Evidence map›Paper›PMID 39894518›Full record

ArticleBMJ open2025

Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial.

Katherine Lloyd, Emma Tenison, Safi Smith, Fiona Lithander, Judi Kidger, Heather Brant, Sabi Redwood, Yoav Ben-Shlomo, Emily J Henderson

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05127057 (Proactive and Integrated Management and Empowerment in Parkinson's Disease), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05127057 nacompletednot on this map

Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME-UK): A New Model of Care

TypeinterventionalSponsorUniversity of BristolRan2022 to 2025Enrolled214ConditionsParkinsonismArmsPRIME Parkinson Care, Usual Care
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Katherine LloydAgeing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK katie.lloyd@bristol.ac.uk.ORCID http://orcid.org/0000-0001-9522-4610
Emma TenisonAgeing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0003-2330-8844
Safi SmithAgeing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK.
Fiona LithanderLiggins Institute, University of Auckland, Auckland, New Zealand.ORCID http://orcid.org/0000-0003-4542-7924
Judi KidgerPopulation Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-1054-6758
Heather BrantPopulation Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0001-9608-7451
Sabi RedwoodPopulation Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-2159-1482
Yoav Ben-ShlomoAgeing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0001-6648-3007
Emily J HendersonAgeing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK.ORCID http://orcid.org/0000-0002-0016-1870

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether 'it works'. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care. METHODS AND ANALYSIS: A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions. ETHICS AND DISSEMINATION: The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, 'PRIME-Qual', which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings. TRIAL REGISTRATION NUMBER: NCT05127057.

Indexed as

Parkinson DiseaseProcess Assessment, Health CareCaregiversHumansQualitative ResearchRandomized Controlled Trials as TopicResearch DesignUnited KingdomCaregiversParkinson-s diseasePatient-Centered Care

Identifiers

PMID39894518
PMCPMC11792278

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.