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

Primary Purpose

Major Depressive Disorder, Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PIMM/SAM
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring Medication adherence, Patient education, Mood disorders, Economic assessment, Mixed methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mood Disorders Program, St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PIMM/SAM

Standard Prescribing Practice(SPP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Medication adherence measured by the Medication Adherence Rating Scale (MARS).
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
Investigators will compare the time to re-hospitalization between each study group.
Costs of re-hospitalization
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.

Full Information

First Posted
October 28, 2014
Last Updated
November 17, 2015
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02285608
Brief Title
Partnership in Medication Management (PIMM) in Patients With Mood Disorders
Acronym
PIMM
Official Title
Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder
Keywords
Medication adherence, Patient education, Mood disorders, Economic assessment, Mixed methods

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIMM/SAM
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Prescribing Practice(SPP)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PIMM/SAM
Other Intervention Name(s)
Partnership in Medication Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Description
Medication adherence measured by the Medication Adherence Rating Scale (MARS). We will measure medication adherence at baseline and each follow up
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
Secondary Outcome Measure Information:
Title
Time to re-hospitalization
Description
Investigators will compare the time to re-hospitalization between each study group.
Time Frame
First time re-hospitalization any point during the 12-month follow-up period
Title
Costs of re-hospitalization
Description
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.
Time Frame
First time re-hospitalization any point during the 12-month follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Oremus, MD, PhD(c)
Phone
+1(905) 522-1155
Ext
36326
Email
coremus@stjoes.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret C McKinnon, PhD,C.Psych.
Phone
+1(905) 522-1155
Ext
35438
Email
mmckinno@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Oremus, MD, PhD(c)
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Simmons, RN,BScN,CPMHNc
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret C McKinnon, PhD,C.Psych.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Program, St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Oremus, MD,PhD(c)
Phone
+1(905) 522-1155
Ext
36326
Email
coremus@stjoes.ca
First Name & Middle Initial & Last Name & Degree
Margaret C McKinnon, PhD,C.Psych.
Phone
+1(905) 522-1155
Ext
36645
Email
mmckinno@stjoes.ca

12. IPD Sharing Statement

Citations:
Citation
The World Health Organization.The global burden of disease: 2004 update, Table A2: Burden of disease in DALYs by cause, sex and income group in WHO regions, estimates for 2004. Geneva, Switzerland, 2008 (accessed on: March 6, 2014).
Results Reference
background
Citation
Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
Results Reference
background
Citation
World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
Results Reference
background
PubMed Identifier
16982121
Citation
Rosa AR, Marco M, Fachel JM, Kapczinski F, Stein AT, Barros HM. Correlation between drug treatment adherence and lithium treatment attitudes and knowledge by bipolar patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):217-24. doi: 10.1016/j.pnpbp.2006.08.007. Epub 2006 Sep 18.
Results Reference
background
PubMed Identifier
14615578
Citation
Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13. Erratum In: Proc Natl Acad Sci U S A. 2005 Nov 8;102(45):16530.
Results Reference
background

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

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