The Usefulness of Patients Receiving Their Own Letter Aft... | NCT00129636

Studies
The Usefulness of Patients Receiving Their Own Letter After an Outpatient Attendance

NCT00129636

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Oct 4, 2019Actual

Enrollment

84Actual

Phase

Not Applicable

Conditions

Heart Diseases
Lung Diseases

Interventions

Additional specific letter written to patient

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004Actual

Primary Completion Date

Jan 2005Actual

Completion Date

Jul 2005Actual

First Submitted Date

Aug 11, 2005

First Submission Date that Met QC Criteria

Aug 11, 2005

First Posted Date

Aug 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2019

Last Update Posted Date

Oct 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As part of the NHS plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners (GPs) following outpatient consultations. The current Secretary of State for Health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation.

The aim of this study is to send patients both a copy of the letter sent to their GPs and a specific letter to themselves and to assess the usefulness and comprehensibility of each.

Detailed Description

As part of the NHS plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners following outpatient consultations. The current Secretary of State for Health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation.

The aim of this study is to send patients both a copy of the letter sent to their GPs and a specific letter to themselves and to assess the usefulness and comprehensibility of each. This study will assess the two styles of letter in Cardiology and Respiratory Outpatient Clinics staffed by 7 consultants and will involve a group of 15-20 patients from each of the clinics, total number approximately 150 patients.

All patients attending the clinics will be given a sheet outlining the study before their consultations. If they are interested in the study, patients will be given a Patient Information Sheet and asked consent to take part. The length of each of the two dictated letters will be recorded. To avoid costs to the NHS, the direct to patient letters will be typed at the study investigators' cost. Two copies of each letter, a short explanatory letter and a questionnaire will be sent to the patient and the patient will be asked to circle points in each of the letters which are unclear and return them to the department. At the end of the study the general practitioners will be contacted and asked their views about the two letters.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient attending hospital clinic	Other	patients were sent a letter especially dictated for them and a copy of the letter written by the hospital consultant to their GP to review	Procedure: Additional specific letter written to patient

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Additional specific letter written to patient	Procedure		Patient attending hospital clinic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comprehensibility of the two styles of letter	(length, reading ease, Flesch Kincaid Grade, items misunderstood)	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Patient preferences for the letters	Patients indicated a preference for either the GP and patient letter or both	baseline
Deficiencies in the patient letter	Deficiencies highlighted by the GP on the patient letter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients attending respiratory/cardiology outpatient clinics

Exclusion Criteria:

Patients with reading/language difficulties

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martyn R Partridge, MD FRCP	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHLI Imperial College		London		W6 8RF	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16426444	Result	Roberts NJ, Partridge MR. How useful are post consultation letters to patients? BMC Med. 2006 Jan 20;4:2. doi: 10.1186/1741-7015-4-2.

Type	Date	Date Unknown
Release	Jan 8, 2020
Reset	Jan 22, 2020
Release	Jan 23, 2020
Reset	Jan 31, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 8, 2020			Jan 22, 2020
Jan 23, 2020

ID	Term
D002318	Cardiovascular Diseases
D012140	Respiratory Tract Diseases

ID	Term
D006331	Heart Diseases
D008171	Lung Diseases