scholarly journals Addressing COVID-19 Barriers to Clinical Trial Enrollment and Implementation in the PHARM-DC Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 104-104
Author(s):  
Joshua Pevnick ◽  
Michelle Keller ◽  
Korey Kennelty ◽  
Michelle Ko ◽  
Logan Murry ◽  
...  

Abstract Recent hospitalization puts older adults at higher risk of experiencing adverse drug events (ADEs) that are a common cause of hospital readmission. Yet, most ADEs are preventable. The PHARMacist Discharge Care (PHARM-DC) study is a multi-site randomized controlled trial that seeks to evaluate the effect of pharmacist-led peri- and post-discharge interventions on 30-day hospital readmissions among older adults taking ≥10 medications or ≥3 high-risk medications. The PHARM-DC intervention includes pharmacist-led patient counseling, medication reconciliation at discharge, and a follow-up phone call post-discharge. We will highlight study protocol adaptations undertaken during the COVID-19 pandemic to address challenges to enrollment and to minimize risk of COVID-19 exposure for study participants and research personnel. Additionally, we will share insights from focus groups and semi-structured interviews with pharmacist interventionists and pharmacy leaders on barriers and facilitators to implementation due to the pandemic and strategies for future clinical trials to overcome barriers.

Gerontology ◽  
2020 ◽  
Vol 66 (6) ◽  
pp. 542-548
Author(s):  
Wendy L. Cook ◽  
Penelope M.A. Brasher ◽  
Pierre Guy ◽  
Stirling Bryan ◽  
Meghan G. Donaldson ◽  
...  

<b><i>Background:</i></b> Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. <b><i>Objective:</i></b> To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. <b><i>Methods:</i></b> A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. <b><i>Results:</i></b> We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (<i>n</i> = 26) and usual care (UC, <i>n</i> = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, <i>p</i> = 0.13). Adverse events were similar in the 2 groups. <b><i>Conclusion:</i></b> The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jonathan Muller ◽  
Barbara Gatton ◽  
Linda Fox ◽  
Joseph A Bove ◽  
Johanna Donovan Turner ◽  
...  

Background and Purpose: At least 12% of stroke patients are readmitted to a hospital within 30 days of discharge. We know that patients hospitalized for other conditions are less likely to be readmitted within 30 days if they are seen by their PCP shortly after discharge. However, less than a third of patients in the New York metropolitan area admitted for heart failure, heart attacks, and pneumonia see their PCP within 14 days after discharge and nearly 40% of patients do not adhere to their prescribed regimen. In the case of cerebrovascular diseases, outpatient follow-up may prevent the majority of avoidable readmissions. The purpose of this project is to identify and reduce unnecessary, unplanned hospital readmissions after stroke. Our goal is to encourage patient adherence to prescribed medication and other therapies, as well as to ensure timely follow-up with their PCP. Methods: Stroke and transient ischemic attack (TIA) patients with a disposition of either home or short-term rehabilitation are visited and offered enrollment. Participants are given a kit which includes a personalized binder (to manage essential medical information) and a 28-slot pill box. Each patient then receives 3 phone call interviews at 7, 21 and 32 days after discharge. The aim of the phone calls is to identify obstacles to compliance with treatment regimen and follow-up care. Results: From January 2015 to June 2016, 247 patients were enrolled and followed up. Within 30 days of discharge, 10% were readmitted and 50% of all readmissions occurred within the first 7 days. Of those readmitted, 19% were due to an injury from physical therapy. Data from follow-up phone calls revealed that 83% were taking all prescribed medications, 89% had completed a follow-up with any physician, 69% were using the binder, and 61% had done all three. Conclusions: While we have not enrolled enough patients to see a statistically significant reduction in readmissions, our interviews showed that weather, depression, as well as a lack of insurance, family support, and a home health aide are all determinants on how patients will follow their prescribed regimen. The results of this study have allowed us to begin implementing stroke support groups and pre-discharge follow-up appointment scheduling.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S711-S711
Author(s):  
Kathryn Anzuoni ◽  
Terry Field ◽  
Kathleen Mazor ◽  
Yanhua Zhou ◽  
Timothy Konola ◽  
...  

Abstract For older adults, the transition from hospital to home is a high-risk period for adverse drug events, functional decline, and hospital readmission. Randomized trials of interventions to improve this transition must recruit potential subjects immediately after hospital discharge, when people are recovering and tired. Within a randomized trial assessing the impact of a pharmacist home visit to provide medication assistance immediately post-discharge, we determined whether individuals who enrolled were comparable to those who were invited but did not enroll, and described reasons for not enrolling. Individuals ≥50 years of age discharged from the hospital and prescribed a high-risk medication were eligible. We attempted to recruit individuals by phone within 3 days of discharge, and recorded reasons for not enrolling. Of 3,606 eligible individuals reached, 3,147 (87%) declined, 361 (10%) were enrolled, and 98 (3%) were initially recruited but did not complete a consent form. Individuals ≥80 years of age (odds ratio 0.45, CI 0.25, 0.78) and those with an assigned visiting nurse (odds ratio 0.64, CI 0.48, 0.85) were least likely to enroll. Among those who provided a reason for declining (2,473) the most common reason given was the belief they did not need medication assistance (22%). An additional 332 (13%) declined because they were receiving visiting nurse services. Recruiting older adults recently discharged from the hospital is difficult and may under-enroll the oldest individuals, limiting the ability to generalize findings across older patient populations. Researchers planning RCTs among newly discharged older adults may need creative approaches to overcome resistance.


2019 ◽  
Vol 7 (4) ◽  
pp. 507-515
Author(s):  
Breanne M Wells ◽  
Stacie A Salsbury ◽  
Lia M Nightingale ◽  
Dustin C Derby ◽  
Dana J Lawrence ◽  
...  

Background: The study focused on perceptions of older adults toward the healthcare processes they experienced during a clinical trial for back pain that involved family medicine residents and licensed chiropractors. Methods: Individual semi-structured interviews were conducted with 115 older adults after a 12-week, 3-arm, randomized controlled trial. Two researchers conducted thematic analysis with inductive coding using qualitative software to identify participants’ salient experiences of the doctor–patient relationship, healthcare process, and collaboration between study providers. Investigators categorized thematic codes within an existing framework of clinical excellence in primary care. Results: Participants emphasized provider communication and interpersonal relationships, professionalism and passion for patient care, clinical and diagnostic acumen, and skillful negotiation of the health-care system. Older adults also described the importance of interdisciplinary collaboration and their preferences for receiving hands-on treatments for musculoskeletal conditions. Conclusion: These older adults valued doctors who communicated clearly and spent time listening to their concerns. Many participants appreciated clinicians who supported an active role for patients in their health-care and who provided touch-based care for musculoskeletal conditions.


2020 ◽  
pp. 073346482096871
Author(s):  
Renee O’Donnell ◽  
Melissa Savaglio ◽  
Helen Skouteris ◽  
Jane Banaszak-Holl ◽  
Chris Moran ◽  
...  

Background: Interventions supporting older adults’ transition from hospital to home can address geriatric needs. Yet this evidence base is fragmented. This review describes transitional interventions that provide pre- and post-discharge support for older adults and evaluates their implementation and effectiveness in improving health and well-being. Method: Articles were included if they examined the extent to which transitional interventions were effective in improving health and well-being outcomes and reducing hospital readmission rates among older adults. Results: Twenty studies met the inclusion criteria. Four types of interventions were identified: education-based (10/20); goal-oriented (4/20); exercise (4/20); and social support interventions (2/20). Education and goal-oriented interventions were effective in improving health and well-being outcomes. The impact of interventions on mitigating hospital readmissions was inconclusive. Only five studies examined implementation. Discussion: Older adults transitioning from hospital to home would benefit from tailored education and goal-oriented interventions that promote their capacity for self-care.


2015 ◽  
Vol 6 (3) ◽  
Author(s):  
Emily M. Laswell ◽  
Elizabeth A. Svelund ◽  
Melody L. Harzler ◽  
Kasandra D. Chambers ◽  
Aleda M.H. Chen

Objective: To determine the impact of pharmacist-provided discharge medication counseling on 30 and 90 day hospital readmissions and ED visits in patients admitted with COPD exacerbation. Methods: A hospital-wide improvement was initiated, where COPD patients received discharge medication counseling and follow up phone call by a pharmacist. A pilot study was implemented, and data on readmission rates at 30- and 90-days were collected and compared to a hand-matched, retrospective control group that had not received discharge counseling by a pharmacist. Differences in readmission rates were analyzed using Chi-squared tests. Results: A total of 28 patients received discharge counseling by the pharmacist and were compared to 28 retrospective patients. Differences in 30-day and 90-day readmission rates were not significant (p=1.000 and p=0.589, respectively). After thirty days, 7 (25%) intervention and 7 (25%) retrospective group patients had been readmitted. After ninety days, 11 (39.3%) intervention and 13 (46.4%) non-intervention patients had been readmitted. Since a small cohort of patients received discharge counseling, the study did not meet power. Conclusions: Although not statistically significant, patients who received discharge medication counseling provided by a pharmacist had lower 90-day readmission rates post discharge. As regulations are implemented that penalize hospitals for readmissions that occur within 30 days of discharge, it is imperative that health care systems develop new strategies aimed at reducing readmission rates. Further studies that are adequately powered are needed to assess the impact pharmacists can have on readmission rates.   Type: Original Research


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Joseph Mojares ◽  
Sherydahn Aldrich ◽  
Maria Novales-Fiel

Background: This project attempts to discover the subjective response needs of 30-day post-acute stroke patients and their family members that were treated in two Northern California hospitals. The goal is to determine the functional level of the Stroke Survivor (SS) as measured by the Modified Rankin Scale (mRS) and to identify post-discharge needs. Purpose: The objective of this project is to identify the patient’s mRS score and post-discharge needs. The study includes stroke education reinforcement, primary care physician follow-up, ancillary services follow-up, discern hospital readmissions rates, and increase patient satisfaction. Methods: A list of discharged acute ischemic stroke patients over a three month period was provided to the Stroke Nurse Champion (SNC). A stroke phone call template was created to elicit the patient’s history, diagnosis, and mRS score. Patients with intracranial hemorrhage diagnosis, patients discharged to Skilled Nursing Facilities, and deceased patients were excluded from the study. The SNC performed chart review to determine patient course of hospitalization and stroke care management; places follow-up phone call to patient or family member; and identify the SS needs. When needs were discovered, they were addressed using electronic in-house messaging to patient’s primary care providers and ancillary staff. Results: Of the 63 participants, nine required stroke resource follow-up. The average mRS score of 1.84 revealed the patient’s knowledge of self-management to be 100%. There were 13 cases that needed outpatient therapy and Home Health therapy with mRS >2. The study outcome includes readmission rate of 0.03% (n=2) and stroke patient satisfaction >12.5%. Conclusions: Based on the mRS score, the SS appropriately met the level of care including rehabilitation needs at home. Post discharge needs of SS included psychosocial support, medication modification and appropriate durable medical equipment. Overall, the SS were satisfied with their care with low incidence of hospital readmission due to their stroke education provided during their hospitalization. Further plans for each hospital facility to consider continuing this project or to change the focus to outpatient support services as well.


Author(s):  
Gene F Kwan ◽  
Lana Kwong ◽  
Yun Hong ◽  
Abhishek Khemka ◽  
Gary Huang ◽  
...  

Background: Readmission rates are high for patients with cardiovascular disease, particularly heart failure (HF) and acute coronary syndrome (ACS). Telephone calls by clinical staff have had mixed effects. We aim to evaluate the degree of implementation and the effect of a quality improvement initiative using a simplified post-discharge phone call by administrative assistants. Methods: Clinical data were retrospectively reviewed at a single urban public hospital. From January through October 2012 all patient discharged home from inpatient cardiology services (intervention group, n=1034 discharges) were identified. Within 7 days, administrative assistants contacted patients via telephone and queried regarding (1) medication compliance, (2) awareness of follow-up appointments and (3) if clinician contact is requested. Outcome events were defined as readmissions (for any cause) within 30 days to the same hospital and are reported as patients experiencing readmission, and total readmissions. A comparison group of all patients discharged home from inpatient cardiology services from January through October 2010 (n=746) were selected as controls (no phone calls). Categorical data were compared in a univariate fashion using the Chi Square test. Statistical significance is defined as p<.05. Results: Of the 1034 discharge events in the intervention group, 620 (60.0%) had phone calls attempted. Of those, 419 (67.6%) were directly contacted. Patients were statistically different with respect to language, ethnicity and insurance status. Of the patients called, 48 (7.7%) reported medication abnormalities, 13 (2.1%) did not understand their follow-up and 38 (6.1%) had a question for a clinician. The rates of patients experiencing events was not statistically different (132 [17.7%] vs. 156 [15.1%], OR 0.85, p=.14). Total readmissions were significantly reduced (157[21.0%] vs. 179 [17.3%], OR 0.82, p=.047). Pre-specified subgroups of ACS and HF patients showed a trend towards decreased re-admissions but were not statistically significant. Conclusion: A simplified post-discharge telephone call strategy is associated with a trend towards reduced hospital readmissions for cardiology patients. Further refinements are needed to improve program implementation.


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