Rationale and design of a randomized controlled trial of home-based primary care versus usual care for high-risk homebound older adults

Abstract Background Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient’s priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. Methods We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. Discussion Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient’s goals and priorities for treatment. Trial registration Clinical Trials.gov NCT02942927. First registered on October 24, 2016.

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Effects of Morning Versus Evening Home-Based Exercise on Subjective and Objective Sleep Parameters in Older Adults: A Randomized Controlled Trial

Journal of Geriatric Psychiatry and Neurology ◽

10.1177/0891988720924709 ◽

2020 ◽

pp. 089198872092470

Author(s):

Jaehoon Seol ◽

Yuya Fujii ◽

Taiki Inoue ◽

Naruki Kitano ◽

Kenji Tsunoda ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Exercise Group ◽

Healthy Older Adults ◽

Low Intensity ◽

Randomized Controlled ◽

Home Based ◽

Sleep Parameters ◽

Objectively Measured

Objective: This study aimed to determine whether the timing of exercise influenced the effects of home-based low-intensity stepping exercises on the sleep parameters of older adults. Method: For 8 weeks, 60 healthy older adults participated in a randomized controlled trial, performing low-intensity aerobic exercise (70-80 bpm) for about 30 minutes every day at home, either in the morning (from waking until 12:00) or evening (18:00 to bedtime). Results: In the evening exercise group, both subjectively and objectively measured sleep latency significantly improved throughout the intervention. Further, postintervention subjective sleep satisfaction was significantly higher in the evening group (6.2 ± 1.3 points) than in the morning group (5.2 ± 1.4 points; P = .006). Additionally, sleep variables related to evening exercise had larger effect sizes (Cohen d) than those performed in the morning. Conclusion: Engaging in low-intensity stepping exercises during the evening is potentially a useful nonpharmacological approach to improving sleep quality among older adults.

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Should Care Managers for Older Adults Be Located in Primary Care? A Randomized Controlled Trial

Journal of the American Geriatrics Society ◽

10.1111/j.1532-5415.2011.03763.x ◽

2012 ◽

Vol 60 (1) ◽

pp. 86-92 ◽

Cited By ~ 25

Author(s):

Matthew Parsons ◽

Hugh Senior ◽

Ngaire Kerse ◽

Mei-hua Chen ◽

Stephen Jacobs ◽

...

Keyword(s):

Older Adults ◽

Primary Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

Care Managers

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A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial

BMC Obesity ◽

10.1186/s40608-018-0226-0 ◽

2019 ◽

Vol 6 (1) ◽

Cited By ~ 3

Author(s):

Clare Viglione ◽

Dylaney Bouwman ◽

Nadera Rahman ◽

Yixin Fang ◽

Jeannette M. Beasley ◽

...

Keyword(s):

Primary Care ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Obesity Treatment ◽

Health Coaching ◽

Randomized Controlled ◽

Coaching Intervention

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Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

Journal of Diabetes Research ◽

10.1155/2020/5013142 ◽

2020 ◽

Vol 2020 ◽

pp. 1-10

Author(s):

Esther du Pon ◽

Nanne Kleefstra ◽

Frits Cleveringa ◽

Ad van Dooren ◽

Eibert R. Heerdink ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Management ◽

Online Platform ◽

Randomized Controlled ◽

Number Of Patients

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients’ self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X21=0.58; p=0.45), and the number of patients who logged on at least once (platform users) (X21=0.46; p=0.50). In addition, no differences were found between the groups in the type of users—patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X21=0.56; p=0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

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