NCT Number: NCT06969261
To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.
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Interventional
Not applicable
Hospital of the University of Pennsylvania (HUP), Philadelphia, Pennsylvania, United States
The opioid use epidemic in the US disproportionately affects women of childbearing age which is evidenced by a 131% in OUD among women giving birth in hospitals from 2010-2017. Substance use in pregnancy increases the risks for a host of maternal and infant medical complications including preterm delivery and intrauterine fetal demise, as well as maternal morbidity and mortality caused by drug overdose. Increasing fatalities due to overdose in Philadelphia specifically have been attributed to decreased access to social support and treatment services. Loneliness and social isolation are implicated as risk factors for initiation and maintenance of OUD and are heighted in the perinatal period. Perinatal OUD care requires frequent contact with providers which may not always be feasible as in-person visits or phone calls to a clinician's office are restricted to business hours and may require a wait time before the necessary attention can be given. In order to increase patient access to OUD and perinatal care, decrease loneliness and a sense of social isolation, and promote engagement in care, we now embark on a study utilizing steps from intervention mapping to identify, develop, and refine content and delivery methods for an adaptation to a two-way short messaging service (SMS) texting chatbot to make it appropriate for perinatal women with OUD.
In Aim 1, we will conduct a needs assessment via in-depth interviews with up to 36 perinatal patients with OUD (12), their partners (12), and their clinicians (12). We will convene an advisory board and used mixed methods analyses to investigate the qualitative data to determine the content to be included and the delivery methods to use in the adapted Chatbot.
In Aim 2, we will pretest with adapted Chatbot with 10 perinatal patients with OUD in order to develop and refine the anticipatory guidance, establish clinical teams, ensure the safety of the protocol, and evaluate the user experience.
In Aim 3, we will pilot test the adapted Chatbot with 20 perinatal patients with OUD. We will conduct a focus group on 10 individuals participating in the pilot study to examine the acceptability, and feasibility of the intervention. We will also collect initial effectiveness data on the Chatbot's effect on loneliness, social isolation, opioid use, mental health and healthcare engagement via self-report surveys and electronic medical record data extraction.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).
The Penny COPILOT chatbot is an interactive short messaging system (SMS) program that provides educational and supportive content for postpartum individuals. The chatbot has been adapted to include information relevant to opioid use disorder recovery in order to decrease the risk of returning to use among people who use drugs. Messages are sent at specified intervals relevant to the postpartum course and the chatbot allows for two way messaging with an interactive lens.
Time frame: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.
The UCLA Loneliness Scale (Version 3) is the most commonly used measure of loneliness, with strong test-retest reliability, high internal consistency, and validity.97 While the word "lonely" is never used explicitly in the 20-item scale, subjects are asked to report the frequency of specific experiences (e.g., "How often do you feel in tune with others around you?") on a 4-point Likert scale (1 = "I never feel this way" to 4 = "I often feel this way.") For dichotomous analysis of loneliness, we will use the loneliness severity threshold adapted from Doryab98 which defines "lonely" as having a score greater than 40, while "not lonely" is defined as having a score less than or equal to 40.
Time frame: During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.
A questionnaire designed by our investigative team that queries a participant's opioid use, specifically identifying their drug of choice, method of administration, pattern of use, triggers for use, frequency and amount of use, barriers to relapse, and recency of relapse.
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Acronym: PENNY-COPILOT
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