The Science of Diabetes Self-Management and Care2024, Vol. 50(5) 418–427© The Author(s) 2024Article reuse guidelines:sagepub.com/journals-permissionsDOI: 10.1177/26350106241268413journals.sagepub.com/home/tde
AbstractPurpose: The purpose of this study was to determine the effectiveness of pharmacist-led interventions on diabetes distress and glucose management among people with type 2 diabetes (T2DM) in a community care clinic.
Methods: Adults with T2DM were recruited during routine visits at the pharmacist-run clinic. Participants completed a baseline A1C, demographic survey, Diabetes Distress Scale (DDS), and Patient Health Questionnaire-2 (PHQ-2). Depending on DDS subscale-specific responses, participants qualified for pharmacist-led educational interventions based on the ADCES7 Self-Care Behaviors™. After 6 months, participants completed another A1C, satisfaction survey, DDS, and PHQ-2. Data analysis included descriptive statistics and paired t tests.
Results: Among 53 participants at baseline, diabetes distress was present in 77.4%; emotional burden was most common in 64.2%, followed by regimen distress in 45.3%, interpersonal distress in 34.0%, and physician distress in 20.8%. After the intervention, significant reductions occurred in mean overall DDS score (2.0 to 1.7), emotional burden (2.4 to 1.8), regimen distress (2.3 to 1.7), A1C (7.0% to 6.5%; 53.0 to 47.5 mmol/mol), and PHQ-2 score (1.6 to 1.0). Participants were highly satisfied with the service, their knowledge, and self-management skills following completion of the study.
Conclusions: Diabetes distress was present in most participants despite glucose management that was largely achieving treatment goals. Pharmacist-led educational interventions significantly reduced overall DDS score, emotional burden, regimen distress, A1C, and PHQ-2 score. The results of this study suggest that people with T2DM should receive routine screening for diabetes distress and that pharmacists can positively affect diabetes management and emotional well-being through tailored education.
Diabetes distress is an emotional response that can develop from the burden, demands, threats, concerns, and fears of living with diabetes as a chronic health condition.1 It is distinct from clinical depression and anxiety but can cooccur.2 Diabetes distress is common, with reported prevalence ranging from 18% to 45% in people with type 2 diabetes (T2DM).3 Evidence suggests presence of diabetes distress correlates with poorer glycemic management and diabetes self-care behaviors, such as medication taking, healthy eating, and physical activity.4,5 The American Diabetes Association recommends routine screening for diabetes distress using validated assessment tools, such as the Diabetes Distress Scale (DDS), and referral to trained health care professionals for treatment as indicated.3
Diabetes care and education specialists are in a prime position to identify and address diabetes distress through screening and tailored education. Although research is expanding on ways to reduce diabetes distress, the impact of structured, pharmacist-led education on diabetes distress levels is unclear. A retrospective chart review demonstrated that pharmacist-led care reduced diabetes distress in 17 people who completed a diabetes self-management education program in a community pharmacy; the program included a one-on-one session with a pharmacist and 3 classes co-led by pharmacists and dietitians.6 In the REDEEM trial, 392 participants were randomized to 1 of 3 programs: a computer-assisted self-management program, a computer-assisted self-management program with a problem-solving course, or a computer-based informational program. All three interventions led to significant reductions in diabetes distress, which correlated with improvements in healthy eating, physical activity, and medication taking but did not change A1C.7
The purpose of this study was to determine the effectiveness of pharmacist-led interventions on diabetes distress and glucose management among people with T2DM in a community care clinic.
Adult patients of the community care clinic with T2DM were eligible to participate in this prospective interventional study, and participation was voluntary. Upon providing informed consent and completing an initial survey, participants were eligible to receive tailored interventions that were implemented at future clinic appointments based on their survey responses.
The study setting was the Consultation and Wellness Center, a pharmacist-run community care clinic that provides free diabetes care and education services through an accredited diabetes self-management education and support (DSMES) program. The clinic is located inside of a supermarket that has a community pharmacy; however, the clinic is run by faculty from a college of pharmacy and functions separately from the community pharmacy. In an average year, the clinic provides diabetes care and education for approximately 150 people with diabetes. Pharmacists work closely with the patients’ prescribers to recommend medication therapy changes when appropriate.
Participants were recruited during regularly scheduled appointments, and enrollment occurred from April 2021 through October 2021. Prior to enrollment, investigators verbally informed participants of the study objectives and procedures. Investigators also informed participants about diabetes distress and its potential impact on their care, if present. Participants provided written informed consent prior to enrollment in the study. The Institutional Review Board at Western New England University approved this study (COPHS No. 67).
Upon obtaining written informed consent, investigators measured participants’ weight and point-of-care A1C. Investigators provided participants with a survey in a prepaid, preaddressed envelope or via an electronic link; participants could return the completed survey via mail, clinic lock box, or electronically, depending on their preference. The survey included baseline demographic questions, the Patient Health Questionnaire-2 (PHQ-2), and the DDS.8 An additional survey question was created by investigators to assess how much the coronavirus disease 2019 (COVID-19) pandemic or COVID-19-related restrictions impacted participants’ diabetes distress level in the prior 3 months using the same 6-point scale from the DDS. Participants did not receive monetary compensation for study participation but were eligible to receive tailored pharmacist education based on their responses to the DDS.
A score of 3 or higher on the PHQ-2 prompted an in-person PHQ-9 screening at the next appointment.9 A PHQ-9 score of 5 or higher, suggesting at least mild depression, prompted an alert to the participant’s primary care provider and provision of information on local behavioral health services. A positive response to item 9 of the PHQ-9 prompted a suicide risk assessment via the Columbia-Suicide Severity Rating Scale (C-SSRS).10 Passive suicidal thoughts prompted a referral to the National Suicide Prevention Lifeline and an alert to the participant’s primary care provider. Active suicidal thoughts prompted a call to the local behavioral health network crisis line and an alert to the participant’s primary care provider. All pharmacists involved in the study completed Mental Health First Aid and C-SSRS training prior to the study implementation.
Depending on the DDS subscale and item-specific responses, participants qualified for various interventions (Figure 1). A mean subscale score of 2.0 or higher or single-item score of 3.0 or higher warranted intervention. Participants had the right to decline interventions. Most of the interventions were pharmacist-led educational modules based on the ADCES7 Self-Care Behaviors™,11 where each module was matched to the relevant diabetes distress subscale(s) and/or item(s). Modules were completed one-on-one with the participant during 1 or more clinic visits dedicated to that particular topic. Investigators reviewed module concepts with participants through use of slide sets and handouts, and each module concluded with setting goals that were specific, measurable, attainable, realistic, and timely. Participants with physician distress were eligible to receive an additional educational module on the diabetes care team; they also received a handout on self-advocacy, and/or a note was sent to their provider when applicable based on item-specific responses. Participants who scored 3.0 or higher on select regimen-related items could choose to complete the following modules, which were considered optional: Healthy Eating, Being Active, Monitoring, and Taking Medication. Participants with interpersonal distress were encouraged to bring a family member or friend to future visits if desired.
Participants remained in the study for 6 months or at least 1 month after completion of their last intervention, whichever was longer. Participants were required to attend at least 3 routine and/or intervention clinic visits over the study duration. Upon completion, investigators obtained the participants’ weight and point-of-care A1C. Participants completed a postintervention survey that included satisfaction questions, 1 question about COVID- 19-related distress as asked at baseline, the DDS, and PHQ-2 or PHQ-9, depending on which was required at baseline. Participants could return the completed survey via mail in a prepaid, preaddressed envelope or via clinic lock box. Satisfaction was measured with the Modified Diabetes Disease State Management Questionnaire (DDSM-QM),12 5 additional quantitative items, and 3 additional qualitative questions.
The DDS is a 17-item scale that can be self-administered to assess diabetes distress over the past month. Item answers range from 1 to 6, with 1 considered “not a problem” and 6 considered “a very serious problem.” The scale is further divided into 4 subscales: emotional burden, physician distress, regimen distress, and interpersonal distress. A mean score of 2.0 to 2.9 on the scale or in any of the 4 subscales is considered “moderate distress”; a score of 3.0 or higher is considered “high distress.”8
The PHQ-2 and PHQ-9 are self-administered tools to assess depressive symptoms over the past 2 weeks. Scores for each item range from 0 for “not at all” to 3 for “nearly every day.” The PHQ-2 includes the first 2 items of the PHQ-9 and serves as an initial screening tool; if the PHQ-2 score is 3 or higher, the PHQ-9 should be administered to evaluate depression severity.9
The DDSM-QM is a 15-item questionnaire that assesses service satisfaction, knowledge satisfaction, and selfmanagement satisfaction; responses range from 1 to 5, with 1 considered “strongly disagree” and 5 considered “strongly agree.”12 Additional quantitative items assessed satisfaction with knowledge of medications, diabetes complications, the diabetes care team, whether the service motivated the participant to implement positive change in managing their diabetes, and whether the participant would recommend the service to others. These additional quantitative items were assessed using the same 5-point Likert scale as the DDSM-QM, and items were categorized by knowledge, self-management, and service to obtain mean satisfaction scores for each category.
Descriptive analyses were used to summarize demographic data and satisfaction results. Paired sample t tests were used to compare baseline and postintervention data for participants who had both data points. The Spearman’s rho test was used to evaluate the relationship between diabetes distress and study variables. All statistical analyses were performed using SPSS Windows (version 28), and a significance level of P < 0.05 was applied.
Fifty-five participants enrolled in the study and provided informed consent. Fifty-four participants completed the initial survey, but 1 participant did not complete the DDS portion of the survey. Fifty-three participants entered the intervention phase, and 45 participants (84.9%) completed the study (Figure 2).
Participant baseline characteristics are summarized in Table 1. The mean participant baseline characteristics included age of 64.5 years (SD 12.0 years), A1C of 7.0% (53.0 mmol/mol; SD 1.2%), weight of 225.4 lbs (102.2 kg; SD 55.2 lbs), and duration with T2DM of 11.5 years (SD 9.3 years). Half of all participants were female (n = 27, 50.0%), and the majority were White (n = 33, 61.1%). Two participants (3.7%) reported current tobacco smoking. Fifty percent of participants had an A1C less than 7.0% (53.0 mmol/mol) at baseline. Participants used a variety of pharmacologic and nonpharmacologic methods to manage their diabetes; 7 participants (13.0%) managed their diabetes with nonpharmacologic methods alone. Since their diabetes diagnosis, 7 participants (13.0%) reported that they had received diabetes education outside of the clinic and their provider appointments, and 13 (24.1%) reported that they had attended a diabetes-related support group.
In the month prior to enrollment, 16 participants (29.6%) experienced hypoglycemia at least once (range 1-15 episodes); 1 participant acknowledged needing assistance during a hypoglycemic episode, and 1 participant acknowledged hypoglycemia unawareness during hypoglycemic episodes. In the 3 months prior to enrollment, there were no diabetes-related hospitalizations, 6 participants (11.1%) visited the emergency room, and most participants had 1 or 2 visits with their primary care provider or specialists (range 0-7 visits).
Eighteen participants (33.3%) reported having a prior diagnosis of depression. Thirteen participants (24.1%) reported current antidepressant medication use, and 11 participants (20.4%) reported receiving therapy or counseling from a licensed mental health practitioner in the past month. Fourteen participants (25.9%) scored 3 or higher on the PHQ-2, prompting a PHQ-9 screen.
At baseline, mean DDS score was 2.0 (SD 0.9); among the 53 participants who entered the intervention phase, 41 participants (77.4%) had at least moderate distress in 1 or more DDS subscale, and 28 participants (52.8%) had distress in more than 1 subscale. Emotional burden was most common in 64.2%, followed by regimen distress in 45.3%, interpersonal distress in 34.0%, and physician distress in 20.8%. DDS and subscale-specific scores did not have a statically significant relationship with A1C. Factors that correlated significantly with diabetes distress included self-identification as female, self-reported depression diagnosis, use of antidepressant medication, and experience of hypoglycemia symptoms (P < 0.05 for all correlations).
The 45 participants who completed the study qualified for 141 educational modules, of which 129 (91.5%) were completed (Table 2). An additional 63 modules were considered optional, of which 11 (17.5%) were completed. Most participants completed all suggested modules based on the protocol; 3 participants completed some of the suggested modules, and 1 participant did not complete any suggested modules beyond routine clinic appointments. Ten notes were sent to participants’ providers regarding physician distress, and 10 notes were sent to participants’ providers regarding PHQ-9 scores.
Following the interventions, significant reductions occurred in overall DDS score (t = 3.11, P = 0.003), emotional burden (t = 3.70, P = 0.001), regimen distress (t = 3.86, P < 0.001), A1C (t = 2.53, P = 0.015), weight (t = 2.23, P = 0.031), and PHQ-2 score (t = 2.38, P = 0.022; Table 3).
Table 4 shows the presence of diabetes distress by subscale at baseline and postintervention. Of the 42 participants who completed the baseline and postintervention DDS, 17 participants (40.5%) had a mean DDS score of 2.0 or higher at baseline compared to 11 participants (26.2%) upon completion; 5 participants (11.9%) had a mean DDS score of 3.0 or higher at baseline compared to 3 participants (7.1%) upon completion. Figure 3 shows the number of participants who had moderate or higher diabetes distress in 1 or more DDS subscales at baseline and postintervention among these 42 participants. Thirty-three participants (78.6%) had at least moderate distress in 1 or more DDS subscale at baseline compared to 23 participants (54.8%) upon completion.
At baseline, 32 of 54 participants (59.3%) acknowledged that the COVID-19 pandemic or COVID-19-related restrictions impacted their diabetes distress level in the prior 3 months compared to 22 of 44 participants (50.0%) upon completion; diabetes distress significantly correlated with COVID-19 distress at baseline (r = .518, P < 0.001), but the relationship was not significant upon study completion (r = .272, P = 0.081).
Mean participant satisfaction scores were 4.9 (SD 0.3) for the service, 4.7 (SD 0.4) for their knowledge, and 4.6 (SD 0.5) for their self-management skills; mean satisfaction and standard deviation results remained the same when satisfaction was calculated from the DDSM-QM and when the additional satisfaction items were included. Forty-three out of 44 participants who completed the satisfaction survey (97.7%) agreed or strongly agreed that they would recommend the service to others.
Diabetes distress was present in most participants at baseline, with 77.4% having at least moderate distress in 1 or more DDS subscale. Correlations between diabetes distress and patient-specific factors at baseline have been previously published.13 Of the participants who completed the study, 54.8% had at least moderate distress in 1 or more DDS subscale upon study completion. Emotional burden was most common, followed by regimen distress, interpersonal distress, and physician distress.
In this study, significant reductions occurred in overall DDS score, emotional burden, and regimen distress. This is similar to findings of the REDEEM trial, where computer-based programs augmented with periodic live phone calls led to significant reductions in diabetes distress, with emotional burden and regimen distress most responsive to the interventions.7 Although physician distress decreased during the study period, results were not statistically significant, and interpersonal distress was largely unchanged. However, baseline mean DDS scores were below 2.0 for physician distress and interpersonal distress, whereas baseline mean scores were above 2.0 for emotional burden and regimen distress. A secondary analysis from a randomized clinical trial determined the minimal clinically important difference (MCID) for the DDS is 0.25, whereas the MCID is 0.38 for emotional burden and interpersonal distress and 0.39 for physician and regimen distress.14 Therefore, the reductions in overall DDS score, emotional burden, and regimen distress were both statistically and clinically significant.
Participants who completed the study were highly engaged; participants completed 91.5% of the recommended modules. The greatest number of participants qualified for the Healthy Coping and Problem-Solving modules. Many participants with regimen distress could choose among the Healthy Eating, Being Active, Taking Medication, and/or Monitoring modules. Only 1 participant chose to complete the Taking Medication module, which may reflect that discussions around medications are central to the routinely scheduled, pharmacist-run visits at the Consultation and Wellness Center.
Although most participants had well-managed diabetes at baseline, with a mean A1C of 7.0% (53.0 mmol/mol) and 50% of participants having A1C values less than 7.0%, a significant reduction in A1C was seen among participants who completed the study. It is unclear if this A1C reduction was directly due to study interventions and corresponding reductions in diabetes distress or due to usual diabetes care and education provided in the clinic. Most participants had never attended diabetes education sessions outside of the clinic and their provider appointments or any diabetes-related support groups. Significant reductions also occurred in weight and PHQ-2 scores. Previous studies have shown a strong correlation between diabetes distress and depression.2 It is unclear if study interventions reduced PHQ-2 scores or if PHQ-2 scores decreased with diabetes distress scores. Additionally, distress from the COVID-19 pandemic has been linked to diabetes distress.15 At baseline, diabetes distress correlated with the participants’ COVID-19 distress score, but this relationship was not significant upon study completion. This may be due to fewer restrictions related to the COVID-19 pandemic when the study concluded, but this suggests that the change in diabetes distress was not solely due to a reduction in COVID-19-related distress.
The DDS is a quick, 17-item tool that can easily be implemented into practice settings to identify the presence and degree of diabetes distress. Additional diabetes distress assessment tools are now available, including the Diabetes Distress Scale for Adults with Type 1 Diabetes, the Type 1 Diabetes Distress Assessment System, and the Type 2 Diabetes Distress Assessment System.16 Awareness of total and subscale-specific levels of diabetes distress may allow practitioners to tailor patient interventions to address sources of distress and make diabetes more manageable. It is also important to consider that diabetes distress can persist and change over time17; as such, a minimum yearly assessment of diabetes distress should be considered, with more frequent screening around high-risk times, such as development of a new complication.18
Strengths of this study include that the interventions were tailored to participant-specific needs based on their results from the DDS subscales. The ADCES7 Self-Care Behaviors™ provided structure and served as the basis for slides and materials utilized during educational modules; therefore, this design could be implemented by Certified Diabetes Care and Education Specialists from various health professions. A small number of participants were lost to follow-up, and the majority of participants completed all interventions as recommended.
Limitations include that participants self-selected into the study, which may have resulted in selection of participants who were highly engaged with their health care and interested in completing study interventions or participants who believed they had diabetes distress at baseline. The protocol initially included referral to a diabetes support group for participants with interpersonal distress. Unfortunately, these were not available during the COVID-19 pandemic, which limited the ability to address interpersonal distress as originally planned. Further studies should evaluate the impact of support groups on diabetes distress, with a focus on interpersonal distress. Investigators were also not able to track the impact of interventions when notes were sent to participants’ providers; educators who work in the same office as the prescribers may be able to assess the impact of interprofessional interventions more effectively. Additionally, surveys did not collect data on use of continuous glucose monitors (CGMs), but at the time of this study, insurance coverage of CGMs was largely limited to patients on multiple daily insulin injections; with expansion in Medicare and Medicaid CGM coverage to patients on any insulincontaining regimens, it is unclear how expanded use of CGMs could have impacted diabetes distress for the participants. Finally, educational interventions were time-intensive, with each module requiring a minimum of 1 hour for completion. Translational efforts to determine scalable interventions that are effective to reduce diabetes distress may enhance implementation in practice.
Diabetes distress was present in most participants despite glucose management that was largely achieving treatment goals. Pharmacist-led educational interventions significantly reduced overall DDS score, emotional burden, regimen distress, A1C, weight, and PHQ-2 score. Participants were highly satisfied with the service. The results of this study suggest that people with T2DM should receive routine screening for diabetes distress and that pharmacists can positively affect diabetes management and emotional well-being through tailored education.
Kimberly Gallo assisted with scheduling patient appointments. Abigail Henry, PharmD, CDCES, assisted with recruitment and enrollment as a participating investigator. Stephanie Cloutier, PharmD, CDCES, and Ebony Evans, PharmD, assisted with design of the protocol and patient education materials.
This study was presented in part at the American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition; December 8, 2021; virtual.
This study was presented in part at the American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition; December 5, 2022; Las Vegas, Nevada.
This study was presented in part at the Association of Diabetes Care and Education Specialists (ADCES 2023) Annual Conference; August 5, 2023; Houston, Texas.
The authors declare that there is no conflict of interest.
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a grant from Western New England University.
Katelyn A. Parsons https://orcid.org/0000-0001-5204-7503
Gladys J. Ekong https://orcid.org/0000-0001-8256-1546
Maria S. Charbonneau https://orcid.org/0000-0001-8285-5026
Kam L. Capoccia https://orcid.org/0000-0002-5099-976X
The data underlying this article will be shared on reasonable request to the corresponding author.
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From Western New England University College of Pharmacy and Health Sciences, Springfield, Massachusetts (Dr Parsons, Dr Ekong, Dr Charbonneau, Dr Capoccia); and Baystate Medical Center, Springfield, Massachusetts (Dr Hopkins).
Kayla E. Hopkins is now affiliated to Hartford Hospital, Hartford, Connecticut.
Corresponding Author:Katelyn A. Parsons, Western New England University College of Pharmacy and Health Sciences, 1215 Wilbraham Road, Springfield, MA 01119, USA.Email: katelyn.parsons@wne.edu