Writing Protocols: A Step-by-Step Guide
It can be a major undertaking for a practice to prepare all of the protocols mandated in the CMO standard Practice Protocols. There are many other topics, clinical or administrative, that a practice may feel warrant a protocol.
Writing practice protocols using an inclusive, engaging process can be time-consuming and, at times, frustrating. By adopting some of the strategies described below, the process may become less onerous, and more stimulating and exciting, and can positively impact the team dynamic of a practice group. Practice protocol writing and review can be integrated into the ongoing self-reflective and quality assurance practice that are central to midwifery practice.
1. Assign Responsibility
Identify who will do the work and deciding on compensation Practices may appoint a midwife to be responsible for moving the protocol development process forward, including setting a timeline, keeping track of the list of protocols to be written, facilitating discussion at the practice group, gathering evidence, tracking revisions, and organizing how protocols are kept and stored. This “coordinating midwife” may designate other midwives as the leads on writing individual protocols. A member of the administrative staff may also be designated to oversee some of these tasks. If one member is particularly interested in, or good at writing protocols, they could be the coordinating midwife and write the protocols too, or protocol development could be shared amongst the midwives. Some administrative protocols may be written by administrative staff, with the coordinating midwife acting as a resource. There are many ways of equitably dividing this and other non-clinical work needed to run a practice group that is not qualify for caseload variables. Some practice groups reallocate profits or pool discretionary funding to compensate midwives for the unpaid work. Other midwives in the practice group may value this contribution (and the time that it saves them) by donating the equivalent of a full or partial BCC to a pool that is used to pay the midwife (or midwives) that write protocols.
2. Identify Priorities
Deciding which protocols are needed, and what to tackle first. Practice members may recognize the need to write or update a practice protocol from a variety or circumstances such as:
- requirements under the CMO standard or a Specified Continuing Education or Remediation Program (SCERP);
- recommendations by the AOM or MEP;
- the need to respond to a clinical or administrative occurrence in the practice;
- implementation of a new CPG, hospital protocol or new evidence; or
- recommendations by a coroner’s report, quality assurance rounds or peer case review.
Evidence suggests that clinicians are less likely to use protocols if protocols are seen as trivial or if an organization has too many. (2) As a result, try to avoid writing trivial protocols as a “knee-jerk” reaction to a single incident, comment from a colleague or feedback from a client. (1) If the situation is likely to be isolated, discussion at a meeting or a peer case review may be more appropriate solution.
3. Create a Template: What to Include in all Protocols
Midwives may find it helpful to develop a standard format for all of the practice’s protocols, which will help to guide protocol-writing. The CMO standard includes a list of what should be included in a protocol. A simple template would include the practice group name at the top, the title of the protocol, and dates of approval and review. A list of the sections recommended in the standard would follow. Some protocols, particularly administrative ones, will not need all sections.
4. Engage Midwives: The Value of a Collaborative Process
Optimally, all midwives, students (and staff, if appropriate) are involved in the development of protocols and are in agreement with the protocols’ content when first developed. This may facilitate a positive working environment, increase protocol adoption and reduce conflict amongst the members. It is often very difficult, however, to get all practice members together. It may also be difficult to get midwives to agree on an approach to an issue or a certain interpretation of research. Some strategies to ensure a robust and inclusive discussion of a practice protocol include:
- Setting aside time at practice group meetings.
- Using a tool to help reach consensus such as “Fist to Five.”
- Circulating draft and final copies of a protocol by email to solicit feedback and gain consensus. An online document sharing tool, such as Google Docs, can allow midwives to edit or make recommendations online whenever and wherever they can.
- Minuting practice meetings and emailing minutes to all members of the practice group with the understanding that everyone will read the minutes and then contact the lead midwife about a new protocol if they missed the meeting.
- Attaching a signature sheet to a draft or final protocol, and placing the protocol in a common space. Practice members would sign the sheet to show they have read the protocol and provided their feedback. Provide a deadline and remind midwives at every meeting.
- Asking the lead midwife for the protocol to be available for questions and discussion if a member of the team was not present for the discussion with the entire group.
Consensus is often difficult to achieve, but it can often be achieved by close review of the literature and by drafting protocols that leave room for professional judgment (e.g., a protocol may say that midwives should consider doing something, rather than that they must).
Although time-consuming, the collaborative process of writing a practice protocol can contribute to a healthy practice culture, maintain knowledge of current research and guidelines, and assist midwives in delivering robust and consistent informed choice discussions. Encouraging robust discussion throughout the protocol-writing process will help practice members agree on a common approach to practice, will help with problem solving challenges specific to the community and will increase a feelings of ownership and “buy in” for the final version of the protocol.
5. Gather Information: Sources, Samples and Resources
Some protocols will require an extensive literature review, while others will simply describe a practice group or community process. Rather than reinventing the wheel, midwives can start by investigating existing protocols or resources that may be adapted to local circumstances. For example:
- The AOM has hundreds of protocols on the website. Some were developed by the AOM as templates to support practice groups. Others were shared by practice groups. Although protocols must be practice and community specific, they can serve as a starting point.
- Colleagues from other practices may be willing to share protocols. Protocols from practice groups that share the same geographic area, client demographics, or hospitals may be the most useful.
- Review hospital maternal-child unit protocols for hospital-specific components.
- Review feedback from clients.
- Review relevant CMO standards, AOM resources including CPGs, and the literature (e.g., Cochrane Collaboration) and/ or clinical practice guidelines, policies or protocols of other organizations (e.g., NICE, SOGC, Childbirth Connection, Canadian Association of Midwives, local community health centre or public health unit).
Creating a series of steps, or using an algorithm (flow chart) may work best for some scenarios (for example PROM). For each of the steps, include instructions that are be unique to your community, hospital, lab or practice group. That way, the protocol can serve as a useful orientation to new members in the community.
6. Final Approval
It needs to be clear how a protocol is finalized, or formally approved and adopted by the practice. For example, practice groups may determine that protocols must be approved unanimously, by a majority vote, consensus (e.g., fist to five), or by circulating a draft for comment and saying that no comments is considered acceptance. Similarly, it should be clear to all practice members when the protocol has been approved and what the final version is. If midwives are not clear that a new protocol has been approved, they may continue to practice based on the previous protocol.
7. Supporting Implementation
The work of practice protocols does not end with their approval, but needs to also include plans for their implementation. The person who writes a protocol can consider barriers that may limit a midwife’s ability to use the protocol. For example, it is difficult to change a well-established routine, so some practice members may forget a step in a new protocol, or may not be as comfortable providing an informed choice discussion to clients including new research that they are not as familiar with. Some of these elements can be resolved by updating the chart checklist to include discussion of a new test or procedure; creating a client handout about a topic or changing the length of certain appointments to accommodate a new informed choice discussion or new procedures.
Once approved, consider how midwives will be able to find, access, refer to and use the protocols at each of their practice locations. For example:
- Give your protocols names that clearly identify the content. (1)
- Use an easy-to-follow table of contents for paper copies and clearly named folders on an accessible computer or shared drive for electronic copies.
- Post practice protocols to a password protected intranet or shared drive so that they can be accessed from the community.
- Have the practice make a plan to help midwives easily consult supporting resources, such as AOM CPG apps and other useful apps and websites.
8. Dating, Review Dates, and Retention
When a protocol is finalized, its header needs to note the date of approval or implementation, what protocol(s) it is replacing (if any), and when it is due to be updated. The CMO standard does not make a specific recommendation regarding an appropriate time frame for review. The Society of Obstetricians and Gynaecologists of Canada, as an example, considers a clinical practice guideline current if it was written or reviewed within the last five years. Protocols may need to be updated earlier than scheduled if there are changes to the evidence, legislation/ standards, hospital protocols or procedures, community resources and/or flow of client care in your community or lessons from near misses or adverse outcomes. Practice groups may want to develop a system to track which protocols are coming near to their review date. One easy system is to prepare a table of contents that lists and dates all practice group protocols and includes the expected date for the next review. If, on review, no editing is required, the practice can simply note the date of the review and the review next date. Midwives may be asked to show what protocols were in place on a specific date by the College or a civil case. An archived protocols binder or computer folder can be used to retain outdated documents. The dates on the protocol will make it clear when it was approved and when it was replaced. Out of date protocols need to be retained for the same length of time as client charts (see the Record Retention Protocol under "Financial").
9. Sharing the Protocol with Clients, the AOM and Other Practice Groups
Because the CMO standard states that “Practice protocols shall be shared with clients upon request," practice groups need to consider how midwives will inform clients of this right. For example, when the practice group communicates the model of care to clients, midwives could mention that clinical practice protocols are available by asking a midwife. The practice may also want to ensure that a client’s midwife is notified of the request for a protocol so that the midwife may discuss it with the client. The practice group may also wish to implement a process where all approved protocols are automatically shared with the AOM for posting on its website so that other practice groups may use them to reflect on their own protocols. Protocols can be emailed to Cara Wilkie.
(1) Carthey J, Walker S, Deelchand V, Vincent C, Griffiths WH. Breaking the rules: understanding noncompliance with policies and guidelines. BMJ 2011; 343:d5283l. doi: 10.1136/bmj.d5283.
(2) Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20; 282(15).