An ADePT Evaluation for Incorporating the TIPPS Periodontal Health Intervention Into Primary Care Ante-Natal Programmes to Enhance Infant Birthweight in Palestine: A Feasibility Study

doi:10.21203/rs.3.rs-47960/v1

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An ADePT Evaluation for Incorporating the TIPPS Periodontal Health Intervention Into Primary Care Ante-Natal Programmes to Enhance Infant Birthweight in Palestine: A Feasibility Study

https://doi.org/10.21203/rs.3.rs-47960/v1

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published 01 Apr, 2021

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Background: A feasibility study was conducted to implement the TIPPS intervention for pregnant women to enhance infant birthweight in a conflict area in a LMIC. The decision tool, ADePT examines the methodological factors, identified in a feasibility study, that may require modification for a full trial.

Objectives: To use the ADePT decision tool to evaluate if the feasibility study had achieved its objectives and to identify the need for intervention, clinical context and trial design modification.

Basic research design: Feasibility study: a one-arm, pre-test-post-test design. The ADePT framework was applied to evaluate the findings from the feasibility study.

Clinical setting: Primary healthcare clinic located in Gaza City, Palestine.

Participants: 25 pregnant women in their first trimester and clinic staff.

Interventions: The TIPPS periodontal health intervention delivered by ante-natal nurses.

Main outcome measures: ADePT checklist: sample size estimation, recruitment, consent, intervention adherence, intervention acceptability, costs and duration, completion and appropriateness of outcome assessments, retention, logistics and synergy between protocol components.

Results: 25 pregnant women attended the baseline and 22 completed the second follow-up appointment. Data acquisition of the primary and secondary outcomes was mainly successful, the adherence and acceptability of the intervention was noted. The participants stated the value of the intervention. The clinic staff voiced concerns regarding time and costs of nurses providing the TIPPS intervention. This allowed suggestions to be made regarding modification of trial design and context of implementation.

Conclusions: The ADePT evaluation showed it was possible to progress to full trial with modifications in trial design.

Media Studies

Maternal periodontal health

oral health education

infant birth-weight

feasibility study

Palestine

During acute periods of political unrest and violent conflict people’s access to routine, secondary and specialist facilities, drops with a greater reliance on alternative forms of healthcare (1). In response to unavailable and inaccessible healthcare, in conflict areas, Spiegel, Checchi (2) called for a radical rethink of ‘health policies and mass interventions’. Central to their call was the incorporation of new healthcare services into existing ones and the ‘mass delivery of interventions for maternal and neo-natal health’. Doing so, they proposed would build capacity through ‘health-care personnel, [existing] centres’ with a focus upon ‘primary and emergency healthcare services’.

Spiegel, Checchi (2) appeal for improved and accessible primary care in which new services use current infra-structure and healthcare personnel has some relevance for pregnant women residing in areas of violence and conflict. In such situations, women are four times at greater risk of having a low birth-weight infant - a major cause of infant death (3–6). For women in Gaza, poor periodontal health, in addition, was shown to have a significant and injurious effect on infant birth-weight (7).

Since anecdotal evidence (8) proposes that periodontal disease is common among pregnant women in areas of conflict and that the European Federation of Periodontology (9) and later the Cochrane Review suggest that periodontal interventions to improve maternal gum health may enhance infant birthweight when the intervention is delivered in the 1st trimester (10), it seems reasonable to postulate that an evidence-based periodontal intervention to improve gum health could enhance infant birth-weight for women residing in conflict zones.

Talk, Instruct, Practice, Plan and Support (TIPPS) is a psychologically-informed and evidence-based intervention to promote gum health, (11) developed by Clarkson et al (12) for primary care settings which may be delivered by appropriately trained healthcare personnel. It seemed that TIPPS could, therefore, be used to promote gingival health in pregnant women in the first trimester of pregnancy. Moreover, TIPPS as a new service could it be merged into existing primary healthcare ante-natal clinics and be delivered by appropriately trained healthcare personnel. However, a series of questions remained as to how feasible would it be to introduce a new preventive intervention into an existing primary healthcare scenario? For instance, how acceptable would it be to ante-natal staff? Would pregnant women wish to participate? Would it be possible to gather a sample and retain participants for follow-up? Therefore, a feasibility study was conducted to test the feasibility and acceptability of incorporating the TIPPS periodontal intervention, into a primary healthcare ante-natal clinic for women in the first trimester of their pregnancy delivered by appropriately trained nursing staff. The purpose of the feasibility study was to; [1] implement the TIPPS intervention for pregnant women in their first trimester, to promote maternal periodontal health (reduced gingival bleeding) and enhance infant birth weight (in kilograms) and [2] to conduct a process evaluation to assess the acceptability of the intervention to staff and pregnant women, the recruitment rate, participant retention, willingness of nurses to recruit, nursing staff willingness to be trained and provide TIPPS, quality of the data, appropriate sample size, and the suitability of the primary (infant birth-weight) and secondary (gingival bleeding and plaque accumulation) outcome measures.

The decision tool known as ADePT: ‘A process for Decision-making after Pilot and feasibility Trials’ by Bugge, Williams (13) examines the ‘methodological issues’, identified in a feasibility study, that may hinder or facilitate progression to a full trial. ADePT permits an examination of the evidence from the feasibility study and the degree to which ‘methodological issues’ such as recruitment, retention, adherence and acceptability of the intervention etc., have been successful. From the feasibility study findings, ADePT provides a framework to decide whether there should be an amendment of the intervention, the context of its delivery and trial design before embarking on a full trial. The aim of the study was to use the ADePT decision tool to evaluate whether the feasibility study had achieved its objectives and to identify the need for intervention, clinical context and trial design modification.

Setting and context

The Pan Arab Survey for Family Health conducted in 2004 has indicated that 95.5% of pregnant women received ante-natal care (14). The Maternal and Child Health Care Programme, Ministry of Health, Palestine includes ante-natal, perinatal and neonatal health care including child vaccination programmes. A primary healthcare clinic supported by World Health Organisation (WHO) and Maternal and Child Health Care Department programmes, located in Gaza City agreed to act as the centre for the feasibility study. The study was conducted with the support from the Maternal and Child Health Care Department in Ministry of Health, Palestine.

Sample

A convenience sample of pregnant women in their first trimester of pregnancy who attended the primary healthcare clinic located in Gaza City for ante-natal care were approached by nurses and invited to participate. The women were eligible to participate, if they were in the first trimester of their pregnancy, dentate, were able to brush their teeth and had provided written and informed consent.

Clinical and administrative staff working in the maternal primary healthcare clinic and providing ante-natal care were invited to take part in a process evaluation of the feasibility study. They were eligible to participate if they were healthcare professionals, administrative staff, provided ante-natal care and gave informed and written consent.

Study design

This feasibility study adopted a one-arm, pre-test-post-test design to examine the intervention effects. Three waves of data were collected at baseline, post-intervention time 1 (1 month from the baseline visit) and post-intervention time 2 (3 months from the baseline visit).

The TIPPS intervention

The aim of TIPPS is to enable patients to remove plaque using effective tooth brushing and interdental cleaning. The TIPPS intervention is patient-centred and evidence-based. It is underpinned by Social Cognitive Theory, which has been demonstrated to be effective in behaviour change interventions in oral health (12, 15). TIPPS promotes periodontal health through the removal of plaque by effective tooth brushing. The first element of TIPPS is the Talk and Instruct phase were advice and a demonstration of effective toothbrush with fluoride toothpaste is provided: the second part is to enable patients to Practise and Plan their toothbrushing activities and finally to Support and increase confidence to ‘remove plaque and. .. plan, how and when’ to care for their teeth and gums (11) (Table 1).

Table 1

The TIPPS intervention
The TIPPS interaction is patient-centred, lasts for several minutes, with more time being taken for patients with greater need. The intervention format, the language used and clinical communications are dependent upon the patients’ health literacy and understanding. The emphasis is on tailoring the intervention to the patient’s needs using appropriate demonstrations of plaque removal using models or watching the patient and providing advice. There are 5 TIPPS phases which are tailored to the needs of the patient at baseline and at subsequent follow-up visits. The different phases are:
1	Talk is the opening phase of TIPPS. Talk includes a discussion of the causes of periodontal disease and the importance of oral hygiene in it prevention. Integral to this phase is the use of visual aids to describe periodontal disease and the imparting of knowledge such as brushing teeth with fluoride toothpaste twice a day for 2 minutes, the use of a small headed toothbrush and to use interdental cleaning once a day.
2	Instruct is the second phase in which the patient is shown how to clean their teeth effectively, using the toothbrush, fluoride toothpaste, dental floss and interdental cleaning brushes.
3	Practise allows the patient to clean their teeth in front of the clinician who provides and requests feedback from the patient, with concerns raised, addressed.
4	Plan, adopts a patient-centred approach as the clinician negotiates and with the patient develops an action plan for effective plaque removal. This plan is reviewed and modified as the patient moves from preparation, through action to maintenance of their oral hygiene behaviours.
5	Support is the final phase of TIPPS and it allows the clinician to support the patient during the early phase of behaviour change and consolidation of toothbrushing and interdental clean as daily routines.

The ante-natal nurses attended a one day TIPPS workshop. They were provided with information about gum disease, the various elements of TIPPS and given the opportunity to practise toothbrushing and interdental cleaning, to role play and to goal set. They were given the TIPPS educational materials (translated and back translated into Arabic) and shown the TIPPS training video. Throughout the day they were encouraged to ask questions to ensure that they understood the elements of TIPPS and that the training had fulfilled their needs. Working in this way ensured the fidelity of the implementation of the TIPPS intervention.

The pregnant women received the tailored TIPPS intervention, together with a personalised and negotiated oral health hygiene plan, including toothbrushes, fluoride toothpaste, dental floss and interdental brushes as an integral part of their anti-natal appointment by the nurses. At each of the 2 subsequent follow-up visits the women were given additional fluoride toothpaste, toothbrushes, interdental brushes and dental floss.

Examination of periodontal health

Using disposable mask and gloves, disposable mirror and WHO Basic Periodontal Examination probe, plaque scores were used as a measure of oral cleanliness and bleeding on probing for gingivitis. Scores of 1 for plaque present and 1 for gingival bleeding were noted for all four sites of the teeth present and examined (11). Percentage scores for upper and lower teeth were calculated separately to give percentage total scores for plaque and bleeding separately. The percentage score was calculated by adding the scores for the number of tooth surfaces with plaque together, multiplying by 100 and dividing by total number of teeth times 4 (11). This adaption of O'Leary et al.’s (16) method allowed comparisons to be made between baseline and follow-up appointments for plaque and bleeding on probing. The percentage plaque scores were conveyed to the nurses to be used to assist the women achieve lower plaque scores and increase their confidence in maintaining their oral hygiene practices.

Process evaluation

Following the Medical Research Council’s (17) advice on process evaluation, a qualitative exploration was conducted. The process evaluation investigated the acceptability of providing the TIPPS intervention in the context of a pre-existing primary healthcare facility by ante-natal nurses, the willingness of women to participate, the willingness of nursing staff to be trained and to provide the TIPPS intervention as part of their routine anti-natal care and the adherence to the intervention.

Three months after baseline, and following completion of the data collection, a series of in-depth semi-interviews were conducted with the five people from the clinic to include participating nursing and clinic staff. Five women who had not attend all of the appointment will be contacted and interviewed. Five women who had attended all three appointments will be invited for interview. All interviews were recorded and transcribed at a later time.

Completion of the outcome assessments

The quality of the data was taken as an indication of the completeness of the outcome assessment. This was assessed using the ‘completeness’ dimension of the Data Quality Assessment Framework (18). The completeness of the data was measured by the amount of missing data of the primary and outcome variables at baseline and Time 2.

Ethical considerations

Ethical approval was gained from the SERC, University of Dundee (UoD\SDEN\2019018) and from the Palestinian Research Council (PHRC/HC/496/19).

Pregnant women were provided with a participant information sheet, given time to consider and their questions answered by the clinic nurses. If the women decided to participate, they were invited to attend a baseline appointment, where additional questions were answered by XX and written and informed consent was obtained. The nursing staff were given a participant information sheet by XX and given time to consider their participation. After a week they were asked to sign the consent if they had chosen to participate.

Data analysis

The data were entered onto Statistical Package for the Social Sciences (SPSS) data sheet (V22.0) and transferred to Stata (V16.0). The quantitative data was subjected to descriptive statistics and non-parametric measures of significance for related samples (19). The intention was to calculate the sample size from the initial data collected in this study to enable a future definitive trial to be powered sufficiently. The transcripts were analysed using content analysis with Nvivo software. The ADePT framework was applied to evaluate the findings from the feasibility study.

Recruitment, consent, retention and sample size

A convenience sample of twenty-five mothers, who fitted the inclusion criteria, were recruited over a three week period. All of the mothers were three months into their pregnancy. This represented 10% of all of the women who attended the clinic over the 3 month period. All the women provided informed and written consent. The women were aged between 16 and 35 years old. Of the 25 mothers, 14 attended the appointment at Time 1 and 22 attended at Time 2. This gave an overall retention rate between baseline and Time 1 of 56% and between baseline and Time 2 of 88%. Four members of the nursing and administrative staff fulfilled the eligibility criteria. They were invited to take part. All provided informed and written consent. Table 2 provides the details of the sample size calculation which indicated a total sample size of 400 participants for a full trial, together with details of eligibility and consent to participate.

Table 2

ADePT Checklist: summary of the evidence to support to progression to full trial
Methodological issues¹	Findings	Evidence
1. Sample size calculation	Completed using the outcome variable of gingival bleeding	The expected difference in mean percentage gingival bleeding between intervention and control was 9 (SD intervention group 31: SD control group 32). The power calculation for these figures at 80% with a two-sided alpha at 5% indicates a total sample size of 400.
2. Eligibility	Achieved: 10% eligible of women for inclusion: all ante-natal clinical and administrative staff eligible.	In the first two weeks of the study a total of 300 pregnant women attended the clinic of whom 10% met the inclusion criteria. 15 women were approached in week 1 and a further 10 in week 2. All women approached agreed participate. Four clinical and administrative staff were approached and all agreed to participate.
3. Recruitment	Recruitment was successful with all participants agreeing to participate	The ante-natal clinic staff were very enthusiastic as their previous experience with dental health services had been positive. They felt that that dental health service should be re-instated.
4. Consent	All participants provided informed and written consent	After being provided with the PIS, all participants, after a cooling off period, agreed to participate in the TIPPS intervention and provided informed and written consent.
7. Adherence to the intervention	The adherence to the intervention was good.	TIPPS intervention appointments attended: baseline: n = 25: Time 1: n = 14 (56%): Time 2: 22 (88%). The TIPPS training day was attended by all of the nurses and administrative staff attended the day’s training workshop: enjoyed learning about TIPPS and implementing it in accordance with the TIPPS intervention protocol.
8. Intervention acceptability	The TIPPS intervention was acceptable but ambivalence over who should deliver it in the clinic	All of the women and the clinic staff felt that the TIPPS intervention was an excellent idea which should be extended throughout pregnancy. The clinic staff felt that others should implement it and not nursing staff. Concerns about staff time and cost of nurses’ time and expertise to deliver TIPPS.
9. Intervention costs and duration	Intervention costs were calculated and duration time of the total intervention known.	Costs of toothbrushes, toothpastes and interdental cleaning together with TIPPS information materials. The total length of time of the intervention including follow-up appointments was 3 months.
10. Completion of the outcome assessments	Outcome assessments were completed	Assessed by the quality of the data: only 12% of data were missing from the outcomes variable, gingival bleeding and 22% from infant birthweight
11. Appropriateness of the outcomes measured	The measures used to assess the primary and secondary outcomes assessed issues of concern	Change in plaque and bleeding scores were measured. Completed infant birthweight will be secured on the birth of the child.
12. Retention	Retention was good for mothers at baseline and at Time 2 but not Time 1: retention for clinic and administrative staff was good	See point 7: the conflict affected 3 participants attendance at Time 2.
13. Logistics of running a feasibility study in a LMIC in an area of conflict	The recruitment went well due to XX’s specialist knowledge and interactions with the clinic staff: Difficulties in transporting dental supplies to Gaza city experienced.	25 women, 2 ante-natal nurses and 2 administrative staff recruited. Dental supplies were delivered to the clinic following intervention with CDOs in Palestine and Israel.
14. Synergy between all components of the protocol	All elements of the study worked well together	The elements of the study flowed well from one part to the next. Knowledge obtained informative for a full trial.
1. Checklist in identical order to the ADePT decision tool. The randomisation criteria (5 and 6) were omitted as this did not form part of the feasibility study

Process evaluation: adherence and acceptability of the intervention

Interviews were conducted with 5 women who attended at baseline and Time 2 appointments but had not attend the Time 1 appointment. From the remaining 17 women who attended all 3 appointments, 5 women were randomly chosen and invited to take part (Table 2).

All of the women interviewed stated they enjoyed TIPPS, found the TIPPS intervention helpful and liked the information and support for how to brush their teeth correctly. They were also very grateful for the supply of toothbrushes and fluoride toothpaste free of charge as one woman commented; ‘It is so important that you gave us the toothpaste and toothbrush, this is why we can brush our teeth’. Many of the women commented that they had never been shown how to brush their teeth before and a consequence of the TIPPS programme was not only that they could brush their teeth effectively, ‘My teeth are crowded, the interdental brush really helps me to clean between them’, but also their ability to take the TIPPS message home to help children brush their teeth. As one woman stated, ‘I’ve taught my sons’ how to brush their teeth now, after learning about it here.’

When asked about additional thoughts on the programme, they stated that the TIPPS programme should be part of the ante-natal programme throughout pregnancy and that dental treatment should also be part of the intervention, with a facility to remove calculus and restore teeth. For the women who had not attended the first follow-up appointment (Time 1), the reasons for non-attendance were associated with family constraints and difficulties experienced travelling to the clinic. These women felt strongly that while they saw the benefit of the TIPPS intervention, they would only attend if the appointments were at the same time and part of their ante-natal appointment.

Five people from the clinical and administrative staff agreed to be interviewed. The nurses in general agreed with the opinions voiced by the women that the TIPPS intervention in general was an excellent idea and enjoyed learning about TIPPS and having the opportunity to implement it with the pregnant women. They appreciated the need for goal setting and while time consuming, some believed that it was important, ‘Because the life style and cultures of people, their ways of tooth brushing and background about oral health importance differ from area to another’. Some nurses and staff also stated that they believed in the importance of the programme and felt that for the TIPPS intervention to be widely appreciated it should: ‘Involve many different areas this would make it more representative and results generalizable.’ Despite this, they felt that they were too busy to recruit the women into the programme or to provide the TIPPS intervention in already understaffed and bust clinic. A commonly voiced concern was that they felt they were too ill-informed to answer any other dental questions other than about gum health, toothbrushing and interdental cleaning. They felt that a dentist should be employed for that purpose. A dental surgery should be provided in the clinic where the TIPPS intervention would be implemented and dental treatment provided by a dental team.

Potential risks to the successful implementation of TIPPS included the lack of engagement of some pregnant women to attend for any appointment, the potential costs of toothbrushes, toothpaste and interdental cleaning being unaffordable for the women and the costs to the clinic and the increased healthcare personnel costs were mentioned by the nurses and others. The following quotes are illustrative:

‘There are mothers do not collaborate with the dentist or nurse, do not return for their appointments and would not follow the instructions for taking care of their teeth. I believe these mothers are in need for more intensive oral health education lessons’.

‘The cost should be considered. Is it going to be frequently available or is it going to be available only for [high risk] groups? The budget [for the programme] needs to be high for staff times and resources.. . [the] ante-natal care programme is already free of charge and if you ask mother to buy toothpaste and brush, she may not be able to afford its cost’.

Thinking to the future, the head of anti-natal care stated that she felt that the TIPPS programme could experience difficulties in the future, especially when violence had resulted in a previous dental treatment service being removed from the clinic; ‘After the increase in political instability this programme was stopped’. Concerns were raised with regard to the disruption of an already busy clinic and especially if the pregnant woman failed to attend or arrived late or on another day for their appointment and the additional effect of TIPPS on an already busy clinic. The division of healthcare into definite disciplines was also voiced, ‘highly skilled midwives involved in oral health care and education to run a programme which previously, had dentist responsible for this work.’

Intervention costs and duration

The total costs for the provision of toothbrushes, toothpastes and interdental cleaning aids together with the costs of the TIPPS information materials for the training day and for the participating pregnant women were known. No economic evaluation was undertaken.

Completion of the outcome assessments: quality of the data

At baseline there was no missing data present for the primary and secondary outcome variables. Twelve percent of the secondary outcome variables were missing at Time 2 and 22% of the primary outcome variable was missing when collected from the mothers on the delivery of their babies (Table 2).

Appropriateness of the outcomes measured

Three of the women were prima gravida, one woman had had a miscarriage. For the remaining 21 mothers they had between 2 to 7 pregnancies and had between 1 and 5 surviving children. For the 21 mothers, the mean birth-weight of their last infant was 3.25 (SD 0.46) kgs with a range of 2.5-4.0 kgs. Twenty-two mothers were contacted following the birth of their babies. The mean birth-weight of their new infants for women with more than 1 previous pregnancy was 3.12 (SD 0.30) kgs with a range of 2.5–3.6 kgs (Table 2). Of the remaining three women who were prima gravida, two were contactable. One woman had twins one of whom died and the other born prematurely at 0.75 kgs (now a healthy baby) and the mean weight of the infant of the other first time mother was 2.50 kgs.

Figure 1 shows the changes in mean percentage plaque and bleeding scores over time. There were statistically significant differences in mean rank percentage plaque scores from baseline to Time 2, for the upper teeth (X² [2] = 21.51:P < 0.001) and lower teeth (X²[2] = 18.31P < 0.001) across the three time points. There were also statistically significant differences in mean rank percentage bleeding scores from baseline to Time 2, for upper teeth (X² [2] = 25.24:P < 0.001) and lower teeth (X²[2] = 22.91: P < 0.001) across the three time points.

Logistics of running a feasibility study in a Low and Middle Income Countries (LMIC) in an area of conflict

Recruitment of the pregnant women and clinic staff went well due to XX’s specialist knowledge, interactions with clinic staff and support from the head of the clinic. Difficulties, however, transporting dental supplies from the UK to Gaza city were experienced. It was following the intervention of the Chief Dental Officers from Palestine and Israel that enabled the toothbrushes, toothpastes and examination kits to be released from customs (Table 2).

Synergy between all components of the protocol

All of the elements of the study worked well together. The findings of the study increased our knowledge and the need for a dedicated place for the TIPPS intervention where women would be happy to discuss their oral health problems and have trained oral health staff provide the TIPPS intervention (Table 2).

This feasibility study was conducted to test the acceptability of incorporating an evidence-based TIPPS periodontal intervention into an ongoing maternal primary healthcare programme in a LMIC experiencing violence and conflict for pregnant women in their first trimester. This was an initial step to assess the methodological issues associated with proceeding to a full trial. In their paper Bugge, Williams (13) suggest that as a result of examining the evidence from feasibility results there are several possible outcomes which inform the conduct and design of the trial. These include, [1] ‘adapting the intervention; [2] changing the context in which the intervention will be delivered, [3] amending the trial design, [4] combination’ of [1]-[3].

The feasibility study provided evidence regarding the success of the recruitment, the retention and acceptability and adherence with the TIPPS intervention. The women, ante-natal nurses and administrative staff appreciated the importance of the intervention and the requirement to provide toothbrushes, toothpastes and interdental brushes to the participants. Therefore, the TIPPS intervention, in itself, did not require amendment, however, the context in terms of additional localities and the personnel to conduct the trial needed careful thought.

Recent research raised the importance of training midwives to identify pregnant women at risk of oral diseases, as they are the first contact many women have with healthcare (20). Studies showed that midwives are able to recognise oral health care needs, if they received a suitable training (21–24). In this study the situation was different. The ante-natal nurses felt, that despite their TIPPS training, they did not have the specialist skills and knowledge nor the time to provide the TIPPS intervention. From the ADePT evaluation, it was apparent that the context in which the TIPPS intervention would be implemented required adjustment. The costs of providing dental health professionals and a dental clinic with all necessary equipment to provide TIPPS, while supported by clinic staff, was felt to be financially prohibitive and unlikely in the current political situation. Moreover, since concerns of the time and costs of skilled nurses were voiced as unaffordable an alternative solution needed to be considered. Community health care workers with their networks and close working with their communities and clinics would assist women to attend for ante-natal care and permit the TIPPS intervention to be implemented in LMIC experiencing violence and conflict. While the majority of women attended the TIPPS appointments especially when they coincided with their ante-natal appointments, for three women, they were unable to do so since they were ‘under fire’ during the time of their appointments at Time 2. Therefore, since a full trial will be conducted in a conflict zone with fragile communities, it is possible that factors out-with the conduct of the trial may have a bearing on success. Thus the need for increased duration of the trial needs to be acknowledged and incorporated into the trial design. The feasibility study took place in a primary healthcare clinic situation in an urban area only. The process evaluation pointed to the importance to include other localities such as rural and additional urban clinics in a full trial. Thus the trial design would require amendment as a multi-centre trial.

It would have been useful to assess the costs for clinic staff’s time and use of clinic facilities including the costs of providing the TIPPS intervention, this was not possible in the feasibility study, although total costs of providing the materials for the intervention was known. Therefore, as part of a full trial an economic assessment, including cost efficiency and the costs of using community health workers should be incorporated into the trial design.

The suitability of the outcome measures was satisfactory and would be included and used in a full trial. An improvement in the gingival health of the pregnant women was shown, with infant birthweight being between 2.50 and 3.4 kgs. Learning from this work, it would have been beneficial to collect a comparison treatment as usual group to assess gingival health and infant birthweight as part of the feasibility study. This was not possible due to funding restrictions. Nevertheless, as a consequence of the feasibility work study there is a need to reconsider the inclusion criteria regarding singleton / multiple births and to amend the trial design to stratify for first or previous pregnancies.

This feasibility study showed that it was possible to introduce and implement a new intervention into an established primary healthcare clinic for women and their children in areas of conflict and violence. It also showed that it was possible to collect appropriate outcome measures and that the TIPPS intervention improved maternal gingival health and improved infant birthweight. Therefore, the findings of this evaluation of the feasibility study demonstrated that an assessment of the methodological issues suggested progression to full trial. The decision to change the context in which the TIPPS intervention would be delivered and the need to amend the proposed trial design, was made as a result of the evidence acquired from the feasibility study. Therefore, the full trial would be multi-centred, the inclusion criteria would be altered to include singleton births only, the analysis would be stratified by number of previous pregnancies, the people providing the TIPPS intervention would be community health workers and an economic evaluation would be included as an integral part of the trial design.

TIPPS Talk, Instruct, Practise and Plan and Support

LMIC Low and Middle Income Countries

ADePT A process for Decision-making after Pilot and feasibility Trials

WHO World Health Organisation

SPSS Statistical Package for the Social Sciences

Ethics approvals and consent to participate

The SERC, University of Dundee (UoD\SDEN\2019018), The Palestinian Research Council (PHRC/HC/496/19) and Participants’ Consents Forms.

Consent for publication

Not Applicable.

Availability of data and materials

Not applicable.

Competing of Interest

The authors declare that they have no competing interests.

Funding

The Scottish Funding Council’s Global Challenge Research Fund.

Authors’ contribution

Feasibility study conception and design RF, LA, PM; Study ethical approval and risk assessments LA, RF; Study conduct: LA, RF, PM, NH; Data acquisition: LA, NH; Data analysis: LA, RF; Data interpretation: RF, LA; Drafted manuscripts: LA, RF.

Acknowledgement

We acknowledge funding from the Scottish Funding Council’s Global Challenge Research Fund. We deeply grateful for Professor Jan Clarkson and Dr Steve McGillivray for advice and supporting the project implementation. We thank the Ministry of Health, Palestine, and the clinical and administrative staff at the Al-Remal primary healthcare clinic for their support. We thank all the clinic staff and the women who participated in the feasibility study.

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published 01 Apr, 2021

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An ADePT Evaluation for Incorporating the TIPPS Periodontal Health Intervention Into Primary Care Ante-Natal Programmes to Enhance Infant Birthweight in Palestine: A Feasibility Study

Status:

Journal Publication

Version 1

Abstract

Figures

Introduction

Methods

Setting and context

Sample

Study design

The TIPPS intervention

Examination of periodontal health

Process evaluation

Completion of the outcome assessments

Ethical considerations

Data analysis

Results

Recruitment, consent, retention and sample size

Process evaluation: adherence and acceptability of the intervention

Intervention costs and duration

Completion of the outcome assessments: quality of the data

Appropriateness of the outcomes measured

Synergy between all components of the protocol

Discussion

Conclusion

Abbreviations

Declarations

References

Status:

Journal Publication

Version 1