Clinical trial NCT04055155: Technology-enabled Task-sharing for Depression in Primary Care
Official title: Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Depression
Depression in Old Age
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics: administrators, primary care providers, behavioral health providers, frontline primary care staff (e.g., nurses, medical assistants)

Patients: older adult primary care patients with mild-to-moderate depressive symptoms

Brief summary: This study will explore and test the feasibility, acceptability, usability, and preliminary effectiveness of a technology-enabled intervention for depression using task-sharing in primary care. We will a) discover barriers and facilitators to task-sharing by frontline primary care staff; b) design an implementation strategy to support task-sharing to deliver a technology-enabled intervention for depression; and c) conduct a small open-label usability trial of the technology-enabled intervention for depression.

Detailed description: Older adults with depression typically present to primary care rather than specialty mental health treatment and are often un- or undertreated, as the demand for mental health services is greater than the supply of trained providers. Technology is one method to improve access to care by making evidence-based psychosocial interventions (EBPIs) readily accessible. A second method comes from global mental health research, demonstrating that task-sharing can equip non-specialists to provide effective mental health care. This study combines these two approaches, exploring how technology-enhanced EBPI could be used by frontline primary care staff (e.g., nurses, medical assistants) to expand workforce capacity to deliver acceptable, sustainable, and effective treatment for depression. Specifically, we will use task-sharing to deliver a mobile Motivational Physical Activity Targeted Intervention (MPATI), which is based on behavioral activation for depression and uses wearable accelerometer technology to trigger personalized activity goal monitoring. This proposal uses the Discover, Design/Build, Test (DDBT) framework, which leverages user-centered design and implementation science to discover implementation barriers to using task-sharing to deliver MPATI in primary care, to design an implementation strategy to support MPATI delivery, and to conduct a pilot usability trial to test the implementation strategy with the most suitable frontline staff.

Eligibility criteria: Inclusion Criteria:

Clinics:

1. have at least 1 full-time registered nurse (RN) and/or medical assistant (MA) on staff
2. include older adults on their patient panels.

Clinic administrators

1. have an administrative or leadership role in the clinic
2. have been employed in their current role for at least 6 months.

Frontline staff

1. provide care as RN, MA, case manager, behavioral health consultant, or similar role identified by Practice Champion
2. be employed at the participating clinic for at least 6 months.

Patients

1. be ≥65 years of age
2. report moderate to moderately severe depressive symptoms based on a PHQ-9 score of 10-20
3. own or have access to a smartphone
4. have internet or cellular data plan
5. receive medical clearance from their primary care provider to participate in unstructured physical activity.

Patient exclusion criteria will be based on medical chart review by Practice Champion and include:

1. current suicidality
2. severe vision or hearing impairment
3. pronounced cognitive impairment
4. use of assistive devices that would impede physical activity.

Primary outcomes:
measure: Usability (system usability scale)
timeFrame: after 2 week usability trial
measure: Usability (qualitative interviews)
timeFrame: after 2 week usability trial
Secondary outcomes:
measure: feasibility -- patient recruitment
timeFrame: end of pilot trial (2 weeks per patient)
measure: acceptability -- patient retention
timeFrame: end of pilot trial (2 weeks per patient)
measure: depressive symptoms (patient)
timeFrame: pre-post 2 week pilot trial
measure: functioning (patient)
timeFrame: pre-post 2 week pilot trial
Other outcomes:
measure: user burden
timeFrame: end of 2 week pilot trial
Locations:
city: Seattle
country: United States
facility: Univeristy of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Oleg Zaslavsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Brenna Renn, PhD
role: PRINCIPAL_INVESTIGATOR
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