long treatments, the patients' beliefs about medications, the lack of knowledge about the medication/treatment purpose, benefits, dosage, and side effects and the relationship between patient and healthcare providers affect treatment continuation.

Investigators are proposing a sequential explanatory mixed methods study to investigate a novel program for medication training in persons with mood disorders. The ultimate purpose of the program is to improve medication adherence in these persons. The primary component of the present study will be quantitative, i.e., a randomized controlled trial with 12 months of follow-up to examine the effect of one-on-one medication training, including the use of a checklist system, on medication adherence in patients with mood disorders. The training program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications. To the best of the investigators' knowledge, no research has comprehensively examined whether one-on-one medication training, as described above, may improve medication adherence in patients with mood disorders.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admitted to the inpatient clinic of the Mood Disorders Program, St. Joseph's Healthcare Hamilton
  • with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
  • able to speak, read, and understand English.

Exclusion Criteria:

  • cut off score on Montreal Cognitive Assessment (MOCA; clinical judgement)
  • significant suicidal or homicidal risk
  • a medical condition/treatment known to affect the brain
  • acquired brain injury.
  Contacts and Locations
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): NCT02285608


Contacts
Contact: Carolina Oremus, MD, PhD(c) +1(905) 522-1155 ext 36326 coremus@stjoes.ca
Contact: Margaret C McKinnon, PhD,C.Psych. +1(905) 522-1155 ext 35438 mmckinno@stjoes.ca

Locations
Canada, Ontario
Mood Disorders Program, St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4K7
Contact: Carolina Oremus, MD,PhD(c)    +1(905) 522-1155 ext 36326    coremus@stjoes.ca   
Contact: Margaret C McKinnon, PhD,C.Psych.    +1(905) 522-1155 ext 36645    mmckinno@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Carolina Oremus, MD, PhD(c) McMaster University
Principal Investigator: Sharon Simmons, RN,BScN,CPMHNc St. Joseph's Healthcare Hamilton
Principal Investigator: Margaret C McKinnon, PhD,C.Psych. McMaster University
  More Information

Publications:
Responsible Party: St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02285608     History of Changes
Other Study ID Numbers: PIMM MDP
PIMM Mood Disorders Program ( Other Grant/Funding Number: Mood Disorders Program, St. Joseph/s Healthcare Hamilton )
First Submitted: October 28, 2014
First Posted: November 7, 2014
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by St. Joseph's Healthcare Hamilton:
Medication adherence
Patient education
Mood disorders
Economic assessment
Mixed methods

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders