Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors.

Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors. A Randomised Controlled Trial. A Non-inferiority Study of the Response Rate for Four Alternative Methods of Administration of 15 Patient Reported Health Status Questions in Stroke Survivors.

A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the patient's perspective, which offers great potential to improve the quality and outcomes of health services (Department of Health 2011).

There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are recommended for use in people who have had a stroke by the International Consortium for Health Outcomes Measurement, but the best way of delivering these questions for stroke survivors is unknown.

At present, the NHS in England, Scotland and Wales are required to offer every stroke survivors a 6 month post stroke follow-up appointment. Currently, the information collected at the 6 month review is not from the patient's perspective and the best method of collecting this information has not been established. The Sentinel Stroke National Audit Programme (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up appointment occur. The current methods in use are face-to-face assessment, telephone interview, online questionnaire or postal questionnaire.

The aim of this research is to understand if there is a difference between these 4 methods of delivering these questions in people who have had a stroke.

As part of the 6 month review this research study will assess the response rate for 15 Patient Reported Health Status questions across the 4 recognised methods of delivery;

• Face-to-Face
• Telephone
• Online
• Post

To conduct this research study a sample of 808 stroke survivors will be asked to take part in the research. From these 808 people, 202 participants will be randomly assigned to each method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire and Online Questionnaire).

The questionnaires received by the research team will not record any personally identifiable information. The data will then be utilised by the researchers for statistical analysis in order to identify, which method of the 4 methods of administration, under investigation, is the most acceptable for stroke survivors. The conclusions of this research will inform the roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for stroke survivors.

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebral Infarction; Cerebral Hemorrhage; Stroke, Ischemic; Stroke Hemorrhagic; Stroke of Uncertain Pathology
• Intervention / Treatment: Other: 15 Patient Reported Health Status Questions

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merthyr Tydfil, United Kingdom, CF47 9DT
    • Prince Charles Hospital
  • Caerphilly
    • Ystrad Mynach, Caerphilly, United Kingdom, CF82 7EP
      • Ysbyty Ystrad Fawr
  • Gwent
    • Newport, Gwent, United Kingdom, NP20 2UB
      • Royal Gwent Hospital
  • Monmouthshire
    • Abergavenny, Monmouthshire, United Kingdom, NP7 7EG
      • Nevill Hall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically confirmed diagnosis of stroke either Cerebral Infarct (ICD I63), Cerebrovascular Haemorrhage (ICD161) or Stroke, not specified as haemorrhage or infarction (ICD I64).
• Patients over 18 years old (≥ 18 years old)
• Had a diagnosis of stroke within the last 4-8 months (Stroke diagnosis ≥ 4months to ≤ 8 months)

Exclusion Criteria:

• Diagnosis of a Transient Ischaemic Attack (ICD G45)
• Diagnosis of a Subarachnoid Haemorrhage (ICD I60)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Postal Questionnaire	Other: 15 Patient Reported Health Status Questions; The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.
EXPERIMENTAL: Online Questionnaire	Other: 15 Patient Reported Health Status Questions; The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.
EXPERIMENTAL: Face-to-face Questionnaire	Other: 15 Patient Reported Health Status Questions; The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.
EXPERIMENTAL: Telephone Questionnaire	Other: 15 Patient Reported Health Status Questions; The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total response rate for all 4 methods of delivery	As defined by response rate. This will be measured by the number of individuals that return the questionnaire for each of the four allocation groups.	120 to 240 days post index event

Secondary Outcome Measures

Outcome Measure	Time Frame
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions with people with communication issues (e.g. aphasia)	120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke severity (as defined by NIHSS on admission)	120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke type (as defined by ICD classification)	120 to 240 days post index event

Collaborators and Investigators

• Sponsor: Dr Jonathan Hewitt
• Collaborators: Stroke Implementation Group (Wales)
• Investigators: Study Director: Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD, Cardiff University & Aneurin Bevan University Health Board

Publications and helpful links

General Publications

• Smith A, Pennington A, Carter B, Gething S, Price M, White J, Dewar R, Hewitt J. Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. Trials. 2018 Jul 3;19(1):349. doi: 10.1186/s13063-018-2694-4.
• Hewitt J, Pennington A, Smith A, Gething S, Price M, White J, Dewar R, Carter B. A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors. BMC Med. 2019 Jul 2;17(1):111. doi: 10.1186/s12916-019-1350-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2017
• Primary Completion (ACTUAL): January 15, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Delivery; PROM; Patient Reported Outcome Measure; Administration; PROMIS; Method; ICHOM; PROMIS-10; PROMIS Global Health; RiksStroke; International Consortium for Health Outcomes Measurement; Wales
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Intracranial Hemorrhages; Infarction; Stroke; Ischemic Stroke; Hemorrhage; Cerebral Infarction; Cerebral Hemorrhage; Hemorrhagic Stroke
• Other Study ID Numbers: IRAS 222226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No