Outcomes of a Pilot Outreach Program to Support Point-of-Care Screening in Individuals with Diabetes who are Experiencing Homelessness in Alberta, Canada

doi:10.21203/rs.3.rs-4385566/v1

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Research Article

Outcomes of a Pilot Outreach Program to Support Point-of-Care Screening in Individuals with Diabetes who are Experiencing Homelessness in Alberta, Canada

https://doi.org/10.21203/rs.3.rs-4385566/v1

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Background

Accessing diabetes care, including screening for microvascular complications, requires effort and time. Social complexity, such as homelessness, often forces individuals to prioritize securing shelter and safety over medical appointments, particularly for the prevention of long-term complications.

Methods

We designed and conducted a non-randomized pilot study of a point-of-care screening program with expedited referral pathways within two inner-city community sites in Calgary, Canada which are accessed by individuals experiencing homelessness. Adults experiencing homelessness and diabetes were recruited through the host sites and invited to two separate visits. Microvascular screening (retinal fundoscopic images, albumin-to-creatinine ratio testing, and foot neurovascular assessment), glycemic monitoring, and footcare were performed at the first visit. The nurse shared the screening results and helped facilitate follow-up at the second visit. We compared the screening completion rates after visiting our program to historical screening over the past two years, based on chart review and patient reports. We also assessed the domains of reach and implementation as per the RE-AIM framework.

Results

Compared to the previous two years, participants (n = 40) experienced a 2.9-fold increase in peripheral neuropathy screening; a 1.7-fold increase in diabetic retinopathy screening; and a 90% increase in diabetic nephropathy screening. We also documented a 73% increase in glycemic monitoring. Most participants (83%) attended both clinic visits. Despite this unique model, challenges facilitating follow-up specialist visits remain, with fewer than half of referred patients attending follow-up visits. The cost of the pilot ($846/visit) illustrates this model requires modifications to yield optimal value.

Conclusions

Our findings show the SAFER model significantly increased screening rates for our sample, however, innovative approaches to healthcare are still needed for this population. Potential value-based adjustments include partnering with more community sites already servicing this population and expanding the scope of the care offered and the target population.

Diabetes secondary prevention

community health

models of care

homelessness

point-of-care screening

barrier-free care

In Canada, out of the estimated 235,000 people experiencing homelessness over the course of a year,(1) as many as 10–20% (or 23,500 − 47,000) also have diabetes, reflecting at least the same prevalence of diabetes in the general population.(2, 3) Higher mortality rates and poorer diabetes-related outcomes in this population, compared to those who are securely housed, have been well documented in the literature.(4–11) One of the contributors to these disparities is the fact that those who experience homelessness are known to be one of the groups with the least access to comprehensive primary and specialty care.(5, 11–13) The lack of outpatient care leads many to delay seeking care until chronic complications become symptomatic or severe which is not only costly to healthcare systems, but also results in permanent, irreversible organ damage that might have been averted if care was provided earlier in the disease course.(14–17)

Regular screening for microvascular complications is recommended by clinical practice guidelines.(14–20)^, By identifying retinopathy, neuropathy, and nephropathy in their early asymptomatic stages, action can be taken to reduce the risk of developing the end-stage complications of amputation, blindness, and the need for renal replacement therapy, such as dialysis or kidney transplantations. Unfortunately, due to the significant barriers faced, those experiencing homelessness are far less likely to access screening for diabetes-related microvascular complications.(13) One study showed that in a cohort of 40 individuals experiencing homelessness, diagnosed with either diabetes or prediabetes, only 35% had received the recommended screening in the past year.(4) The follow-up care provided in this study provided participants with a copy of their results and student navigators were available to assist participants with scheduling follow-up in areas required. Follow-up was verbally encouraged with participants only.

In order to address the barriers faced by this population, we developed and piloted a point-of-care screening clinic within two inner city community sites already accessed by individuals experiencing homelessness.(21) Our objective was to facilitate screening for microvascular complications, according to the Diabetes Canada recommendations,(14–17) and to facilitate referrals to, and follow-up care with, specialists as needed for participants. (21) We sought to document whether this new program was effective at increasing the rate of microvascular screening and glycemic monitoring as recommended. Our hypothesis was that there would be an increase in such screening for individual participants. Our secondary objectives guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)(22) framework, allowed us to thoroughly examine the reach, effectiveness, and implementation of our program. To further assess the effectiveness of the program, we monitored the number of successful follow-up appointments with specialists when needed and any changes in patient-reported ease of getting the screening tests done. Similarly to the cohort study mentioned earlier where screening rates were low, within the SAFER protocol, our research team shared a public-friendly copy of all results obtained with participants and encouraged specialist follow-up as required. Furthermore, our team intentionally reached out to local specialists and co-created pathways for follow-up that would in theory make the specialist follow-up process easier for both patients and practitioners.(21)

To assess the reach of the program, we monitored the interest in the program of those asked to participate, and for those who consented to participate. We also monitored how many participants returned for the second nurse visit. To assess implementation aspects, we observed the fidelity of the program, documenting delivery consistency and if the program was delivered as intended. Finally, we examined the costs associated with the program.

Patient and Public Involvement

The SAFER model of care was created in response to experiences shared by a community-based participatory research group comprised of individuals with lived experience of homelessness and diabetes. This group expressed that competing priorities, relationships with healthcare professionals, and navigating healthcare services were important barriers they faced, amongst other challenges.(23) There was a desire expressed for a "one-stop-shop" where all diabetes care could be provided under one, familiar roof.(24) Another group with whom we worked identified that healthcare, diabetes education, and screening for diabetes were significant challenges.(25) With this group, we discussed the idea of the SAFER program and its operations, which helped generate the idea for the program.

Study Design

We employed a nonrandomized pilot study using mixed methods approaches to explore and document the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)(22) of the intervention with both qualitative and quantitative data. This manuscript is dedicated to the quantitative findings; qualitative findings will be published separately.

Setting

The clinic was offered over 12 months, from January to December 2022 in Calgary, Alberta - a large Canadian metropolitan city of 1.4 million inhabitants. In Canada, all residents with legal status are entitled to receive medical and hospital care free-of-charge through their provincial health insurance program.(26) In the province of Alberta, the costs associated with retinal screening are covered for all people with diabetes once per year.(27) As per the 2022 point-in-time count, Calgary had 2782 individuals experiencing homelessness on a given night.(28) The clinic was offered in two locations in Calgary’s inner-city. The Calgary Drop-In Centre is Canada’s largest emergency shelter, accommodating an average of 445 people per night, while also providing a comprehensive mix of housing and social support programs, as well as a primary healthcare team.(29) The Mustard Seed’s Wellness Centre provides a variety of services including primary healthcare, navigational supports, and mental health counselling to adults experiencing homelessness or poverty.(30)

Intervention

We named the clinic SAFER (Screening A1C, Feet, Eyes, and Renal function). We screened glycemia (glycated hemoglobin, A1C) via a point-of-care analyzer using a finger prick. Foot health was assessed using the Alberta Health Services diabetes foot screening tool(31) and we provided preventative basic footcare. Eye health was assessed using measures of visual acuity and interocular pressure, and by obtaining retinal photographs via pupillary dilation and teleophthalmology technology. Renal function was determined via albumin-to-creatinine ratio (ACR) from a urine sample that was also analyzed at point-of-care. Given the concomitant risk of hypertension and cardiovascular disease, we also checked systolic and diastolic blood pressure using a Bios Diagnostic automatic professional blood pressure monitor. The point-of-care analyzer used in this program was the Siemens DCA Vantage Analyzer, which has been shown to be accurate for the measurement of both A1C and ACR.(32, 33) The retinal camera used for imaging the retinal fundus was the TRC-NW8/8F multi-functional, non-mydriatic retinal camera, which has been used for teleretinopathy programs in Alberta for many years, with strong evidence, even when not being used by an expert operator.(34) We originally planned to use a different handheld retinal camera, but we experienced operational problems with it from the outset. As such, we pivoted to the model outlined above early on in implementation and were able to offer reassessment to the first five participants who did not initially have access to this technology.

This screening program was also accompanied by dedicated referral pathways which were negotiated with colleagues who were specialists in diabetology/endocrinology, renal care, retinal disease, foot care, and vascular/podiatric surgery. Given the challenges this population faces with follow-up visits, we sought to have most cases seen within two weeks, which is quite different from standard practice in our setting.

All four screens were offered to participants by the study nurse at their initial visit, where they were also offered basic footcare (i.e., nail trimming, minor ingrown toenail removal, callus removal, foot soak, moisturizing lotion application, as well as new socks offered). Participants were booked for a follow-up visit, usually one week after the initial visit. During the intervening time, the nurse would help arrange any required follow-up visits. During the follow-up visit, participants were told about the results of their screening tests, the recommended course of action, and any appointments that had been arranged for them. Where possible, we worked with the host site to arrange transportation for participants to be able to attend their specialist follow-up visits when transportation was a challenge, however, transportation budgets were often limited to bus chits.

Recruitment

All participants were recruited through the host site staff and through posters displayed within each facility. If staff members were already aware of clients managing diabetes, they mentioned the program to them and if they were interested, the staff went through the consent to contact form with the potential participant. For our selection criteria, we used the definition of homelessness developed by the Canadian Observatory on Homelessness that includes: (1) individuals who are unsheltered (or rough sleeping), (2) those who are utilizing emergency shelters, and (3) those who are provisionally accommodated.(35) We later included (4) those at risk of homelessness to expand our sample pool.(35) Individuals that already had access to comprehensive diabetes specialist care including consistent access to all of the following: primary care provider/diabetes specialist, ophthalmologist/optometrist, nephrologist/kidney care team, and foot care nurse/podiatrist, were excluded from the study as they would not have benefitted from our screening program. Participants were provided a $10 study honorarium after the first visit and a $20 honorarium after the second visit to thank them for their time. A diabetes-friendly snack, water, sunglasses, and new socks were also provided to all participants.

Data Collection

Upon the initial visit at the host site location, prior to completion of the screening tests, research staff obtained informed consent from each individual participant. They also helped participants to complete the baseline survey, which collected information about participants’: housing history, diabetes history, comorbidities, prior screening test completion, diabetes self-management abilities (using the DSMQ),(36) presence of diabetes distress (using the PAID-5),(37) and self-reported ease of completing screening tests (using a bespoke 4-item Likert scale). During the initial visit, screening data was documented within the participant clinical record. After the follow-up visit with the nurse, each participant was invited to participate in a short semi-structured qualitative interview with research staff to share their perspectives on their participation in the program, and to repeat the questionnaire on ease of screening test completion. Finally, the host site medical staff performed a chart review for each individual participant, extracting information from their local electronic medical records, which receive data directly from the official provincial health record of each patient. Specific information that was extracted included: current medications, history of prior relevant screening and laboratory tests, and prior specialist consultations. The research team kept detailed participant records and field notes to track the fidelity and uptake of the program. Detailed financial records were also kept to track the total costs of the SAFER program.

Data Analysis

To accomplish our primary objective of assessing effectiveness, we compared the screening completion rate after enrollment in SAFER with the rate of screening completion in the relevant period prior to enrollment in SAFER. This period was two years for each of the microvascular screening tests, and six months for glycemic monitoring. This historical assessment was made based on patient self-report and chart review. Change in screening completion rate was assessed for each individual test, and for completion of all tests. A proportions test was used to determine the statistical significance of the differences in proportions of those screened before and after participation in SAFER. Pre-post differences in self-reported ease of screening test completion were assessed using the Wilcoxon Signed-Rank Test(38) via Stata statistical software.(39)

To assess the remaining quantitative domains of reach, effectiveness, and implementation (including cost), we compared the consent to contact forms completed with potential participants with the participants who attended the initial screening visit. We then compared the initial visits documented in the participant clinical record to the follow-up visit with the nurse to determine how many participants attended both the first and second visits of the screening program. We later confirmed with specialty clinics, without disclosing names, the number of SAFER participants who attended any recommended follow-up. We noted time spent with each participant in our field notes and how many screens were completed with each participant in the clinical record and used this data to determine the average time spent and total screens performed. Cost analysis was performed by summing the total program costs and dividing this value by the total number of participants in the study.

Over the course of one year, we enrolled 40 participants in the SAFER program. Participants mostly had type 2 diabetes, and we had a near-even split of men and women (Table 1), despite the fact that there tend to be more men than women who experience homelessness in Calgary. (28) There was a high rate of anxiety and/or depression in our sample (28/40).

Table 1

Sociodemographic Characteristics of the Study Participants
	Characteristic	n	Proportion (%)
Self-Reported Gender	Man Woman Non-binary Prefer not to disclose	22 18 0 0	55 45 0 0
Ethnicity	White Indigenous Non-White, Non-Indigenous Don’t know/Not Listed	20 12 6 2	50 30 15 5
Diabetes Type	Type 1 Type 2 Other/unsure	5 31 4	12.5 77.5 10
Prior Diagnosis of Anxiety or Depression	Yes No	28 12	70 30
Duration of Diabetes (years)	Mean (SD) Range	10.8 (9.41) < 1–40 years
Age (years)	Mean (SD) Range	54 years (11.42) 31–73 years
Duration of homelessness (those < 1 year, n = 21)	Mean (SD) Range	3.9 months (3.28) 1 day – 10 months
(those > 1 year, n = 18)	Mean (SD) Range	9.86 years (9.41) 1–30 years
PAID-5 Score measuring diabetes distress	Mean (SD) Range	6.83 (1.61) 0–20
“I take my diabetes medication (e.g., insulin, tablets) as prescribed.” (n = 38)	Applies very much Applies to a considerable degree Applies to some degree Does not apply	26 5 3 4	68 13 8 11
Self-reported smoking status (n = 40)	Never Past use (quit completely) Current use	12 3 25	30 8 63

The screening provided by our program during the initial nurse visit yielded that our population consisted of individuals whose glycemia was largely not within the target range (60% with A1C > 7%) and that many participants had evidence of diabetic kidney disease based on the presence of albuminuria (37% with ACR > 3mg/mmol). Some degree of loss of protective sensation in the lower extremity was present in 31/40 participants, and 8/34 had evidence of retinopathy (Table 2).

Table 2

SAFER Screening Findings
Parameter	Mean (SD)	Median (Range)	Distribution			Referrals Made / Seen
				n	%
A1C (n = 40)	8.0% (2.29)	7.6% (5–14)	< 7% 7–8% 8–10% 10%+	16 8 8 8	40 20 20 20	8 / 4
Albumin-to-creatinine ratio (n = 38)	7.19mg/mmol (13.01)	1.9mg/mmol (< 1–40)	0-2.9 mg/mmol 3-29.9 mg/mmol ≥ 30 mg/mmol	24 12 2	63 32 5	2 / 1
Foot Exam Risk (n = 39)			Low Moderate High Urgent	8 24 6 1	21 62 15 2	4 / 1 (2 were already being seen)
Eye Exam Risk (n = 31)			Low Moderate High Urgent Repeat scans recommended	17 5 2 1 6	55 16 6 3 20	7 / 3
Systolic Blood Pressure (n = 40)	134.33mmHg (20.09)	132mmHg (95-203mmHg)	< 120mmHg 120-135mmHg > 135mmHg	6 17 17	15 42.5 42.5	0 / 0
Diastolic Blood Pressure (n = 40)	83.43 mmHg (9.73)	84mmHg (62–108 mmHg)	≤ 80mmHg 80-95mmHg > 96mmHg	13 23 4	32.5 57.5 10	0 / 0

Given that the qualitative elements of our RE-AIM evaluation are documented elsewhere; this manuscript presents results only regarding components of Reach, Effectiveness, and Implementation. The following sections discuss the primary objective along with the remaining RE-AIM domain findings that were considered either facilitators or barriers to the sustainability of this program.

Primary Objective - Effectiveness

Of the 40 participants in the study, none were up-to-date with all of their microvascular screening (at least once in the past two years) and glycemic monitoring (at least once within the past 6 months) at the time of enrollment. However, after having gone through the program, 29/40 had completed all the tests. One participant reported nausea post pupil dilation in the screening clinic. The study nurse kept the participant a bit longer for monitoring, made the host site staff aware, asked the medical staff to monitor the participant for the remainder of the day and instructed staff to arrange for transport to the nearest hospital if nausea progressed to vomiting or if any visual disturbances increased. No further follow up was required. The proportions test showed that this was a statistically significant difference. With respect to the individual screening tests (Fig. 1), we documented statistically significant increases in screening for: diabetic neuropathy (2.9-fold increase: 10/40 à 39/40, p = < 0.0001); diabetic retinopathy (1.7-fold increase: 11/40 à 30/40, p = < 0.0001); diabetic nephropathy (90% increase: 20/40 à 38/40, p = < 0.0001); and glycemic monitoring over the past 6 months (73% increase: 23/40 à40/40, p = < 0.0001).

The second aspect of the effectiveness domain was with respect to the program’s ability to connect participants with specialists when microvascular complications were identified or there was a need for major glycemic improvement. One in ten screened for foot health were referred to a footcare specialist (partnering podiatrist or foot surgeon) for high or urgent needs that were identified. Unfortunately, only one out of the four referrals made was seen by the foot care specialty team. Nearly one quarter (7/31) of those screened for retinal disease were referred to retinal specialists for repeat screening, fluorescein angiograms, or for treatment. Fewer than half (3/7) were ultimately seen by the retina specialist. Despite a high prevalence of albuminuria, most were mild-to-moderate, so only 2/38 were flagged for needing specialty follow-up, one of whom was seen. With respect to glycemia, 8/40 participants were referred for specialist follow-up with a diabetes educator or medical specialist due to elevated A1C. Only half were seen, two by a pharmacist who was immediately available after the nurse had completed the follow-up visit, and two were seen by the principal investigator/partnering endocrinologist during outreach clinics. We were unable to ascertain whether the remaining four participants were seen by specialists at some point after their initial visit.

Finally, we also assessed effectiveness with respect to patient-reported ease of completion of the screening tests (Table 3). At baseline, pre-SAFER, when asked about the ease of completing their regular microvascular screening, approximately one-quarter stated that these were difficult to access: blood and urine tests (9/40), retinal screening (11/40), and foot exams (13/40). Comparing the patient-reported assessment of ease demonstrated that there was a statistically significant change (to increased ease) after completing the SAFER program for both foot assessment and eye assessments. There was a non-significant trend towards increased ease for laboratory assessment.

Table 3

Patient-reported ease of completing screening tests
		Pre-SAFER assessment, n	Post-SAFER assessment, n	Change, n		p-value*
“It is easy for me to have my annual screening foot exam.” (n = 39)	Strongly Disagree	2	0	More difficult	4	0.0073
	Disagree	11	0	Easier	15
	Agree	15	17	No change	12
	Strongly Agree	11	14
“It is easy for me to have my annual screening eye exam completed (dilated eye exam with an eye doctor).” (n = 40)	Strongly Disagree	1	1	More difficult	3	0.0163
	Disagree	10	0	Easier	12
	Agree	18	18	No change	16
	Strongly Agree	11	13
“It is easy for me to have my blood work and urine tests completed” (n = 40)	Strongly Disagree	1	1	More difficult	6	0.0919
	Disagree	8	0	Easier	13
	Agree	19	19	No change	14
	Strongly Agree	12	13
* using the Wilcoxon signed-rank test

Our secondary objectives were to assess quantitative aspects related to reach and implementation. Reach is concerned with whether there was interest in the program under evaluation.(40) In this regard, 40/49 (82%) of the potential participants who were approached by the partner sites and who signed the consent to contact form attended the initial visit. Reasons documented for five of the nine who did not attend included: hospitalization (n = 2); change in their housing situation (n = 2); and a family member that did not trust the clinic, forbidding the potential participant from attending (n = 1). We had a high rate of return visits, with 33/40 (82.5%) of those who attended the initial visit also attended the follow-up visit. Reasons for not attending the second visit were: individual was barred from the site where the clinic was offered (n = 2); person had extended hospital stays after the initial visit (n = 2); participant moved out of town (n = 1); and death (of unrelated causes) days after the initial visit (n = 1).

There are several dimensions of implementation within the RE-AIM framework.(22) One of which is fidelity – which questions whether the intervention was delivered consistently and as it was intended in the study protocol. We found that generally, the SAFER intervention was delivered as intended, with 72% of participants receiving all four of the offered tests, and another 25% received three out of the four tests. There were various reasons that some did not complete all the screening tests. One individual had bilateral below-the-knee amputations, making foot assessment impossible. One-third of participants did not have their retinal screening completed for various reasons: technical problems/equipment failure (n = 2); refusal on the basis of not wanting eyes to be dilated (n = 3); no place to store contact lenses during the assessment (n = 1); inability to capture satisfactory images (n = 6); and already being followed by an eye care specialist regularly (n = 3). For nephropathy screening using urinary albumin quantification, two individuals declined to provide a urine sample for analysis.

Another domain of implementation pertains to the feasibility of the intervention and whether enough resources had been allocated to the program. The initial visit was intended to last 75 minutes. In practice, initial visits lasted 84 minutes, on average. This included the informed consent process and completion of the research surveys. The follow-up visit was intended to be 45 minutes in length. The average length of the follow-up visit was 60 minutes. We originally planned to see four participants in each four-hour clinic. However, given that each visit took longer than anticipated, this was never achieved. Oftentimes there were last-minute cancellations or no-shows, therefore, we were able to spend extra time as needed with each participant who attended.

The final domain of implementation we assessed was with respect to costs and resources. Throughout the program, a nurse was employed two days a week to implement the clinic. A research associate (RA) was hired one day a week to obtain informed consent, assist with questionnaires, conduct the interviews, and assist with other needs within the clinic as they arose, costing $43,680 for staff time to cover the 37 clinic dates offered. In preparation for implementing SAFER, the staff received distress and non-violent crisis intervention training. The nurse also received footcare and cardiopulmonary resuscitation for healthcare providers training, as well as training specific to each screening tool, costing a total of $5,430. Total supply costs for the program equalled $12,636. This value does not include the cost of the retinal camera or the point-of-care biospecimen analyzer as both were provided in kind to the project by our partners. We determined that it cost $846 per visit, or $1544 per participant screened (Table 4).

Table 4

SAFER Cost Breakdown
Description	Costs
Salary of one nurse (2 days per week) and one RA (1 day per week) x 52 weeks)	$43,680
Staff Training	$5430
Total cost of supplies (not including supplies gifted in kind to the program)	$12,636
Total cost of implementing SAFER pilot for one year	$61,746
Cost per clinic visit (total of 73 visits) ($61,746/73)	$845.83
Cost per patient (with 2 visits available to them) ($61,746/40)	$1543.65

The SAFER clinic was effective at dramatically increasing the completion of microvascular screening per current clinical practice guidelines. Similarly, the program was also associated with an increase in patient-reported ease of test completion. This was accomplished by eliminating transportation and other access barriers for participants because the SAFER clinic was provided at community sites already accessed by and familiar to this population. Secondly, it was important to ensure that the nurse was afforded adequate time to facilitate therapeutic relationship building, creating a safe clinical environment that was less triggering to people who are likely to have had a history of prior traumatic experiences in healthcare settings. The barriers to optimizing reach, effectiveness and implementation of this program included a limited sampling frame to draw from – as it seemed to us that there were fewer people living with diabetes accessing the host sites than we had anticipated at the outset – which led to gaps in scheduling where there were no participants to see. Secondly, the operation of the program took considerably longer than anticipated, as such, the costs per clinic visit were substantially higher than projected. Finally, despite our efforts to create dedicated and expedited referral pathways, barriers to successful specialty follow-up visits continue to be a major challenge, due in part to transportation barriers in getting to the specialist offices that were not onsite like the nurse screening clinics, long wait times, and care that remains provider-centric. Unfortunately, successful screening programs are also highly dependent on successful follow-up that is recommended as a result of the screening tests performed.(41)

Adaptations to the program are required to enhance the value and sustainability of this model of care. These modifications can be grouped into the domains of reach, effectiveness, and implementation.

Reach

To expand the reach of SAFER, the next iteration should increase mobility of the program. The program should aim to serve more locations beyond the original two sites, continuing to grow collaborative partnerships with community sites already serving this population. Furthermore, expanding the target population – beyond simply those currently experiencing homelessness, to those who are at risk of homelessness and who face other social disadvantages – would broaden the reach to more of those for whom this service could be meaningful. A larger referral pool would make it easier to pivot to accommodate walk-ins when last minute cancellations occur, thus, maximizing the use of the clinic staff’s time.

Effectiveness

To maximize the effectiveness of the next iteration of SAFER, the healthcare services offered through the clinic should be expanded upon, meeting more of the needs of individuals experiencing diabetes and social complexity, including macrovascular screening, healthy food prescriptions, and barrier-free specialist medical care (i.e., endocrine consultation, and diabetes self-management education). Furthermore, mental healthcare pathways should be developed to respond to the overrepresentation of depression, anxiety, and diabetes distress seen in this population. Indigenous-specific supports should be offered through the program as well to respond to the overrepresentation of Indigenous individuals encountered in the pilot. (42–44)

Implementation

Once adaptations have been made to the current model and implementation restarts, an iterative process(45, 46) should be used by the researchers and implementation partners to promote buy-in from all involved (patients, health authorities and community sites), monitor progress, and guide further adaptions to ensure optimal outcomes.

Strengths and Limitations

One of the major strengths of this study is the fact that we worked alongside trusted health/social care providers within institutions that are already known to clients. The nurses who helped recruit for our study had already established trust with many of the patients and were in a position to help us invite them to participate in the SAFER program. However, this study is not without limitations. Notably, no control group was included to allow us to make causal inferences. Withholding these important screens and patient-centered approaches from individuals who face social disadvantage by having a control group could be considered unethical and was deemed to conflict with the host site’s responsibilities to offer care to all. Despite this limitation, we were able to do individual-level pre/post comparisons based on historical trends using multiple sources of data (chart review and participant recall). Now that the pilot study has demonstrated that this approach is an effective way to increase screening completion, we feel that a future study could consider the possibility of randomization to confirm effectiveness to various end-users. While intended as a pilot study, the sample size was smaller than anticipated due to budget constraints and the lack of a sampling pool at the two research sites. Unfortunately, we were unable to continue offering the clinic to increase our sample size due to funding that was available for only one year. This smaller sample size, and the fact that we only offered this program in two locations, limits the generalizability of the results. While the sample size was small, addressing the needs outlined by the community-based participatory research group early and on a small scale allowed our team the time to rigorously evaluate this innovation. This study still holds merit and allows researchers to learn about what may or may not work with this population. Smaller pilot studies play an important role in healthcare innovation research in justifying future scaled-up novel initiatives.(47) Finally, while we were able to assess the costs and implications for resources of the SAFER program, an individual-level cost-effectiveness analysis was outside the scope of this work. Planning this type of evaluation would be important for a future study with a larger sample size.

Our program, which provided screening for microvascular complications and glycemic control to adults managing diabetes and experiencing homelessness, in partnership with community sites, showed promising results in this study setting. However, additional strategies are still needed to bolster successful specialist follow-up as required in this population.

It is advantageous to both individuals and healthcare systems when preventive care is provided in outpatient community settings, as opposed to in acute care settings once irreversible end-stage complications have developed. Even though the SAFER program was more costly than intended and reached fewer than anticipated, it is possible that this upstream investment would pay itself off by the early detection and treatment of microvascular complications. It is our hope that programs can continue to iterate on the SAFER model of care to optimize the efficiency and value of offering comprehensive point-of-care screening and diabetes specialty care for individuals experiencing homelessness and diabetes.

Abbreviation	Term
A1C	Glycated Hemoglobin Levels
ACR	Albumin to Creatinine Ratio (mg/mmol)
DSMQ	Diabetes Self-Management Questionnaire
PAID-5	The Problem Area in Diabetes Scale – 5 Item
RA	Research Associate
RE-AIM	Reach, Effectiveness, Adoption, Implementation, Maintenance
SAFER	Screening for A1c, Feet, Eyes and Renal health

Acknowledgements

Our first thanks are to all those participants who took part in this study. We would also like to thank the community partners at the Calgary Drop-In Centre and the Mustard Seed Wellness Centre for their hard work in co-creating the operating procedures for this protocol tailored to their respective facilities, recruiting and identifying participants, completing study documentation, contributing to clinic supplies, for their general support of the study and taking the time to learn aside us (Danielle Szabo LPN, Kyle Ovens, Renae Kapteyn RN, Fatima Macavinta LPN, Joseph Smithies LPN, Erin Bareham LPN, Laura Campbell, and Samantha Pownall); Dr. Monty Ghosh and Nicola Gale RPh for partnering with us in supporting participants; Ellen Novak NP and the Nephrology Central Triage group of the University of Calgary Medical Group for partnering with us in supporting participant kidney health; Abshir Moalin, Dr. Mathew Tennant, Dr. Michael Fielden, and Dr. Trent Colberg for the tailored eye screen training you provided for the nurse and for partnering with us in supporting participant eye health; Dr. Joanna Debosz and Dr. Francois Harton for partnering with us to support participant feet health. Finally, a sincere thank you to the Diabetes, Obesity and Nutrition Strategic Network (Lene Jorgenson, Melanie Mainville RN and Kathy Dmytruk RD) for offering support and guidance during the development of the protocol.

Author’s Contributions

DC conceived of the intervention under study, applied for and secured the funding for this study, refined the protocol, approved the analysis, and provides ongoing oversight for this work. SS completed the analysis and developed the initial version and first draft of the manuscript, refined the protocol and the standard operating procedures of this study, and was the nurse implementing the study protocol and collecting the clinical screening data. EG refined the study protocol and operating procedures of this study, was the RA implementing the study protocol, and conducted the baseline and follow-up questionnaires and interviews. All authors contributed to the writing of the manuscript and approved the final version.

Availability of Data and Materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Funding Sources

The SAFER pilot study was funded by the Petro Canada Young Innovator Award in community health (Suncor Energy), an Equipment Grant from the Libin Cardiovascular Institute, a Seed Grant from the Cumming School of Medicine’s Clinical Research Fund, and an in-kind donation from Alberta Retina Consultants and Siemens Canada. The funders have had no role in the design of the study, or the collection, or future analysis or interpretation of the data. The authors would like to thank these funders for making this important research possible.

Ethics Statements

Patient consent for publication

Not required.

Ethics approval

This study involved human participants. All activities were approved by and conducted in accordance with the University of Calgary’s Conjoint Health Research Ethics Board (REB21-0081). The participants in this study received both verbal and written information about the research. Informed consent was collected ahead of all data collection from all participants.

Consent for Publication

Not applicable. No individual person’s data in any form was included in this manuscript.

Competing Interests Statement

We received equipment to use in kind from Siemens Healthineers Canada and Alberta Retina Consultants for this research. DC and SS will receive honorariums from Siemens Healthineers to share about their experiences using the point-of-care analyzer in a future webinar.

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Competing interest reported. We received equipment to use in kind from Siemens Healthineers Canada and Alberta Retina Consultants for this research. DC and SS will receive honorariums from Siemens Healthineers to share about their experiences using the point-of-care analyzer in a future webinar.

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Outcomes of a Pilot Outreach Program to Support Point-of-Care Screening in Individuals with Diabetes who are Experiencing Homelessness in Alberta, Canada

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Abstract

Background

Methods

Results

Conclusions

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Background

Patient and Public Involvement

Research Design and Methods

Study Design

Setting

Intervention

Recruitment

Data Collection

Data Analysis

Results

Primary Objective - Effectiveness

Discussion

Strengths and Limitations

Conclusion

Abbreviations

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References

Additional Declarations

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Version 1