Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05884749 |
| Other study ID # |
P2CPilot |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2023 |
| Est. completion date |
September 1, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study has been designed to conduct a pilot evaluation of a novel model of support aimed
at promoting community integration (CI) following homelessness. This model is called the Peer
to Community Model (P2C). The P2C model is an outreach peer support model aimed at
facilitating CI for individuals living with concurrent disorders following homelessness. This
approach uses relationship-building and engagement in meaningful activity facilitated by peer
support specialists (PSS) in concert with occupational therapy (OT) and social work (SW)
consultation. This model includes four distinct components: 1) peer support delivered in a
community space dedicated to the program or community locations at a maximum ratio of 10:1;
2) OT and SW offering consultation to PSSs and service users; 3) a weekly support meeting for
PSSs, OT and SW aimed at providing a venue for problem-solving through complex cases and
providing mutual emotional support in the context of service delivery with a complex
population; and 4) opportunities for social enterprise (developing ideas for income
generation) within the community space.
***NOTE: This is a single model of support that includes the components identified above -
these are not separate interventions, but various components of one intervention designed in
previous research by the study team.
In this clinical trial, the investigators will implement the P2C model for the first time.
The study team will conduct a pilot study using an open randomized controlled trial,
crossover design. A total of 20 participants will be assigned randomly to the intervention
group, where they will receive P2C supports at baseline, and 20 participants will be assigned
to a waitlist condition for six months, after which time, they will be offered the P2C
intervention. Participants will be interviewed at baseline and every three months using mixed
(qualitative and quantitative) interviews. Waitlisted participants will be interviewed during
these same intervals using the same interview protocols, and while waiting, will receive care
as usual.
Description:
The investigators will conduct an open randomized controlled trial to pilot and evaluate the
P2C model. The purpose of this pilot is to not only pilot the P2C intervention to determine
the feasibility, acceptability, and initial effectiveness of the model, but also to pilot the
study design to inform future, larger scale, implementation science research. While the study
team will enter this pilot with the intention to complete a randomized controlled trial
design, they will use a quasi-experimental design should the participants decline
randomization. At the end of the trial, the study team will use the knowledge generated to
inform refinements to the P2C model for future implementation science research.
Baseline data collection: Once all participants have been referred, research assistants will
be provided with the names and contact information of potential participants. Research
assistants will conduct interviews in person and read all interview components aloud to
overcome threats to validity and reliability associated with illiteracy. These interviews
will be composed of demographic elements (age, gender, sexual orientation, race, ethnicity,
months housed/unhoused in the past year, health conditions, income), and a range of
standardized measures that correspond with key constructs including community integration
(primary outcome), meaningful activity engagement, mental well-being and substance use.
Research assistants will use a visual stimulus when delivering these measures to reduce
respondent fatigue. The team has used this strategy with a high degree of success in previous
research when a large number of items is presented to individuals living with mental illness,
substance use, or concurrent disorders and experiences of homelessness.
Qualitative interviews: In addition to demographic and quantitative items, the study team
will deliver a baseline qualitative interview with participants in both UC and P2C groups to
uncover participants' experiences of CI in the past and present. Interviews will be
semi-structured, recorded on a digital recording device, and transcribed verbatim.
Recruitment, group assignment, and sample size estimation: The investigators will recruit
participants through advertisements placed in the common areas of shelters, housing case
management programs, and health care services in the recruitment city (Kingston, Ontario,
Canada). The study team will also engage service providers in these organizations in our
recruitment process by asking them to share information about this research with service
users. Participants will be enrolled over a one-month period and will be included if they
are: over the age of 16; have secured a tenancy within the last three months or are in the
midst of moving into a tenancy; have experienced homelessness for at least one month in the
past year; and acknowledge living with a mental illness and/or substance use disorder. The
study team will assign participants to one of two groups: 1) usual care (UC); and 2) P2C. The
UC group will receive typical services available in the community. The P2C group will be
engaged in the P2C model in addition to any other supports available in their community.
Participants will be assigned to groups that have been carefully matched based on gender,
age, health condition, number of months of housed/unhoused in the past year, and income. The
investigators will enroll 20 participants in each group (n=40 total). This sample size has
been determined by modelling after sample sizes recommended for pilot research, with an
attrition estimate of 15% [51].
Implementation: Once baseline interviews have been completed and participants have been
assigned to P2C or UC groups, program staff will implement the P2C intervention with the P2C
group. PSSs will be provided with the names and contact information for all participants in
this group and will initiate the process of making contact with each within the first week to
ensure that service for all participants begins at the same time. PSSs will initiate the
development of relationships with each participant, while OT and SW at each site will ensure
their availability for two days per week each for consultation. PSSs will meet with
participants in the P2C group in community locations at least once per week. PSSs, OT and SW
at each site will meet weekly for personal and professional support meetings as described in
the overview of the P2C intervention in this proposal. The intervention and associated data
collection will continue for a one-year period.
Data collection over the intervention period with UC and P2C participants: Research
assistants will collect data every three months over the one-year intervention period with
both UC and P2C groups. Quantitative interview components delivered with both UC and P2C
groups at baseline will remain the same to facilitate comparison across time points and
groups. Program staff will record encounters with P2C participants on a common reporting
system associated with the collaborating organizations (Providence Care, Kingston, ON;
Trellis HIV and Community Care, Kingston, ON) to enable our team to capture data related to
frequency and nature of service interactions. Qualitative interviews will be delivered every
six months with both groups (baseline, 6-months, 12-months). This will help us to uncover
experiences of CI for the UC group over a one-year period without support, and to understand
CI experiences and acceptability of the intervention for P2C participants. Qualitative
interviews will be semi-structured, recorded on a digital recording device, and transcribed
verbatim.
Data collection over the intervention period with P2C program staff: At baseline and every
six months during the one-year intervention period, the study team will deliver qualitative
interviews with PSSs, OTs and SWs. The purpose of these interviews will be to identify
program staff experiences of delivering this approach, acceptability to program staff, and to
determine any challenges encountered with implementation (feasibility). Interviews will be
semi-structured, recorded on a digital recording device, and transcribed verbatim.
Data collection with service providers in community services: At the end of the one-year
intervention period, 15 participants working in health and social service agencies that
provide supports to individuals experiencing homelessness from each site will be recruited
for qualitative interviews aimed at identifying community service provider perspectives on
the P2C intervention, acceptability of the approach in the community, and feasibility of
implementing the approach in the future. Interviews will be semi-structured, recorded on a
digital recording device, and transcribed verbatim. This sample size has been modelled after
sample sizes used in similar published research [61].
Fidelity measurement: Every three months, research assistants will observe one session
delivered by each program staff to determine the extent to which services are aligned with
the central tenets of the P2C model using the fidelity checklist developed in Phase II. These
observations will continue over the 12-month intervention period. Research assistants will be
asked to observe a session with a different participant during each encounter with program
staff.
Strategies for reducing attrition and withdrawal among UC and P2C groups: The study team
recognizes that individuals who live in poverty and have experiences of homelessness may
struggle to remain in contact with our research team due to changing circumstances. To reduce
attrition, the study team will ask interested participants at the stage of recruitment for a
range of contact sources for follow up including social media contact information, phone
numbers, email addresses, and contact information for family, friends and other health and
social care professionals to facilitate follow-up. Research assistants will also remain in
regular contact with UC and P2C participants and program staff to schedule interviews,
provide reminders throughout the study and remind participants of the benefits of
participation. These strategies have been described to support retention in previous
implementation science research.
Analysis of quantitative data: The study team will calculate internal consistency scores for
all standardized measures, and descriptive statistics for all demographic variables. To
compare the effectiveness of the P2C intervention over time, the study team will conduct
parametric (repeated measures and independent samples t-tests, multi-level linear models) and
non-parametric (Wilcoxon signed rank and Kruskal-Wallis tests) statistics to compare
participant scores on all standardized measures across time points with both UC and P2C
participants. This will enable the study team to identify any mean differences and change on
indices of CI, mental well-being, meaningful activity engagement, substance use, and service
contacts across data collection points and groups, noting any statistically significant
differences within and between groups. The investigators will also separate groups based on
gender to conduct gender-based analyses to identify any differences in outcomes across
gendered groups. Using a combination of parametric and non-parametric statistics (t-tests,
Mann-Whitney U, and chi-square), the investigators will compare the demographic
characteristics of any participants lost to follow-up with participants remaining in the
study to determine the presence of any significant differences between these groups. This
will enable us to uncover any demographic explanations for attrition. Significance will be
set to p≤.05 for all tests.
Analysis of qualitative data: Qualitative interview transcripts conducted with UC and P2C
groups, program staff and community service providers will be uploaded to Dedoose, a
qualitative data management program for coding and analysis. Transcripts will be coded
abductively, informed by a social ecological lens, using thematic analysis [64]. Themes
representing each data set will be generated during this process. In line with thematic
analysis, the investigators will generate a central essence describing each set of themes in
concert with the approach described by Braun and Clarke. Using the same processes, the study
team will separate qualitative interview transcripts by site and gender to conduct site and
gender specific analyses for all groups.
