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

Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders

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.

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Other: PIMM/SAM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolina Oremus, MD, PhD(c); Phone Number: 36326 +1(905) 522-1155; Email: coremus@stjoes.ca
• Study Contact Backup: Name: Margaret C McKinnon, PhD,C.Psych.; Phone Number: 35438 +1(905) 522-1155; Email: mmckinno@stjoes.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4K7
      • Recruiting
      • Mood Disorders Program, St. Joseph's Healthcare Hamilton
      • Contact: Carolina Oremus, MD,PhD(c); Phone Number: 36326 +1(905) 522-1155; Email: coremus@stjoes.ca
      • Contact: Margaret C McKinnon, PhD,C.Psych.; Phone Number: 36645 +1(905) 522-1155; Email: mmckinno@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Measures

Outcome Measure	Measure Description	Time Frame
Time to re-hospitalization	Investigators will compare the time to re-hospitalization between each study group.	First time re-hospitalization any point during the 12-month follow-up period
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.	First time re-hospitalization any point during the 12-month follow-up period

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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).
• Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
• World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Medication adherence; Patient education; Mood disorders; Economic assessment; Mixed methods
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Depressive Disorder; Disease; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: PIMM MDP; PIMM Mood Disorders Program (Other Grant/Funding Number: Mood Disorders Program, St. Joseph/s Healthcare Hamilton)