Impact of pharmacist interventions on adherence and patient outcomes among depressed patients.

ISRCTN ISRCTN34879893
DOI https://doi.org/10.1186/ISRCTN34879893
Secondary identifying numbers N/A
Submission date
22/11/2014
Registration date
30/12/2014
Last edited
22/03/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Making sure major depressive disorder (MDD) patients take their antidepressant treatment (adherence to medication) is essential in managing their condition. Adherence to medication is a dynamic decision-‎‎making process, and pharmacists play an important role in improving adherence to ‎‎antidepressant treatment in different settings within the health care system. Shared decision making (SDM) is a conversation between a patient and a healthcare professional whereby decisions are made about a patients treatment, taking into account what is important to both parties. Here, we want to test a pharmacist intervention (programme) based on SDM‎‏ ‏to see whether it improves adherence to medication and, ultimately, how successful the treatment is at treating MDD.

Who can participate?
Adults (aged between 18-60) newly diagnosed with MDD.

What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 (intervention group) attend a SDM session with a pharmacist which focused on improving the patients involvement in decision ‎making, their beliefs towards antidepressants and their knowledge about ‎antidepressants‎. Those in group 2 do not attend a SDM session. Adherence to medication, severity of depression, health-related quality of life, patient satisfaction and the patients beliefs about medicine is assessed for all participants at the start of the study, 3 months after the study begins and then again at 6 months.

What are the possible benefits and risks of participating?
The study was designed to minimize any potential risks to the patients. Participants may benefit from intervention conducted in this study.

Where is the study run from?
Al Amal Hospital (Saudi Arabia)

When is the study starting and how long is it expected to run for?
February 2014 to July 2014

Who is funding the study?
Investigator initiated and funded (Saudi Arabia)

Who is the main contact?
Khalaf Aljumah ‎
khalafaljumaah@yahoo.com ‎

Contact information

Dr Khalaf Aljumah
Scientific

P.O.Box 33626 ‎
Riyadh
11458‎
Saudi Arabia

Study information

Study designInterventional prospective randomised controlled study with a 6-month follow-‎up
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImpact of pharmacist interventions on adherence and measurable patient outcomes among depressed patients: a randomised controlled study
Study objectivesThe evidence relating to patients’ active participation in depression treatment decision ‎making supports the hypothesis that this will result in improved adherence, ‎satisfaction, and improved clinical outcomes.
Ethics approval(s)AM2013-12
Health condition(s) or problem(s) studiedPatients diagnosed with major depression disorders
InterventionThe intervention focused on the enhancement of the patients’ involvement in decision ‎making, their beliefs towards antidepressants and their knowledge about ‎antidepressants‎.

Pharmacists followed the SDM competency framework proposed by Simmons et al, which was designed specifically for depressed patients, to ensure the coverage of all aspects of SDM for each patient. Before the SDM session started, the research team distributed a decision aid, which was developed and validated by Aljumah et al. and was specified for Arabic-speaking patients, to patients in the intervention group (IG). The intervention focused on the enhancement of the patients’ involvement in decision making, their beliefs towards antidepressants and their knowledge about antidepressants. The average time for the first SDM session (at baseline) was 15 minutes and 10 minutes for the remaining SDM sessions.

Randomisation:
A simple randomisation process was used. Study participants were individually randomised to one of two parallel groups with an allocation ratio of 1:1 using a computer-generated list. The computer-generated allocation was done by a research assistant with no clinical involvement in the trial. Pharmacists and psychiatrists were not blinded to the patients’ distribution between groups. The research assistant who collected all the data was blinded to the distribution of patients
Intervention typeBehavioural
Primary outcome measureAdherence measured by ‎Medication Adherence Scale (MMAS) at baseline, 3 months and 6 months
Secondary outcome measures1. Patients’ beliefs about medicine measured by Beliefs About Medicine Questionnaire (BMQ)
2. Severity of depression ‎ measured by MADRS scale
3. Patients’ involvement in decisions
4. Health-related quality of life - measured by EuroQOL-5D
5. Patient satisfaction with treatment
Measured at baseline, 3 months and 6 months.
Overall study start date10/02/2014
Completion date29/07/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants‎195 patients ‎
Key inclusion criteria1. Patients within the age range of 18 to 60 years
2. Patients newly diagnosed with a MDD, according to the scales in the ‎Diagnostic and Statistical Manual of Mental Disorders, 4th Ed (DSM-IV)
3. Patients having no psychotic or bipolar history
4. Patients having no drug or dependency history
5. Patients having no cognitive impairment that may hinder the assessment‎
Key exclusion criteria1. Patients having a psychiatric or bipolar disorder history
2. Patients having drug or dependency history.
3. Patients suffering from any cognitive impairment that may hinder the ‎assessment
4. Patients not responding at any level to the antidepressant within 8 weeks of ‎recruitment
Date of first enrolment10/02/2014
Date of final enrolment29/07/2014

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

Al Amal Hospital
Shobah
PO box ‎‏87904‏
Riyadh
11652‎
Saudi Arabia

Sponsor information

Al Amal Psychiatric Hospital
Hospital/treatment centre

Alkozam Aria
Riyadh
00996
Saudi Arabia

ROR logo "ROR" https://ror.org/00zszzj16

Funders

Funder type

Other

Investigator initiated and funded (Saudi Arabia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/09/2015 Yes No

Editorial Notes

22/03/2016: Publication reference added.