Using Patient-Reported Outcome Measures (PROMs) in clinical diabetes consultations : Feasibility testing and piloting the DiaPROM trial among adults with type 1 diabetes

Background: The demands of type 1 diabetes (T1D) may constitute a great burden for people living with the disease. Diabetes distress reflects a range of emotional experiences, such as worry, guilt, and fear, potentially impairing self-management and glycaemic control. Serious diabetes distress is reported by 20-40% of adults with T1D. Consequently, regular assessment in clinical care is recommended. Using Patient-Reported Outcome Measures (PROMs) to assess diabetes distress is considered useful as tools to improve screening and communication between clinicians and people with T1D. Therefore, we developed the Diabetes Patient-Reported Outcome Measure (DiaPROM) trial, an empowerment-based intervention using the Problem Areas in Diabetes (PAID) scale to assess diabetes distress and as a dialogue tool in adult T1D consultations. Aims: The overall aim of the studies conducted as part of this thesis was to feasibility and pilot test the DiaPROM trial, thereby investigate uncertainties associated with running a full-scale randomised controlled trial (RCT). The specific aims were as follows: 1. To examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice (Paper I). 2. To develop a study protocol for the DiaPROM pilot trial (Paper II). 3. To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale RCT in order to evaluate whether the trial methods and the intervention are feasible (Paper III). 4. To explore young adults’ experiences with outpatient follow-up appointments, completing electronic PROMs and using the PAID scale during the DiaPROM pilot trial (Paper IV). Materials and methods: Three studies designed to complement each other: a feasibility study, a pilot trial and a qualitative study, were conducted at the endocrinology outpatient clinic at Haukeland University Hospital, Bergen. Eligible participants were adults with T1D and a minimum of one year diabetes duration. In the feasibility study, we invited adults ≥ 40 years to avoid including potential candidates for the upcoming pilot trial, in which we recruited younger adults aged 18-39 years. In the qualitative study, we invited pilot trial participants after they had attended the 12-month follow-up visit. The feasibility study had a cross-sectional design (Paper I). The participants completed a set of electronic PROMs on a touchscreen computer at the outpatient clinic. The set contained five validated PROMs (42 items; covering diabetes distress, emotional wellbeing, perceived diabetes competence, hypoglycaemia awareness and health-related quality of life), three glucose variability items and two items concerning current glucose monitoring. Participants also completed a paper questionnaire regarding their perceptions about the PROMs. In addition, we monitored the touchscreen computer’s technical performance, observed the participants’ actions and collected data on the time needed to complete the PROMs, and we also recorded any missing items. The pilot trial was a two-arm RCT with baseline and 12-month data collection points (Papers II & III). All participant completed electronic PROMs before two annual check-ups. We used computer-generated block-randomisation without blinding to assign participants in a 1:1 ratio, stratified by sex, to receive the intervention or standard care. All intervention arm participants’ PAID scores were reviewed by and discussed with a physician, and participants with PAID scores ≥30 or items scored ≥3 were offered additional follow-up. During a minimum of two diabetes specialist nurse consultations guided by an empowerment-based communication manual, reported problem areas were further discussed. Our primary outcome measure was the Diabetes Distress Scale (DDS), secondary outcome measures were the WHO 5-Well-being Index, the Perceived Competence for Diabetes Scale and glycaemic control measured by HbA1c. The pilot trial outcomes were recruitment and retention rates, estimation of variance, between-group differences of follow-up scores and correlations of DDS scores to assist sample size calculations and, finally, participants’ perceptions about the intervention components. In the qualitative study, we performed semi-structured individual telephone interviews of pilot trial participants, asking about their experiences with diabetes follow-up and participation in the pilot trial (Paper IV). We analysed the data using Braun & Clarke’s thematic analysis. Results: In the feasibility study, we recruited 69 participants (50.7% men; median age 51.0 years; median diabetes duration 26.0 years). The median time for completing the electronic PROMs was 8 minutes and 19 seconds, and the average completion rate was 81.4%. Overall, the touchscreen computer functioned well, and the participants found the PROMs understandable and relevant and acceptable for annual completion. In the pilot trial, we randomised 80 participants (mean age 27.2 years; mean diabetes duration 13.7 years) to the control or intervention arm (one participant was later excluded); 23 of 39 intervention arm participants qualified for additional consultations and 17 of these were referred. At 12 months, 67 participants attended the follow-up (15.2% attrition); thereof, 5 (29.4%) of the 17 referred to additional nurse consultations were lost to follow-up. Participants found the PROMs relevant and acceptable but rated the additional nurse consultations’ usefulness as moderate. Furthermore, using results from the primary outcome measure, the DDS, we estimated that at least 107 participants would be required per arm in a fully powered, single-site RCT. In the qualitative study, we interviewed 19 participants (age 22-39 years; diabetes duration 5-32 years): 8 from the control arm and 11 from the intervention arm. The analyses generated three themes, each with two subthemes: (1) Follow-up with limitations; Marginal dialogue about everyday challenges and Value of supportive relationships and continuity indicated that the participants experienced the previous follow-up as challenging and insufficient. (2) New insights and raised awareness; More life-oriented insights and Moving out of the comfort zone suggested mostly positive experiences with completing the PAID and using the scores in the dialogue. (3) Addressing problem areas with an open mind; Need for elaboration and Preparedness for dialogue indicated that further exploration of the PAID scores and openness were essential. Conclusions: The studies’ findings highlight the value of combining quantitative and qualitative methods in feasibility and pilot testing to uncover factors that may impede effective interventions in clinical practice. Capturing electronic PROMs was technically feasible and accepted by the participants. Although they found it somewhat uncomfortable and challenging to disclose their diabetes-related problem areas, addressing diabetes distress as part of the consultations was considered highly relevant and important for future diabetes follow-up. Using the PAID helped the healthcare providers see beyond biomedical outcomes, which promoted patient empowerment and person-centred care and facilitated improved patient-provider relationships. However, we decided not to proceed directly to a full-scale evaluation trial. This decision was based on findings indicating attrition, fidelity issues related to implementation and low acceptance or over-inclusion of cases, suggesting that the intervention requires additional development. Consequently, before commencing a full-scale RCT, the intervention requires modifications and additional development and possibly further feasibility and acceptability testing, focusing on inclusion criteria, intervention flexibility and healthcare provider training, specifically using the PAID in the patient-provider interaction.Doktorgradsavhandlin

Young adults with type 1 diabetes and their experiences with diabetes follow‐up and participation in the DiaPROM pilot trial: A qualitative study

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.Aim To explore young adults' experiences of outpatient follow‐up appointments, completing electronic Patient‐Reported Outcome Measures (PROMs), and using the Problem Areas In Diabetes (PAID) scale during the Diabetes Patient‐Reported Outcome Measures (DiaPROM) pilot trial. Methods We performed a qualitative study among 19 young adults (aged 22–39 years) with type 1 diabetes who participated in the pilot trial. Between February and June 2019, we conducted individual, semi‐structured telephone interviews with participants from the intervention and control arms. We analysed the data using thematic analysis. Results Our analyses generated three themes, each with two subthemes: (1) Follow‐up with limitations; (i) Marginal dialogue about everyday challenges, (ii) Value of supportive relationships and continuity, indicate that previous follow‐up had been experienced as challenging and insufficient. (2) New insights and raised awareness; (i) More life‐oriented insights, (ii) Moving out of the comfort zone, suggest mostly positive experiences with completing questionnaires and discussing the PAID scores. (3) Addressing problem areas with an open mind; (i) Need for elaboration, (ii) Preparedness for dialogue, indicate that both openness and explanations were vital in the follow‐up. Conclusions Participants characterised the previous follow‐up as challenging and insufficient. They described completing and using the PAID as somewhat uncomfortable yet worthwhile. Our findings also suggest that by utilising diabetes distress data alongside health and biomedical outcomes, consultations became more attuned to the young adults' wishes and needs, mainly because the dialogue was more focused and direct. Hence, the PAID has the potential to facilitate person‐centredness and improve patient–provider relationships.publishedVersio

Using Patient-Reported Outcome Measures (PROMs) in clinical diabetes consultations : Feasibility testing and piloting the DiaPROM trial among adults with type 1 diabetes

Background: The demands of type 1 diabetes (T1D) may constitute a great burden for people living with the disease. Diabetes distress reflects a range of emotional experiences, such as worry, guilt, and fear, potentially impairing self-management and glycaemic control. Serious diabetes distress is reported by 20-40% of adults with T1D. Consequently, regular assessment in clinical care is recommended. Using Patient-Reported Outcome Measures (PROMs) to assess diabetes distress is considered useful as tools to improve screening and communication between clinicians and people with T1D. Therefore, we developed the Diabetes Patient-Reported Outcome Measure (DiaPROM) trial, an empowerment-based intervention using the Problem Areas in Diabetes (PAID) scale to assess diabetes distress and as a dialogue tool in adult T1D consultations. Aims: The overall aim of the studies conducted as part of this thesis was to feasibility and pilot test the DiaPROM trial, thereby investigate uncertainties associated with running a full-scale randomised controlled trial (RCT). The specific aims were as follows: 1. To examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice (Paper I). 2. To develop a study protocol for the DiaPROM pilot trial (Paper II). 3. To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale RCT in order to evaluate whether the trial methods and the intervention are feasible (Paper III). 4. To explore young adults’ experiences with outpatient follow-up appointments, completing electronic PROMs and using the PAID scale during the DiaPROM pilot trial (Paper IV). Materials and methods: Three studies designed to complement each other: a feasibility study, a pilot trial and a qualitative study, were conducted at the endocrinology outpatient clinic at Haukeland University Hospital, Bergen. Eligible participants were adults with T1D and a minimum of one year diabetes duration. In the feasibility study, we invited adults ≥ 40 years to avoid including potential candidates for the upcoming pilot trial, in which we recruited younger adults aged 18-39 years. In the qualitative study, we invited pilot trial participants after they had attended the 12-month follow-up visit. The feasibility study had a cross-sectional design (Paper I). The participants completed a set of electronic PROMs on a touchscreen computer at the outpatient clinic. The set contained five validated PROMs (42 items; covering diabetes distress, emotional wellbeing, perceived diabetes competence, hypoglycaemia awareness and health-related quality of life), three glucose variability items and two items concerning current glucose monitoring. Participants also completed a paper questionnaire regarding their perceptions about the PROMs. In addition, we monitored the touchscreen computer’s technical performance, observed the participants’ actions and collected data on the time needed to complete the PROMs, and we also recorded any missing items. The pilot trial was a two-arm RCT with baseline and 12-month data collection points (Papers II & III). All participant completed electronic PROMs before two annual check-ups. We used computer-generated block-randomisation without blinding to assign participants in a 1:1 ratio, stratified by sex, to receive the intervention or standard care. All intervention arm participants’ PAID scores were reviewed by and discussed with a physician, and participants with PAID scores ≥30 or items scored ≥3 were offered additional follow-up. During a minimum of two diabetes specialist nurse consultations guided by an empowerment-based communication manual, reported problem areas were further discussed. Our primary outcome measure was the Diabetes Distress Scale (DDS), secondary outcome measures were the WHO 5-Well-being Index, the Perceived Competence for Diabetes Scale and glycaemic control measured by HbA1c. The pilot trial outcomes were recruitment and retention rates, estimation of variance, between-group differences of follow-up scores and correlations of DDS scores to assist sample size calculations and, finally, participants’ perceptions about the intervention components. In the qualitative study, we performed semi-structured individual telephone interviews of pilot trial participants, asking about their experiences with diabetes follow-up and participation in the pilot trial (Paper IV). We analysed the data using Braun & Clarke’s thematic analysis. Results: In the feasibility study, we recruited 69 participants (50.7% men; median age 51.0 years; median diabetes duration 26.0 years). The median time for completing the electronic PROMs was 8 minutes and 19 seconds, and the average completion rate was 81.4%. Overall, the touchscreen computer functioned well, and the participants found the PROMs understandable and relevant and acceptable for annual completion. In the pilot trial, we randomised 80 participants (mean age 27.2 years; mean diabetes duration 13.7 years) to the control or intervention arm (one participant was later excluded); 23 of 39 intervention arm participants qualified for additional consultations and 17 of these were referred. At 12 months, 67 participants attended the follow-up (15.2% attrition); thereof, 5 (29.4%) of the 17 referred to additional nurse consultations were lost to follow-up. Participants found the PROMs relevant and acceptable but rated the additional nurse consultations’ usefulness as moderate. Furthermore, using results from the primary outcome measure, the DDS, we estimated that at least 107 participants would be required per arm in a fully powered, single-site RCT. In the qualitative study, we interviewed 19 participants (age 22-39 years; diabetes duration 5-32 years): 8 from the control arm and 11 from the intervention arm. The analyses generated three themes, each with two subthemes: (1) Follow-up with limitations; Marginal dialogue about everyday challenges and Value of supportive relationships and continuity indicated that the participants experienced the previous follow-up as challenging and insufficient. (2) New insights and raised awareness; More life-oriented insights and Moving out of the comfort zone suggested mostly positive experiences with completing the PAID and using the scores in the dialogue. (3) Addressing problem areas with an open mind; Need for elaboration and Preparedness for dialogue indicated that further exploration of the PAID scores and openness were essential. Conclusions: The studies’ findings highlight the value of combining quantitative and qualitative methods in feasibility and pilot testing to uncover factors that may impede effective interventions in clinical practice. Capturing electronic PROMs was technically feasible and accepted by the participants. Although they found it somewhat uncomfortable and challenging to disclose their diabetes-related problem areas, addressing diabetes distress as part of the consultations was considered highly relevant and important for future diabetes follow-up. Using the PAID helped the healthcare providers see beyond biomedical outcomes, which promoted patient empowerment and person-centred care and facilitated improved patient-provider relationships. However, we decided not to proceed directly to a full-scale evaluation trial. This decision was based on findings indicating attrition, fidelity issues related to implementation and low acceptance or over-inclusion of cases, suggesting that the intervention requires additional development. Consequently, before commencing a full-scale RCT, the intervention requires modifications and additional development and possibly further feasibility and acceptability testing, focusing on inclusion criteria, intervention flexibility and healthcare provider training, specifically using the PAID in the patient-provider interaction

Living with diabetes during menopause

Living with diabetes can be difficult, and menopause can make it even more challenging. The change in hormone levels during menopause can have an impact on glucose levels. The same hormones that fluctuate during the menstrual cycle fluctuate much less predictably during menopause. Because there is no one-size-fits-all approach to adjusting insulin and medication doses in response to menopause, this can make it more challenging to manage the glucose regulation during this phase of life. Furthermore, lack of knowledge to best manage diabetes during menopause can affect quality of life and inflict an emotional and psychosocial burden on these women. Therefore, we aim to identify and evaluate literature on the physical and psychosocial aspects of menopause for women with diabetes

Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study

Introduction: Although diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient–clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study. Methods: and analysis We will undertake a two-arm pilot RCT of an intervention using the Problem Areas In Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants’ mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients’ and healthcare providers’ experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis. Ethics and dissemination: Ethical approval has been obtained from the Western Norway Regional Committee for Medical and Health Research Ethics (2017/1506/REC west). We will present the findings from the study phases at national and international conferences and submit manuscripts to peer-reviewed journals and popular science journals

Electronic capturing of patient-reported outcome measures on a touchscreen computer in clinical diabetes practice (the DiaPROM trial): a feasibility study

Abstract Background Living with type 1 diabetes (T1D) is demanding, and emotional problems may impair ability for diabetes self-management. Thus, diabetes guidelines recommend regular assessment of such problems. Using patient-reported outcome measures (PROMs) to assess diabetes-related distress and psychological well-being is considered useful. It has been proposed that future work should examine the use of PROMs to support the care of individual patients and improve the quality of health services. To our knowledge, the use of PROMs has not been systematically evaluated in diabetes care services in Norway. Electronically captured PROMs can be directly incorporated into electronic patient records. Thus, the study’s overall aim was to examine the feasibility and acceptability of capturing PROMs electronically on a touchscreen computer in clinical diabetes practice. Methods Adults with T1D age ≥ 40 years completed PROMs on a touchscreen computer at Haukeland University Hospital’s diabetes outpatient clinic. We included 46 items related to diabetes-related distress, self-perceived diabetes competence, awareness of hypoglycaemia, occurrence of hyperglycaemia, hypoglycaemia and fluctuating glucose levels, routines for glucose monitoring, general well-being and health-related quality of life. Participants subsequently completed a paper-based questionnaire regarding comprehension and relevance of the PROMs, acceptance of the number of items and willingness to complete electronic PROMs annually. We wrote field notes in the outpatient clinic based on observations and comments from the invited participants. Results During spring 2017, 69 participants (50.7% men), age 40 to 74 years, were recruited. Generally, the touchscreen computer functioned well technically. Median time spent completing the PROMs was 8 min 19 s. Twenty-nine (42.0%) participants completed the PROMs without missing items, with an 81.4% average instrument completion rate. Participants reported that the PROMs were comprehensible (n = 62) and relevant (n = 46) to a large or very large degree, with an acceptable number of items (n = 51). Moreover, 54 were willing to complete PROMs annually. Participants commented that the focus on living with diabetes was valued. Conclusions Capturing PROMs on a touchscreen computer in an outpatient clinic was technically and practically feasible. The participants found the PROMs to be relevant and acceptable with a manageable number of items, and reported willingness to complete PROMs annually

Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study

Introduction Although diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient–clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study. Methods and analysis We will undertake a two-arm pilot RCT of an intervention using the Problem Areas In Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants’ mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients’ and healthcare providers’ experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis

Routine assessment of Patient-Reported Outcome Measures (PROMs) in the DiaPROM trial

Objective: We aimed to investigate willingness to complete patient-reported outcome measures (PROMs) on a touchscreen computer in the outpatient clinics’ waiting area, estimate the proportion of participants with elevated scores in need of further follow-up, and examine the association between diabetes-related distress and psychological well-being. Methods: We recruited 149 adults (18-74 years) with type 1 diabetes to complete PROMs on a touchscreen computer at Haukeland University Hospital’s diabetes outpatient clinic. We used the Problem Areas in Diabetes Scale (PAID) and the WHO-5 Well-being Index (WHO-5) to examine diabetesrelated distress and psychological well-being. A PAID score ≥40 suggest serious diabetes-related emotional problems whereas a score of ≥30 or minimum one item scored ≥3 qualify for extra follow-up. WHO-5 scores ≤50 indicate suboptimal psychological well-being and scores ≤28 suggest depression. Results: One-hundred twenty (80.5%) participants were to at least a large degree willing to complete PROMs electronically. PAID scores of concern were reported by 74 (49.7%) participants, of which 26 (17.5%) scored ≥40. Forty-one (27.5%) reported suboptimal well-being, while nine (6.0%) reported scores suggesting likely depression. We found a moderate correlation (rho = 0.48, P <.001) between increased diabetes-related distress and reduced psychological well-being. Conclusion: The majority of participants reported willingness to complete electronic PROMs in the outpatient waiting area. Half of them reported moderate to serious diabetes-related distress and about one-fourth reported suboptimal psychological well-being. Using PROMs may help clinicians to identify emotional problems and to become aware of diabetes-related challenges and thus to facilitate targeted follow-up in forthcoming studies

Routine assessment of Patient-Reported Outcome Measures (PROMs) in the DiaPROM trial

Objective: We aimed to investigate willingness to complete patient-reported outcome measures (PROMs) on a touchscreen computer in the outpatient clinics’ waiting area, estimate the proportion of participants with elevated scores in need of further follow-up, and examine the association between diabetes-related distress and psychological well-being. Methods: We recruited 149 adults (18-74 years) with type 1 diabetes to complete PROMs on a touchscreen computer at Haukeland University Hospital’s diabetes outpatient clinic. We used the Problem Areas in Diabetes Scale (PAID) and the WHO-5 Well-being Index (WHO-5) to examine diabetesrelated distress and psychological well-being. A PAID score ≥40 suggest serious diabetes-related emotional problems whereas a score of ≥30 or minimum one item scored ≥3 qualify for extra follow-up. WHO-5 scores ≤50 indicate suboptimal psychological well-being and scores ≤28 suggest depression. Results: One-hundred twenty (80.5%) participants were to at least a large degree willing to complete PROMs electronically. PAID scores of concern were reported by 74 (49.7%) participants, of which 26 (17.5%) scored ≥40. Forty-one (27.5%) reported suboptimal well-being, while nine (6.0%) reported scores suggesting likely depression. We found a moderate correlation (rho = 0.48, P <.001) between increased diabetes-related distress and reduced psychological well-being. Conclusion: The majority of participants reported willingness to complete electronic PROMs in the outpatient waiting area. Half of them reported moderate to serious diabetes-related distress and about one-fourth reported suboptimal psychological well-being. Using PROMs may help clinicians to identify emotional problems and to become aware of diabetes-related challenges and thus to facilitate targeted follow-up in forthcoming studies