Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder (D-TECT)

The main objective of the study is to evaluate the feasibility of utilizing digital health technology with opioid use disorder (OUD) patients as measured by a 12-week period of continuous assessment using smartphone surveys and digital sensing. In addition, we will examine the utility of 3 types of digital data (Ecological Momentary Assessment (EMA); Digital sensing; and social media data) in predicting OUD treatment retention and buprenorphine medication adherence.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder

Detailed Description

This is an observational study designed to (1) evaluate the feasibility and utility of digital health technology in a Medication for Opioid Use Disorder (MOUD) treatment population, and (2) capitalize on the availability of Electronic Health Record (EHR) data to relate passive and active sensing data to treatment retention and medication adherence.

Eligible participants are identified through EHR records, sent an invitational letter through secure message, and then called to recruit and screen. Following verbal consent to screen, research staff will perform a screening assessment over the phone/video to determine preliminary study eligibility prior to scheduling the baseline phone/video appointments. Following electronic signed informed consent, participants will be asked to complete an interviewer administered Baseline assessment. In addition to the screening and baseline assessments, the participants will be asked to wear a smartwatch and carry a smartphone continuously for a period of 12 weeks. Smartphone and smartwatch data will be passively collected. In addition, participants will be prompted to respond to questions through a smartphone (i.e., Ecological Momentary Assessment (EMA)) 3 times daily for 12 weeks. In addition to the EMA prompts, individuals will be asked to self-initiate EMAs if substance use occurred.

After the 12-week active study phase, participants will be asked to complete a follow-up phone/video appointment.

EHR and medical claims data will be extracted 16 weeks after study completion (data will be collected 12 months prior to EMA start through 12 weeks after EMA start).

For those who consent to the optional social media component, social media data will be downloaded by the participant directly from the social media platform to a secure server using a remote desktop at the beginning of the study and at the end of the study.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California, Division of Research

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This study is recruiting individual who are active in medication treatment for opioid use disorder (MOUD) with buprenorphine for at least 2 weeks.

Description

Inclusion Criteria:

1. Have been active in Kaiser outpatient buprenorphine treatment for OUD for the past 2 weeks (determined at screening);
2. Be ≥18 years old (determined at screening);
3. Be able to understand English (determined at screening);
4. Be available to participate in the full duration of the study (12 weeks) (determined at screening);
5. Have an active email account and willing to provide the email address to researchers (determined at screening);
6. Permit researchers to access personal electronic health record (EHR) and medical claims data (determined at screening);
7. Be willing to carry and use personal or study provided smartphone for 12 weeks (determined at screening); and
8. Be willing to wear a smartwatch continuously (except during pre-defined activities such as showering) for 12 weeks (determined at screening).

Exclusion Criteria:

1. Are unwilling or unable to provide informed consent (determined during the Consent process and during Consent Quiz); and
2. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities (determined by Prisoner Status Assessment at each study visit).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EMA plus passive sensing; Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smartphone Sensor Data	The percentage of days carried the smartphone at least 8 hours per day.	84 days (or 12-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Media Data	The percentage of participants who consented to download social media data.	At baseline
The Number of Ecological Momentary Assessments (EMA) With Response	The response rate to Ecological Momentary Assessment prompts during the 12-week study phase. The EMA Response Rate for each participant is the number of EMAs responded to over the last 83 days of the study (up to 249 responses [83 days X 3 EMA]) (yields a percentage). The total mean EMA response rate was based on the EMA response rate (percentage) across all participants in the study (N=62).	up to 3 times per day for 84 days (or 12-weeks)
Smartwatch Sensor Data	The percentage of days wore the smartwatch at least 18 hours per day.	84 days (or 12-weeks)

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); Dartmouth College; Kaiser Permanente; National Drug Abuse Treatment Clinical Trials Network
• Investigators: Principal Investigator: Cynthia Campbell, PhD, Kaiser Permanente; Principal Investigator: Lisa A Marsch, PhD, Dartmouth College

Publications and helpful links

General Publications

• Marsch LA, Chen CH, Adams SR, Asyyed A, Does MB, Hassanpour S, Hichborn E, Jackson-Morris M, Jacobson NC, Jones HK, Kotz D, Lambert-Harris CA, Li Z, McLeman B, Mishra V, Stanger C, Subramaniam G, Wu W, Campbell CI. The Feasibility and Utility of Harnessing Digital Health to Understand Clinical Trajectories in Medication Treatment for Opioid Use Disorder: D-TECT Study Design and Methodological Considerations. Front Psychiatry. 2022 Apr 29;13:871916. doi: 10.3389/fpsyt.2022.871916. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): June 12, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Digital Health; Substance Use Disorder; Social Media
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: CTN-0084-A2; UG1DA040309 (U.S. NIH Grant/Contract); UG1DA040314 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified dataset will be made available by the Principal Investigators upon request.
• IPD Sharing Time Frame: Data will be available after the completion of the study and data lock.
• IPD Sharing Access Criteria: Prior to receiving any study data, researchers/institutions will need to enter into a data sharing agreement with the institution(s) providing the de-identified study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No