Consent

The PKB record can capture a patient's consent for a procedure.

Why

PKB is the best place to capture this consent because:

  1. The patient, their carers, and all appropriate professionals can see documentation of the consent (including consent a professional captured from speaking with the patient).

  2. The patient can be informed before consenting as the consent form can include full text, embedded videos and external links. The patient and carers can learn from these explanations gradually, repeatedly, and together.

  3. The patient can contributed to the information assessing the appropriateness of the procedure (e.g. the fitness of the patient) alongside professionals' entries (e.g. the anaesthetist's assessment).

  4. This is another reason to explain to the patient the benefits of registering.

Note that the patient does not need to log into PKB to document consent. A professional can gain the patient's consent verablly and document this consent on behalf of the patient, or the professional can log in and ask the patient to enter their consent after reading the form.

How

The best way to achieve this is with a care plan template. Here is an example to show this.

Professional starts the care plan

1. Professional chooses the consent form care plan template in the patient's record

2. Professional enters the name of the procedure and fills out the form

3. Professional enters their name in the signature field - this counts as a signature as PKB captures that the logged in professional had entered this information

Professional documents the patient's consent

4. Professional can enter consent information on behalf of patient based following a conversation with the patient

5. Professional clicks the Save button and PKB logs what the professional had entered into each field

Patient can also directly document consent

4. Alternatively, professional can save care plan and ask patient to sign to consent

5. PKB notifies the patient of a new saved care plan and provides a link to the care plan waiting for the patient's consent

6. Patient clicks to see care plan then clicks the Edit button

7. Patient documents their consent

5. Patients clicks the Save button and PKB logs what the patient had entered into each field

9. Professional edits care plan

10. Professional counter-signs patient's consent

11. Professional clicks the Save button and PKB logs what the professional had entered into each field

Functionality

PKB can handle consent because:

  1. PKB authenticates each user as they add data, recording that a user had successfully entered their password to see and add data.

  2. PKB stores the data in a medico-legal record, showing who said what when.

  3. PKB stores all the versions of a care plan, showing which data was entered by the professional and which by the patient, in a consent form.

Other consents

This page is about consents for procedures. Other consents are covered elsewhere. In particular:

  1. No consent is required for a health care provider to store data in PKB as PKB is a medical record. More details are available in the information governance wiki.

  2. Consent of the patient for storing patient-entered data is captured automatically during PKB's registration process. Other forms are neither required nor relevant, the consent that PKB captures is all that is needed. You can see the patient experience at joinpkb.com registration page. The information governance wiki explains the privacy policy and user agreement.

  3. Consent for sharing data is handled through the sharing settings. The patient either explicitly shares data by adding a team. Or a team can document a relationship of care giving them implicit consent to access, or document an emergency giving them temporary access while the patient lacks capacity to consent but needs urgent treatment. A patient can opt out of all sharing by asking to disable sharing.

  4. Consent for research contact and research sampe storage is also in the sharing settings. A team must configure the advanced consents in the Institutions page for PKB to ask the team's patients for their consents.

Example care plan template code for consent form

<div class="form-inline">

<h2>Consent Form 1: Patient agreement to examination or treatment</h2>

<p>This form will be used for people aged 16 years and over with mental capacity and people under 16 years of age who are Gillick competent</p>

<p><strong>Special Requirements</strong> (e.g. other language/other communication method) <br /> <textarea class="form-control" rows="3" name="special_requirements" style="width: 100%;"></textarea></p>

<p><strong>Name of proposed procedure or course of treatment</strong> (include brief explanation if medical term not clear) <br /> <input type="text" name="proposed_procedure" class="form-control" style="width: 100%;"></input></p>

<h3>Anaesthetic</h3>

<p>

This procedure will involve

<label class="checkbox-inline">

<input type="checkbox" name="general_a" value="General and/or regional anaesthesia"> General and/or regional anaesthesia</input>

</label>

<label class="checkbox-inline">

<input type="checkbox" name="local_a" value="Local Anaesthesia"> Local Anaesthesia</input>

</label>

<label class="checkbox-inline">

<input type="checkbox" name="sedation_a" value="Sedation"> Sedation</input>

</label>

<label class="checkbox-inline">

<input type="checkbox" name="none_a" value="None"> None</input>

</label>

</p>

<h3>Any extra procedures which may be necessary during the procedure</h3>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="none_expected" value="None expected"> None expected</input>

</label>

<label class="checkbox-inline">

<input type="checkbox" name="blood_transfusion" value="Blood Transfusion"> Blood Transfusion</input>

</label>

<input type="text" name="blood_transfusion_info" class="form-control"></input>

<label class="checkbox-inline">

<input type="checkbox" name="other_procedure" value="Other"> Other procedure (please specify)</input>

</label>

<textarea class="form-control" rows="3" name="other_procedure_info"></textarea>

</p>

<h3>Statement of health professional</h3>

<p>(health professional must have appropriate knowledge of proposed procedure)</p>

<p><strong>People aged 16 years and over</strong> (are presumed to have capacity to consent to treatment). Please select:</p>

<p>

<label class="radio-inline">

<input type="radio" name="capacityOption" value="In my opinion there are no reasons to doubt the patient's capacity to make this decision">

In my opinion there are no reasons to doubt the patient's capacity to make this decision;

</input>

</label>

<strong>OR</strong>

<label class="radio-inline">

<input type="radio" name="capacityOption" value="Capacity Assessed and able to make the decision">

The patient's mental capacity to consent to/refuse this treatment has been assessed and the patient has the mental capacity to make this decision. A note of the assessment has been placed on the patient's record.

</input>

</label>

</p>

<p><strong>People under 16 years of age</strong></p>

<p>After a full explanation of the procedure and its risks and benefits, I believe that the child has sufficient maturity and intelligence to be capable of understanding fully the treatment proposed and making a decision based on the information provided. I therefore believe that the patient <strong>is Gillick competent</strong> to make this decision.</p>

<p>

The child has

<label class="radio-inline">

<input type="radio" name="childAgreement" value="Agreed">

<strong>agreed</strong>

</input>

</label>

<label class="radio-inline">

<input type="radio" name="childAgreement" value="declined">

<strong>declined</strong>

</input>

</label>

to involve someone with parental responsibility in this decision

</p>

<p><strong>Advance decisions</strong> (for patients aged 18 years and over only)</p>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="Oedema" value="Oedema"> The patient has made a valid and applicable advance decision refusing this treatment/procedure <strong>or</strong> a treatment or procedure which may become necessary during the treatment/procedure in question</input>

</label>

(<em>Ensure the patient completes full details in the Advance decisions section (ADD LINK TO THE SECTION HERE)</em>)

</p>

<h3>Information about the procedure/treatment</h3>

<p>I have explained the procedure to the patient. In particular, I have explained</p>

<p>Intended benefits: <br /> <textarea class="form-control" rows="3" name="procedure_benefits" style="width: 100%;"></textarea></p>

<p>Significant, unavoidable or frequently occurring risks: <br /> <textarea class="form-control" rows="3" name="procedure_risks" style="width: 100%;"></textarea></p>

<p>

I have also discussed:<br />

<label class="checkbox">

<input type="checkbox" name="procedure_discuss_1" value="What the procedure is likely to involve"> What the procedure is likely to involve</input>

</label><br />

<label class="checkbox">

<input type="checkbox" name="procedure_discuss_2" value="Any particular concerns of the patient"> Any particular concerns of the patient.</input>

</label><br />

<label class="checkbox">

<input type="checkbox" name="procedure_discuss_3" value="The benefits and risks of any available alternative treatments"> The benefits and risks of any available alternative treatments (including no treatment)</input>

</label>

</p>

<p>Please include details <br /> <textarea class="form-control" rows="3" name="procedure_discuss_details" style="width: 100%;"></textarea></p>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="information_provision" value="I have provided the following"> I have provided the following leaflet/cd/dvd/weblink (please specify title of the leaflet and date of issue; title of the cd/dvd and "version" if it has been amended).</input>

</label>

<br />

<input type="text" name="information_provision_detail" class="form-control" style="width: 100%;"></input>

</p>

<p>Signed: <input type="text" name="Professional_signature" class="form-control"></input></p>

<p>Date: <input type="text" name="Professional_signature_date" class="form-control" placeholder="dd/mm/yyyy"></input></p>

<p>Job Title: <input type="text" name="Professional_job_title" class="form-control"></input></p>

<p>Professional registration number (e.g. GMC, NMC, GDC, HCPC etc.): <input type="text" name="Professional_registration" class="form-control"></input></p>

<h2>Statement of interpreter</h2>

<p>(where appropriate)</p>

<p>I have interpreted the above information to the patient to the best of my ability and in a way in which I believe s/he can understand</p>

<p>Signed: <input type="text" name="interpreter_sign" class="form-control"></input></p>

<p>Date: <input type="text" name="interpreter_sign_date" class="form-control" placeholder="dd/mm/yyyy"></input></p>

<p>Contact Details: <input type="text" name="interpreter_sign_details"></input></p>

<h2>Statement and signature of patient</h2>

<p>You will be offered a copy of this form. If you have any further questions, do ask - we are here to help you. <strong>You have the right to change your mind at any time,</strong> including after you have signed this form.</p>

<p><strong>I understand:</strong></p>

<ul>

<li style="list-style:inherit">the information that I have been given about the examination or treatment described on this form.</li>

<li style="list-style:inherit">that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate experience.</li>

<li style="list-style:inherit">That I will have the opportunity to discuss the details of the anaesthesia with an anaesthetist before the procedure, unless the urgency of my situation prevents this. (This only applies to patients having general or regional anaesthesia.)</li>

<li style="list-style:inherit">that any procedures <em>in addition</em> to those described on this form and which are not the subject of an advance decision (see below) will only be carried out if necessary to save my life or prevent serious harm to my health.</li>

</ul>

<p><strong>I agree</strong> to the procedure or course of treatment described on this form.</p>

<p>

<strong>

<select class="form-control" name="agree_statement">

<option value="UnSelected">Select</option>

<option value="Yes">I do</option>

<option value="No">I do not</option>

</select>

agree

</strong>

that students may be present during the procedure.

</p>

<h3>Advance decisions</h3>

<p>(for patients aged 18 years and over only)</p>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="previous_decision" value="I have previously made an advance decision refusing this treatment or procedure, but have now changed my mind and am happy to have the treatment/procedure described on this form."> I have previously made an advance decision refusing this treatment or procedure, but have now changed my mind and am happy to have the treatment/procedure described on this form.</input>

</label>

</p>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="existing_decision" value="I have an existing advance decision refusing a treatment/procedure which may become necessary during the treatment/procedure on this form"> I have an existing advance decision refusing a treatment/procedure which may become necessary during the treatment/procedure on this form</input>

</label>

This includes <input type="text" name="existing_decision_info" class="form-control"></input> <br />

<em>(if this advance decision is in writing, file a copy in the medical record. If it is verbal, make detailed notes. If it refuses life sustaining treatment it must be in writing, signed, dated, witnessed and clearly state that the decision applies even if the patient's life is at risk)</em>

</p>

<p>

<label class="checkbox-inline">

<input type="checkbox" name="additional_procedures" value="I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures which I do not wish to be carried out without further discussion, even if not performing such procedures immediatley could or would lead to serious permanent injury or death."> I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures <strong>which I do not wish to be carried out</strong> without further discussion, even if not performing such procedures immediately could or would lead to serious permanent injury or death.</input>

</label>

<br />

<textarea class="form-control" rows="3" name="additional_procedures_info" style="width: 100%;"></textarea>

</p>

<p>Patient's Signature: <input type="text" name="patients_signature" class="form-control"></input></p>

<p>Date: <input type="text" name="patients_signature_date" class="form-control"></input></p>

<p>A witness should sign below if the patient is unable to sign but has indicated his or her consent. Young people/children may also like a parent to sign here (see notes).</p>

<p>Signature: <input type="text" name="witness_signature" class="form-control"></input></p>

<p>Date: <input type="text" name="witness_signature_date" class="form-control"></input></p>

<p>Relationship to patient: <input type="text" name="witness_signature_relationship" class="form-control"></input></p>

<h3>Confirmation of consent</h3>

<p>(to be completed by a health professional when the patient is admitted for the procedure, if the patient has signed the form in advance)</p>

<p>On behalf of the treating patient, I have confirmed with the patient that s/he has no further questions and wishes the procedure to go ahead.</p>

<p>Signed: <input type="text" name="confirmation_signature" class="form-control"></input></p>

<p>Date: <input type="text" name="confirmation_signature_date" class="form-control"></input></p>

<p>Job title: <input type="text" name="confirmation_signature_job" class="form-control"></input></p>

<p>Professional registration number (e.g. GMC, NMC, GDC, HCPC etc.): <input type="text" name="confirmation_registration" class="form-control"></input></p>

<p>I confirm that I still want the procedure/treatment to go ahead.</p>

<p>Patient's signature: <input type="text" name="patient_signature_confirmation" class="form-control"></input></p>

<p>Date: <input type="text" name="patient_signature_confirmation_date" class="form-control" placeholder="dd/mm/yyyy"></input></p>

<h3>Patient has withdrawn consent</h3>

<p>Ask patient to sign/date here and write "<strong>VOID</strong>" across all pages of the form.</p>

<p>Patient's signature: <input type="text" name="patient_void_signature" class="form-control"></input></p>

<p>Date: <input type="text" name="patient_void_signature_date" class="form-control" placeholder="dd/mm/yyyy"></input></p>

</div>

Further information