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The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.

ABSTRACT: BACKGROUND:Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore. METHODS:Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study. Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation. This conversation is facilitated by a trained CSP practitioner who engages them in discussion of concerns, goals and action plans, and documents their plans for subsequent review. Participants in the two Control clinics will receive standard diabetes care. Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18?months of the study. The sample size is calculated at 1620 participants, with glycated haemoglobin (HbA1c) as the primary outcome measure. Secondary outcome measures include patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost. DISCUSSION:This study is a pragmatic trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in a real world setting. It promises to provide insights with regard to the implementation of this model of care in Singapore and the region. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT04288362. Retrospectively registered on 28 February 2020.

SUBMITTER: Tan WH

PROVIDER: S-EPMC7305581 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.

Tan Wee Hian WH Loh Victor Weng Keong VWK Venkataraman Kavita K Choong Shoon Thai ST Lew Yii Jen YJ Sundram Meena M Tsou Keith K Tan Soon Guan SG Gibbons Brent B Entwistle Vikki V Young Doris D Tai E Shyong ES Yew Tong Wei TW

BMC family practice 20200619 1

<h4>Background</h4>Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in ...[more]

PMID: 32560689

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Project description:BackgroundType 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: 1) Meetings of peer support groups 2) Personalised telephone-based health coaching for patients with low literacy and/or low patient activation 3) Personalised patient feedback 4) A browser-based web portal METHODS: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention.DiscussionIf the intervention proves effective, it may be included into the DMPs for T2DM and CHD.Trial registrationThe study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network ( https://www.drks.de/drks_web/setLocale_EN.do ) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given ( https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

Project description:ObjectiveTo evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia, and the stability of those preferences after six weeks.DesignRandomised controlled trial conducted between 1 September 2007 and 30 May 2008. Setting Four primary care clinics (two geriatric and two adult medicine) affiliated with three academic medical centres in Boston.ParticipantsConvenience sample of 200 older people (>or=65 years) living in the community with previously scheduled appointments at one of the clinics. Mean age was 75 and 58% were women.InterventionVerbal narrative alone (n=106) or with a video decision support tool (n=94).Main outcome measuresPreferred goal of care: life prolonging care (cardiopulmonary resuscitation, mechanical ventilation), limited care (admission to hospital, antibiotics, but not cardiopulmonary resuscitation), or comfort care (treatment only to relieve symptoms). Preferences after six weeks. The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care.ResultsAmong participants receiving the verbal narrative alone, 68 (64%) chose comfort care, 20 (19%) chose limited care, 15 (14%) chose life prolonging care, and three (3%) were uncertain. In the video group, 81 (86%) chose comfort care, eight (9%) chose limited care, four (4%) chose life prolonging care, and one (1%) was uncertain (chi(2)=13.0, df=3, P=0.003). Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher, good or better health status, greater health literacy, white race, and randomisation to the video arm. In multivariable analysis, participants in the video group were more likely to prefer comfort care than those in the verbal group (adjusted odds ratio 3.9, 95% confidence interval 1.8 to 8.6). Participants were re-interviewed after six weeks. Among the 94/106 (89%) participants re-interviewed in the verbal group, 27 (29%) changed their preferences (kappa=0.35). Among the 84/94 (89%) participants re-interviewed in the video group, five (6%) changed their preferences (kappa=0.79) (P<0.001 for difference).ConclusionOlder people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description. They also have more stable preferences over time.Trial registrationClinicaltrials.gov NCT00704886.

Project description:BACKGROUND:Research in type 1 diabetes management has increased exponentially since the irruption of mobile health apps for its remote and self-management. Despite this fact, the features affect in the disease management and patient empowerment are adopted by app makers and provided to the general population remain unexplored. OBJECTIVE:To study the gap between literature and available apps for type 1 diabetes self-management and patient empowerment and to discover the features that an ideal app should provide to people with diabetes. METHODS:The methodology comprises systematic reviews in the scientific literature and app marketplaces. We included articles describing interventions that demonstrated an effect on diabetes management with particular clinical endpoints through the use of mobile technologies. The features of these apps were gathered in a taxonomy of what an ideal app should look like to then assess which of these features are available in the market. RESULTS:The literature search resulted in 231 matches. Of these, 55 met the inclusion criteria. A taxonomy featuring 3 levels of characteristics was designed based on 5 papers which were selected for the synthesis. Level 1 includes 10 general features (Personalization, Family support, Agenda, Data record, Insulin bolus calculator, Data management, Interaction, Tips and support, Reminders, and Rewards) Level 2 and Level 3 included features providing a descriptive detail of Level 1 features. Eighty apps matching the inclusion criteria were analyzed. None of the assessed apps fulfilled the features of the taxonomy of an ideal app. Personalization (70/80, 87.5%) and Data record (64/80, 80.0%) were the 2 top prevalent features, whereas Agenda (5/80, 6.3%) and Rewards (3/80, 3.8%) where the less predominant. The operating system was not associated with the number of features (P=.42, F=.81) nor the type of feature (P=.20, ?2=11.7). Apps were classified according to the number of level 1 features and sorted into quartiles. First quartile apps had a regular distribution of the ten features in the taxonomy whereas the other 3 quartiles had an irregular distribution. CONCLUSIONS:There are significant gaps between research and the market in mobile health for type 1 diabetes management. While the literature focuses on aspects related to gamification, rewarding, and social communities, the available apps are focused on disease management aspects such as data record and appointments. Personalized and tailored empowerment features should be included in commercial apps for large-scale assessment of potential in the self-management of the disease.

Dataset Information

The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.

Publications

The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.

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