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. 2018 Jul 3;19(1):349.
doi: 10.1186/s13063-018-2694-4.

Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol

Alexander Smith  1 , Anna Pennington  1 , Ben Carter  2 , Stephanie Gething  1 , Michelle Price  3 , James White  4 , Richard Dewar  4 , Jonathan Hewitt  5   6
Affiliations

Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol

Alexander Smith et al. Trials. .

Abstract

Background: UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration.

Methods/design: A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group.

Discussion: The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services.

Trials registration: ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.

Keywords: CVA; Face-to-face; Non-inferiority; Online; PROM; Postal; Questionnaire; Response rate; Stroke; Telephone.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from the North West – Greater Manchester South Research Ethics Committee via the Health Research Authority (HRA) Central Booking Service as a member panel of the NHS Research Ethics Committees (IRAS ID – 222,226 - REC ID – 17/NW/0269). All potentially eligible participants will be approached to offer their informed consent.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Participant flow diagram
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure
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