Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial.

BACKGROUND: MyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams. OBJECTIVE: Assess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics. METHODS: We conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups. RESULTS: One thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments-two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors. CONCLUSION: An interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

The Sustained Value of an Early Pregnancy Assessment Clinic in the Management of Early Pregnancy Complications: A 10-Year Retrospective Study.

OBJECTIVE: This study sought to evaluate the sustained value of an early pregnancy assessment clinic (EPAC) in the management of early pregnancy complications and its effect on the incidence emergency room (ER) visits. METHODS: A 10-year retrospective study (January 2006 to December 2015) was conducted. The number of patients assessed, sources and reasons for referral, and treatments provided were reviewed. The numbers of ER assessments and reassessments for abortion, hemorrhage, and ectopic pregnancy from January 2004 to December 2005 (pre-EPAC) and January 2006 to December 2015 (post-EPAC) were also reviewed. RESULTS: There were 11 349 new referrals and 10 764 follow-up visits. The reasons for referral were threatened miscarriage (n = 3568, 31.4%), missed miscarriage (n = 3056, 26.9%), incomplete miscarriage (n = 1064, 9.4%), complete miscarriage (n = 991, 8.7%), ectopic pregnancy (n = 857, 7.6%), hyperemesis gravidarum (n = 139, 1.2%), and others (n = 1674, 14.8%). There has been a significant decreasing trend (tau = -0.60, P = 0.0127) and a significant decrease in the post-EPAC rate of ER reassessments (P = 0.0396) for hemorrhage, with a concomitant decrease in EPAC visits for hemorrhage. In addition, there has been a significant increasing trend (tau = 0.64, P = 0.0081) and a significant increase in the post-EPAC rate of ER assessments (P = 0.00001) for ectopic pregnancies. CONCLUSION: Over the 10-year period, the EPAC has remained a vital service for managing early pregnancy complications for women. However, the clinic has not yet had a sustained impact on ER visits for miscarriage, ectopic pregnancy, and hemorrhage. It is possible that a reduction in ER assessments and reassessments for early pregnancy complications can be achieved through a clinic with daily access.

A Comparison of the Number of Patient Visits Required for Different Management Options for Early Pregnancy Loss at an Early Pregnancy Assessment Clinic.

OBJECTIVE: To compare the total number of patient visits required for the conservative, medical, or surgical management of early pregnancy loss in an early pregnancy assessment clinic (EPAC). METHODS: A retrospective study of the number of patient visits at an EPAC for conservative, medical, or surgical management of early spontaneous abortion from October 2013 to September 2015 was undertaken. Visits counted included initial assessment, follow-up visits, and surgery date, if separate from a clinic visit. RESULTS: A total of 945 patients were seen, with 2144 visits during the study period. Conservative management required an average of 3.01 visits (n = 159, median = 3, SD = 1.16, range [1,7]) and misoprostol treatment required an average of 2.51 visits (n = 329, median = 2, SD = 0.83, range [1,6]) to achieve a complete abortion. Dilatation and curettage (D&C) required an average of 1.60 visits (n = 417, median = 1, SD = 0.80, range [1-6]), when including scheduling limitations or an average of 1.13 visits when excluding these limitations. The difference in the number of visits required for the three management options was statistically significant (P <0.0001). Management with D&C was more likely to require less than two visits to achieve complete abortion compared with the other options (93.8% for D&C vs. 64.5% for misoprostol vs. 37.8% for conservative). CONCLUSION: An EPAC provides a significant value in the management of early pregnancy losses. There is a significant difference in the total number of visits required for different treatment options. Patients may find this information helpful when considering and deciding upon their preferred treatment option.

Changes Over Time in Hepatic Markers Predict Changes in Insulin Sensitivity, ß-Cell Function, and Glycemia.

Context: Serum concentrations of liver enzymes and the hepatokine fetuin-A have been linked to the risk of type 2 diabetes, but their longitudinal impact on insulin resistance and ß-cell dysfunction is unclear. Objective: To evaluate the impact of changes over 2 years in fetuin-A and the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST), and γ-glutamyltransferase (GGT) on changes in insulin sensitivity, ß-cell function, and glycemia in women with varying degrees of previous gestational dysglycemia, reflecting a range of future diabetic risk. Design/Setting/Participants: In total, 336 women underwent glucose challenge test (GCT) and oral glucose tolerance test (OGTT) in pregnancy, followed by repeat OGTT and measurement of ALT/AST/GGT/fetuin-A at both 1 year and 3 years postpartum. The antepartum GCT/OGTT identified four gestational glucose tolerance groups: gestational diabetes (n = 104), gestational impaired glucose tolerance (n = 59), abnormal GCT with normal OGTT (n = 98), and normal GCT/OGTT (n = 75). Results: At 1 and 3 years postpartum, ALT, AST, GGT, and fetuin-A did not differ across the four groups, but the intervening change in ALT/AST ratio was greater in the gestational dysglycemia groups (P = 0.05). Higher baseline ALT/AST (t = -1.99, P = 0.05) and fetuin-A (t = -3.17, P = 0.002) predicted lower insulin sensitivity (Matsuda) at 3 years, as did their respective changes from 1 to 3 years (ALT/AST: t = -5.47, P < 0.0001; fetuin-A: t = -3.56, P = 0.0004). Change in ALT/AST predicted lower ß-cell function (t = -2.33, P = 0.02) and higher fasting glucose at 3 years (t = 2.55, P = 0.01). Moreover, baseline fetuin-A predicted prediabetes/diabetes at 3 years (OR, 1.38; 95% CI, 1.01 to 1.88). Conclusion: Circulating hepatic markers, particularly ALT/AST ratio and fetuin-A, track with changes in insulin sensitivity and ß-cell function, supporting a pathophysiologic basis in their prediction of diabetic risk.

HIV antiretroviral exposure in pregnancy induces detrimental placenta vascular changes that are rescued by progesterone supplementation.

Adverse birth outcomes are common in HIV-positive pregnant women receiving combination antiretroviral therapy (cART), especially when cART is initiated in early pregnancy. The mechanisms remain poorly understood. Using a mouse model we demonstrate that protease inhibitor based-cART exposure beginning on day 1 of pregnancy was associated with a pro-angiogenic/pro-branching shift in the placenta driven by lower Flt-1 levels and higher Gcm-1 expression. Micro-CT imaging revealed an increase in the number of arterioles in cART-treated placentas, which correlated with fetal growth restriction. Delaying initiation of cART, or supplementing cART-treated mice with progesterone, prevented the pro-angiogenic/pro-branching shift and the associated placenta vascular changes. In agreement with our mouse findings, we observed an increase in the number of terminal-villi capillaries in placentas from HIV-positive cART-exposed women compared to HIV-negative controls. Capillary number was inversely correlated to maternal progesterone levels. Our study provides evidence that cART exposure during pregnancy influences placenta vascular formation that may in turn contribute to fetal growth restriction. Our findings highlight the need for closer investigation of the placenta in HIV-positive pregnancies, particularly for pregnancies exposed to cART from conception, and suggest that progesterone supplementation could be investigated as a possible intervention to improve placenta function in HIV-positive pregnant women.

Definitive class I human leukocyte antigen expression in gestational placentation: HLA-F, HLA-E, HLA-C, and HLA-G in extravillous trophoblast invasion on placentation, pregnancy, and parturition.

PROBLEM: The extravillous trophoblasts (EVT) express HLA-C and HLA-G, but HLA-E and HLA-F are the subject of conflicting reports. In this study, we define the HLA expression profile during active EVT placental implantation, pregnancy development, and parturition. METHOD OF STUDY: Immunohistochemistry, q-PCR, and Western blot were used to investigate HLA-C, HLA-E, and HLA-F placental expression across gestation from the early first trimester, late first trimester, second trimester (n=10 in each), preterm gestation (n=6) to elective term cesarean section and term vaginal deliveries (n=12, 38-41 weeks). EVT explants and Swan71 cells were used to assess HLA-C and HLA-F during active EVT migration. RESULTS: HLA-G, HLA-C, and HLA-F were expressed by 1st-trimester EVT and became intracellular and weaker as gestation progressed. HLA-E was only expressed in 1st-trimester placenta. HLA-F and HLA-C mRNA and protein expression levels showed a significant increase in the fetal villous mesenchyme across gestation. HLA-C levels increased with labor. We detected a 100-kDa HLA-F band in early pregnancy suggesting dimer formation on the EVT surface. These results were confirmed in EVT outgrowths and Swan71 trophoblast which showed that HLA-F and HLA-G are increased on the cell surface of migrating EVT, while HLA-C was internalized. CONCLUSION: Expression of HLA-F and HLA-G on the cell surface of actively migrating EVT supports their specific role in early EVT invasion and interactions with uterine natural killer cells. HLA-C's limited expression to the proliferative EVT suggests a protective role in the earliest events of implantation but not in active EVT invasion. We also show for the first time that HLA-C may be involved in parturition.