Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment (Medlink)
Major depressive disorder (MDD) is common and imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. While primary care is the de facto site for treatment of MDD, outcomes in primary care are poor. Two principal reasons for the poor outcomes in primary care are poor patient adherence to antidepressant medications (ADMs) and the failure of physicians to provide guideline-congruent care. This problem is aggravated by a lack of communication between patients and the care team.
A growing body of research indicates that primary care-centered strategies aimed at enhancing guideline-congruent care have not been effective. Interventions aimed at improving adherence in the patient have been successful in changing patient adherence behavior; however these frequently fail to improve depression outcomes, particularly when there is no intervention on the physician side to encourage optimization of ADMs. The most effective strategies address both provider and patient behaviors, usually through the use of a case-manager who monitors and supports patient adherence and response to treatment, and provides actionable feedback to the PCP. However, case-managers have not been widely implemented in primary care settings.
Recent technology developments have opened new opportunities to improve health care, and to link patients and their providers. The investigators proposal harnesses these advances to develop and pilot the medLink system. ADM adherence will be passively measured using an electronic pill dispenser, which is connected to a mobile smartphone via GSM, so that targeted, timely reminders can be provided when the patient fails to take the ADM. When the patient is adherent, the patient will not be bothered with reminders. Depressive symptoms and side-effects will be periodically monitored weekly via the phone. Every 4 weeks, or if indicated (e.g intolerable side effects or urgent situations), primary care teams will receive notifications via the electronic medical record that include a summary of patient data on treatment response and side effects, guideline-congruent treatment recommendations based on patient data and a recommendation to contact the patient, if indicated. Simultaneously, a similar message will be provided to the patient via short message service (or text), including feedback, possible treatment options, and a recommendation to contact the physician's office. Thus, both the patient and care team will be activated to provide, request and adhere to guideline-congruent care.
The aim of this proposal is to develop and pilot the medLink system. Development will employ an iterative user-centered approach. The pilot trial will compare 12 weeks of the medLink system to a treatment as usual control among primary care patients with MDD initiating ADM treatment. Outcomes will include patient adherence to ADM, physician adherence to treatment guidelines, and depression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment|
- Objective patient adherence to antidepressant medication [ Time Frame: 4,8 and 12 weeks ] [ Designated as safety issue: No ]Objective adherence will be evaluated using the pill dispenser, which contains a chip that can monitor with a time and date stamp each dispensing of a dose. The adherence metric will be % of days adherent. This method is potentially the most objective, but is vulnerable to technical problems.
- Patient Adherence Questionnaire (PAQ) [ Time Frame: 4,8 and 12 weeks ] [ Designated as safety issue: No ]Self-reported adherence will be measured using the Patient Adherence Questionnaire (PAQ) at weeks 4, 8 and 12. The PAQ, developed for the STAR*D trial. Patients will be asked to report on the previous 2 weeks' adherence. Self-reported data has generally been found to underestimate actual medication use, and is subject to recall bias and social desirability, but is less vulnerable to threats to technical reliability.
- Adequency of anti depressant medication dosage [ Time Frame: 4, 9 and 13 weeks. ] [ Designated as safety issue: No ]Adequacy of dosage will use a framework developed by Simon in which doses are coded 0=subthreshold; 1=minimal clinical dosage; 2=twice minimal and 3=three times minimal or greater. Based on the prescription data obtained from the EMR, a score for each week will be generated.
- Number of contacts with Primary Care team [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Guideline-congruent care will be operationalized as the number of patient visits or telephone consultations, and the number of medication and dose changes, consistent with other trials of interventions with primary care physicians.
- Depression [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]Depression will be measured by the QIDS-C, IDS-SR, and MINI MDD module
- Usability and Satisfaction with system [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]This will be measured through use of the Medlink system and the USE questionnaires
- Medication side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Side Effects will be measured by the Patient Report Inventory of Side Effects (PRISE)
- Attitudes towards Anti Depressant Medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Attitudes towards ADMs will be measured using the Beliefs about Medicine scale and the Depression Beliefs Inventory
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Medlink system
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.
Behavioral: Medlink system
Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
No Intervention: Treatment as Usual
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583764
|Contact: Susan M Kaiser, MPHemail@example.com|
|Contact: Joyce Ho, Ph.D.||firstname.lastname@example.org|
|United States, Illinois|
|Northwestern University||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Principal Investigator: David C Mohr, Ph.D.|